Palynziq (Pegvaliase-pqpz)
- Medicine Name: Palynziq
- Generic Name: Pegvaliase-pqpz
- Dosage Form & Strength: Injection: 2.5 mg/0.5 mL, 10 mg/0.5 mL, & 20 mg/mL in a single-dose
- Manufactured By: BioMarin Pharmaceutical Inc.
Palynziq is a phenylalanine (Phe)-metabolizing enzyme used to reduce blood Phe concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood Phe concentrations greater than 600 micromol/L on existing management.
Recommended Dosage: Therapy with Palynziq injection should be managed by a health specialist experienced in the management of PKU. Baseline blood phenylalanine concentration needs to be obtained prior to initiating therapy.
The recommended injection sites for Palynziq are: the front middle of thighs and the abdomen at least 2 inches (5 centimeters) away from the navel. In case a caregiver is giving Palynziq, the top of the buttocks and the back of the upper arms can also be considered.
Induction: The recommended initial induction dosage for medicine Palynziq is 2.5 mg administered subcutaneously once weekly for 4 weeks. The initial dose needs to be administered under the supervision of a health specialist.
Titration: Titrate the dosage of Palynziq injection in a step-wise manner, depending on tolerability, over at least five weeks, to achieve a dosage of 20 mg subcutaneously once daily.
Maintenance: Therapeutic response may not be achieved until the respective patient is titrated to a useful maintenance dosage of Pegvaliase-pqpz. Consider the lowest and tolerated dosage of Pegvaliase-pqpz.
Assess patient tolerability, blood phenylalanine concentrations, and dietary protein and phenylalanine intake throughout the therapy.
Individualize the maintenance dosage of Palynziq to achieve blood phenylalanine control (blood phenylalanine concentrations ≤ 600 micromol/L), taking into account patient tolerability to Palynziq and dietary protein intake.
Maintain the Palynziq dosage at 20 mg once in a day for at least 24 weeks. Consider increasing the dosage to 40 mg once in a day in those who have been on Palynziq 20 mg once in a day continuously for at least 24 weeks without achieving blood phenylalanine control. Consider increasing the dosage to a maximum of 60 mg once in a day in those who have been on 40 mg once in day continuously for at least 16 weeks without achieving blood phenylalanine control.
Missed Dose: If a dose of Palynziq is missed, instruct patients to take their very next dose as scheduled and to not take a couple of doses of Palynziq to make up for the missed dose.
- After starting therapy with pegvaliase injection, obtain blood phenylalanine concentrations every 4 weeks until the maintenance dosage. After a maintenance dosage, monitor periodic blood phenylalanine to assess blood phenylalanine control.
- Monitor patients’ dietary protein as well as phenylalanine intake throughout therapy with pegvaliase and counsel them on how to adjust their dietary intake, as required, depending on the blood phenylalanine concentrations.
- Hypersensitivity reactions, other than anaphylaxis, may occur in those treated with Pegvaliase-pqpz. For hypersensitivity reactions, consider premedication with an H1/H2-receptor, or antipyretic prior to the administration of Palynziq depending on individual patient tolerability.
- Do not inject Pegvaliase-pqpz into moles, scars, birthmarks, rashes, bruises, or areas where the skin is tender, hard, red, damaged, inflamed, burned, or tattooed. Assess the injection site for swelling, redness, or tenderness.
- Palynziq 20 mg may cause fetal harm if used by a pregnant woman. There are risks to the fetus related to poorly controlled phenylalanine concentrations in those with PKU throughout pregnancy including increased risk for miscarriage, major birth defects, intrauterine fetal growth retardation, and future intellectual disability with low IQ; therefore, monitor phenylalanine concentrations in those with PKU during pregnancy.
- There is no finding on the existence of pegvaliase-pqpz in human milk, the effects on the breastfed infant, or the effects on milk production. A pre-/post-natal study in animlas demonstrated that pegvaliase-pqpz is present in milk and that use of pegvaliase-pqpz throughout lactation reduced pup weight as well as survival. Assess blood phenylalanine concentrations in breastfeeding women treated with pegvaliase-pqpz.
What documents are required to import PALYNZIQ to India?
PALYNZIQ (Pegvaliase-pqpz) Injection can be imported by patients or government hospitals on the name of the patients only.
The following documentation required to import the product:
- Valid prescription from a qualified doctor.
- Patients diagnostic reports
- Patients Identity Proof (issued by government of India)
How does order be confirmed?
The order will be confirmed only after the receipt of:
- Valid prescription of Doctor
- Import permit if applicable
Is PALYNZIQ available in India?
PALYNZIQ (Pegvaliase-pqpz Injection) is a (prescription drug, prescription medication or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
IPN (Indian Pharma Network) helps import cancer medicines on the named patient supply (NPS). Indian Pharma Network is facilitator providing input
On availability of Palynziq in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore and Pune etc.)
- Medicine Price.
- Finding Genuine and reliable source from Canada, Europe, USA and Australia
- Ensuring 100% transparency.
PALYNZIQ can be made available to patients, doctors and hospitals at Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow and Pune and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and import permit.
IPN (Indian Pharma Network) can facilitate the supply of PALYNZIQ (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable)
Please contact +91-9310090915 | Toll-Free Number: 1800-889-1064 or write us at info@indianpharmanetwork.in for Palynziq price in India.
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What is the Generic Name for the trade name drug Palynziq®?
Pegvaliase-pqpz is Generic Name for the trade name drug Palynziq®.
What is the Manufacturer Name of Palynziq®?
Palynziq® is manufactured by BioMarin Pharmaceutical Inc.
Is Palynziq® approved by the FDA?
Yes, Palynziq® is approved by the FDA. Date of first/initial approval: May 24, 2018.
Where can I get Palynziq® at the best price in India?
To get the best Palynziq price, contact Indian Pharma Network (a WHO-GDP and ISO 9001 : 2008 authorized Company). A valid medical prescription is required while buying Palynziq®.
What is the dosage and form of Palynziq® supplied?
Palynziq® is supplied as Injection: 2.5 mg/0.5 mL, 10 mg/0.5 mL, and 20 mg/mL in a single-dose prefilled syringe for subcutaneous administration.
What are the most common side effects with Palynziq®?
The most common side effects with Palynziq® are: cough, injection site reactions, hypersensitivity reactions, arthralgia, headache, generalized skin reactions lasting at least 14 days, nausea, vomiting, abdominal pain, nasal congestion, oropharyngeal pain, pruritus, diarrhea, fatigue, dizziness, and anxiety.
How much does Palynziq® cost in India?
Palynziq cost in India is less and can vary. In order to buy or procure this medication authentically, you can Call or WhatsApp +91-9310090915 or send mail to info@indianpharmanetwork.in.
What are the storage conditions of Palynziq®?
Store this medicine in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton in order to protect from light. It is not advisable to freeze or shake.
Is it safe to buy Palynziq® online from India?
Yes, You can buy Palynziq online in India at the best price from Indian Pharma Network if Palynziq® has not been approved or is not available in your country.
What are the Highlights of prescribing information for Palynziq®?
Click Here to download full Palynziq prescribing information.
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