Nivolumab (nye-VOL-ue-mab), Relatlimab-rmbw (rel-AT-li-mab - rmbw)

Treats melanoma (skin cancer).

Brand Name(s):

Opdualag

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will give you other medicines (including steroid medicine) before you receive this medicine and during treatment to help prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can bear children, 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 during treatment with this medicine and for at least 5 months after your last dose.
• Do not breastfeed during treatment and for at least 5 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, Crohn disease, diabetes, stomach or bowel problems, thyroid problems, an autoimmune disease (including Crohn disease, lupus, sarcoidosis, ulcerative colitis), muscle or nerve problems (including Guillain-Barré syndrome, myasthenia gravis), or if you have had a transplant.
• This medicine may cause the following problems because of the way it affects your immune system:
  • Severe inflammation (swelling) or other problems caused by the immune system, including pneumonitis (lungs), colitis (bowels), hepatitis (liver), nephritis (kidneys), myocarditis (heart), encephalitis (brain), or eye or vision problems
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Muscle or nerve problems
  • Infusion reactions, which could be severe
  • Increased risk for possible transplant problems
• 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or cloudy urine, decrease in how much or how often you urinate, swelling of your face, feet, or lower legs
• Blurred vision, trouble seeing, eye pain, or other vision changes
• Confusion, seizures, stiff neck, headache, sleepiness
• Cough, chest tightness or pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea that may contain blood, severe stomach pain
• Fast or uneven heartbeat, swelling in your hands, ankles, or feet
• Fever, chills, dizziness, or skin rash while receiving the infusion
• Increased hunger or thirst, dry mouth, sweating
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe muscle pain, cramps, or weakness
• Unusual bleeding or bruising
• Weakness, headache, tiredness, weight changes, feeling cold, changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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