Opdivo (nivolumab)

Cancer

What is Opdivo?

Opdivo is a brand-name prescription drug. It’s approved for
use in adults with certain types of the following cancers:

Opdivo is also approved for use in children ages 12 years
and older with certain types of colorectal cancer.

Opdivo contains the drug nivolumab. It’s a monoclonal
antibody, which is a drug that’s made in a lab from immune system proteins.

Opdivo comes as a liquid solution. It’s given as an
intravenous (IV) infusion, which is an injection into your vein. Opdivo infusions
last about 30 minutes. They’re typically given every few weeks.

Effectiveness

Opdivo has been found effective for treating several
different forms of cancer, including non-small cell lung cancer (NSCLC).
It’s been found effective in treating metastatic NSCLC that has worsened during
or after treatment with other medications.

A clinical study
included people with squamous NSCLC. (Squamous cells are flat cells that line
parts of your body, including the airways in your lungs.) The people took
either Opdivo or docetaxel (Taxotere). Those taking Opdivo had a 41% lower risk
of dying compared to people taking docetaxel.

In another clinical study,
people with non-squamous NSCLC took either Opdivo or docetaxel. Those who took
Opdivo had a 27% lower risk of dying compared to people taking docetaxel.

For more information on Opdivo’s effectiveness, see the “Opdivo
for lung cancer” and “Opdivo other uses” sections below.

Opdivo generic

Opdivo is available only as a brand-name medication. It’s
not currently available in generic form.

Opdivo contains the active drug nivolumab.

Opdivo side effects

Opdivo can cause mild or serious side effects. The following
lists contain some of the key side effects that may occur while taking Opdivo.
These lists do not include all possible side effects.

For more information on the possible side effects of Opdivo,
talk with your doctor or pharmacist. They can give you tips on how to deal with
any side effects that may be bothersome.

More common side effects

The more common side effects of Opdivo can include:

  • headache
  • belly pain
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • loss of appetite
  • skin rash
  • fatigue (lack of energy)
  • muscle pain
  • bone pain
  • back pain
  • joint pain
  • itchy skin
  • weakness
  • cough
  • shortness of breath
  • upper respiratory infections, such as the common
    cold
  • fever
  • weight loss*

Most of these side effects may go away within a few days or
a couple of weeks. If they’re more severe or don’t go away, talk with your
doctor or pharmacist.

* Occurred in studies only in people with skin cancer

Serious side effects

Serious side effects from Opdivo can occur. Call your doctor
right away if you have serious side effects. Call 911 if your symptoms feel
life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the
following:

  • Hepatitis (inflammation in your liver). Symptoms can include:

    • nausea
    • vomiting
    • loss of appetite
    • itchy skin
    • jaundice (yellowing of your skin and the whites of your eyes)
  • Hormonal problems, including changes in thyroid hormone and cortisol levels. Symptoms can include:
    • fatigue (lack of energy)
    • loss of appetite
    • weight loss
    • weakness
    • trouble sleeping
  • Type 1 diabetes. Symptoms can include:

    • feeling very hungry or thirsty
    • fatigue (lack of energy)
    • urinating more often than usual
    • weight loss
  • Kidney damage. Symptoms can include:
    • decreased urine output
    • nausea
    • vomiting
    • swelling in your legs and feet
    • blood in your urine
  • Severe skin reactions, including Stevens-Johnson syndrome. Symptoms can include:
    • severe rash
    • red-colored skin
    • blisters on your skin
    • pus-filled lesions on your skin
  • Encephalitis (swelling in your brain). Symptoms can include:

    • headache
    • fever
    • sensitivity to light
    • weakness
    • confusion
    • seizures
  • Infusion reactions (reaction that occurs during or shortly after you receive a drug by intravenous infusion). Symptoms can include:
  • Immune system reaction (when your immune system attacks your organs). This can cause swelling in other parts of your body, including your:
    • muscles
    • heart
    • nerves
    • stomach
    • eyes

Other serious side effects, which are discussed in detail
below, include:

Side effect details

You may wonder how often certain side effects occur with
this drug. Here’s some detail on several
of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic
reaction after taking Opdivo. It’s not known how many people have had allergic reactions
to Opdivo. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible.
Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your
    eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic
reaction to Opdivo. Call 911 if your symptoms feel life-threatening or if you
think you’re having a medical emergency.

Skin rash

You may have a skin rash while taking Opdivo. This is one of
the most common side effects of the drug.

In clinical studies, between
16% and 40% of people who took Opdivo alone had a skin rash. For people who
took other cancer drugs, between 7% and 47% had a skin rash.

The percentage of people who had a skin rash while using
Opdivo varied depending on the condition that Opdivo was being used to treat. The
percentage also varied depending on whether people were taking Opdivo in
combination with another cancer treatment.

If you have a skin rash while you’re taking Opdivo, talk
with your doctor. They will monitor the rash and recommend ways to reduce any discomfort
it causes.

Pneumonitis

Pneumonitis (inflammation
in your lungs) is a serious, and possibly life-threatening, side effect of Opdivo.
Symptoms of pneumonitis include:

  • fever
  • muscle or joint pain
  • chills
  • dry cough
  • tightness in your chest
  • fatigue (lack of energy)

In clinical studies,
pneumonitis occurred in 3.1% of people who took Opdivo alone. Pneumonitis
occurred in 1.7% to 6% of people who took Opdivo in combination with another
cancer treatment called ipilimumab (Yervoy).

Talk with your doctor about how to recognize the symptoms of
pneumonitis. Your doctor can discuss with you when you should be concerned
about your symptoms and when you should call for help.

If you have pneumonitis, you may need to take
corticosteroids (such as prednisone) to reduce the swelling in your lungs. You
may also need to stop taking Opdivo for a while until your symptoms go away. If
you have severe pneumonitis while you’re taking Opdivo, your doctor may
recommend that you permanently stop Opdivo treatment.

Joint pain

You many have joint pain while you’re taking Opdivo. This is
one of the more common side effects of the drug.

In clinical studies,
joint pain occurred in 10% to 21% of people who took Opdivo alone. The
percentage of people who had joint pain varied depending on whether Opdivo was
taken in combination with other drugs. The percentage also differed depending on
which condition Opdivo was being used to treat.

If you have joint pain while you’re taking Opdivo, talk with
your doctor about ways to manage your pain.

Fatigue

You may have fatigue (lack of energy) while you’re taking
Opdivo. This is one of the most common side effects of the drug.

In clinical studies,
39% to 59% of people who took Opdivo alone had fatigue. The number of people
who had fatigue with Opdivo was similar to the number of people with fatigue who
took other cancer drugs.

Some people who took Opdivo reported having extreme fatigue.
This is fatigue that doesn’t get better after resting and also affects your ability
to do daily activities. In clinical studies, up
to 7% of people who took Opdivo had extreme fatigue. This percentage was
similar or higher in people who took other cancer drugs.

