Opdyta 100mg injection | Nivolumab | Millionpharma

OPDYTA 100MG

DESCRIPTION:

Opdyta 100mg consist of human monoclonal antibody to compute cell death receptor 1 (PD-1), which harmonize T cell immune reactivity and is necessary in the immunotherapy of cancer.
Opdyta 100mg injection has most important side effects and Specific immune related conditions, containing acute liver injury which can be severe and even life threatening.
Opdyta 100mg which is used asprescription drug under supervision of doctor.

Non-Small Cell Lung Cancer

INDICATION:

Opdyta 100mg is anticancer medication which is;
Indicated for the treatment of patients having Melanoma
Indicated for the treatment of patients having Non-Small Cell Lung Cancer
Indicated for the treatment of patients having Kidney (Renal Cell) Cancer

MECHANISM OF ACTION:

Nivolumab belongs to type of immunotherapy. This type of treatment provokes the body’s immune system to fight cancer cells.
Nivolumab aims and stops a protein called PD-1 on the surface of certain immune cells called T-cells.
Inhibiting PD-1 activates the T-cells to find and kill cancer cells.

OPDYTA 100Mg

PRODUCT DETAILS:

Brand :Opdyta
Ingredients : Nivolumab
Strength : 100mg
Manufactured : BMS India Pvt Ltd
Package : 1 injection in 1 vial

ADME

Maximum 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.

DOSAGE MANAGEMENT:

Opdyta 100mg injection prescribed dosage for unresectable or metastatic melanoma
As Monotherapy is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity
Interaction with ipilimumab. The usual dose of Opdyta 100mg is 1mg/kg given as an intravenous infusion over 30 minutes, followed by ipilimumab 3mg/kg given as IV over 90 minutes on the same day. A period 3 weeks of max 4 doses, after completing combination dose continue the single agent treatment
As single agent for adjuvant treatment of melanomathe usual dose is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease development or unacceptable toxicity for up to 1 year.
As single agent for Non-small cell lung cancerthe usual dose is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity.
As single agent for small cell lung cancer the usual dose is either 240mg every 2 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity for up to 1 year.
As single agent for renal cell carcinoma the usual dose is either 240mg every 2 weeks or 480mg every 4 weeks given as IV infusion over 30 minutes until disease progression or unacceptable toxicity.
Opdyta 100 injection with ipilimumab the usual doseis 3mg/kg administrated as IV infusion over 30 minutes and followed by 1mg/kg administrated as IV infusion over 30minutes on the same day. A period3 weeks of max 4 doses, after completing combination dose continue the single agent treatment.

PRECAUTIONS:

• When treatment with Opdyta 100mg,Immune-mediated hepatitis observed in clinical trials; check for difference in liver function; withhold for moderate and permanently stop for severe or life-threatening transaminase or total bilirubin elevation
• When treatment with Opdyta 100mg injection Immune-mediated pneumonitis may appear to the patients; withhold for moderate and permanently discontinue for serious or life-threatening pneumonitis
• When treatment with Opdyta 100mg Other clinically significant and possible fatal immune-mediated side effects (eg, myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis) can appear after therapy discontinuation.
• When treatment with Opdyta 100mg injection 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
• When treatment with Opdyta 100mg Immune-mediated colitis resulted; withhold for moderate or serious and permanently stop for life-threatening colitis
• When treatment with Opdyta 100mg injection 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.
• When treatment with Opdyta 100mg It may cause fetal harm; advise of possible risk to a foetus and use of effective contraception

SIDE EFFECTS:

Common side effects of Opdyta 100mg :

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

Less common side effects Opdyta 100mg :

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 immediately, if time reach for next dose, then swap missed dose and follow regular schedule. Avoid taking two doses at a time. Avoid taking missed dose within 12hrs of the next dose.

PREGNANCY:

Pregnancy category D: Inform 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.

LACTATION:

Inform breastfed women to discontinue breastfeeding during treatment with the drug Opdyta 100mg

STORAGE:

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

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