Class: Biological Therapy

Generic Name: nivolumab

Trade Name: Opdivo®

For which conditions is this drug approved? Opdivo is approved to treat melanoma that: a) can’t be removed by surgery; or b) metastatic melanoma that’s progressed after treatment with Yervoy® (ipilimumab) or, if BRAF V600 mutation positive, progressed after treatment with a BRAF inhibitor. Opdivo is also approved to treat a type of advanced stage lung cancer (squamous non-small cell lung cancer [NSCLC]) that has spread or grown after treatment with platinum-based chemotherapy; squamous cell carcinoma of the head and neck that has spread or grown after platinum-based therapy; and advanced renal cell carcinoma that has progressed after anti-angiogenic treatment. Furthermore, Opdivo is approved to treat classical Hodgkin’s lymphoma (cHL) that has progressed following a hematopoietic stem cell transplant (HSCT) which has been followed by the chemotherapy/biologic drug Adcetris®.

What is the mechanism of action? Opdivo works by blocking the action of a protein called PD-1. Because PD-1 inhibits certain types of immune responses, drugs that block it may enhance the ability of the immune system to fight cancer.

How is Opdivo typically given (administered)? Opdivo is given as an intravenous infusion over 60 minutes usually every two weeks. (***Dosing for Opdivo was changed and approved by the FDA in 09/2016 for the treatment of melanoma, lung cancer, and non-small cell lung cancer. Be sure to look at prescribing information for correct dosages for these diseases.)

How are patients typically monitored? Opdivo is designed to work with your immune system to treat melanoma, lung cancer, kidney cancer, or blood cancer, but it can also cause your immune system to attack normal organs and tissues. Your doctor will monitor you (using blood tests and exams) for these complications: lung, intestinal, liver, kidney, and thyroid problems.

What are the most common side effects of treatment with Opdivo? 

• Fatigue
• Muscle, joint, and bone pain
• Diarrhea
• Rash
• Itchy skin
• Nausea
• Fever
• Shortness of breath
• Vomiting (with ipilimumab)
• Cough
• Constipation
• Decreased appetite
• Upper respiratory tract infection

What are the less common but serious side effects of treatment with Opdivo?

• Chills or shaking
• Itching or rash
• Flushing
• Difficulty breathing
• Dizziness
• Fever
• Feeling like passing out

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Keep your scheduled appointments for blood work or other laboratory tests that are used to monitor your health during treatment.

Are there any special precautions patients should be aware of before starting treatment?

Tell your doctor about all of your medical conditions, particularly the following:

• Immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• If you’ve had an organ transplant
• Lung or breathing problems
• Liver problems
• Tell your doctor if you are pregnant or plan to become pregnant. Opdivo can harm your unborn baby, so you should not become pregnant during treatment with Opdivo. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
• Women who are able to become pregnant should use effective birth control during treatment with Opdivo and for one month after the last dose.
• Men who are sexually active should use a condom during treatment with Opdivo and for three months after the last dose.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Opdivo will pass into your breast milk. You and your healthcare provider should decide if you will take Opdivo or breastfeed—you should not do both.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show them to your healthcare providers and pharmacist when you get a new medicine.

When should patients notify their physician? Contact your doctor if you experience any of the following:

• Signs of lung problems (new or worsening cough; chest pain; shortness of breath)
• Signs of intestinal problems (diarrhea or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; severe stomach pain or tenderness)
• Signs of liver problems (yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach-area; drowsiness; dark urine; bleeding or bruise more easily than normal; feeling less hungry than usual)
• Signs of kidney problems (decrease in the amount of urine; blood in your urine; swelling in your ankles; loss of appetite)
• Signs of hormone gland problems (headaches that will not go away or unusual headaches; weight gain or weight loss; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; dizziness or fainting; feeling cold; constipation; deepening voice)
• Signs of other problems, including: rash, changes in eyesight, severe or persistent muscle or joint pains; severe muscle weakness

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 09/16.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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