If you have fatigue while you’re taking Opdivo, tell your
doctor. They can recommend ways to improve your energy levels during treatment.

Diarrhea

You may have diarrhea while you’re using Opdivo. This is one
of the most common side effects of the drug.

In clinical studies,
17% to 43% of people who took Opdivo alone had diarrhea. The percentage was
higher when people took Opdivo in combination with another cancer drug called ipilimumab
(Yervoy). A similar percentage of people who took cancer treatments other than
Opdivo also had diarrhea in clinical studies.

If you have diarrhea while you’re taking Opdivo, tell your
doctor. They can recommend ways to reduce this side effect. They can also
recommend ways to prevent dehydration (low fluid level in your body), which can
be caused by diarrhea.

Diarrhea may be a symptom of colitis (see “Colitis” below). This
condition is a serious side effect of Opdivo.

Tell your doctor right away if you have severe diarrhea (diarrhea
that’s painful or doesn’t stop). Your doctor may stop your Opdivo treatment for
a while to allow your colon to heal. If your diarrhea is very severe, your
doctor may stop your Opdivo treatment permanently.

Colitis

Colitis (inflammation in
your intestines) is a serious side effect of Opdivo. This condition can occur
when your immune system attacks the lining of your colon by mistake. This
causes diarrhea and swelling in your colon.

Symptoms of colitis include:

  • belly pain and cramps
  • bloating
  • diarrhea, with or without blood in it
  • blood in your stool
  • urgent need to move your bowels
  • weight loss

In clinical studies,
2.9% of people who took Opdivo alone had colitis. This condition was seen in 7%
to 26% of people who took Opdivo with another cancer drug called ipilimumab
(Yervoy).

If you develop colitis while you’re taking Opdivo, you may
need to take corticosteroids, such as prednisone. You may also need to stop
taking Opdivo until your symptoms go away. If you have severe colitis, your
doctor may recommend that you permanently stop Opdivo treatment.

If you have concerning symptoms of diarrhea and belly pain,
talk with your doctor right away.

Back pain

You may have back pain while you’re taking Opdivo. This is a
common side effect of the drug.

In one clinical study, 21%
of people who took Opdivo had back pain. This side effect was seen in 16% of
people who took another cancer drug called everolimus.

Muscle pain and bone pain were also commonly reported in
studies. In clinical studies, between
26% and 42% of people taking Opdivo had muscle and bone pain.

The percentage of people who had muscle or bone pain while
taking Opdivo varied depending on whether Opdivo was taken in combination with
other drugs. It also differed depending on which condition Opdivo was being
used to treat.

If you have back pain while you’re taking Opdivo, talk with
your doctor about ways to treat your pain.

Nausea

You may have nausea while you’re taking Opdivo. This is a
common side effect of the drug.

In clinical studies,
20% to 34% of people who took Opdivo alone had nausea. The number of people who
had nausea varied depending on which condition Opdivo was used to treat, and
whether the drug was being used in combination with other treatments.

If you have nausea while you’re taking Opdivo, talk with
your doctor about ways to manage this side effect.

Cough

You may develop a cough while you’re using Opdivo. Cough is
one of the common side effects of Opdivo.

In clinical studies,
17% to 36% of people who took Opdivo had a cough. This number was different depending
on which condition Opdivo was treating. It also varied depending on whether
Opdivo was used in combination with other medications.

If you have a cough while you’re taking Opdivo, talk with
your doctor. They’ll check to make sure that your cough isn’t a symptom of a
more serious side effect, including pneumonitis. (See the
section “Pneumonitis” above.) Your doctor can also recommend ways to help
relieve this side effect.

Shortness of breath

You may have shortness of breath while you’re using Opdivo.
This is a common side effect of the drug.

In clinical studies,
8% to 27% of people who took Opdivo had shortness of breath. The number of
people who had this side effect varied depending on which condition they were
treating, and whether Opdivo was taken in combination with other cancer
treatments.

If you have shortness of breath while you’re taking Opdivo,
talk with your doctor. They’ll check to make sure that your shortness of breath
isn’t a symptom of a more serious side effect, including pneumonitis. (See
the section “Pneumonitis” above.) Your doctor can also recommend ways to
improve the quality of your breathing.

Headache

You may have headaches while you’re using Opdivo.

In clinical studies,
16% to 23% of people who took Opdivo reported having a headache. This percentage
varied depending on which condition Opdivo was used to treat, and whether the
drug was used in combination with other medications.

If you have headaches while you’re taking Opdivo, talk with
your doctor. They can recommend safe ways to treat your headaches.

Hair loss

Hair loss isn’t a common side effect of Opdivo. However, it
could be a symptom of hormonal problems, which are a more serious side effect
of Opdivo.

One hormonal problem that can occur with Opdivo use is hypothyroidism
(low thyroid hormone levels). Your body needs normal thyroid hormone levels to
maintain healthy hair growth. When your thyroid hormone levels are too low,
hair loss can occur.

In clinical studies,
9% of people who took Opdivo on its own had low thyroid hormone levels. Of
those who took Opdivo with another cancer drug called ipilimumab, 15% to 22% of
people had low thyroid hormone levels.

If you have hair loss while you’re taking Opdivo, talk with
your doctor. They will check to see if your hair loss is related to hormonal
problems. If needed, they can prescribe treatment to help regulate your hormone
levels.

Side effects in children

Side effects in children are expected to be similar to side
effects in adults, when Opdivo is used to treat colorectal cancer. This
condition is the only one that Opdivo is approved to treat in children.

However, there haven’t been any clinical studies testing the
safety of Opdivo or how often side effects occur in children using the drug.


Opdivo for lung cancer

The Food and Drug Administration (FDA) approves prescription
drugs such as Opdivo to treat certain conditions.

Opdivo for non-small cell lung cancer

Opdivo is FDA-approved to treat non-small cell lung cancer (NSCLC)
that’s metastatic (has spread from the lungs to other parts of the body).

It’s approved for use in adults whose NSCLC has gotten worse
during or after treatment with certain chemotherapy drugs. Examples of these chemotherapy
drugs include cisplatin and carboplatin.

Some people’s NSCLC has certain genetic changes, called either
EGFR or ALK. People with these genetic changes need to receive medication that’s
FDA-approved to treat that specific type of cancer before they use Opdivo.
Their cancer should have gotten worse during or after treatment with those drugs
before they can take Opdivo.

Effectiveness for non-small cell lung cancer

Opdivo has been found effective in treating metastatic NSCLC
that has gotten worse during or after treatment with other medications.

