Navigo IV Infusion

Introduction

Navigo IV Infusion 40 mg/4 ml is a monoclonal antibody that works by targeting the PD-1 pathway that is responsible for regulating the body’s immune response. It is used to treat several types of cancers, including melanoma, lung cancer, renal cell cancer, and Hodgkin's lymphoma.

Uses

Navigo IV Infusion 40 mg/4 ml is used for treating certain types of metastatic cancer, including certain types of melanoma, non-small cell lung cancer, and Hodgkin lymphoma. It is also used for treating certain types of bladder cancer, colorectal cancer, and renal cell cancer.

Brand Name	Navigo
Type	IV Infusion
Weight	40 mg/4 ml
Generic	Nivolumab
Manufacturer	Incepta Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Navigo IV Infusion 40 mg/4 ml works by targeting the PD-1 pathway, a part of the body’s immune system. It enhances the body’s ability to fight cancer cells by blocking the PD-1 receptor on T-cells. This helps activate the T-cells and enhances their ability to fight cancer.

How Long Does It Take to Work?

The effects of nivolumab can start to appear within a few weeks of treatment. However, it can take several weeks or months for the full effects to be seen. The response rate to nivolumab varies from person to person.

Absorption

Navigo IV Infusion 40 mg/4 ml is rapidly absorbed and peaks in the serum within 24-48 hours following administration. The absorption rate of nivolumab is not affected by the route of administration.

Route of Elimination

Navigo IV Infusion 40 mg/4 ml is mainly cleared via the hepato-biliary route. The majority of nivolumab is bound to albumin and is eliminated in the bile as an inactive conjugate. Minor amounts are excreted in the urine.

Dosage

Administer by intravenous infusion 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, then 240 mg every 2 weeks or 480 mg every 4 weeks.

Adjuvant treatment of melanoma: 240 mg every 2 weeks or 480 mg every 4 weeks.

Metastatic non-small-cell lung cancer:

3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks.
360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy.
240 mg every 2 weeks or 480 mg every 4 weeks.

Malignant pleural mesothelioma: 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks.

Advanced renal cell carcinoma:

3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.
240 mg every 2 weeks or 480 mg every 4 weeks administered in combination with cabozantinib 40 mg once daily without food.
240 mg every 2 weeks or 480 mg every 4 weeks.

Classical Hodgkin lymphoma: 240 mg every 2 weeks or 480 mg every 4 weeks.

Recurrent or metastatic squamous cell carcinoma of the head and neck: 240 mg every 2 weeks or 480 mg every 4 weeks.

Locally advanced or metastatic urothelial carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks.

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer:

Adult and pediatric patients ≥40 kg: 240 mg every 2 weeks or 480 mg every 4 weeks.
Pediatric patients <40 kg: 3 mg/kg every 2 weeks.
Adult and pediatric patients ≥40 kg: 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks.

Hepatocellular carcinoma:

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, then 240 mg every 2 weeks or 480 mg every 4 weeks.

Esophageal squamous cell carcinoma: 240 mg every 2 weeks or 480 mg every 4 weeks.

Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC, GEJC, or EAC):

360 mg every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks.
240 mg every 2 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks.

Navigo IV Infusion 40 mg/4 ml is administered as a single intravenous dose of 240 mg every 2 weeks. In some cases, a higher dose may be used. The duration of treatment depends on the type of cancer being treated and the patient’s response to treatment.

Administration

Navigo IV Infusion 40 mg/4 ml is administered intravenously (IV) in a hospital setting. The dose is usually given after diluting it in a 0.9% sodium chloride solution. The infusion should not exceed 2 hours. It is important to closely monitor the patient during the infusion for any adverse reactions.

Side Effects

Common side effects of nivolumab include nausea, diarrhea, fatigue, rash, and fever. Other less common side effects may include liver problems, swelling of the hands and feet, increased blood pressure, and cough.

Toxicity

Navigo IV Infusion 40 mg/4 ml is generally well tolerated and is associated with a low incidence of serious adverse events. The most commonly reported serious adverse effects include immune-related events such as pneumonitis and colitis.

Precautions

Before starting treatment with nivolumab, it is important to inform your doctor of any other medications or supplements that you are taking. It is also important to inform your doctor if you have any allergies or a history of liver or kidney disease.

Interactions

Navigo IV Infusion 40 mg/4 ml may interact with other medications, including chemotherapy drugs, immunosuppressants, and corticosteroids. It is important to inform your doctor of any medication or herbal supplement that you are taking before starting treatment with nivolumab.

Disease Interactions

Navigo IV Infusion 40 mg/4 ml may interact with certain diseases, including infections and viral infections. It is important to inform your doctor of any medical condition that you have before starting treatment.

Drug Interactions

Navigo IV Infusion 40 mg/4 ml may interact with other drugs, including medication used to treat heart problems, high blood pressure, diabetes, and infections. It is important to inform your doctor of any other medications or supplements that you are taking before starting treatment.

Food Interactions

Navigo IV Infusion 40 mg/4 ml may interact with certain food items, so it is important to discuss any dietary restrictions or food allergies that you have before starting treatment.

Pregnancy Use

Navigo IV Infusion 40 mg/4 ml is classified as a pregnancy category D drug, which means that there is evidence that it may cause harm to a developing fetus. It should not be used during pregnancy unless the benefits outweigh the risks.

Lactation Use

Navigo IV Infusion 40 mg/4 ml should not be used during lactation. If you are breastfeeding, it is important to discuss the risks and benefits of treatment with your doctor before starting treatment.

Acute Overdose

There is no known antidote for an acute overdose of nivolumab. If an overdose is suspected, the patient should be monitored closely and supportive care should be provided as needed.

Contraindications

Navigo IV Infusion 40 mg/4 ml should not be used in patients with a known hypersensitivity to the drug. It should also not be used in combination with other PD-1 or PD-L1 inhibitors or with live vaccines.

Use Directions

Navigo IV Infusion 40 mg/4 ml should be administered under the supervision of a healthcare professional in a hospital setting. The drug should be given as an intravenous infusion after diluting it in 0.9% sodium chloride solution. The infusion should not exceed 2 hours.

Storage Condition

Navigo IV Infusion 40 mg/4 ml should be stored at room temperature in a dry place. It should be kept away from heat and direct sunlight. It should also be stored away from children and pets.