Medical Use
Empaveli is a complement inhibitor used to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Recommended Dosage:
- -Vaccination: Patients should be vaccinated against encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B, at least two weeks before starting Empaveli (1,080 mg/20 mL, 54 mg/mL) therapy, following current ACIP guidelines.
- -Antibacterial Prophylaxis: If Pegcetacoplan needs to be started urgently and vaccines were administered less than two weeks prior, provide two weeks of antibacterial prophylaxis.
Dosage: The recommended dose is 1,080 mg, administered by subcutaneous infusion twice weekly using a commercially available infusion pump with a reservoir of at least 20 mL.
Missed Dose: If a dose is missed or skipped, administer it as soon as possible and then return to the regular dosing schedule.
Warning & Precautions
Systemic Hypersensitivity Reactions: Patients treated with Empaveli may experience systemic hypersensitivity reactions such as facial swelling, rash, or urticaria. In the event of a severe reaction, including anaphylaxis, discontinue the infusion immediately, provide appropriate treatment as per standard care, and monitor until symptoms resolve.
Risk of Severe Infections: Pegcetacoplan (1,080 mg/20 mL, 54 mg/mL) can increase the risk of severe, life-threatening, or fatal infections caused by encapsulated bacteria, including Neisseria meningitidis (types A, C, W, Y, and B), Streptococcus pneumoniae, and Haemophilus influenzae type B (Hib).
Vaccination: Patients without a known history of vaccination should receive the necessary vaccines at least two weeks before starting Pegcetacoplan. If immediate treatment is required, administer the vaccines as soon as possible and provide two weeks of antibacterial prophylaxis.
Monitoring and Management: Monitor patients closely for early signs of severe infection and promptly assess any suspected infections. Treat known infections immediately, as severe infections can quickly become dangerous or fatal if not addressed early. Consider discontinuing Empaveli in patients undergoing treatment for severe infections.
Post-Treatment Monitoring: After stopping Empaveli (54 mg/mL), monitor patients for signs of hemolysis, such as elevated LDH levels, sudden reduction in PNH clone size or hemoglobin, or symptoms like abdominal pain, dyspnea, fatigue, hemoglobinuria, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Evaluate patients for at least eight weeks after discontinuation to detect hemolysis and other reactions. If hemolysis occurs, consider restarting Pegcetacoplan.
Pregnancy and Breastfeeding: Women who can become pregnant should use effective contraception during treatment with Pegcetacoplan and for 40 days after the last dose. Women should not breastfeed during treatment and for 40 days after the final dose.
Documentation Availability
Documents required to import EMPAVELI to India?
EMPAVELI (pegcetacoplan) injection can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing EMPAVELI (Cancer Treatment Medicines) from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the Generic Name for Empaveli®?
The generic name for Empaveli® is Pegcetacoplan.
Who Manufactures Empaveli®?
Empaveli® is manufactured by Apellis Pharmaceuticals, Inc.
Is Empaveli® FDA Approved?
Yes, Empaveli® was approved by the FDA on May 14, 2021.
What is the Dosage and Form of Empaveli®?
Empaveli® is available as an injection: 1,080 mg/20 mL (54 mg/mL) in a single-dose vial for subcutaneous use.
What are the Common Side Effects of Empaveli®?
Common side effects include viral infections, injection-site reactions, abdominal pain, infections, diarrhea, respiratory tract infections, and fatigue.
How Much Does Empaveli® Cost in India?
The cost of Empaveli® in India varies. For authentic procurement, you can reach out to Rx4u team.
How Should Empaveli® be Stored?
Store Empaveli® vials at 2-8°C (36-46°F) in the original carton to protect from light. Do not use beyond the expiration date on the carton.
Is it safe to buy Empaveli® online in India?
Yes, you can safely purchase Empaveli® online in India through https://rx4u.in/.
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