A clinical study
included people with squamous NSCLC. (Squamous cells are flat cells that line parts
of your body, including the airways in your lungs.) The people took either
Opdivo or docetaxel (Taxotere). Those taking Opdivo had a 41% lower risk of
dying compared to people taking docetaxel.

In another clinical study,
people with non-squamous NSCLC took either Opdivo or docetaxel. In this study, those
who took Opdivo had a 27% lower risk of dying compared to people taking
docetaxel.

Opdivo for small cell lung cancer

Opdivo is FDA-approved to treat small cell lung cancer (SCLC)
that’s metastatic (has spread from the lungs to other parts of the body).

It’s approved for use in adults whose SCLC has gotten worse
during or after treatment with certain cancer drugs. Examples of these drugs include
carboplatin and cisplatin, and at least one other cancer medication.

Effectiveness for small cell lung cancer

Opdivo has been found effective in an ongoing clinical study
for metastatic SCLC. Currently, the overall response rate (the percentage of
people whose cancer has become smaller or disappeared) is 12% in those taking
Opdivo. Of people whose cancer became smaller or disappeared:

  • 77% kept this response for at least 6 months
  • 62% kept this response for at least 1 year
  • 39% kept this response for at least 1.5 years

This study is ongoing. More information on how effective
Opdivo is to treat SCLC will be available in the future.

Opdivo other uses

In addition to treating lung cancer
(described in the section “Opdivo for lung cancer” just above), the Food and
Drug Administration (FDA) has also approved Opdivo to treat other conditions.
Opdivo may also be used off-label for other conditions. Off-label use is when a
drug that’s approved to treat one condition is used to treat a different
condition.

Opdivo for liver cancer

Opdivo is FDA-approved to treat hepatocellular (liver) cancer.
It’s used for people who’ve taken the drug sorafenib (Nexavar) in the past to
treat their liver cancer.

Effectiveness for liver cancer

Opdivo has been found effective in a clinical study to
treat liver cancer. In this study, the overall response rate (the percentage of
people whose cancer has become smaller or disappeared) is 22% for those who
took Opdivo. Of people whose cancer became smaller or disappeared:

  • 91% kept this response for at least 6 months
  • 55% kept this response for at least 1 year

Opdivo for kidney cancer

Opdivo is FDA-approved to treat advanced renal cell (kidney) cancer.
Opdivo is approved for use in these two groups of people:

  • Those who’ve taken anti-angiogenesis drugs in
    the past for their kidney cancer. These drugs block the growth of blood vessels
    in and around cancer cells. This prevents the cancer cells from getting
    nutrients and oxygen, which they need in order to survive. Examples of anti-angiogenesis
    drugs include axitinib (Inlyta) and lenalidomide (Revlimid). For these people,
    Opdivo is used on its own.
  • Those who haven’t received treatment in the past
    for their kidney cancer. In these people, Opdivo is used in combination with
    ipilimumab (Yervoy) to treat kidney cancer that’s considered intermediate or
    poor risk. Kidney cancer is considered intermediate or poor risk based on
    several factors. These factors include your hemoglobin levels and calcium
    levels.

Effectiveness for kidney cancer

Opdivo has been found effective in treating kidney cancer.

One clinical study
looked at people whose kidney cancer had gotten worse during or after
anti-angiogenesis treatment. The people received either Opdivo or another
cancer drug called everolimus.

In this study, half of the people who took Opdivo lived for
25 months or longer. Of those who took everolimus, half of the people lived for
19.6 months or longer. The percentage of people whose cancer became smaller or
disappeared was 21.5% in those taking Opdivo, and 3.9% in those taking
everolimus.

Another clinical study
looked at people who had kidney cancer that hadn’t been treated in the past. People
received either Opdivo with another cancer drug called ipilimumab, or they were
given a cancer drug called sunitinib. In this study, people taking the Opdivo
treatment combination had a 37% lower risk of dying compared to those who were
taking sunitinib.

Opdivo for bladder cancer

Opdivo is FDA-approved to treat urothelial cancer. This type
of cancer starts in the cells that line your bladder, ureters, and urethra. Urothelial
cancer is often called bladder cancer.

Opdivo is used to treat bladder cancer that has spread to
organs near the bladder (locally advanced cancer). Opdivo is also used to treat
bladder cancer that has spread from the bladder to other areas in the body
(metastatic cancer).

Opdivo is used in people whose bladder cancer has gotten
worse during or after treatment with other cancer drugs. These drugs include
cisplatin or carboplatin.

Effectiveness for bladder cancer

Opdivo has been found effective in treating bladder cancer.
In a clinical study, the
overall response rate (the percentage of people whose cancer became smaller or
disappeared) was measured. This rate was 19.6% in people who took Opdivo. Half
of these people maintained this response for 10.3 months or longer.

Opdivo for colorectal cancer

Opdivo is FDA-approved to treat colorectal cancer (CRC).
This type of cancer starts in your colon or rectum.

Opdivo is approved for use in adults and children ages 12
years and older with CRC that:

  • is metastatic (has spread from the colon or
    rectum to other parts of the body)
  • has gotten worse after treatment with certain
    other cancer drugs (such as oxaliplatin, irinotecan, and a drug that contains fluoropyrimidine,
    such as capecitabine)
  • has certain genetic changes called either microsatellite
    instability-high (MSI-H) or mismatch repair deficient (dMMR)

Opdivo is approved for use on its own, and in combination
with ipilimumab (Yervoy), to treat colorectal cancer.

Effectiveness for colorectal cancer

Opdivo has been found effective in treating metastatic CRC.

In a clinical study,
people with metastatic CRC took Opdivo either alone or in combination with
ipilimumab. In this study, the overall response rate (the percentage of people
whose cancer became smaller or disappeared) was measured. This rate was 32% in people
who took Opdivo on its own, and 49% in people who took Opdivo with ipilimumab.

Of people who took Opdivo on its own and whose cancer became
smaller or disappeared:

  • 63% kept this response for at least 6 months
  • 38% kept this response for at least 1 year

Of people who took Opdivo in combination with ipilimumab and
whose cancer became smaller or disappeared:

  • 83% kept this response for at least 6 months
  • 19% kept this response for at least1 year

Opdivo for head and neck cancer

Opdivo is FDA-approved to treat squamous cell carcinoma of
the head and neck (SCCHN). Squamous cell cancer starts in the flat cells (squamous
cells) that make up the surface of your skin, eyes, and other internal organs.

Opdivo is used for SCCHN that has come back after improving
with past treatments (recurrent cancer). It’s also used to treat SCCHN that has
spread to other organs (metastatic cancer).

Opdivo is approved to treat SCCHN that has gotten worse
during or after treatment with certain other cancer drugs. Examples of these
drugs include cisplatin and carboplatin.

Effectiveness for head and neck cancer

Opdivo has been found effective in treating locally advanced
and metastatic SCCHN.

