About NIVOLUMAB
NIVOLUMAB is an anti-cancer medicine used in the treatment of Melanoma in combination with ipilimumab and other cancers in adults. Melanoma is a severe form of skin cancer that spreads primary melanoma cells to distant organs such as lymph nodes, lungs, liver, brain, and bones. This medicine is used in treating advanced renal cell carcinoma, hepatocellular carcinoma, colorectal cancer, metastatic non-small cell lung cancer, metastatic melanoma, gastric cancer, classical Hodgkin’s disease, urothelial carcinoma, malignant pleural mesothelioma and head and neck cancer.
NIVOLUMAB contains Nivolumab, which belongs to the class of monoclonal antibody. It works by inhibiting the action of a programmed death receptor-1 (PD-1), thereby stopping the abnormal growth of cancer cells.
NIVOLUMAB may cause certain side effects such as diarrhoea, nausea, vomiting, tiredness, itching, rash, headache, fever, shortness of breath, muscle/joint pain, loss of appetite and injection site reactions. Inform your doctor if any of these side effects persist for longer. NIVOLUMAB will be administered by an oncologist trained in administering anti-cancer agents.
Avoid receiving NIVOLUMAB and inform your doctor if you are allergic to it or any other components of it. Before taking NIVOLUMAB, tell your doctor if you have/had liver or kidney disease, autoimmune disorders such as ulcerative colitis or Crohn's disease, a history of organ transplants, received an allogeneic stem cell transplant, or had radiation treatment to the chest. This medicine is known to cause embryo-fetal toxicity. Hence, it is not recommended for use in pregnancy. Avoid breastfeeding while taking this NIVOLUMAB.
Uses of NIVOLUMAB
Metastatic Melanoma, metastatic non-small cell lung cancer, Renal Cell Carcinoma, Hepatocellular carcinoma, Colorectal Cancer, Malignant pleural mesothelioma, Stomach Cancer, Squamous cell carcinoma of head and neck, Urothelia carcinoma.
Medicinal Benefits
NIVOLUMAB contains Nivolumab, which is used in the treatment of different types of cancers. It works by inhibiting the action of a programmed death receptor-1 (PD-1) that causes the multiplication of cancerous cells. This helps stop the abnormal growth of cancer cells and thus reduce the further spread to other body parts.
Directions for Use
Storage
Side Effects of NIVOLUMAB
- Nausea
- Vomiting
- Diarrhoea
- Loss of appetite
- Tiredness
- Dizziness
- Weakness
- Muscle pain
- Cough
- Headache
- Fever
- Itching
- Rash
- Back pain
- Upper respiratory tract infections
- Injection site reactions
In-Depth Precautions and Warning
Drug Warnings
To treat your condition effectually, continue receiving NIVOLUMAB for the period that your doctor has prescribed. NIVOLUMAB may cause severe immune-mediated adverse reactions (IMAR) such as immune-mediated colitis, hepatitis, hepatotoxicity, nephritis, endocrinopathies, pneumonitis, complications of allogeneic Hematopoietic Stem Cell Transplantation (allo HSCT) and dermatologic reactions. It may also cause infusion-related reactions in some patients. Therefore, caution should be exercised if you have/had liver or kidney disease, any history of organ transplant, gastrointestinal disorders, myasthenia gravis, received a stem cell transplant that uses donor stem cells (allogeneic), undergone radiation treatment to the chest and autoimmune disorders such as ulcerative colitis, or Crohn’s disease while receiving NIVOLUMAB. Discontinue the treatment if any severe infusion reactions occur. Inform your doctor if you are pregnant or are planning to become pregnant before starting the treatment, as this medicine is known to cause embryo-fetal toxicity. Breastfeeding should be discontinued in nursing mothers during the treatment as it passes into breast milk and may cause a possible risk to the infant. This medicine is not recommended for use in children below 12 years of age as the safety and efficacy are not established.
Drug Interactions
Drug-Drug Interactions: NIVOLUMAB may have interaction with immunomodulator drugs (thalidomide), corticosteroids (prednisolone, methylprednisolone, prednisone), etc.
Drug-Food Interactions: Avoid alcohol consumption and smoking.
Dug-Disease Interactions: Tell your doctor if you have liver or kidney disease, heart problems, GI disorders, eye problems, dermatitis, or a weak immune system before starting the treatment.
Drug-Drug Interactions Checker List:
Safety Advice
Alcohol
consult your doctorIt is unknown whether NIVOLUMAB interacts with alcohol. Consult your doctor for more information.
Pregnancy
unsafeNIVOLUMAB is not recommended for use in pregnancy as it may cause embryo-fetal toxicity and harm your foetus. Hence, if you are pregnant or planning pregnancy, inform your doctor before receiving NIVOLUMAB. You should not become pregnant while you are receiving NIVOLUMAB for at least five months from the last dose of NIVOLUMAB. Using effective birth control methods while on treatment is suggested.
Breast Feeding
unsafeNIVOLUMAB should not be taken if you are breastfeeding as it passes into breast milk and may harm your infant. Avoid nursing your child while on treatment with this medicine and for at least five months from the last dose of medicine.
