Ayvakit (Avapritinib) is indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations, advanced systemic mastocytosis (AdvSM) which includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), mast cell leukemia (MCL) and indolent systemic mastocytosis (ISM). 

It is a selective tyrosine kinase inhibitor targeting KIT D816V, PDGFRA D842V, and multiple KIT mutations with potent IC50s (<25 nM). It inhibits autophosphorylation and cell proliferation in KIT/PDGFRA mutant cell lines and shows anti-tumor activity in xenograft models, including imatinib-resistant GIST and mastocytoma.

It offers a targeted treatment option for advanced systemic mastocytosis and gastrointestinal stromal tumors (GIST). With strong central nervous system penetration and selectivity, avapritinib demonstrates high efficacy and durable responses. Its unique mechanism supports use in mutation-driven cancers with limited treatment options.

Avapritinib is not recommended for the treatment of patients with AdvSM or ISM with platelet counts of less than 50 X 109/L. The common side effects of avapritinib use include intracranial hemorrhage, cognitive effects and photosensitivity. 

There is no data on the presence of avapritinib or its metabolites in human milk or effects on breastfed children or milk production. Post partum women are advised not to breastfeed during treatment or two weeks following the final dose. Advise effective contraception during treatment and for 6 weeks post final dose due to potential fetal harm. Avapritinib may impair male and female fertility. Safety and effectiveness in pediatric patients not established. No overall differences in safety or effectiveness in patients above 65 years of age, compared to younger patients. No dose adjustment required for patients with mild or moderate renal or hepatic impairment. Recommended dose not established for patients with severe renal impairment. A lower starting dose for patients with severe hepatic impairment is advised. 

Pricing and Availability 

Avapritinib is not approved for commercial sale in India and is therefore unavailable through regular pharmacies or local distributors. Since it is a prescription-only therapy, pricing details for those looking to import avapritinib in India are provided upon request, after submitting valid medical documents and a doctor’s prescription. For the latest pricing information and procurement support, patients or caregivers should contact our team directly.

The price of avapritinib in India may vary depending on several factors, including supplier source, market conditions, regulatory requirements, and international availability. Additional elements such as shipping costs, documentation fees, origin country, and currency exchange rates may also influence the final price.

Fluctuations in GST or local taxes, as well as adjustments in manufacturer pricing policies, can further affect total cost. We facilitate patient access to avapritinib in India under the Named Patient Supply (NPS) program, ensuring full legal and regulatory compliance. Our dedicated support team oversees the process from document verification to final delivery, ensuring safety and transparency at each stage.

Access Pathway

Since avapritinib is not commercially licensed in India, it can only be accessed through the Named Patient Import Program (NPIP). Through this route, we assist patients in obtaining unregistered medicines like avapritinib under the NPS framework, in accordance with applicable import regulations.

Avapritinib is available as 25 mg, 50 mg, 100 mg, 200 mg and 300 mg tablets, in bottles of 30 tablets. 

Import Process

1. Submission of Request: Patients or caregivers initiate the process by submitting a formal request, along with treatment details and a valid prescription.
2. Form 12A Application: An application must be submitted in Form 12A, accompanied by a prescription issued by a Registered Medical Practitioner (RMP).
3. Document Verification: All submitted medical and identification documents are reviewed to confirm eligibility for import under the personal medical use category.
4. Regulatory Authorization: Upon approval from the Drugs Controller General (India), the import procedure is initiated as per the approved prescription.
5. Global Sourcing: Our procurement team collaborates with authorized international suppliers to source the medicine at the most competitive rate, ensuring product authenticity and compliance.
6. Delivery and Fulfilment: Following regulatory approval, logistics and customs procedures are coordinated to ensure secure, compliant, and timely delivery to the patient’s address in India.
   

Required Documentation

To facilitate import of avapritinib in India, patients are required to provide:

• A valid doctor’s prescription specifying the medicine name, dosage, treatment duration, and diagnosis.
• Recent medical history and supporting laboratory reports (preferably within the past three months).
• Government-issued identification and proof of residence of the patient.
• Import permit (if applicable).
  

Orders are finalized only upon receipt of all required documents and verification of medical eligibility. Once the import permit is approved, the licensed supplier arranges shipment of avapritinib to India from approved international sources such as the United States, Canada, Europe, or Australia.

We ensure that every import is conducted safely, ethically, and in full regulatory compliance. Our organization provides nationwide delivery through verified suppliers, guaranteeing product authenticity and complete transparency in pricing and process. All prescriptions are reviewed and dispensed by registered pharmacists prior to delivery.

For detailed information or pricing, patients can contact 247QualityMeds.com directly. Our team is available to assist with all inquiries and guidance.