Opdyta 100mg


Description


Nivolumab is a generic form of brand name Opdyta 100mg which is a targeted therapy drug presently used to cure from melanoma, non-small cell lung cancer or kidney (renal cell) cancer. 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.


Indication


Opdyta 100mg is indicated for the treatment of patients having conditions like :
• Melanoma which has spread or can’t be removed with surgery
• Non-Small Cell Lung Cancer which has spread or come back after chemotherapy
• Kidney (Renal Cell) Cancer which has come back after chemotherapy.


ADME


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.







Mechanism Of Action


Opdyta stops the moleculeactivity called PD-1, and it is a protein whichinhibits T cells from identifying and attacking inflamed tissues and cancer cells. PD-1 can trick the immune system into overlooking melanoma cells as normal cells. Opdyta triggers your immune system’s reacting to melanoma by inhibiting the PD-1 protein on T cells. The drug activates T cells so which they can attack melanoma cells anywhere in your body.

Dosage and administration


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 30 minutes on the same day. Duration 3 weeks of max 4 doses, after completing combination dose continue the single agent treatment.
For classical Hodgkin lymphoma :
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.
Squamous cell carcinoma of head and neck:
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.
Urothelial 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.

Precautions


Immune-mediated pneumonitis may appear to the patients; withhold for moderate and permanently discontinue for serious or life-threatening pneumonitis
Immune-mediated colitis resulted; withhold for moderate or seriousand 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.
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
It may cause fetal harm; advise of possible risk to a foetus and use of effective contraception

Pregnancy


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

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 :
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.

Missed Dose


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.



Lactation


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


Storage


Store at under refrigeration at 20C to 80C.


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