Nivolumab (Intravenous route)
Uses of This Medicine:
Nivolumab injection is used alone or together with other medicines (eg, ipilimumab) to treat melanoma (skin cancer) that has spread throughout the body (metastatic) or that cannot be removed by surgery. It is also used to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
It is also used to treat non-small cell lung cancer that has spread throughout the body and after other cancer medicines have been tried but did not work well.
This medicine is also used to treat small cell lung cancer that has spread throughout the body and after at least two different kinds of cancer medicines have been tried but did not work well.
Nivolumab injection is used alone to treat kidney cancer that has spread throughout the body in patients who have received other medicines. It is also used together with ipilimumab to treat kidney cancer that has spread throughout the body in patients who have not received other medicines.
It is also used to treat classical Hodgkin lymphoma (white blood cell cancer) that has come back or spread after autologous hematopoietic stem cell transplantation (HSCT) and used brentuximab vedotin after stem cell transplant, or after you received at least 3 kinds of treatment including autologous HSCT.
This medicine is also used to treat squamous cell cancer of the head and neck (SCCHN) that has come back or spread throughout the body after receiving medicines containing platinum.
It is also used to treat patients with urothelial cancer (bladder cancer) that has spread or grown and have tried cancer medicines containing platinum but did not work well.
Nivolumab injection is also used alone or together with other medicines (eg, ipilimumab) to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (cancer of the colon or rectum) that has spread or cannot be removed by surgery. It is given to patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, irinotecan) that did not work well.
Nivolumab injection is also used to treat hepatocellular cancer (liver cancer) in patients who have received other medicines (eg, sorafenib).
Nivolumab is a monoclonal antibody that affects the immune system and helps control the growth of cancer cells.
This medicine is to be given only by or under the supervision of your doctor.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nivolumab injection to treat colon and rectum cancer in children 12 years of age and older. Safety and efficacy have not been established in children younger than 12 years of age to treat colon and rectum cancer or in children to treat other approved conditions.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab injection in the elderly.
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.
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Crohn disease or
- Diabetes or
- Immune system problems or
- Kidney disease or
- Liver disease or
- Lung or breathing problems or
- Stomach or bowel problems or
- Systemic lupus erythematosus (lupus, SLE) or
- Thyroid problems or
- Ulcerative colitis—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, 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 this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. The infusion will be given every 2 or 4 weeks (when used alone) or every 3 weeks (when given with ipilimumab).
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine 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 This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 5 months after the last dose. If you think you have become pregnant while receiving 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 this medicine. These could be symptoms of a serious lung problem.
Colitis (inflammation of the colon) may occur with this medicine. 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 this medicine. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, unusual or continuing headaches, or weight changes.
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Tell your doctor right away if you have bloody or cloudy urine, decrease in the amount of urine, nausea, 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.
Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.
This medicine may increase your risk for possible organ transplant rejection. It may also cause transplant complications (eg, graft-versus-host-disease [GVHD]) in patients who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), which can be severe and life-threatening. Check with your doctor right away if you have skin rash, stomach pain, diarrhea, yellow skin or eyes, swelling in the legs or ankles, dark urine, pale stools, nausea, or vomiting.
Side Effects of This Medicine:
- More common
- Back pain
- blistering, peeling, or loosening of the skin
- chest tightness
- depressed mood
- dry skin and hair
- feeling cold
- feeling of warmth
- hair loss
- hoarseness or husky voice
- joint or muscle pain
- loss of appetite
- muscle cramps and stiffness
- red, irritated eyes
- redness of the face, neck, arms and occasionally, upper chest
- 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
- sensitivity to heat
- stomach cramps
- thickening of bronchial secretions
- trouble sleeping
- upper right abdominal or stomach pain
- watery or bloody diarrhea
- weight loss
- yellow eyes and skin
- bloody or cloudy urine
- blurred vision or other change in vision
- darkening of the skin
- eye pain
- fast heartbeat
- fruity breath odor
- increased hunger, thirst, and urination
- mental depression
- pains in the stomach, side, or abdomen, possibly radiating to the back
- redness of the eye
- sensitivity of the eyes to light
- skin rash
- swelling of the face, feet, or lower legs
- Incidence not known
- feeling of constant movement of self or surroundings
- sensation of spinning
- very deep pain in the eyes
- More common
- Stuffy or runny nose
- Incidence not known
- Increase in blood flow to the whites of the eyes
- seeing flashes or sparks of light
- seeing floating spots before the eyes or a veil or curtain appearing across a part of vision
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:
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:
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.
Last Updated: 9/5/2019