Sapropterin Dihydrochloride
- Medicine Name: Kuvan
- API: Sapropterin Dihydrochloride
- Dosage Form & Strength: Tablets:100 mg
- Manufactured By: BioMarin Pharmaceutical Inc.
Sapropterin dihydrochloride is a phenylalanine hydroxylase activator used to reduce blood phenylalanine (Phe) levels in adult and pediatric patients aged one month and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). This treatment should be used in conjunction with a Phe-restricted diet.
Recommended Dosage
All patients with PKU who are being treated with sapropterin dihydrochloride tablets should also follow a Phe-restricted diet, including dietary protein and Phe restriction.
- Pediatric Patients aged 1 month to 6 years: The recommended starting dose of sapropterin dihydrochloride is 10 mg/kg taken orally once daily.
- Patients aged 7 years and older: The recommended starting dose of sapropterin dihydrochloride is 10 to 20 mg/kg taken once daily. Doses may be adjusted in the range of 5-20 mg/kg taken once daily. Regularly monitor blood Phe levels, particularly in pediatric patients.
Take sapropterin dihydrochloride with a meal. Tablets should be swallowed whole or after mixing in a small amount of soft foods or dissolving in recommended liquids. The oral solution should be swallowed after mixing the powder in a small amount of soft foods or dissolving it in recommended liquids.
- Patients receiving sapropterin dihydrochloride 100 mg tablets may experience severe allergic reactions, including anaphylaxis and hypersensitivity reactions. Monitor patients closely for signs and symptoms of allergic reactions, and discontinue sapropterin dihydrochloride immediately if such reactions occur.
- Regular monitoring of blood phenylalanine levels is essential during this treatment to ensure optimal dosage adjustments. Adjustments in dietary phenylalanine intake and/or other therapeutic interventions may be necessary based on individual patient responses.
- This medicinal product may cause neurological side effects, including headaches and dizziness. Patients should be monitored for these symptoms, and dose adjustments or discontinuation of treatment may be necessary if signs and symptoms persist or worsen.
- Treatment with this therapeutic drug may lead to hypophenylalaninemia in patients with phenylketonuria (PKU). Regular monitoring of blood phenylalanine levels is essential to prevent hypophenylalaninemia and ensure appropriate dietary management.
- The safety of sapropterin dihydrochloride use during pregnancy and lactation has not been established. Use caution when prescribing sapropterin dihydrochloride to pregnant or breastfeeding women, and weigh the potential risks and benefits before initiating treatment.
- The safety and efficacy of sapropterin dihydrochloride in pediatric patients below the age of 1 year have not been established. Use caution when prescribing sapropterin dihydrochloride to pediatric patients, and closely monitor for any potential adverse effects.
- Sapropterin dihydrochloride may interact with certain medications, including levodopa. Patients should inform their healthcare provider about all medications they are taking before starting sapropterin dihydrochloride treatment.
- Monitor liver function regularly during sapropterin dihydrochloride treatment, especially in patients with pre-existing liver conditions. Discontinue treatment if significant liver dysfunction or abnormalities occur.
What documents are required to import Sapropterin Dihydrochloride to India?
Sapropterin dihydrochloride tablets can be imported by patients or government hospitals in the name of the patients 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 is the order confirmed?
The order will be confirmed only after the receipt of:
- A valid prescription from the doctor.
- Import permit if applicable.
Is Sapropterin Dihydrochloride available in India?
Sapropterin dihydrochloride tablets are a pharmaceutical drug that legally requires a medical prescription to be dispensed. The Indian Pharma Network (IPN) helps import these medicines on a named patient supply (NPS) basis. IPN provides assistance in sourcing genuine and reliable supplies from the USA, Canada, Europe, and Australia, ensuring 100% transparency.
Sapropterin dihydrochloride can be made available to patients, doctors, and hospitals in Mumbai, Goa, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, Pune, and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and an import permit.
The Indian Pharma Network can facilitate the supply of sapropterin dihydrochloride (prescription medicines) to all locations in the world and India after fulfilling the legal requirements (if applicable).
Please contact +91-9310090915 | Toll-Free Number: 1800-889-1064 or write to info@indianpharmanetwork.in for sapropterin dihydrochloride 100 mg price in India. IPN guarantees quality and delivery anywhere in the world as per the buyer’s requirements.
The Indian Pharma Network can source sapropterin dihydrochloride from across the globe and supply it. IPN offers its customers worldwide access to the best available treatment.
The 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.
What is the Generic Name for the trade name drug Kuvan®?
Sapropterin dihydrochloride is a Generic Name for the trade name drug Kuvan®.
What is the Manufacturer’s Name of Kuvan®?
Kuvan® is manufactured by BioMarin Pharmaceutical Inc.
Is Kuvan® approved by the FDA?
Yes, Kuvan® is approved by the FDA. Date of first approval: December 13, 2007.
What is the dosage and form of Kuvan® supplied?
Kuvan® is supplied as Tablets: 100 mg of sapropterin dihydrochloride and Powder for Oral Solution 100 mg/500 mg for oral administration.
What are the most common side effects of Kuvan®?
The most common side effects of Kuvan® are headache, pharyngolaryngeal pain, vomiting, diarrhea, rhinorrhea, cough, and nasal congestion.
How much does Kuvan® cost in India?
Prices may fluctuate over time due to market dynamics and regulatory changes. To obtain accurate and up-to-date information on the cost of Kuvan in India, it is recommended to Call/WhatsApp +91-9310090915 or send mail to info@indianpharmanetwork.in.
How can I buy Kuvan® in India?
Kuvan is a prescription-only medicine and is not approved for marketing in India. Indian Pharma Network (IPN) is authorized by BioMarin Pharmaceutical Inc. to provide access to their therapeutic drugs including Kuvan to Indian patients through Named-Patient Import.
IPN facilitates such access only against legitimate prescriptions in conformity with all local laws and regulations. Patients/ Clinicians/ Researchers can contact IPN at our TOLL-FREE: 18008891064 or write your query at info@indianpharmanetwork.in. We will reply ASAP with the details of the Kuvan price and buying procedure.
What are the storage conditions of Kuvan®?
Store tablets at 20 to 25°C (68 to 77°F); excursions allowed between 15 to 30°C (59 to 86°F). Keep the container well closed. Protect the medicine from moisture.
Is it safe to buy Kuvan® online in India?
Yes, one can buy Kuvan online 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 supply of Kuvan® through legal channels.
Can Sapropterin Dihydrochloride help athletes with PKU?
Yes, it may allow for better protein intake management, aiding muscle repair and energy levels in athletes with PKU.
Does Sapropterin Dihydrochloride improve mental health in PKU patients?
Controlling Phe levels with this medication may improve mood and reduce anxiety in PKU patients.
How does Sapropterin Dihydrochloride affect growth in children?
It may support more normal growth patterns by allowing a balanced diet with necessary nutrients.
Can Sapropterin Dihydrochloride boost energy levels?
By enabling a more varied diet, it may help improve daily energy and physical stamina in PKU patients.
Is Sapropterin Dihydrochloride used with experimental PKU therapies?
Yes, it can be used alongside experimental treatments like gene therapy, potentially enhancing outcomes.
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