Pronunciation:

nye-VOL-ue-mab

Brand Names:

• Opdivo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

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 Stage IIB, Stage IIC, Stage III, or Stage IV melanoma from coming back after it has been completely removed by surgery.

Nivolumab injection is also used with chemo medicines containing platinum before having surgery for non-small cell lung cancer (NSCLC).

Nivolumab injection is also used with ipilimumab as first-line treatment for metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and do not have an abnormal EGFR or ALK gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine.

It is also used with ipilimumab and 2 cycles of chemo medicines containing platinum as first-line treatment for non-small cell lung cancer that has come back or spread in patients whose tumors do not have an abnormal EGFR or ALK gene.

Nivolumab injection is also used to treat non-small cell lung cancer that has spread throughout the body and after other cancer medicines (eg, medicines containing platinum). It is given to patients whose tumors have an abnormal EGFR or ALK gene and have disease progression during treatment.

Nivolumab injection is also used with ipilimumab as first-line treatment for malignant pleural mesothelioma (cancer that affects the inside lining of the lungs and chest wall) that cannot be removed by surgery.

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 other medicines (eg, ipilimumab or cabozatinib) 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 but did not work well.

Nivolumab injection is also used to treat urothelial carcinoma (bladder cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery (locally advanced). This medicine is given to patients who have received other cancer medicines (eg, platinum) that did not work well or whose cancer has worsened within 12 months of treatment containing platinum, either before or after surgery to remove your cancer. It is also used to help prevent urothelial carcinoma from coming back after it has been removed by surgery. This medicine is also used in combination with cisplatin and gemcitabine as first-line treatment of urothelial carcinoma that has spread throughout the body or cannot be removed by surgery.

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. 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 together with other medicines (eg, ipilimumab) to treat hepatocellular cancer (liver cancer) in patients who have previously received treatment with sorafenib.

Nivolumab injection is also used to treat esophageal or gastroesophageal junction cancer in patients who have received combination of chemotherapy and radiation followed by surgery to remove the cancer. It is given to patients who still have some cancer cells in the removed tumor or lymph nodes.

Nivolumab injection is also used together with other medicines (eg, fluoropyrimidine and platinum, or ipilimumab) as first-line treatment for squamous cell carcinoma of the esophagus that has spread or cannot be removed by surgery. This medicine is also used to treat squamous cell carcinoma of the esophagus that has returned, spread, or cannot be removed by surgery in patients who have received other medicines (eg, fluoropyrimidine and platinum).

Nivolumab injection is also used together with other medicines (eg, fluoropyrimidine and platinum) to treat cancer of the stomach (gastric cancer), gastroesophageal junction, or esophagus (esophageal adenocarcinoma) that has spread or cannot be removed by surgery.

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nivolumab injection to treat colon and rectal cancer and melanoma 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 rectal cancer and melanoma or in children to treat other approved conditions.

Older adults—

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.

Other 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. 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.

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Other interactions—

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 an IV placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 minutes.

This medicine is usually given every 2, 3, or 4 weeks. Your doctor may adjust how often you will receive this medicine or how long the infusion will take.

Your doctor will give you other medicines (eg, steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

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. If you can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. 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 (eg, pneumonitis).

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.

Serious problems with adrenal, pituitary, or thyroid gland may occur while you are receiving this medicine. Tell your doctor if you have changes in mood or behavior (eg, being irritable or forgetful), 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, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sores or ulcers on the skin, mouth or lips, or swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

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 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:

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

blurred vision

bone, joint, or muscle pain

burning, numbness, tingling, or painful sensations

change or loss of taste

chest tightness

chills

constipation

cough

depressed mood

diarrhea

difficulty in moving

dizziness

dry skin and hair

fainting

fast, slow, pounding, or irregular heartbeat or pulse

feeling cold

feeling of warmth

fever

hair loss

headache

hoarseness or husky voice

itching

loss of appetite

muscle cramps and stiffness

nausea

nervousness

palpitations

red, irritated eyes

redness of the face, neck, arms, and occasionally, upper chest

redness, swelling, pain of the skin

scaling of the skin on the hands and feet

sore throat

sores, ulcers, or white spots in the mouth or on the lips

tingling of the hands and feet

trouble breathing

ulceration of the skin

unsteadiness or awkwardness

unusual tiredness or weakness

vomiting

weight gain

weakness in the arms, hands, legs, or feet

Less common

Chest pain

dark urine

general feeling of discomfort or illness

light-colored stools

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

change in vision

darkening of the skin

drowsiness

eye pain

fruity breath odor

increased hunger, thirst, and urination

indigestion

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

tearing

Incidence not known

Feeling of constant movement of self or surroundings

lightheadedness

sensation of spinning

very deep pain in the eyes

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

swelling or inflammation of the mouth

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

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.