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Care During Chemotherapy and Beyond

Nivolumab
(nye VOL ue mab)
Trade name: Opdivo®
Nivolumab is the generic name for the trade drug name Opdivo®. In some cases, health care
professionals may use the generic name nivolumab when referring to the trade drug name Opdivo®.
Drug type: Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1)
blocking antibody. (For more detail, see "How this drug works," below.)

What Nivolumab Is Used For:

For the treatment of patients with unresectable or metastatic melanoma and disease
progression in combination with ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor.
For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with
progression on or after platinum-based chemotherapy.
Treatment of advanced renal cell cancer in patients who have received prior anti-angiogenic
therapy. Or in combination with Ipilimumab.
Treatment of patients with classical Hodgkins lymphoma (cHL) that has relapsed or
progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-
transplantation brentuximab vedotin.
Treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and
neck (SCCHN) with disease progression on or after a platinum-based therapy.
Treatment of locally advanced or metastatic urothelial carcinoma who have disease
progression during or following platinum-containing chemotherapy.
Treatment of metastatic small cell lung cancer (SCLC) with progression after platinum-based
chemotherapy and at least one other line of therapy.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other
problems if they believe it may be helpful.

How Nivolumab Is Given:

Nivolumab is administered intraveniously (IV) into the vein over 60 minutes every 2 weeks.
The amount of nivolumab that you will receive depends on many factors, your general health
or other health problems, and the type of cancer or condition being treated. Higher doses do
 not give a better response and may cause increased toxicity. Your doctor will determine your
dose and schedule.
If you miss any appointments call your healthcare provider as soon as possible to reschedule
your appointment.

Side Effects:
Important things to remember about the side effects of nivolumab:
Most people do not experience all of the side effects listed.
Side effects are often predictable in terms of their onset and duration.
Side effects are almost always reversible and will go away after treatment is complete.
There are many options to help minimize or prevent side effects.
There is no relationship between the presence or severity of side effects and the effectiveness
of the medication.
The following side effects are common (occurring in greater than 30%) for patients taking nivolumab:
Fatigue
Lymphocytopenia (low white blood cells)
Low sodium
Shortness of breath
Musculoskeletal pain
Decreased appetite
Cough

These side effects are less common side effects (occurring in about 10-29%) of patients receiving
nivolumab:
Nausea
Anemia
Constipation
Increased serum creatinine
Colitis
Low potassium
Low magnesium
High calcium
Vomiting
Weakness
Diarrhea
High potassium
Low calcium
Swelling
Fever
Rash
Abdominal pain
Increased serum AST
Thrombocytopenia
 Increased serum alkaline phosphatase
Chest pain
Weight loss
Joint pain
Increased serum ALT
Itching
Pneumonia
Pain
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not
listed here. However, you should always inform your health care provider if you experience any unusual
symptoms.

A few rare but severe side effects include:

Immune-mediated Pneumonitis
Immune-mediated Colitis
Immune-mediated Hepatitis
Immune-medicated Nephritis and Renal Dysfunction
Immune-mediated Hypothyroidism and Hyperthyroidism

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the
following symptoms:

Fever of 100.4° F (38° or higher, chills)

Signs of an allergic reaction, like rash; hives; itching; red, peeling, or blistered, skin with or
without fever; tightness in the chest or throat; wheezing; trouble breathing or talking; unusual
hoarseness; or swelling of the lips, mouth, face, throat, or tongue.

Always inform your health care provider if you experience any unusual symptoms.
The following symptoms require medical attention, but are not an emergency. Contact your health
care provider within 24 hours of noticing any of the following:

Diarrhea should be reported to your health care provider

Nausea (interferes with ability to eat and unrelieved with prescribed medication)
Vomiting (vomiting more than 4-5 times in a 24 hour period)
Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth,
dark and decrease amount of urine, or dizziness
Sudden change in eyesight
Sudden onset of shortness of breath, accompanied by cough and/or fever
Skin or the whites of your eyes turn yellow
Light colored stools
Blood in stools
Dark, tarry or sticky stools
Urine turns dark or brown (tea color)
 Blood in the urine
Big weight gain
Unable to pass urine or change in the amount of urine passed
Decreased appetite
Stomach pain or upset stomach
Bleed or bruise more easily than normal
Fast heartbeat
Cough with or without mucus
Any skin change, irritation, itching or rash
Very bad muscle or weakness
Very bad joint pain
Swelling in the arms or legs
Signs of trouble with your thyroid or pituitary gland (change in mood or the way you act,
change in weight, constipation, dizziness, deeper voice, feeling cold, fainting, hair loss, feeling
very tired, headache or loss of sex drive)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:
Before starting nivolumab treatment, make sure you tell your doctor about any other
medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies,
etc.).
Do not receive any kind of immunization or vaccination without your doctor's approval while
taking nivolumab.
Inform your health care professional if you are pregnant or may be pregnant prior to starting
this treatment. Pregnancy category D (nivolumab may be hazardous to the fetus. Women who
are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
For both men and women: Do not conceive a child (get pregnant) while taking nivolumab
Barrier methods of contraception, such as condoms, are recommended while you are taking
this drug and for 5 months after you stop taking it. Discuss with your doctor when you may
safely become pregnant or conceive a child after therapy.
Do not breast feed while taking this medication.

Self-Care Tips:
Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
Nivolumab can cause visual changes, dizziness and tiredness. If you have any of these
symptoms, use caution when driving a car, using machinery, or anything that requires you to be
alert.
Wash your hands often.
Avoid contact sports or activities that could cause injury.
To reduce any potential nausea eat small, frequent meals. Sucking on lozenges and chewing
gum may also help.
Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
 In general, drinking alcoholic beverages should be kept to a minimum or avoided completely.
You should discuss this with your doctor.
Get plenty of rest.
Maintain good nutrition. (see eating well during chemotherapy)
If you experience symptoms or side effects, be sure to discuss them with your health care
team. They can prescribe medications and/or offer other suggestions that are effective in
managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking nivolumab to
monitor side effects and check your response to therapy.

How Nivolumab Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the
differences between cancer cells and normal cells. To date, cancer treatment has focused primarily
on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly.
Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific
differences in the cancer cells and the normal cells. This information is used to create a targeted
therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side
effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of
the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted
therapies focus on the internal components and function of the cancer cell. The targeted therapies
use small molecules that can get into the cell and disrupt the function of the cells, causing them to
die. There are several types of targeted therapy that focus on the inner parts of the cells. Other
targeted therapies target receptors that are on the outside of the cell. Therapies that target
receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood
vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1, PD-L1 and
PD-L2. Binding of these ligands to the PD-1 receptor found on T cells, inhibits T cell proliferation and
cytokine production. Upregulation of the PD-1 ligands occurs in some tumors and signaling through
this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab
is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and
blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the
immune response, including the anti-tumor immune response, resulting in decreased tumor growth.

Note: We strongly encourage you to talk with your health care professional about your specific
medical condition and treatments. The information contained in this website is meant to be helpful
and educational, but is not a substitute for medical advice.

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