In a clinical study,
people with SCCHN took either Opdivo or another cancer drug. These other cancer
drugs could be one of the following: cetuximab, methotrexate, or docetaxel. In
the study, people taking Opdivo had a 30% lower risk of dying compared to the
risk in people taking other cancer drugs.

Opdivo for melanoma skin cancer

Opdivo is FDA-approved to treat melanoma skin cancer.
Melanoma is a type of cancer that starts in cells that make melanin (the pigment
that gives color to your skin). Melanoma can occur in your skin or in other
parts of your body.

Opdivo for unresectable or metastatic melanoma skin
cancer

Opdivo is approved to treat melanoma skin cancer that is
unresectable (can’t be removed surgically). It’s also approved to treat
melanoma that is metastatic (has spread from the area where it first started to
other parts of your body).

For these conditions, Opdivo is approved for use on its own,
or in combination with another cancer drug called ipilimumab (Yervoy).

Effectiveness for unresectable or metastatic melanoma

Opdivo has been found effective in treating unresectable or metastatic
melanoma skin cancer in several studies.

In one clinical study,
people with metastatic melanoma skin cancer took Opdivo after their cancer got
worse during or after treatment with ipilimumab. The overall response rate (the
percentage of people whose cancer became smaller or disappeared) was measured.
This rate was 32% in people who took Opdivo. Most of the people whose cancer became
smaller or disappeared maintained this response for 2.6 to 10 months.

Another clinical study
included people who hadn’t taken treatment in the past for their metastatic
melanoma skin cancer. These people took either Opdivo or another cancer drug
called dacarbazine. Over 1 year, Opdivo reduced people’s risk of dying by 58%
compared to the risk in people taking dacarbazine.

A second clinical study
looked at people who hadn’t taken treatment in the past for their metastatic
melanoma skin cancer. In this study, people took either Opdivo with ipilimumab,
Opdivo on its own, or ipilimumab on its own. People who took Opdivo with ipilimumab
had a 45% lower risk of death than those who took ipilimumab on its own. People
who took Opdivo alone had a 37% lower risk of death than people who took
ipilimumab on its own.

Opdivo to prevent melanoma skin cancer from returning

Opdivo is also FDA-approved as adjuvant treatment of
melanoma skin cancer. Adjuvant treatment is therapy that’s given after surgery
or use of other medication. The goal of adjuvant treatment is to reduce the
risk of the cancer returning.

Opdivo is approved as adjuvant therapy for melanoma skin
cancer that has spread to lymph nodes or other parts of the body (metastatic
cancer). Opdivo is approved for this use after surgery has been done to
completely remove the cancer.

Effectiveness as adjuvant treatment for melanoma

Opdivo has been found effective as adjuvant treatment of
melanoma skin cancer. One clinical study included
people who had surgery to remove their cancer within the past 3 months. The
people took either Opdivo or ipilimumab. Over about 2 years, people who took
Opdivo had a 35% lower risk of their cancer returning than people who took
ipilimumab.

Opdivo for classical Hodgkin’s lymphoma

Opdivo is FDA-approved to treat classical Hodgkin’s lymphoma (cHL). Opdivo
is used to treat cHL that has returned or gotten worse after treatment with
either:

  • autologous hematopoietic stem cell transplant
    (HSCT) and a drug called Adcetris (brentuximab vedotin), or
  • three or more cancer treatments in the past, where
    one of the treatments was HSCT

An autologous HSCT is a bone marrow transplant that’s done using
stem cells that were harvested in the past from your own body. Stem cells work
in your body to make new blood cells, which help you stay healthy as you fight
off cancer.

Effectiveness for classical Hodgkin’s lymphoma

Opdivo has been found effective in treating cHL in two
studies. In these clinical studies,
the overall response rate (the percentage of people whose cancer became smaller
or disappeared) was measured. The rate was 66% in people who took Opdivo after
past treatment with HSCT and Adcetris (brentuximab vedotin). The overall
response rate was 69% in people who took Opdivo after past treatment with HSCT.

Opdivo for other conditions

In addition to the uses listed above, Opdivo may be used
off-label. Off-label drug use is when a drug that’s approved for one use is
used for a different one that’s not approved. And you may wonder if Opdivo is
used for certain other conditions.

Opdivo for anal cancer (off-label use)

Opdivo is not approved to treat anal cancer. However, sometimes
it’s used off-label for this condition.

Opdivo is recommended in treatment guidelines
as a preferred option for anal cancer. It’s recommended for use after someone
has received treatment with other cancer drugs.

Studies for
off-label uses of Opdivo

  • Pancreatic cancer. An ongoing
    study
    is being done
    to test Opdivo as a treatment for pancreatic cancer.
    Opdivo is being testing in combination with an experimental vaccine for this
    condition.
  • Ovarian cancer. An ongoing
    study
    is testing the
    use of Opdivo on its own and in combination with ipilimumab (Yervoy) to treat ovarian cancer.
  • Prostate cancer. A recent clinical study
    found that Opdivo was effective in treating certain types of prostate cancer
    when it was used in combination with ipilimumab (Yervoy). It hasn’t been
    approved yet for this purpose, but studies
    are ongoing
    .
  • Breast cancer. An ongoing study
    is testing the use of Opdivo in combination with cabozantinib (Cabometyx,
    Cometriq) to treat a type of breast cancer called triple-negative breast cancer.
  • Gastric cancer and esophageal cancer. Early-stage studies
    have found that Opdivo may be effective in treating these two types of cancer.
    However, the National Comprehensive Cancer Network (NCCN) states that more
    research is needed before they can recommend Opdivo as a treatment for gastric or esophageal cancer.
  • Non-Hodgkin’s lymphoma. Ongoing studies
    are testing Opdivo’s effectiveness to treat certain forms of non-Hodgkin’s lymphoma.
  • Multiple myeloma. Opdivo is part of ongoing studies
    and has been tested in several early-stage studies to see if it has a role in treating
    multiple myeloma.

More research is needed to know the safety and effectiveness
of Opdivo treatment for each of the conditions listed above.

Opdivo for brain cancer (may not be an appropriate
use)

The manufacturer of Opdivo recently announced
that this drug wasn’t effective in treating glioblastoma multiforme (a type of
brain cancer). Opdivo is still being tested in a different ongoing study to see if it’s effective in
treating brain cancer. In this ongoing study, Opdivo is used in combination
with other cancer treatments.

Opdivo for children

Opdivo is FDA-approved for use in children ages 12 years and
older with colorectal cancer
that:

  • is metastatic (has spread from the colon or
    rectum to other parts of the body)
  • has certain genetic changes called either
    microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
  • became worse during or after treatment with
    other cancer drugs

See the section above called “Opdivo for colorectal cancer”
for more details on this type of cancer.

