Description
Nivolumab and hyaluronidase-nvhy combination injection is used alone as first-line treatment of advanced renal cell carcinoma (RCC), a kind of kidney cancer, that has spread in patients who have received other medicines (eg, nivolumab, ipilimumab). It is also used in combination with other medicines (eg, cabozantinib) as first-line treatment to treat kidney cancer that has spread throughout the body. It is also used alone to treat kidney cancer that has spread in patients who have received other medicines.
Nivolumab and hyaluronidase-nvhy combination injection is used alone to treat melanoma (skin cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery. It is also used alone to treat melanoma that has spread throughout the body or cannot be removed by surgery in patients who have received other medicines (eg, nivolumab, ipilimumab). 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 and hyaluronidase-nvhy combination injection is also used with medicines containing platinum before having surgery for non-small cell lung cancer (NSCLC). This medicine is also used with medicines containing platinum before having surgery for NSCLC in patients who do not have an abnormal EGFR or ALK gene and then used alone after surgery to help prevent lung cancer from coming back.
Nivolumab and hyaluronidase-nvhy combination injection is also used to treat non-small cell lung cancer (NSCLC) 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 received other medicines but did not work well.
Nivolumab and hyaluronidase-nvhy combination injection is also used alone 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 and hyaluronidase-nvhy combination 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 alone 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 and hyaluronidase-nvhy combination injection is also used alone or after treatment with other medicines (eg, ipilimumab, nivolumab) 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 and hyaluronidase-nvhy combination injection is also used alone to treat hepatocellular cancer (liver cancer) in patients who have previously received treatment with sorafenib and after treatment with other medicines (eg, ipilimumab, nivolumab).
Nivolumab and hyaluronidase-nvhy combination injection is also used alone 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 and hyaluronidase-nvhy combination 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 alone 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 and hyaluronidase-nvhy combination 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.
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 have not been performed on the relationship of age to the effects of nivolumab and hyaluronidase-nvhy combination injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab and hyaluronidase-nvhy 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Cholera Vaccine
- Dexlansoprazole
- Ebola Zaire Vaccine, Live
- Esomeprazole
- Influenza Virus Vaccine, Live
- Lansoprazole
- Omeprazole
- Pantoprazole
- Rabeprazole
- Rotavirus Vaccine, Live
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:
- Colitis (inflammation of the bowels) or
- Diabetes or
- Hepatitis (inflammation of the liver) or
- Hyperthyroidism (overactive thyroid gland) or
- Hypophysitis (inflammation of the pituitary gland) or
- Hypothyroidism (underactive thyroid gland) or
- Immune system problems (eg, Crohn's disease, ulcerative colitis, lupus) or
- Kidney disease or
- Lung or breathing problems or
- Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
- Stomach or bowel problems or
- Pancreatitis (inflammation of the pancreas) or
- Pneumonitis (inflammation of the lungs)—Use with caution. May make these conditions worse.
- Organ transplant or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.
- 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. This medicine is given as a shot under your skin, usually in the stomach or thigh. It is usually given every 2, 3, or 4 weeks for at least 3 to 5 minutes.
This medicine should come 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 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.
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 if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.
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 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
- Agitation
- arm or leg pain
- back pain
- black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- body aches or pain
- burning, numbness, tingling, or painful sensations
- chest pain or discomfort
- coma
- confusion
- constipation
- cough
- dark urine
- darkening of the skin
- depressed mood
- diarrhea
- difficult, burning, or painful urination
- difficulty in moving
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- dry skin and hair
- ear congestion
- eye pain
- fainting
- fast heartbeat
- feeling cold
- fever and chills
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- general feeling of discomfort or illness
- hair loss
- headache
- hoarseness or husky voice
- hostility
- increased hunger
- increased thirst
- increased urination
- irritability
- lethargy
- light-colored stools
- loss of appetite
- loss of voice
- lower back or side pain
- mental depression
- muscle cramps, stiffness, and twitching
- muscle or bone pain
- nausea
- nervousness
- numbness or tingling of the hands, feet, or face
- pain, swelling, or redness in the joints
- pale skin
- palpitations
- pinpoint red spots on the skin
- pounding in the ears
- rapid weight gain
- redness of the eye
- seizures
- sensitivity of the eye to light
- sensitivity to heat
- skin rash
- slowed heartbeat
- sneezing
- sore throat
- spinal pain
- stomach pain, cramps, or tenderness
- stuffy or runny nose
- stupor
- sweating
- swelling of the face, throat, or tongue
- swollen glands
- tearing
- tenderness of the palms and soles
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- upper right abdominal or stomach pain
- vomiting
- watery or bloody diarrhea
- weakness in the arms, hands, legs, or feet
- weakness or heaviness of the legs
- yellow eyes and skin
Less common
- Anxiety
- coughing up blood
- decreased urine output
- difficulty in swallowing
- increased menstrual flow or vaginal bleeding
- nosebleeds
- paralysis
- prolonged bleeding from cuts
Rare
- Stiff neck
Incidence not known
- Blistering, peeling, or loosening of the skin
- blue or pale skin
- chest pain, possibly moving to the left arm, neck, or shoulder
- difficulty in chewing or talking
- double vision
- drooping eyelids
- drowsiness
- inability to move the arms and legs
- red irritated eyes
- red skin lesions, often with a purple center
- redness, soreness, or itching skin
- sudden numbness and weakness in the arms and legs
- throbbing pain
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
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- change or loss of taste
- lack or loss of strength
- stomach bloating
- swelling or inflammation of the mouth
- thinning of the hair
- voice changes
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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