Opdyta 100mg (Nivolumab)

Nivolumab
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Brand nameOpdytaInternational trade nameOpdivoActive substanceNivolumabStrength100mgCategoryAnti Cancer

Description of Opdyta 100mg (Nivolumab 100mg)

Opdyta 100mg (Nivolumab 100mg) is prescription medicine which is used under supervision of doctor

Opdyta 100mg (Nivolumab 100mg) belongs to human monoclonal antibody whichstops the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Opdyta 100mg (Nivolumab 100mg) is an IgG4 kappa immunoglobulin which has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line.

Opdyta 100mg (Nivolumab 100mg) is also known as an immune checkpoint inhibitor. Sometimes these medicines are called targeted therapies because they target specific proteins (receptors) on the surface of cells.

Medical use /Indication of Opdyta 100mg (Nivolumab 100mg)

Opdyta 100mg (Nivolumab 100mg) is indicated for the treatment of patients having :

  • Melanoma
  • Non-Small Cell Lung Cancer
  • Kidney (Renal Cell) Cancer

Mechanism of Action Opdyta 100mg (Nivolumab 100mg)

Binding of these ligands to the PD-1 receptor occur on T cells, prohibits T cell multiplication and cytokine production. Upregulation of the PD-1 ligands occurs in some tumor and signallingvia this pathway can provide to prohibition of active T-cell immune surveillance of tumor. Nivolumab belongs to human immunoglobulin G4 (IgG4) monoclonal antibody which binds to the PD-1 receptor and stops its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated prevention of the immune response, containing the anti-tumor immune response, resulting in reduced tumor growth.

Absorption of Opdyta 100mg (Nivolumab 100mg)

The time to peak plasma concentration is between 1-4 hours

Distribution of Opdyta 100mg (Nivolumab 100mg)

Volume of distribution is reported to be 8L

Metabolism of Opdyta 100mg (Nivolumab 100mg)

Not Available

Excretion of Opdyta 100mg (Nivolumab 100mg)

Half-life elimination of Opdyta 100mg (Nivolumab 100mg)  is 26.7 days.

Side effects of Opdyta 100mg (Nivolumab 100mg)

Common side effects :

Fatigue; Lymphocytopenia (Low White Blood Cells); Low Sodium; Shortness of breath; Musculoskeletal Pain; Decreased Appetite; Cough

Less common side effects :

Constipation; Increased serum creatinine; Colitis; Low potassium; Low magnesium; High calcium; Vomiting; Weakness; Diarrhea; High potassium; Low calcium; Swelling; Fever; Rash; Abdominal pain; Increased serum AST; Thrombocytopenia; Increased serum alkaline phosphatase; Chest pain; Weight loss

Precautions of Opdyta 100mg (Nivolumab 100mg)

Immune-mediated pneumonitis may appear to the patients, hence withhold for moderate and permanently discontinue for serious or life-threatening pneumonitis.

Other clinically important and possible fatal immune-mediated side effects (eg, myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis) can appear after therapy discontinuation.

Severe infusion reactions resulted (rare, <1%); discontinue if severe or life-threatening; break or slow rate of infusion in patients with mild or moderate infusion reactions

Immune-mediated hepatitis seen in clinical trials; check for liver function changes; withhold for limited and permanently stop for serious or life-threatening transaminase or total bilirubin elevation.

Opdyta 100mg (Nivolumab 100mg)  may cause fetal harm; advise of possible risk to a foetus and use of effective contraception

Pregnancy of Opdyta 100mg (Nivolumab 100mg)

There are no available human data informing the medicine-associated risk. Advise pregnant women of the potential risk to a fetus.

Lactation of Opdyta 100mg (Nivolumab 100mg)

Opdyta 100mg (Nivolumab 100mg) Excretion in human breast milk is not known; advise women to discontinue breastfeeding during treatment

Dosage of Opdyta 100mg (Nivolumab 100mg)

Opdyta 100mg (Nivolumab 100mg)  recommended dosage for unresectable or metastatic melanoma:

As single agent is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity

With ipilimumab:

The recommended dose of Opdyta is 1mg/kg administrated as an intravenous infusion over 30 minutes, followed by ipilimumab 3mg/kg given as IV over 90 minutes on the same day.

Duration 3 weeks of max 4 doses, after completing combination dose continue the single agent treatment

For adjuvant treatment of melanoma:

As single agent is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity for up to 1 year.

For Non-small cell lung cancer:

As single agent is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity.

For small cell lung cancer :

As single agent is either 240mg every 2 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity for up to 1 year.

For renal cell carcinoma:

As single agent

Dosage either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity.

With ipilimumab

Opdyta of 3mg/kg administrated as IV infusion over 30 minutes and followed by 1mg/kg administrated as IV infusion over 30minutes on the same day. Duration 3 weeks of max 4 doses, after completing combination dose continue the single agent treatment.

Storage of Opdyta 100mg (Nivolumab 100mg)

Store at under refrigeration at 2℃ to 8℃.

Missed dose of Opdyta 100mg (Nivolumab 100mg)

If you missed a dose take it as soon as possible, if time reach for next dose, then skip missed dose and continue regular schedule. Avoid taking two doses at a time. Avoid taking missed dose within 12hrs of the next dose.

Brand name:
Opdyta
International trade name:
Opdivo
Active substance:
Nivolumab
Strength:
100mg
Category:
Anti Cancer
Packaging:
1 Vial
Product form:
Injection

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