Effectiveness in children

The effectiveness of Opdivo to treat colorectal cancer in
children hasn’t been tested in children ages 12 though 18 years. However, the
drug was approved for this use in people these ages based on clinical studies of
Opdivo’s effectiveness in adults with the same condition.

Also, colorectal cancer with MSI-H and dMMR genetic changes
in children is expected to be similar to such cancer in adults.

Opdivo was also approved for this use based on how the body
processes the drug. Opdivo is expected to be processed in children (ages 12
through 18 years) very similarly to how it’s processed in adults.


Opdivo use with other drugs

Opdivo is approved by the Food and Drug Administration (FDA)
to be used in combination with ipilimumab (Yervoy) for certain types of cancer.
This combination of treatment is approved to treat specific forms of the
following cancers:

See “Opdivo other uses” above for more details about how
Opdivo is used in combination with ipilimumab.

Alternatives to Opdivo

Other drugs are available that can treat your type of cancer.
Some may be better suited for you than others. If you’re interested in finding
an alternative to Opdivo, talk with your doctor. They can tell you about other
medications that may work well for you.

Note: Some of the drugs listed here are used off-label
to treat these specific conditions. Off-label use is when a drug that’s approved
to treat one condition is used to treat a different condition.

Alternatives for non-small cell lung cancer

Examples of other drugs that may be used to treat non-small
cell lung cancer
include:

  • pembrolizumab (Keytruda)
  • atezolizumab (Tecentriq)
  • ipilimumab (Yervoy)
  • durvalumab (Imfinzi)
  • crizotinib (Xalkori)
  • vandetanib (Caprelsa)
  • gemcitabine (Gemzar, Infugem)
  • docetaxel (Taxotere)

Alternatives for small cell lung cancer

Examples of other drugs that may be used to treat small cell lung cancer
after the cancer has gotten worse with treatment with certain forms of
chemotherapy include:

  • ipilimumab (Yervoy)
  • pembrolizumab (Keytruda)
  • vinorelbine (Navelbine)
  • gemcitabine (Gemzar, Infugem)
  • topotecan (Hycamtin)
  • irinotecan (Camptosar, Onivyde)

Alternatives for liver cancer

Examples of other drugs that may be used to treat liver cancer after it’s
been treated with sorafenib (Nexavar) include:

  • pembrolizumab (Keytruda)
  • regorafenib (Stivarga)
  • cabozantinib (Cabometyx, Cometriq)
  • ramucirumab (Cyramza)

Alternatives for kidney cancer

Examples of other drugs that may be used to treat kidney cancer
include:

  • axitinib (Inlyta)
  • pembrolizumab (Keytruda)
  • pazopanib (Votrient)
  • sunitinib (Sutent)
  • ipilimumab (Yervoy)
  • cabozantinib (Cabometyx, Cometriq)
  • avelumab (Bavencio)

Alternatives for bladder cancer

Examples of other drugs that may be used to treat bladder cancer include:

  • pembrolizumab (Keytruda)
  • atezolizumab (Tecentriq)
  • durvalumab (Imfinzi)
  • avelumab (Bavencio)
  • erdafitinib (Balversa)
  • paclitaxel (Abraxane, Taxol)
  • docetaxel (Taxotere)
  • gemcitabine (Gemzar, Infugem)

Alternatives for colorectal cancer

Examples of other drugs that may be used to treat colorectal cancer that
has certain gene abnormalities (either microsatellite instability-high [MSI-H] or
mismatch repair deficient [dMMR]) include:

  • pembrolizumab (Keytruda)
  • ipilimumab (Yervoy)

Alternatives for head and neck cancer

Examples of other drugs that may be used to treat squamous
cell head and neck cancer include:

  • pembrolizumab (Keytruda)
  • afatinib (Gilotrif)
  • cisplatin
  • carboplatin
  • cetuximab (Erbitux)
  • docetaxel (Taxotere)
  • paclitaxel (Abraxane, Taxol)

Alternatives for melanoma skin cancer

Examples of other drugs that may be used to treat melanoma skin cancer
include:

  • pembrolizumab (Keytruda)
  • dabrafenib (Tafinlar)
  • trametinib (Mekinist)
  • ipilimumab (Yervoy)

Alternatives for classical Hodgkin’s lymphoma

Examples of other drugs that may be used to treat classical
Hodgkin’s lymphoma include:

  • brentuximab vedotin (Adcetris)
  • bendamustine (Belrapzo, Bendeka, Treanda)
  • rituximab (Rituxan, Ruxience, Truxima)
  • cisplatin
  • cytarabine
  • etoposide
  • vinorelbine (Navelbine)


Opdivo vs. Keytruda

You may wonder how Opdivo compares to other medications that
are prescribed for similar uses. Here we look at how Opdivo and Keytruda are alike
and different.

Uses

Opdivo and Keytruda are both approved to treat certain forms
of the following types of cancer:

Keytruda is also approved to treat certain forms of the
following cancers:

Both drugs are approved to treat colorectal cancer in
children. Keytruda is also approved to treat other types of cancer in children.

Drug forms and administration

Opdivo contains the drug nivolumab. Keytruda contains the
drug pembrolizumab.

Opdivo and Keytruda each come as a liquid solution. They’re
given by intravenous (IV) infusion (an injection into your vein that’s given
over a period of time). The infusions for each drug last about 30 minutes. They’re
given in a healthcare facility.

Opdivo infusions are given every 2, 3, or 4 weeks. Your infusion
schedule will depend on the condition you’re using Opdivo to treat and the
dosage your doctor prescribes.

Keytruda infusions are given every 3 weeks.

Side effects and risks

Opdivo and Keytruda contain similar drugs. Therefore, both
medications can cause very similar side effects. Below are examples of these
side effects.

More common side effects

This list contains examples of more common side effects that
can occur with both Opdivo and Keytruda, when they’re taken individually:

  • fatigue (lack of energy)
  • muscle pain
  • bone pain
  • loss of appetite
  • diarrhea
  • itchy skin
  • nausea
  • skin rash
  • fever
  • cough
  • shortness of breath
  • constipation
  • belly pain
  • back pain
  • joint pain
  • headache
  • weakness
  • vomiting
  • upper respiratory infections, such as the common
    cold
  • weight loss*

* Occurred in studies only in people with skin cancer

Serious side effects

This list contains examples of serious side effects that can
occur with both Opdivo and Keytruda, when they’re taken individually:

  • pneumonitis (inflammation
    in your lungs)
  • colitis (inflammation in
    your intestines)
  • hepatitis (inflammation
    in your liver)
  • hormonal problems, including changes in your thyroid
    hormone and cortisol levels
  • type 1 diabetes
  • kidney damage
  • severe skin reactions, including Stevens-Johnson
    syndrome
  • encephalitis
    (swelling in your brain)
  • infusion reactions (reaction that occurs during
    or shortly after you receive a drug infusion)
  • immune system reaction (when your immune system
    attacks your organs), which can cause swelling in other parts of your body,
    including your muscles, heart, nerves, stomach, and eyes

Effectiveness

Opdivo and Keytruda have different approved uses, but they’re
both used to treat the following conditions:

  • melanoma skin cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • squamous cell head and neck cancer
  • classical Hodgkin’s lymphoma
  • bladder cancer
  • colorectal cancer
  • liver cancer
  • kidney cancer

These drugs haven’t been directly compared in clinical
studies. But separate studies have found both Opdivo and Keytruda to be
effective for treating these conditions.