Driving
not applicableNIVOLUMAB will be administered to hospitalized patients.
Liver
cautionIf you have a pre-existing or a history of liver problems, tell your doctor before receiving this medicine. Inform your doctor if you experience severe nausea or vomiting, right-sided upper stomach pain, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes). Your doctor may suggest tests to monitor your liver function while on treatment with this medicine.
Kidney
cautionIf you have a pre-existing or a history of kidney diseases, inform your doctor before receiving NIVOLUMAB. Tell your doctor if you have little or no urination, swelling in your feet or ankles, or blood in your urine. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Children
safe if prescribedNIVOLUMAB is not recommended for children below 12 years. It is safe for use in children above 12 years for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. It will be administered only if the benefits outweigh the risks.
Habit Forming
Diet & Lifestyle Advise
- Physical activity helps strengthen muscles, reduces fatigue, helps in weight loss, and gives strength. Gentle activities like 20-30 minutes of walking or swimming would be helpful.
- Maintain a healthy weight by performing regular low-strain exercises and eating healthy food.
- Getting adequate sleep as resting helps improve your health and mental ability and improves attention.
- De-stress yourself by meditating, reading books, taking a warm bubble bath, or listening to soothing music.
- Eat food rich in antioxidants such as berries, spinach, etc.
- Foods containing fibre help in better digestion. These include beans, peas, lentils, whole grains, nuts, and seeds.
- Avoid smoking and alcohol consumption.
- Maintain a healthy weight.
Special Advise
- Your doctor may suggest periodic liver function tests, kidney function tests, and lung function tests to monitor the function of the liver, kidney and lungs due to the use of NIVOLUMAB.
- Using contraceptive pills while using NIVOLUMAB to prevent pregnancy is advised.
- Thyroid function and adrenocorticotropic hormone levels will be monitored during treatment to avoid any life-threatening side effects.
Patients Concern
Disease/Condition Glossary
Renal Cell Carcinoma: It is the most common type of cancer in which cancer/ malignant cells grow uncontrollably in the kidney and form a tumor. Symptoms include red, orange, or pink-coloured urine due to the presence of blood in the urine. NIVOLUMAB is used in combination with ipilimumab in adult patients who have already taken prior treatment and in combination with cabozantinib in patients who have not taken prior treatment.
Hepatocellular carcinoma: It occurs when the cancer/ malignant cells grow out of control. This infects the liver, destroys the liver cells and affects the ability of the liver to work properly. Symptoms may include abdominal pain, loss of appetite, weight loss, and pale bowel motions. NIVOLUMAB is used in combination with ipilimumab in adult patients.
Colorectal cancer: It is a condition in which the cancerous/malignant cells grow out of control in the colon or rectum. Symptoms may include diarrhoea, constipation, bloody stools, change in bowel habits, abdominal discomfort, etc.
Metastatic Malignant Melanoma: Melanoma is a type of skin cancer in which the cancer cells grow in melanocytes. It is mainly caused by harmful UV radiation from the sun. Malignant melanoma is common in fair-skinned and freckled individuals. It results in mole formation, typically on the skin of the face. NIVOLUMAB is used in combination with ipilimumab in adults and children above 12 years of age.
Malignant pleural mesothelioma: It is a type of cancer that develops in the mesothelium (a lining that covers the outer surface of organs), mainly caused by exposure to asbestos. Symptoms may include chest pain, shortness of breath, extreme tiredness, persistent cough, loss of appetite, unexplained weight loss, fever and sweating.
Non-Small Cell Lung Cancer (NSCLC): It is the most common form of lung cancer, which occurs when cells that form the lining of the lung start growing uncontrollably. It is mostly seen in persons who smoke. Symptoms may include chest pain, weight loss, hoarseness, and difficulty breathing. NIVOLUMAB is used in combination with chemotherapy that contains platinum and another chemotherapy medicine.
Head and neck cancer: It is a type of cancer which causes abnormal growth of cancer cells in the tissues of the neck and head. This cancer generally starts in the cells known as squamous cells, which appear in the lining of the surface of moist mucosa in the head and neck (e.g., inside of the throat, nose, and mouth).
Bladder cancer: It is a cancer that begins in the bladder. It typically affects older adults. The most common symptom is blood in the urine..
Stomach Cancer (Gastric adenocarcinoma): It is a type of cancer that develops from the stomach lining. When the cancer cells spread to other organs of the body, it is called metastatic. This condition can occur mainly due to smoking, a highly processed or salty diet, and severe bacterial infection of H. pylori. Symptoms of stomach cancer include feeling bloated after eating, feeling full after eating small amounts of food, nausea, heartburn or indigestion.
Classical Hodgkin’s Disease: Hodgkin’s disease or lymphoma is a blood cancer of a certain type of cells called WBCs, specifically lymphocytes. Lymphocytes normally help control infection and maintain the body's normal immunity. However, in a cancerous state, there is an abnormal multiplication of these blood cells, causing many problems such as fatigue, fever, loss of appetite, itching, night sweats and lymph node swelling.
