Nivolumab/relatlimab-rmbw (Intravenous)

Nivolumab and relatlimab-rmbw combination injection is used to treat melanoma (skin cancer) that has spread to other parts of the body (metastatic) or that cannot be removed with surgery.

This medicine should only be given by your doctor or under their supervision.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to look for unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. If you are a woman who can become pregnant, your doctor may give you a pregnancy test before you start using this medicine to confirm that you are not pregnant. Use an effective form of birth control to avoid getting pregnant during treatment with this medicine and for at least 5 months after your last dose. If you think you might be pregnant while receiving the medicine, tell your doctor immediately.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem while taking this medicine. These could be signs of a serious lung issue (e.g., pneumonitis).

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

Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Serious issues with the adrenal, pituitary, or thyroid glands may occur while you are receiving this medicine. Tell your doctor if you experience changes in mood or behavior (e.g., being irritable or forgetful), constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, unusual or persistent headaches, or changes in weight.

This medicine may affect blood sugar levels. If you notice a change in your blood or urine sugar test results or have any questions, consult your doctor.

Inform your doctor immediately if you have bloody or cloudy urine, a decrease in urine output, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be signs of a serious kidney problem.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis can occur with this medicine. Contact 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, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while using this medicine.

This medicine may cause inflammation of the heart muscle (myocardium) known as myocarditis. Tell your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Consult your doctor if you experience a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be signs of encephalitis (inflammation of the brain).

Contact your doctor immediately if you have severe muscle pain or cramps, unusual weakness in your arms or legs, or a burning, numbness, tingling, or painful sensation in your arms, hands, legs, or feet. These could be signs of a serious muscle or nerve issue.

Inform your doctor right away if you have blurred vision, difficulty reading, eye pain, or any other change in your vision while taking this medicine. Your doctor may want you to have your eyes 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 (e.g., graft-versus-host-disease [GVHD]) in patients who have received a bone marrow (stem cell) transplant using donor stem cells (allogeneic), which can be severe and life-threatening. Contact your doctor immediately if you have a skin rash, stomach pain, diarrhea, yellowing of the skin or eyes, swelling in the legs or ankles, dark urine, pale stools, nausea, or vomiting.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your health care professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems that would limit the use of nivolumab and relatilimab-rmbw combination injection in children aged 12 years and older who weigh at least 40 kilograms (kg). Safety and effectiveness have not been established in children aged 12 years and older who weigh less than 40 kg, or in children younger than 12 years old.

Geriatric

Studies conducted to date have not shown any specific problems that would limit the use of nivolumab and relatilimab-rmbw combination injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Crohn disease or
• Diabetes or
• Guillain-Barré syndrome or
• Immune system problems or
• Kidney disease or
• Liver disease or
• Lung or breathing problems or
• Myasthenia gravis (severe muscle weakness) or
• Recent or history of organ transplant or
• Stomach or bowel problems or
• Systemic lupus erythematosus (lupus, SLE) or
• Thyroid problems or
• Ulcerative colitis—Use with caution. May worsen these conditions.

• Patients who have had an allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May worsen 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, they may need medical attention.

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

More common

• Back pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• chest pain or tightness
• chills
• constipation
• cough
• dark urine
• depressed mood
• diarrhea
• dry skin and hair
• feeling cold
• fever
• flushing
• hair loss
• headache
• hoarseness or husky voice
• itching
• joint or muscle pain
• light-colored stools
• muscle cramps and stiffness
• nausea and vomiting
• nervousness
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• slowed heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps, pain, or tenderness
• sweating
• swollen glands
• trouble breathing
• trouble sleeping
• unusual bleeding or bruising
• unusual tiredness and weakness
• upper right abdominal or stomach pain
• watery or bloody diarrhea
• weight loss or gain
• yellow eyes and skin

Less common

• Bloody or cloudy urine
• chest discomfort
• darkening of the skin
• decrease in urine output or decrease in urine-concentrating ability
• dizziness
• fainting
• fast heartbeat
• loss of appetite
• mental depression
• muscle spasms
• pain or discomfort in the arms, jaw, back or neck
• pale skin
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• skin rash
• swelling of the face, feet, or lower legs
• swelling or redness in the joints
• thickening of bronchial secretions

Rare

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• bloating
• blue or pale skin
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• burning feeling in the chest or stomach
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• difficulty in breathing, chewing, swallowing, or talking
• double vision
• drooping eyelids
• drowsiness
• dry mouth
• eye pain
• fruit-like breath odor
• heavier menstrual periods
• inability to move the arms and legs
• increased hunger
• increased thirst
• increased urination
• indigestion
• irritability
• loss of consciousness
• muscle weakness
• nosebleeds
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• redness, soreness, or itching skin
• redness of the eye
• seizures
• sensation of pins and needles
• sensitivity of the eyes to light
• stabbing pain
• stiff neck or back
• stomach upset
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• 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

• Decreased appetite

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.

In the U.S.

• Opdualag

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Find detailed information on biosimilars for this medication.

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.

This medicine is usually given every 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.