Costs

Opdivo and Keytruda are both brand-name drugs. There are
currently no generic forms of either drug. Brand-name medications usually cost
more than generics.

According to estimates on GoodRx.com, Opdivo may
cost less than Keytruda. The actual price you’ll pay for either drug depends on
your insurance plan, your location, and the medical facility where you receive
your drug infusions.

Opdivo vs. Tecentriq

You may wonder how Opdivo compares to other medications that
are prescribed for similar uses. Here we look at how Opdivo and Tecentriq are
alike and different.

Uses

Opdivo and Tecentriq are both approved to treat certain
forms of the following types of cancer:

Opdivo is also approved to treat certain forms of the
following cancers:

Opdivo is approved to treat both adults and children ages 12
years and older with certain forms of colorectal cancer.

Tecentriq is also approved to treat a certain form of breast
cancer called triple-negative breast cancer.

Drug forms and administration

Opdivo contains the drug nivolumab. Tecentriq contains the
drug atezolizumab.

Opdivo and Tecentriq each come as a liquid solution. They’re
given as an intravenous (IV) infusion (an injection into your vein that’s given
over a period of time).

Opdivo infusions are given every 2, 3, or 4 weeks. These
infusions last about 30 minutes.

Tecentriq infusions are also given every 2, 3, or 4 weeks.
These infusions last either 30 or 60 minutes.

Your schedule for infusions of either drug will depend on
the condition you’re using the drug to treat.

Side effects and risks

Opdivo and Tecentriq both contain different drugs.
Therefore, both medications can cause some similar side effects and some
different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects
that can occur with Opdivo, with Tecentriq, or with both drugs (when taken
individually).

  • Can occur with Opdivo:

    • headache
    • bone pain
    • upper respiratory infections (such as the common cold)
    • weight loss*
  • Can occur with Tecentriq:
  • Can occur with both Opdivo and Tecentriq:

    • fatigue (lack of energy)
    • weakness
    • nausea
    • cough
    • shortness of breath
    • loss of appetite
    • belly pain
    • vomiting
    • diarrhea
    • constipation
    • skin rash
    • itchy skin
    • back pain
    • joint pain
    • fever
    • muscle pain

* Occurred in studies only in people with skin cancer

Serious side effects

These lists contain examples of serious side effects that
can occur with Opdivo, with Tecentriq, or with both drugs (when taken
individually).

  • Can occur with Opdivo:

    • few unique serious side effects
  • Can occur with Tecentriq:
  • Can occur with both Opdivo and Tecentriq:

    • pneumonitis (inflammation in your lungs)
    • colitis (inflammation in your intestines)
    • hepatitis (inflammation in your liver)
    • hormonal problems, including changes in your thyroid hormone and cortisol levels
    • type 1 diabetes
    • infusion reactions (reaction that occurs during or shortly after you receive a drug infusion)
    • immune system reaction (when your immune system attacks your organs), which can cause swelling in other parts of your body, including your muscles, heart, nerves, stomach, and eyes
    • encephalitis (swelling in your brain)
    • kidney damage
    • severe skin reactions, including Stevens-Johnson syndrome

Effectiveness

Opdivo and Tecentriq have different approved uses, but they’re
both used to treat certain forms of the following conditions:

  • bladder cancer
  • non-small cell lung cancer
  • small cell lung cancer

These drugs haven’t been directly compared in clinical
studies. But separate studies have found both Opdivo and Tecentriq to be
effective for treating these conditions.

Costs

Opdivo and Tecentriq are both brand-name drugs. There are
currently no generic forms of either drug. Brand-name medications usually cost
more than generics.

According to estimates on GoodRx.com, Opdivo
and Tecentriq generally cost about the same. The actual price you’ll pay for
either drug depends on your insurance plan, your location, and the medical
facility where you receive your drug infusions.

Opdivo dosage

The Opdivo dosage your doctor prescribes will depend on
several factors. These include:

  • the condition you’re using Opdivo to treat
  • your treatment schedule (how often you’re taking
    Opdivo)
  • whether you’re taking Opdivo in combination with
    a drug called ipilimumab (Yervoy)
  • your weight

The following information describes dosages that are
commonly used or recommended. However,
be sure to take the dosage your doctor prescribes for you.
Your doctor will determine the best
dosage to suit your needs.

Drug forms and strengths

Opdivo contains the active drug nivolumab. It comes as a
liquid solution inside vials. The vials contain 10 mg (milligrams) of drug in
every mL (milliliter) of solution.

Opdivo is given as an intravenous (IV) infusion. With IV
infusions, the drug is slowly injected into your vein over a certain period of
time.

Opdivo infusions typically last for 30 minutes. They’re given
at a healthcare provider’s office or clinic.

Dosage for non-small cell lung cancer

The usual dosage of Opdivo for non-small cell lung cancer is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for small cell lung cancer

The usual dosage of Opdivo for small cell lung cancer
is 240 mg every 2 weeks.

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for liver cancer

The usual dosage of Opdivo for liver cancer is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for kidney cancer

The usual dosage of Opdivo for kidney cancer is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for kidney cancer when Opdivo is used in
combination with ipilimumab

The usual Opdivo dosage when it’s used in combination with
ipilimumab (Yervoy) is as follows:

  • Your first four doses of Opdivo depend on your body
    weight. The usual dosage is 3 mg of drug per kilogram (about 2.2 pounds) of
    body weight, given every 3 weeks.

    • For example, if a person weighs 150 pounds
      (which is about 68 kilograms), their dose would be 3 mg of drug multiplied by
      68 kilograms. This equals 204 mg of Opdivo, which is given every 3 weeks for the
      first four doses.
    • After your first four doses of Opdivo, the usual
      dosage is either 240 mg every 2 weeks, or 480 mg every 4 weeks.

Dosage for bladder cancer

The usual dosage of Opdivo for bladder cancer is
either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for colorectal cancer

The usual dosage for adults with colorectal cancer
is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

The usual dosage for children ages 12 years and older is described
in the section below called “Pediatric dosage.”

