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nivolumab (Intravenous route)

nye-VOL-ue-mab

Commonly used brand name(s)

In the U.S.

  • Opdivo

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For nivolumab

Nivolumab injection is used to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery. It is only used after receiving ipilimumab and a BRAF inhibitor (if BRAF V600 mutation positive). Nivolumab is a monoclonal antibody that changes the immune system to help control the growth of cancer cells in the skin.

Nivolumab injection is also used to treat squamous non-small cell lung cancer that has spread after receiving cancer medicines (eg, cisplatin).

nivolumab is to be given only by or under the immediate supervision of your doctor.

Before Using nivolumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nivolumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nivolumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nivolumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of nivolumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Immune system problems (eg, Crohn’s disease, ulcerative colitis, or lupus) or
  • Kidney disease or
  • Liver disease or
  • Lung or breathing problems or
  • Stomach or bowel problems or
  • Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of nivolumab

Medicines used to treat cancer are very strong and can have many side effects. Before using nivolumab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you nivolumab. nivolumab is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for 60 minutes and the infusion will be given every 2 weeks.

nivolumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

nivolumab needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using nivolumab

It is very important that your doctor check your progress at regular visits to make sure that nivolumab is working properly. Blood tests may be needed to check for unwanted effects.

Using nivolumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 5 months after the last dose of nivolumab. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with nivolumab. These could be symptoms of a serious lung problem.

Colitis (inflammation of the colon) may occur with nivolumab. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Adrenal, pituitary, or thyroid gland problems may occur while you are receiving nivolumab. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, or weight changes.

Tell your doctor right away if you have bloody or cloudy urine, nausea or vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of a serious kidney problem.

nivolumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Back pain
  • blistering, peeling, or loosening of the skin
  • chest tightness
  • chills
  • constipation
  • cough
  • depressed mood
  • diarrhea
  • dry skin and hair
  • feeling cold
  • fever
  • flushing
  • hair loss
  • headache
  • hoarseness or husky voice
  • itching
  • joint or muscle pain
  • muscle cramps and stiffness
  • nausea and vomiting
  • red, irritated eyes
  • slowed heartbeat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • trouble breathing
  • unusual tiredness or weakness
  • weight gain
Less common
  • Chest pain
  • dark urine
  • general feeling of discomfort or illness
  • light-colored stools
  • nervousness
  • pain
  • sensitivity to heat
  • stomach cramps
  • sweating
  • tenderness
  • thickening of bronchial secretions
  • trouble sleeping
  • upper right abdominal or stomach pain
  • watery or bloody diarrhea
  • weight loss
  • yellow eyes and skin
Rare
  • Bloating
  • bloody or cloudy urine
  • blurred vision or other change in vision
  • darkening of the skin
  • dizziness
  • drowsiness
  • eye pain
  • fainting
  • fast heartbeat
  • indigestion
  • loss of appetite
  • mental depression
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • redness of the eye
  • sensitivity of the eye to light
  • skin rash
  • swelling of the face, feet, or lower legs
  • tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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