Description
Nivolumab and relatlimab-rmbw combination injection is used to treat melanoma (skin cancer) that has spread throughout the body (metastatic) or that cannot be removed by surgery.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nivolumab and relatilimab-rmbw combination injection in children 12 years of age and older weighing at least 40 kilograms (kg). Safety and efficacy have not been established in children 12 years of age and older weighing less than 40 kg, and in children younger than 12 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab and relatilimab-rmbw combination injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
- 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
- Organ transplant, recent or history of 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.
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.
Proper Use
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.
Precautions
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 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 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.
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. 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.
This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.
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 (inflammation of the brain).
Check with your doctor right away if you are having severe muscle pain or cramps, unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious muscle or nerve problem.
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
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
- 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.
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