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for colorectal cancer when Opdivo is used in combination
with ipilimumab

The usual dosage of Opdivo when it’s used in combination
with ipilimumab (Yervoy) is as follows:

  • Your first four doses depend on your weight. The
    usual dosage is 3 mg of drug per kilogram (about 2.2 pounds) of body weight,
    given every 3 weeks.

    • For example, if a person weighs 150 pounds
      (which is about 68 kilograms), their dose would be 3 mg of drug multiplied by
      68 kilograms. This equals 204 mg of Opdivo, which is given every 3 weeks for
      the first four doses.
    • After your first four doses of Opdivo, the usual
      dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks.

Dosage for head and neck cancer

The usual dosage of Opdivo for head and neck cancer is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for melanoma skin cancer

The usual dosage of Opdivo for metastatic melanoma skin cancer
is either:

  • 240 mg every two weeks, or
  • 480 mg every four weeks

This dosage is used as treatment for metastatic melanoma
skin cancer and also as adjuvant treatment (treatment given after surgery or use
of other medications) of melanoma skin cancer.

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Dosage for melanoma skin cancer when Opdivo is used in
combination with ipilimumab

The usual dosage of Opdivo when it’s used in combination
with ipilimumab (Yervoy) is as follows:

  • Your first four doses depend on your weight. The
    usual dosage is 1 mg of drug per kilogram (about 2.2 pounds) of body weight,
    given every 3 weeks.

    • For example, if a person weighs 150 pounds
      (which is about 68 kilograms), their dose would be 1 mg of drug multiplied by
      68 kilograms. This equals 68 mg of Opdivo, which is given every 3 weeks for the
      first four doses.
    • After your first four doses of Opdivo, the usual
      dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks.

Dosage for classical Hodgkin’s lymphoma

The usual dosage for classical Hodgkin’s lymphoma is either:

  • 240 mg every 2 weeks, or
  • 480 mg every 4 weeks

Opdivo is given at your healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

Pediatric dosage

The usual dosage of Opdivo for children with colorectal cancer
who are ages 12 years and older, and who weigh 88 pounds or more, is the same
as it is for adults.

The usual dosage for children who are ages 12 years and
older, and who weigh less than 88 pounds, is based on their body weight. Their
dosage of Opdivo is 3 mg of drug per kilogram (about 2.2 pounds) of body
weight.

For example, if a child weighs 100 pounds (which is about 45
kilograms), their dose would be 3 mg of drug multiplied by 45 kilograms. This
equals 135 mg of Opdivo, which is given every 2 weeks.

Opdivo is given at a healthcare provider’s office. It’s
given as an IV infusion that lasts 30 minutes.

What if I miss a dose?

Call your doctor’s office right away if you realize that you’ve
missed an appointment for your Opdivo infusion. The office staff will
reschedule the appointment for you.

To help make sure that you don’t miss a dose, try setting a
reminder in your phone.

Will I need to use this drug long term?

Opdivo is meant to be used as a long-term treatment. If you
and your doctor determine that Opdivo is safe and effective for you, you’ll
likely take it long term.

Common questions about Opdivo

Here are answers to some frequently asked questions about
Opdivo.

How long do people using Opdivo treatment live?

That’s different for each person since it depends on many
factors. Your life expectancy (the length of time you are expected to survive) depends
on:

  • the type of cancer you have
  • the stage of your cancer
  • your age
  • other health conditions you may have

See Opdivo the sections “Opdivo for lung cancer” and “Opdivo
other uses” above for more details about life expectancy in people with specific
types of cancer.

Do I need to follow a certain diet while I’m using Opdivo?

Your doctor may recommend that you follow a certain healthy
diet while you’re receiving treatment with Opdivo. However, the recommended diet
would be based on the type of cancer you have and on your overall health. It
wouldn’t be based on how Opdivo works.

Talk with your doctor about ways to maintain a healthy diet
that reduces your risk of side effects and helps maintain your energy level during
treatment.

Can I take Opdivo before or after a stem cell transplant?

Yes, you might be able to. Opdivo can be used to treat classical
Hodgkin’s lymphoma in people
whose cancer has returned or gotten worse after they’ve had a stem cell transplant.

However, some people who took Opdivo before or after a stem
cell transplant have had transplant complications. One complication is graft-versus-host disease.
With this condition, the transplanted cells attack your healthy cells. This can
cause side effects such as skin rash, diarrhea, and liver problems.

Other complications can include blockages in your veins and
severe fevers.

Talk with your doctor about whether taking Opdivo before or
after a stem cell transplant is right for you.

Where will I get my Opdivo treatments?

You’ll receive Opdivo as an intravenous (IV) infusion at a healthcare
facility. IV infusions are injections into your vein that are given slowly over
a period of time. Opdivo infusions last about 30 minutes.

Your healthcare provider will administer your infusion and monitor
you for any side effects that may occur during your infusion.


Opdivo and alcohol

There aren’t any known interactions between Opdivo and
alcohol.

Talk with your doctor if you’re concerned about whether
drinking alcohol is safe for you during treatment.

Opdivo interactions

There aren’t any known drug interactions with Opdivo.
However, before taking any drug, it’s always a good idea to talk with your
doctor and pharmacist. Tell them about all prescription, over-the-counter, and
other drugs you take. Also tell them about any vitamins, herbs, and supplements
you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may
affect you, ask your doctor or pharmacist.

Opdivo and herbs and supplements

There aren’t any herbs or supplements that have been
specifically reported to interact with Opdivo. However, you should still check
with your doctor or pharmacist before using any of these products while taking Opdivo.

Opdivo cost

As with all medications, the cost of Opdivo can vary. To
find current prices for Opdivo in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without
insurance. The actual price you’ll pay depends on your insurance plan, your location,
and the pharmacy you use.

Financial and insurance assistance

If you need
financial support to pay for Opdivo, or if you need help understanding your
insurance coverage, assistance is available.

Bristol-Myers
Squibb, the manufacturer of Opdivo, offers a program called BMS Access Support.
For more information and to find out if you’re eligible for support, call
800-861-0048 or visit the program website.

How Opdivo is given

Your healthcare provider will give Opdivo to you at a doctor’s
office or clinic.

Opdivo is given as an intravenous (IV) infusion. With an IV
infusion, the drug is given as an injection into your vein over a period of
time. Opdivo IV infusions last about 30 minutes.

If you’re taking Opdivo in combination with ipilimumab
(Yervoy), you’ll be given each drug as a separate infusion on the same day.

When to take

Opdivo infusions are given either every 2 weeks or every 4 weeks
when you’re receiving Opdivo on its own.

If you’re receiving Opdivo in combination with ipilimumab
(Yervoy), your infusions will be every 3 weeks for your first four doses. After
that, you’ll receive infusions of only Opdivo every 2 or 4 weeks.

