Opdyta 100MG

Opdyta 100mg belongs to a group of cancer drugs known as monoclonal antibodies. Opdyta 40mgis 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 100mg is prescription drug which is used under supervision of doctor

Nivolumab

Opdyta

100mg

BMS India Pvt Ltd




INDICATION

Opdyta 100mg is indicated for the treatment of patients having Melanoma

Opdyta 100mg is indicated for the treatment of patients having Non-Small Cell Lung Cancer

Opdyta 100mg is indicated for the treatment of patients having Kidney (Renal Cell) Cancer .

Mechanism of action

Opdyta prohibits the molecule activity called PD-1, and it is a protein which prevents T cells from recognize and attacking inflamed tissues and cancer cells. PD-1 can deceitthe immune system into overlooking melanoma cells as normal cells. Opdyta triggers your immune system’s reacting to melanoma by preventing the PD-1 protein on T cells. The drug stimulate T cells so which they can attack melanoma cells anywhere in your body.



Pharmacokinetic

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

Volume of distribution is reported to be 8L

There is no information regarding the plasma protein bounding

Half-life elimination of Opdyta is 26.7 days.



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drug
Brand Opdyta
Ingredients Nivolumab
Strength 100mg
Manufactured BMS India Pvt Ltd
Rating

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
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 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 :
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.

Side effects

Common side effects
• Fatigue • Lymphocytopenia (Low White Blood Cells) • Low Sodium • Shortness of breath • Musculoskeletal Pain • Decreased Appetite • Cough

Less common side effects

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 • Drug interaction • No formal pharmacokinetic drug interaction studies

Precautions

Immune-mediated pneumonitis may appear to the patients; withhold for moderate and permanently discontinue for serious or life-threatening pneumonitis
Other clinically significant and possible fatal immune-mediated side effects (eg, myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis) can appear after therapy discontinuation.
Serious infusion reactions resulted (rare, <1%); stop if severe or life-threatening; break or slow rate of infusion in patients with mild or moderate infusion reactions
Immune-mediated colitis resulted; withhold for moderate or serious and permanently stop for life-threatening colitis
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.
It may cause fetal harm; advise of possible risk to a foetus and use of effective contraception




There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a foetus. Since the effects of Opdyta 100mg are expected to be greater during the second and third trimesters of pregnancy.

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

Store at under refrigeration at 2°C to 8°C.

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.


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