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Navigo 40
Incepta Pharmaceuticals Ltd.
Generic: Nivolumab
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Navigo 40. Please consult your doctor.
CONSULT YOUR DOCTOR
Navigo 40 is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.
CONSULT YOUR DOCTOR
Navigo 40 is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
SAFE
Navigo 40 does not usually affect your ability to drive.
SAFE IF PRESCRIBED
Navigo 40 is safe to use in patients with kidney disease. No dose adjustment of Navigo 40 is recommended.
SAFE IF PRESCRIBED
Navigo 40 is safe to use in patients with liver disease. No dose adjustment of Navigo 40 is recommended.
Medicine Overview of Navigo 40mg/ml iv_infusion
Introduction
Navigo 40 is used in the treatment of non-small cell lung cancer, kidney cancer, head and neck cancer, melanoma, Hodgkin's disease, and liver cancer. Navigo 40 is given as an infusion into vein by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take...
... Show moreUses of Navigo 40
- Non-small cell lung cancer
- Kidney cancer
- Head and neck cancer
- Melanoma
- Hodgkin’s disease
- Liver cancer
Side effects of Navigo 40
Common
- Rash
- Weakness
- Headache
- Fever
- Musculoskeletal (bone, muscle or joint) pain
- Back pain
- Stomach pain
- Nausea
- Itching
- Constipation
- Diarrhea
- Upper respiratory tract infection
- Decreased appetite
- Breathlessness
- Cough
How to use Navigo 40
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Navigo 40 works
Navigo 40 is an anti-cancer medication. It works by blocking a protein (PD-1) on the surface of certain immune cells called T-cells. This action activates the T-cells to locate and kill cancer cells.
Brief Description
Description
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in enhanced T-cell function that is greater than the effects of either antibody alone, and results in improved anti-tumor responses in metastatic melanoma and advanced RCC.
Indications
Nivolumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated for:•Melanoma•Non-Small Cell Lung Cancer (NSCLC)•Malignant Pleural Mesothelioma•Renal Cell Carcinoma (RCC)•Classical Hodgkin Lymphoma (cHL)•Squamous Cell Carcinoma of the Head and Neck (SCCHN)•Urothelial Carcinoma•Colorectal Cancer•Hepatocellular Carcinoma (HCC)•Esophageal Cancer•Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
Dosage & Administration
Administer by intravenous infusion after dilution based upon recommended infusion rate for each indication.Unresectable or metastatic melanoma• 240 mg every 2 weeks or 480 mg every 4 weeks• 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then240 mg every 2 weeks or 480 mg every 4 weeksAdjuvant treatment of melanoma• 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)Neoadjuvant treatment of resectable (tumors ?4 cm or node positive) non-small cell lung cancer• 360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cyclesMetastatic non-small...
... Show moreSide Effects
Most common adverse reactions (incidence ?20%) in patients were:• As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea,constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache,abdominal pain, vomiting, and urinary tract infection• In combination with ipilimumab: fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia,cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia,headache, hypothyroidism, constipation, decreased weight, and dizziness• In combination with platinum-doublet chemotherapy: nausea, constipation, fatigue, decreased appetite, andrash• In combination with cabozantinib: diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysaesthesiasyndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea,dysgeusia, abdominal pain,...
... Show morePrecautions
• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue,including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediatedhepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adversereactions, and immune-mediated nephritis and renal dysfunction• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function atbaseline and periodically during treatment. Withhold or permanently discontinue based on severity and typeof reaction• Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue Nivolumab basedon severity of reaction• Complications of allogeneic HSCT: Fatal and other serious complications can occur in patient who receiveallogeneic HSCT before or...
... Show moreUse in Pregnancy & Lactation
Pregnancy: Nivolumab can cause fetal harm when administered to a pregnant woman.Lactation: There are no data on the presence of nivolumab in human milk, the effects on the breastfed child, orthe effects on milk production.Contraception: Based on its mechanism, Nivolumab can cause fetal harm when administered to a pregnantwoman. Advise females of reproductive potential to use effective contraception during treatment with Nivolumaband for at least 5 months following the last dose of Nivolumab.Pediatric Use: The safety and effectiveness of Nivolumab have not been established in pediatric patients lessthan 12 years old with MSI-H or dMMR mCRC or in pediatric patients...
... Show moreStorage
Store at 2-8° C (in a refrigerator). Do not freeze. Keep away from light and out of reach of children.
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