Medical Use
Ultomiris is a complement inhibitor prescribed for:
- -Treating adults and children (aged one month and older) with paroxysmal nocturnal hemoglobinuria (PNH).
- -Treating adults and children (aged one month and older) with atypical hemolytic uremic syndrome (aHUS) to prevent complement-mediated thrombotic microangiopathy (TMA).
Recommended Dosage:
For both PNH and aHUS in patients aged one month or older and weighing 5 kg or more, the dosing regimen includes an initial loading dose followed by maintenance doses. These are administered via intravenous infusion and are based on the patient’s body weight. Maintenance doses should begin two weeks after the loading dose and continue every 4 or 8 weeks, depending on body weight. The schedule can occasionally vary within one week of the planned infusion day (except for the first maintenance dose), but subsequent doses should follow the original schedule.
Dosage by Body Weight:
- -5 to <10 kg: 600 mg (Loading Dose); 300 mg maintenance dose every 4 weeks.
- -10 to <20 kg: 600 mg (Loading Dose); 600 mg maintenance dose every 4 weeks.
- -20 to <30 kg: 900 mg (Loading Dose); 2,100 mg maintenance dose every 8 weeks.
- -30 to <40 kg: 1,200 mg (Loading Dose); 2,700 mg maintenance dose every 8 weeks.
- -40 to <60 kg: 2,400 mg (Loading Dose); 3,000 mg maintenance dose every 8 weeks.
- -60 to <100 kg: 2,700 mg (Loading Dose); 3,300 mg maintenance dose every 8 weeks.
- -100 kg or more: 3,000 mg (Loading Dose); 3,600 mg maintenance dose every 8 weeks.
Warning & Precautions
Ravulizumab and Meningococcal Infections:
Patients treated with Ravulizumab are at an increased risk of developing serious meningococcal infections, such as septicemia and meningitis. These infections can arise from any serogroup.
Vaccination and Prophylaxis:
- -Vaccination: Ensure patients without a known history of meningococcal vaccination are immunized at least 14 days before their first dose of Ultomiris.
- -Urgent Therapy: If immediate Ultomiris therapy is necessary for an unvaccinated patient, administer the meningococcal vaccine(s) as soon as possible and provide 14 days of antibacterial prophylaxis.
Monitoring and Patient Education:
- -Early Detection: Closely monitor patients for early signs and symptoms of meningococcal infection. Promptly evaluate any suspected infections.
- -Patient Awareness: Educate patients about the signs and symptoms of meningococcal infection and the importance of seeking immediate medical attention. Meningococcal infections can become life-threatening or fatal if not identified and treated promptly.
Post-Therapy Monitoring:
After discontinuing Ultomiris, monitor patients closely for signs of hemolysis, such as elevated LDH levels, sudden drops in PNH clone size or hemoglobin, and symptoms like abdominal pain, fatigue, shortness of breath, hemoglobinuria, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction.
Infusion-Related Reactions:
Ravulizumab may cause infusion-related reactions, including anaphylaxis and hypersensitivity. These reactions typically do not require stopping the therapy. However, if signs of cardiovascular instability or respiratory compromise occur, interrupt the infusion and provide appropriate supportive measures.
Documentation Availability
Documents required to import ULTOMIRIS to India?
ULTOMIRIS (ravulizumab) 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 ULTOMIRIS (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 Ultomiris®?
The generic name for Ultomiris® is Ravulizumab.
Who Manufactures Ultomiris®?
Ultomiris® is manufactured by Alexion Pharmaceuticals, Inc.
Is Ultomiris® FDA Approved?
Yes, Ultomiris® received FDA approval on December 21, 2018.
What are the Dosage Forms and Strengths of Ultomiris®?
Ultomiris® is available as an injection in three dosage strengths:
- -300 mg/30 mL (10 mg/mL) in a single-dose vial.
- -300 mg/3 mL (100 mg/mL) in a single-dose vial.
- -1,100 mg/11 mL (100 mg/mL) in a single-dose vial.
What are the Common Side Effects of Ultomiris®?
For patients with PNH, common side effects include upper respiratory tract infections and headaches. For patients with aHUS, common side effects include diarrhea, upper respiratory tract infections, nausea, hypertension, vomiting, headaches, and fever (pyrexia).
How Much Does Ripretinib Cost in India?
The cost of Ultomiris® in India is reasonable and can vary. For authentic procurement, you can reach out to Rx4u team.
What are the Storage Conditions for Ultomiris®?
Store Ultomiris® vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in their original carton to protect from light. Do not freeze or shake the vials.
Is it Safe to Buy Ultomiris® Online from India?
Yes, you can safely purchase Ultomiris® online in India through https://rx4u.in/.
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