Brand Name : Opdyta
Composition : Nivolumab
Strength availability : 40mg
Manufactured by : BMS India Pvt ltd
Pack : 1 injection in 1 vial
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Opdyta 40mg is prescription drug which is used under supervision of doctor
Opdyta 40mg belongs to human monoclonal antibody whichstops the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Opdyta 40mg 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 40mg is also known as an immune checkpoint inhibitor. Sometimes these drugs are called targeted therapies because they target specific proteins (receptors) on the surface of cells.
Opdyta 40mg is indicated for the treatment of patients having :
• Non-Small Cell Lung Cancer
• Kidney (Renal Cell) Cancer
Opdyta 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
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.
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.
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.
The time to peak plasma concentration is between 1-4 hours
Distribution:Volume of distribution is reported to be 8L
There is no information regarding the plasma protein bounding
Elimination: Half-life elimination of Opdyta is 26.7 days.
No formal pharmacokinetic drug interaction studies
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 may cause fetal harm; advise of possible risk to a foetus and use of effective contraception
Store at under refrigeration at 2℃ to 8℃.
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.
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