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.
Medical Uses
Before beginning treatment with Pegvaliase-pqpz, your healthcare provider will measure your baseline blood phenylalanine levels. The initial dosage is 2.5 mg, given as a subcutaneous injection (under the skin) once a week for the first 4 weeks.
Increasing the Dosage:
- After the initial 4 weeks, the dosage will gradually be increased over at least 5 weeks. This step-by-step increase allows your body to adjust and helps achieve the target dose of 20 mg once daily.
- Your healthcare provider will monitor how well you tolerate the medication and your blood phenylalanine levels during this period.
Maintenance Dosage:
- Once the 20 mg daily dosage is reached, it will be maintained for at least 24 weeks. Your blood phenylalanine levels and dietary intake will continue to be monitored.
- If after 24 weeks of 20 mg daily treatment, your blood phenylalanine levels have not decreased by at least 20% or have not fallen below 600 micromol/L, your doctor may increase the dose to a maximum of 40 mg once daily.
Continuing or Stopping the Treatment:
- If, after 16 weeks on the maximum dose of 40 mg daily, you still do not see a sufficient reduction in blood phenylalanine levels, your healthcare provider may decide to discontinue Pegvaliase-pqpz.
Adjusting Dosage as Needed:
- If your blood phenylalanine levels drop too low, below 30 micromol/L, your dosage might be reduced, and your dietary protein and phenylalanine intake might be adjusted to keep levels within a safe range.
Monitoring and Dietary Adjustments:
- Regular Monitoring: Your blood phenylalanine levels will be checked every 4 weeks until you are on a stable dose. Once your dose is stable, monitoring will be done periodically.
- Dietary Guidance: It is important to monitor your protein and phenylalanine intake throughout your treatment. Your healthcare provider will give you guidance on how to adjust your diet based on your blood phenylalanine levels.
Premedication:
- In some cases, your healthcare provider might recommend taking medication before your Pegvaliase-pqpz injection to help reduce the risk of allergic reactions.
Warning & Precautions
Anaphylaxis Risk:
- Anaphylaxis has been reported with Pegvaliase-pqpz administration and can occur at any time during treatment.
- The initial dose must be administered under the supervision of a healthcare provider with appropriate resources to manage anaphylaxis.
- Patients should be observed for at least 60 minutes post-injection.
Self-Administration:
- Before transitioning to self-administration, confirm the patient’s competency in handling the injection and recognizing the signs of anaphylaxis.
- Patients must carry auto-injectable epinephrine at all times during treatment and be instructed on its proper use.
Pegvaliase-pqpz REMS Program:
- Pegvaliase-pqpz is available only through a restricted program due to the risk of anaphylaxis. Patients must be enrolled in this program, which ensures they are educated on the risks and equipped to manage potential severe allergic reactions.
Hypersensitivity Reactions:
- Other hypersensitivity reactions may occur and should be managed based on severity, including dosage adjustment, temporary interruption of treatment, or the use of antihistamines and corticosteroids.
Monitoring and Precautions:
- Continuous monitoring for anaphylaxis and other hypersensitivity reactions is crucial during treatment.
- Evaluate the risk-benefit ratio of continuing treatment in patients who have experienced anaphylaxis.
Documentation & Availability
If you are considering the import of Pegvaliase-pqpz to India, please be aware that it 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 doctor.
- Patient’s diagnostic reports.
- Government-issued identification proof for the patient, as recognized by the Government of India.
Order Confirmation Process:
The order for Pegvaliase-pqpz will be confirmed upon the receipt of the following documents:
- A valid prescription from a qualified doctor.
- An import permit, if applicable.
Availability of Pegvaliase-pqpz in India:
Pegvaliase-pqpz is classified as a prescription pharmaceutical drug. Consequently, it legally requires a medical prescription to be dispensed. S S Healthcare 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.
Pegvaliase-pqpz 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.
S S Healthcare (S S Healthcare) is dedicated to facilitating the supply of Pegvaliase-pqpz (prescription medicines) to locations both within India and worldwide, while adhering to relevant legal requirements.
For inquiries regarding the price of Pegvaliase-pqpz in India and to initiate the ordering process, please reach out to us through the following contact details:
Our commitment lies in assuring quality and timely delivery to meet the healthcare needs of patients and medical professionals across the globe.
Sourcing & Delivery
S S Healthcare is proficient in sourcing Pegvaliase-pqpz 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
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 S S Healthcare (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 +91-7575883015 or send mail to sshealthcare1012@gmail.com.
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 S S Healthcare if Palynziq® has not been approved or is not available in your country.
What is Pegvaliase-pqpz used for?
Pegvaliase-pqpz is prescribed to lower blood phenylalanine levels in adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine levels above 600 micromol/L despite existing treatments.
How is Pegvaliase-pqpz administered?
Pegvaliase-pqpz is given as a subcutaneous injection. The initial dose is typically 2.5 mg once weekly, with gradual increases over several weeks based on the patient’s response and tolerability.
What are the common side effects of Pegvaliase-pqpz?
Common side effects include injection site reactions (redness and swelling), joint pain, headaches, and allergic reactions. Severe allergic reactions can occur and require immediate medical attention.
How will my blood phenylalanine levels be monitored during treatment?
Blood phenylalanine levels will be monitored regularly, initially every 4 weeks until a stable dosage is achieved, and then periodically to ensure levels remain within the desired range.
What should I do if I experience an allergic reaction while using Pegvaliase-pqpz?
If you experience severe allergic reaction symptoms, such as difficulty breathing or swelling of the face or throat, use an auto-injectable epinephrine immediately and seek emergency medical help. Always carry your epinephrine injector during treatment.
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