You and your doctor will determine the dosing schedule that’s
best for you. To help make sure that you don’t miss an appointment for your
dose, try setting a reminder in your phone.


How Opdivo works

Opdivo is a monoclonal antibody. These drugs are made from
immune system cells in a lab. They work by blocking the action of certain
substances in your body.

Opdivo belongs to a class of drugs called programmed death
receptor-1 (PD-1) inhibitors. PD-1 receptors (attachment sites) are found on
immune system cells in your body. When certain proteins bind to these receptors,
the immune cells stop making other proteins that attack and kill cancer cells.

Some forms of cancer, like those that Opdivo is used to
treat, have higher-than-normal amounts of proteins that bind to PD-1 receptors.
This means the cancer is able to prevent your immune system from attacking
cancer cells.

Opdivo blocks the activity of the PD-1 receptor. When Opdivo
binds to the PD-1 receptor, it prevents other proteins from attaching to it.
This allows your immune system to make and release more proteins that attack
cancer cells.

Because there are greater numbers of proteins attacking the
cancer cells, the cancer shrinks or even disappears, in some cases.

How long does it take to work?

It’s not known exactly how long Opdivo takes to work in your
body. Your doctor will recommend that you come to their office every few weeks or
months after you start taking Opdivo. They’ll monitor your cancer at these
appointments to see if the drug is working for you.

Opdivo and pregnancy

Opdivo isn’t safe to take during pregnancy. Animal studies have
shown harm to fetuses when the pregnant mother received Opdivo. The drug has
also been shown to cause miscarriage and fetal death.

If you’re a female who’s able to become pregnant, you’ll
need to have a negative pregnancy test before you start Opdivo treatment. This will
help make sure you’re not pregnant before you start the drug.

If you become pregnant while you’re taking Opdivo, tell your
doctor right away. See the section “Opdivo and birth control” for more details.


Opdivo and birth control

Opdivo isn’t safe to take during pregnancy. If you’re sexually
active and able to become pregnant, you should use effective birth control
while you’re taking Opdivo. You should continue to use birth control for at
least 5 months after your last dose of Opdivo.

Talk with your doctor about your birth control needs while
you’re using Opdivo.

Opdivo and breastfeeding

There aren’t any studies to know how safe Opdivo use is while
you’re breastfeeding. It’s not known if Opdivo passes into breast milk.

However, the side effects of Opdivo are severe, and if the
drug does appear in breast milk, it may harm a child who consumes it. Because
of this, women shouldn’t breastfeed while they’re taking Opdivo. They also
shouldn’t breastfeed for at least 5 months after taking their last dose of
Opdivo.

Talk to your doctor about ways to safely feed your child while
you’re taking Opdivo.


Opdivo precautions

Before taking Opdivo, talk with your doctor about your
health history. Opdivo may not be right for you if you have certain medical
conditions or other factors affecting your health. These include:

  • Stem cell
    transplant.
    Opdivo can cause serious complications if it’s taken before or
    after you have an allogenic hematopoietic stem cell transplant
    (transplant of blood-forming cells from someone who has a similar genetic
    makeup as you). If you’ve had a stem cell transplant or are planning to have
    one, talk with your doctor about whether Opdivo is right for you.
  • Pregnancy.
    Opdivo can cause harm to a growing fetus. You shouldn’t take Opdivo while
    pregnant. For more information, please see the “Opdivo and pregnancy” and
    “Opdivo and birth control” sections above.
  • Breastfeeding.
    You should not breastfeed your child while you’re taking Opdivo, or for at
    least 5 months after your last dose of Opdivo. For more information, please see
    the “Opdivo and breastfeeding” section above.

Note: For more
information about the potential negative effects of Opdivo, see the “Opdivo side
effects” section above.

Professional information for Opdivo

The following information is provided for clinicians and
other healthcare professionals.

Indications

Opdivo (nivolumab) is approved by the Food and Drug
Administration (FDA) to treat the following:

  • unresectable or metastatic melanoma, as
    monotherapy or in combination with ipilimumab (Yervoy)
  • melanoma in patients with lymph node involvement
    or metastases who’ve had complete resection, as adjuvant treatment
  • metastatic non-small cell lung cancer (NSCLC),
    following platinum-based treatment
  • metastatic small cell lung cancer, following
    platinum-based treatment and at least one other treatment
  • advanced renal cell carcinoma, as a single agent
    following anti-angiogenic treatment, or in combination with ipilimumab in
    patients who haven’t received prior treatment but who are considered
    intermediate or poor risk
  • classical Hodgkin’s lymphoma, in adult patients
    following autologous hematopoietic stem cell transplant (HSCT) with brentuximab
    vedotin, or following three or more prior treatments that include HSCT
  • squamous cell carcinoma of the head and neck
    (recurrent or metastatic), following platinum-based treatment
  • urothelial carcinoma (locally advanced or
    metastatic), following platinum-containing treatment or 12 months of
    neoadjuvant or adjuvant platinum-containing treatment
  • colorectal cancer (microsatellite
    instability-high [MSI-H] or mismatch repair deficient [dMMR]) in adults and
    children ages 12 years and older, following treatment with a fluoropyrimidine
    (such as capecitabine), oxaliplatin, and irinotecan
  • hepatocellular carcinoma, in patients previously
    treated with sorafenib

Mechanism of action

Opdivo is a monoclonal antibody with activity against the
programmed death receptor-1 (PD-1).

The PD-1 receptor is activated by the PD-L1 and PD-L2
ligands, which results in inhibition of T-cell proliferation and cytokine
production. Some tumor cells cause an upregulation of PD-L1 and PD-L2, preventing
T-cell surveillance of cancerous cells. This allows tumor cells to grow and
spread unchecked.

When Opdivo binds to PD-1, T-cells are able to proliferate,
produce cytokines, and prompt antitumor responses. This prevents the growth of
tumor cells.

Pharmacokinetics and metabolism

Opdivo is administered by intravenous infusion, resulting in
nearly complete bioavailability. When administered every 2 weeks, steady-state
concentrations are reached within 3 months. Metabolism studies have not been
conducted, but mean elimination half-life is approximately 25 days.

Contraindications

There are no contraindications to Opdivo’s use.

Storage

Opdivo vials should be stored in the refrigerator (36°F to
46°F/2°C to 8°C) in the original packaging. Protect from light. Do not shake or
freeze vials.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually
correct, comprehensive, and up-to-date. However, this article should not be
used as a substitute for the knowledge and expertise of a licensed healthcare
professional. You should always consult your doctor or other healthcare
professional before taking any medication. The drug information contained
herein is subject to change and is not intended to cover all possible uses,
directions, precautions, warnings, drug interactions, allergic reactions, or
adverse effects. The absence of warnings or other information for a given drug
does not indicate that the drug or drug combination is safe, effective, or
appropriate for all patients or all specific uses.

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