Opdivo (nivolumab)

Opdivo is a prescription medicine used to treat:

• people with a type of skin cancer called melanoma:
  • that has spread or cannot be removed by surgery (advanced melanoma). You may receive Opdivo alone or in combination with ipilimumab, or
  • to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
  • people with a type of advanced stage lung cancer (called non-small cell lung cancer).

Opdivo may be used when your lung cancer:

• has spread or grown, and
• you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
• people with kidney cancer (renal cell carcinoma).

Opdivo may be used alone when your cancer has spread or grown after treatment with other cancer medicines.

Opdivo may be used in combination with ipilimumab in certain people when their cancer has spread.

• adults with a type of blood cancer called classical Hodgkin lymphoma.

Opdivo may be used if:

• your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and o you used the drug brentuximab vedotin (Adcetris) before or after your stem cell transplant, or
• you received at least 3 kinds of treatment including a stem cell transplant that uses your own stem cells (autologous).
• people with head and neck cancer (squamous cell carcinoma)

Opdivo may be used when your head and neck cancer:

• has come back or spread, and
• you have tried chemotherapy that contains platinum and it did not work or is no longer working.
• people with bladder cancer (urothelial carcinoma).

Opdivo may be used when your bladder cancer:

• has spread or grown, and
• you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer).

Opdivo may be used when your colon or rectal cancer:

• has spread to other parts of the body (metastatic),
• is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), and
• you have tried chemotherapy with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
• people with liver cancer (hepatocellular carcinoma)

Opdivo may be used after you have received treatment with sorafenib (Nexavar).

It is not known if Opdivo is safe and effective:

• in children less than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or
• in children less than 18 years of age for the treatment of any other cancers.

Opdivo can cause serious side effects, including:

• Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of Opdivo:
  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness
  • fever
  • feeling like passing out
• Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with Opdivo. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of Opdivo when used alone include:

• feeling tired
• pain in muscles, bones, and joints
• diarrhea
• weakness
• shortness of breath
• decreased appetite
• upper respiratory tract infection
• headache
• rash
• itchy skin
• nausea
• cough
• constipation
• back pain
• fever
• stomach pain

The most common side effects of Opdivo when used in combination with ipilimumab include:

• feeling tired
• diarrhea
• fever
• shortness of breath
• itching
• decreased appetite
• rash
• nausea
• vomiting
• pain in muscles, bones, and joints
• cough

These are not all the possible side effects of Opdivo. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Your healthcare provider will give you Opdivo into your vein through an intravenous (IV) line over 30 minutes.

• Opdivo is usually given every 2 weeks or 4 weeks depending on the dose you are receiving.
• When used in combination with ipilimumab, Opdivo is usually given every 3 weeks, for a total of 4 doses. Ipilimumab will be given on the same day. After that, Opdivo will be given alone every 2 weeks or 4 weeks depending on the dose you are receiving.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

No formal pharmacokinetic drug-drug interaction studies have been conducted with Opdivo

Based on its mechanism of action and data from animal studies, Opdivo can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death. Human IgG4 is known to cross the placental barrier and nivolumab is an immunoglobulin G4 (IgG4); therefore, nivolumab has the potential to be transmitted from the mother to the developing fetus. The effects of Opdivo are likely to be greater during the second and third trimesters of pregnancy.

It is not known whether Opdivo is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Opdivo, advise women to discontinue breastfeeding during treatment with Opdivo.