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Avlayah (tividenofusp alfa-eknm)

  • Medicine Name: Avlayah
  • API: Tividenofusp alfa-eknm
  • Dosage Form & Strength: Lyophilized Powder for Injection: 150 mg
  • Manufactured By: Denali Therapeutics Inc.

Medical Uses

Avlayah (tividenofusp alfa-eknm) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg before advanced neurologic impairment.

This indication is approved under accelerated approval depending on reduction of cerebrospinal fluid heparan sulfate noticed in patients treated with Avlayah.

Limitations of Use: This therapeutic drug is not recommended for use in combination with other enzyme replacement therapies.

Recommended Dosage:
The recommended starting dosage of Avlayah for pediatric patients weighing at least 5 kg is 3 mg/kg administered once weekly via intravenous infusion. Administer each dosage level for at least 4 weeks before escalating to the next dosage level.
The recommended maintenance dosage of Avlayah for pediatric patients who weigh at least 5 kg is 15 mg/kg administered once weekly via intravenous infusion.
The recommended dosage of Avlayah for pediatric patients weighing ≥5 kg is as follows:

  • Week 1 to Week 4: 3 mg/kg once weekly
  • Week 5 to Week 8: 7.5 mg/kg once weekly
  • Week 9 and beyond: 15 mg/kg once weekly (maintenance dosage)

Do not escalate the dosage level of Avlayah (tividenofusp alfa-eknm) if the current dosage level is not tolerated.

If any dose of Avlayah is missed, skip the missed dose. Avoid taking a double dose to compensate for a missed dose. Restart treatment as soon as possible, maintaining the one-week interval between infusions thereafter. Resume dosing at the last administered dosage following the recommended infusion rate.

Warning & Precautions

  • Infusion-associated reactions may occur during or after the use of Avlayah. Monitor patients closely for symptoms such as fever, chills, rash, breathing difficulties, or low blood pressure. If a severe infusion-associated reaction occurs, permanently discontinue treatment and provide appropriate medical treatment immediately.
  • Avlayah may cause or worsen anemia in some patients. Obtain baseline hemoglobin levels before starting treatment and monitor hemoglobin approximately three months after initiation and as clinically indicated. Provide appropriate supportive care, including evaluation and treatment, based on clinical judgment.
  • Membranous nephropathy has been reported with this treatment. Monitor serum creatinine levels and urinary protein-to-creatinine ratio during therapy. If membranous nephropathy is suspected, perform a complete diagnostic evaluation promptly and initiate appropriate treatment and management measures as necessary.
  • Treatment with Avlayah may cause fetal harm when administered during pregnancy. Advise women of reproductive potential to inform their healthcare provider if they are pregnant or planning pregnancy. Effective contraception should be used during treatment and for the recommended period afterward.
  • It is not known whether this therapeutic drug passes into human breast milk. Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment and for the recommended period after the final dose.

Documentation & Availability

What documents are required to import AVLAYAH to India?

AVLAYAH (tividenofusp alfa-eknm) Injections may be imported by patients or government hospitals in the patients’ names only.
The following documentation is required to import the product:

  • A valid prescription from a qualified doctor.
  • Patient’s diagnostic reports
  • Patient ID proof (issued by the Government of India)
How does the order get confirmed?

The order will be confirmed only after the receipt of:

  • A valid prescription from the Doctor
  • Import permit if applicable
Is AVLAYAH available in India?

AVLAYAH (tividenofusp alfa-eknm Injections) is a (prescription drug, prescription medication, or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.

IPN (Indian Pharma Network) facilitates the import of cancer medicines under named patient supply (NPS). Indian Pharma Network is the facilitator, providing input

  • On the availability of Avlayah in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, etc.)
  • On availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE).
    Avlayah price in India.
  • Finding Genuine and reliable sources from the USA, Canada, Europe, and Australia
  • Ensuring 100% transparency.

AVLAYAH can be made available to patients, doctors, and hospitals in Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and other cities across India. The order will be confirmed only after the receipt of a valid prescription from the doctor and an import permit.

IPN (Indian Pharma Network) can facilitate the supply of AVLAYAH (prescription medicines) to all locations in the world and India after fulfilling the legal requirements (if applicable).

Please contact us at WhatsApp: +91 98104 69557 | Toll-Free Number: 1800-1200-365 or write us at info@indianpharmanetwork.in for Avlayah cost in India.

We guarantee quality and delivery anywhere in the world as per the buyer’s requirements.

Sourcing & Delivery

Indian Pharma Network can source AVLAYAH (Cancer Treatment Medicines) from across the globe and can supply. Indian Pharma offers its customers worldwide access to the best available treatment.

Indian Pharma Network (IPN) can dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.

FAQ

What is the Generic Name for the trade name drug Avlayah®?

Tividenofusp alfa-eknm is the generic name for the trade name drug Avlayah®.

What is the Manufacturer’s Name of Avlayah®?

Avlayah® is manufactured by Denali Therapeutics Inc.

Is Avlayah® approved by the FDA?

Yes. Avlayah® is approved by the FDA. Date of first approval: March 24, 2026.

What strengths and dosage forms are available for Avlayah®?

Avlayah® is available for injection: 150 mg of tividenofusp alfa-eknm as a lyophilized powder in a single-dose vial for reconstitution and further dilution for intravenous use.

What are the most common side effects of Avlayah® Injections?

The most commonly reported side effects of Avlayah are upper respiratory tract infection, rash, ear infection, vomiting, pyrexia, anemia, cough, diarrhea, COVID-19, nasal congestion, fall, rhinorrhea, skin abrasion, headache, and urticaria.

How does Avlayah Import in India work?

Avlayah Import in India can be done through the Named Patient Program (NPP). This means the medicine can be imported on behalf of the patient with a valid doctor’s prescription. Indian Pharma Network (IPN) helps manage the complete process, including approvals and delivery, making sure the medicine reaches the patient safely and legally.

Who is a reliable Avlayah supplier in India?

Indian Pharma Network (IPN) is a trusted Avlayah supplier in India, facilitating compliant access through global sourcing channels and structured documentation support for eligible patients under applicable regulatory provisions.

How much does Avlayah® Injection cost in India?

Avlayah® is not yet approved in India. However, patients in India can legally access it through the provision called the Named Patient Program (NPP). Avlayah prices may fluctuate over time because of market dynamics and regulatory changes. For the most transparent and latest Avlayah cost in India, please call/WhatsApp +91 98104 69557 or send an email to info@indianpharmanetwork.in.

Can Avlayah® Injections be available in SAARC countries?

Apart from Gulf countries, Avlayah® Injections can be accessed through import provisions like the Named Patient Program (NPP) in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). Indian Pharma Network (IPN) can help facilitate the legal supply of Avlayah® Injections in these countries. We help provide legal access to this therapeutic drug through our reliable channels.

Is it safe to buy Avlayah® Injections online in India?

Yes, one can buy Avlayah in India at the lowest price from the Indian Pharma Network (IPN) if this medicinal product is not yet registered or available in their country. We can help facilitate the import of Avlayah® Injections through legal channels.

Who is an authorized Avlayah importer in India?

Indian Pharma Network (IPN) acts as an Avlayah importer in India. We help with Named Patient Import processes, regulatory documentation, and compliant procurement from leading international manufacturers for patients who need this therapy.

What are the storage conditions of Avlayah® Injections?

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. It is not advisable to freeze or shake the medicine.

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