Medical Use
Before Starting Treatment:
Your healthcare provider will measure your baseline blood phenylalanine levels before beginning treatment with Pegvaliase-pqpz. The initial dose is 2.5 mg, administered as a subcutaneous injection once a week for the first 4 weeks.
Increasing the Dosage:
After the initial 4 weeks, the dosage will be gradually increased over at least 5 weeks. This gradual increase helps your body adjust and aims to reach the target dose of 20 mg once daily. During this period, your healthcare provider will monitor your tolerance to the medication and your blood phenylalanine levels.
Maintenance Dosage:
Once the 20 mg daily dose is achieved, 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 Treatment:
If, after 16 weeks on the maximum dose of 40 mg daily, there is still insufficient 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 may be reduced, and your dietary protein and phenylalanine intake may be adjusted to maintain safe levels.
Monitoring and Dietary Adjustments:
- -Regular Monitoring: Your blood phenylalanine levels will be checked every 4 weeks until you are on a stable dose. Once 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 guide you 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 and can occur at any time during treatment. The initial dose must be given under the supervision of a healthcare provider equipped to manage anaphylaxis. Patients should be observed for at least 60 minutes after the injection.
Self-Administration
Before patients transition to self-administration, ensure they are competent in handling the injection and recognizing anaphylaxis signs. Patients must always carry auto-injectable epinephrine and be instructed on its proper use.
Pegvaliase-pqpz REMS Program
Due to the risk of anaphylaxis, Pegvaliase-pqpz is available only through a restricted program. Patients must be enrolled in this program, which educates them on the risks and equips them to manage severe allergic reactions.
Hypersensitivity Reactions
Other hypersensitivity reactions may occur and should be managed based on severity. This may include dosage adjustment, temporary treatment interruption, 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
Documents required to import Palynziq to India?
Palynziq (Pegvaliase-pqpz) injection can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing Pegvaliase-pqpz from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the Generic Name for Palynziq®?
The generic name for the trade name drug Palynziq® is Pegvaliase-pqpz.
Who is the Manufacturer of Palynziq®?
Palynziq® is manufactured by BioMarin Pharmaceutical Inc.
Please share the FDA Approval Status of the drug?
Yes, Palynziq® is approved by the FDA. The initial approval date was May 24, 2018.
Kindly share the best Price for Palynziq® in India?
To find the best price for Palynziq® in India, you can contact Rx4u team.
What is the dosage and form of Palynziq®?
Palynziq® is available as an injection in the following forms:
- -2.5 mg/0.5 mL
- -10 mg/0.5 mL
- -20 mg/mL
These are provided in single-dose prefilled syringes for subcutaneous administration.
What are the Common Side Effects of Palynziq®?
The most common side effects of Palynziq® include: Cough, Injection site reactions, Hypersensitivity reactions, Arthralgia (joint pain), Headache, generalized skin reactions lasting at least 14 days, nausea, vomiting, abdominal pain, nasal congestion, oropharyngeal pain (throat pain), pruritus (itching), diarrhea, fatigue, dizziness, anxiety.
What is the cost of Palynziq® in India?
The cost of Palynziq® in India can vary. To purchase or procure this medication, you can order from https://rx4u.in/
What is the Storage Conditions of Palynziq®?
Store Palynziq® in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze or shake the medication.
Is it safe to buy Palynziq® Online from India?
Yes, it is safe to buy Palynziq® online in India at the best price from https://rx4u.in/
What is Pegvaliase-pqpz used for?
Pegvaliase-pqpz is prescribed to reduce blood phenylalanine levels in adults with phenylketonuria (PKU) who have not been able to control their blood phenylalanine levels above 600 micromol/L with existing treatments.
How is Pegvaliase-pqpz administered?
Pegvaliase-pqpz is administered as a subcutaneous injection. The starting dose is usually 2.5 mg once a week, with gradual increases over several weeks based on the patient’s response and tolerance.
What are the common side effects of Pegvaliase-pqpz?
Common side effects include reactions at the injection site (such as 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?
Your 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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