- Medicine Name- Ayvakit
- API- Avapritinib
- Strength- it is available as Tablets: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.
- Manufactured by- Blueprint Medicines Corporation
Medicinal Uses:
Gastrointestinal Stromal Tumor (GIST):
- AYVAKIT is indicated for the treatment of adults with unresectable or metastatic GIST.
- Specifically recommended for GIST cases harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including the challenging PDGFRA D842V mutations.
Advanced Systemic Mastocytosis (AdvSM):
- AYVAKIT is approved for the treatment of adult patients diagnosed with AdvSM.
- AdvSM includes various conditions such as aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).
- Limitations of Use for AdvSM: AYVAKIT is not recommended for patients with AdvSM having platelet counts less than 50 X 10^9 /L.
- AYVAKIT is indicated for the treatment of adult patients diagnosed with Indolent Systemic Mastocytosis (ISM).
- Limitations of Use for ISM: AYVAKIT is not recommended for the treatment of patients with ISM having platelet counts less than 50 X 10^9 /L.
Note: Careful consideration of platelet counts is emphasized as a limitation of use for both AdvSM and ISM, ensuring the suitability of AYVAKIT in patients with platelet counts equal to or greater than 50 X 10^9 /L.
Recommended Dosage
Gastrointestinal Stromal Tumor (GIST):
- Patients should be selected for AYVAKIT treatment based on the presence of a PDGFRA exon 18 mutation.
- The recommended dosage for GIST is 300 mg orally once daily.
Advanced Systemic Mastocytosis (AdvSM):
- The recommended dosage for AdvSM is 200 mg orally once daily.
- Indolent Systemic Mastocytosis (ISM):
- The recommended dosage for ISM is 25 mg orally once daily.
Patients with Severe Hepatic Impairment (Child-Pugh Class C):
In cases of severe hepatic impairment (Child-Pugh Class C), the dose of AYVAKIT should be reduced. Specific guidance on dose reduction in this population should be determined based on clinical assessment and medical supervision.
Important Administration Instructions:
- AYVAKIT should be taken orally, with or without food.
- The medication should be swallowed whole with a glass of water.
- Patients should be educated on the importance of adhering to the prescribed dosage and administration schedule.
Note: Dosage adjustments and administration guidance for specific patient populations, such as those with severe hepatic impairment, should be made under the supervision of a healthcare professional, taking into account the patient's individual clinical condition and response to treatment. Regular monitoring may be necessary in such cases.
Warning and Precautions:
Intracranial Hemorrhage: Serious intracranial hemorrhage may occur; fatal events in less than 1% of patients. Monitor closely for risk factors: history of vascular aneurysm, prior intracranial hemorrhage, anticoagulant use, or thrombocytopenia. Symptoms: headache, nausea, vomiting, vision changes, altered mental status. Seek immediate medical attention.
Cognitive Effects: Cognitive adverse reactions in 33% of patients; manage with dose adjustments. Severity-dependent actions: continue at the same dose, resume at the same or reduced dose upon improvement, or permanently discontinue.
Platelet Counts and Thrombocytopenia: In AdvSM, platelet count monitoring essential. Perform every 2 weeks for the first 8 weeks, then adjust frequency based on platelet values.
Cognitive Effects in Specific Conditions: AYVAKIT patients may experience a wide range of cognitive adverse effects. Depending on the severity, patients with GIST, AdvSM, or ISM should continue taking AYVAKIT at the same dose, stop for a while and return at the same or lower dose when they feel better, or stop taking it permanently.
Photosensitivity: Photosensitivity reactions in 2.5% of patients. Advise limiting direct ultraviolet exposure during AYVAKIT treatment and for one week after discontinuation.
Embryo-Fetal Toxicity: AYVAKIT can cause fetal harm based on animal studies. Advise pregnant women of potential risk; use effective contraception during treatment and for 6 weeks after the final dose.
Documentation & Availability in India:
If you are considering the import of Ayvakit (avapritinib) to India, please be aware that Ayvakit 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 Ayvakit (avapritinib) will be confirmed upon the receipt of the following documents:
- A valid prescription from a qualified doctor.
- An import permit, if applicable.
Availability of Ayvakit (avapritinib) in India:
Ayvakit (avapritinib) 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.
Ayvakit (avapritinib) 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 Ayvakit (avapritinib)
(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.
Sourcing & Delivery:
Indian Pharma Network is proficient in sourcing Ayvakit (avapritinib) from around the world and ensuring efficient delivery to patients. We provide worldwide access to the best available treatments and expedite prescription dispensing and delivery, with all prescriptions being dispensed and scrutinized by registered pharmacists before dispatching them to the patient's address, exclusively from New Delhi, India.
FAQ's
What is AYVAKIT, and what is it used for?
AYVAKIT is a kinase inhibitor used for treating unresectable or metastatic Gastrointestinal Stromal Tumor (GIST) with specific mutations, as well as Advanced Systemic Mastocytosis (AdvSM) and Indolent Systemic Mastocytosis (ISM).
How is AYVAKIT dosed for different conditions?
The dosage varies depending on the condition: 300 mg orally once daily for GIST, 200 mg for AdvSM, and 25 mg for ISM. In severe hepatic impairment, the AYVAKIT dose should be reduced.
What are the common side effects of AYVAKIT?
Common side effects include edema, nausea, fatigue, cognitive impairment, vomiting, and diarrhea, among others.
Are there any contraindications to using AYVAKIT?
No, there are no contraindications listed for AYVAKIT.
What precautions should be taken while using AYVAKIT?
Precautions include discontinuing AYVAKIT for intracranial hemorrhage, managing cognitive effects, advising about photosensitivity, and using effective contraception due to potential embryo-fetal toxicity.
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