Xenpozyme (olipudase alfa-rpcp)

For the treatment of adult and pediatric patients with non-central nervous system signs of acid sphingomyelinase deficiency (ASMD), XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme.

Dosage and Administration:

• Prior to initiating treatment with Xenpozyme (olipudase alfa-rpcp), it is essential to conduct preliminary assessments, including verifying the pregnancy status in females of reproductive potential and obtaining baseline transaminase levels.
  
•  To enhance the overall treatment experience, consideration should be given to pre-treating individuals with antihistamines, antipyretics, and/or corticosteroids. 
  
• The recommended starting dose for adults is 0.1 mg/kg, administered as an intravenous infusion, offering a tailored approach to meet the individual needs of adult patients. 
  
• For pediatric cases, the starting dose is adjusted to 0.03 mg/kg, ensuring safety and appropriateness for younger patients. 
  
• For a comprehensive guide on dose escalation, maintenance dosage, modifications to minimize adverse reactions, and detailed preparation and administration instructions, healthcare professionals are advised to refer to the Full Prescribing Information accompanying Xenpozyme (olipudase alfa-rpcp). 
  

• Hypersensitivity Reactions: Before administering XENPOZYME, consider pretreatment and have appropriate medical support for potential hypersensitivity reactions. Discontinue immediately in case of severe reactions, including anaphylaxis, and initiate prompt treatment. It is advisable to test for antibodies in patients experiencing severe hypersensitivity reactions.
  
•  Infusion-Associated Reactions: To mitigate the risk of infusion-associated reactions (IARs), antihistamines may be given prior to XENPOZYME administration. In the event of severe IARs, discontinue XENPOZYME and assess the risks before considering re-administration. Adjusting the infusion rate or temporarily withholding the dose may be appropriate for mild to moderate reactions.
  
• Elevated Transaminases Levels: Regular monitoring of transaminases levels is crucial during XENPOZYME treatment. Adjust the dosage or temporarily withhold treatment based on the observed levels. Most cases of elevated transaminases returned to baseline values at the next scheduled infusion.
  
• Risk of Fetal Malformations: The initiation or escalation of XENPOZYME dosage during pregnancy is not recommended due to the potential risk of fetal malformations. Before starting treatment, verify the pregnancy status, discuss potential risks, and advise females of reproductive potential to use effective contraception during XENPOZYME therapy and for 14 days after the last dose.

If you are considering the import of Xenpozyme (olipudase alfa-rpcp)  to India, please be aware that Xenpozyme (olipudase alfa-rpcp)can be imported by patients or government hospitals solely in the name of the patients. The following documentation is essential for the successful import of this medication:

Required Documentation for Import:

• A valid prescription from a qualified medical practitioner.
  
• Diagnostic reports of the patient.
  
• Government-issued identification proof for the patient, as recognized by the Government of India.

Order Confirmation Process: 

The order for Xenpozyme (olipudase alfa-rpcp) will be confirmed upon the receipt of the following documents:

• A valid prescription from a qualified doctor.
  
• An import permit, if applicable.

Availability of Xenpozyme (olipudase alfa-rpcp) in India: 

Xenpozyme (olipudase alfa-rpcp)  is classified as a prescription pharmaceutical drug. Consequently, it legally requires a medical prescription to be dispensed. Indian Pharma Network (IPN) specializes in facilitating the import of cancer medicines through named patient supply (NPS), ensuring transparency and authenticity by sourcing from reputable suppliers in the USA, Canada, Europe, and Australia.

Xenpozyme (olipudase alfa-rpcp) can be made accessible to patients, doctors, and hospitals in various cities across India, including but not limited to Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and Pune. To confirm an order, a valid prescription from a doctor and an import permit will be required.

IPN (Indian Pharma Network) is dedicated to facilitating the supply of Xenpozyme. (prescription medicines) to locations both within India and worldwide, while adhering to relevant legal requirements.Our commitment lies in assuring quality and timely delivery to meet the healthcare needs of patients and medical professionals across the globe.

Is Xenpozyme FDA-approved?

Yes, Xenpozyme (olipudase alfa-rpcp) received FDA approval as an enzyme replacement therapy for acid sphingomyelinase deficiency (ASMD), providing a treatment option for patients with this rare genetic disorder.

How did the FDA evaluate Xenpozyme’s safety and efficacy?

The FDA approval for Xenpozyme was based on clinical trials demonstrating its safety and effectiveness in addressing acid sphingomyelinase deficiency. The approval process involved a thorough review of clinical data, ensuring the medication meets regulatory standards for patient use.

What is Xenpozyme?

Xenpozyme is an enzyme replacement therapy for acid sphingomyelinase deficiency (ASMD), addressing the deficiency in patients with this rare genetic disorder.

Any potential reactions or side effects?

Possible hypersensitivity reactions, including anaphylaxis, and infusion-associated reactions. Monitoring and managing reactions are crucial during therapy.

Can Xenpozyme be used during pregnancy?

Avoid initiating or escalating dosage during pregnancy. Verify pregnancy status, advise contraception, and carefully weigh risks and benefits for pregnant individuals.