applepharmaceutical@gmail.com
drugs

PRODUCT DETAILS

Brand Name : Opdyta
Composition : Nivolumab
Strength availability : 100mg
Manufactured by : BMS India Pvt ltd
Pack : 1 injection in 1 vial
for MORE INFORMATION !!!

Opdyta 100mg is prescription drug which is used under supervision of doctor
Opdyta 100mg belongs to human monoclonal antibody whichstops the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Opdyta 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 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.

INDICATION

Opdyta 100mg is indicated for the treatment of patients having :
• Melanoma
• Non-Small Cell Lung Cancer
• Kidney (Renal Cell) Cancer

DOSAGE

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
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.

MECHANISM

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.

ADME

Absorption:
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.

DRUG INTERACTION

No formal pharmacokinetic drug interaction studies

PRECAUTION

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

STORAGE

Store at under refrigeration at 2℃ to 8℃.

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.

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

We'd Like to Hear From You!

PRESCRIPTION POLICY

1. myapplepharma.com, a fully licensed and regulated pharmacy, takes all precautions to strictly abide by the laws and regulations set forth in the dispensing of prescription medications. By placing the order for your prescription medicines, you acknowledge and accept the following terms regarding the purchase of any prescription medicines.
2. myapplepharma.com will not dispense any prescription medication without a valid prescription from a licensed physician.
3. If you are ordering prescription medication(s), you hereby confirm that you will send us a scanned copy of your valid prescription(s) via email, fax, Whatsapp, or by post, and this prescription shall then be subject to the scrutiny of and approval by our qualified Pharmacists.
4. The drug information provided in the myapplepharma.com is for informative purposes only and this Website is not intended to provide diagnosis, treatment or medical advice. We are not liable for any adverse effects or harm to you as a result of your reliance on the information in the Website.
5. myapplepharma.com requires either the User or Customer or the Caregiver to confirm he/she is completely aware of the indications, side effects, drug interactions, effects of missed dose or overdose of the medicines he/she orders from us. It is imperative to seek professional advice from your physician before purchasing or consuming any medicine from myapplepharma.com.
6. At myapplepharma.com, a Caregiver can order prescription medicines on your behalf.


This information should not be used to decide whether to accept this product or any other medicine. Only a health care provider is knowledge and training to decide that a medicine suitable for a specific patient. This information does not support any drug as safe, are effective or approved for the treatment of any patient or health condition. It's simple a brief overview of general information about this product. It does not include all information on possible applications, indications, warnings, precautions, interactions, adverse effects or risks that may be relevant to this product. This information is not specific medical advice and does not replace information obtained from your health care provider. You should check with your health care provider for complete information about the risks and benefits of using this product.