• Pegvaliase-pqpz injection comes as a pre-filled syringe intended for single use and should be administered subcutaneously or just under the skin.
• Injection should be inspected for the presence of particulate matter or any discoloration before administration and should be discarded immediately if such things are present.
• The preferred sites for pegvaliase-pqpz injection are front middle thigh, abdomen, buttocks, and back of the upper arm. Inject 2 inches away from the navel area.
• The initial dose should be administered only under the supervision of the physician to manage any unexpected allergic or hypersensitivity reactions.
• The dose of pegvaliase-pqpz injection can be increased gradually based on the patient's tolerability to pegvaliase-pqpz for at least five weeks.
• The maintenance dose of pegvaliase-pqpz injection is 20 mg once daily for 24 weeks.
• The maximum dose of pegvaliase-pqpz injection is 40 mg once a day for 16 weeks.
• The maximum dose should be prescribed only to patients who have been kept on a maintenance dose and have not shown a decrease of either 20% of phenylalanine in blood or a concentration less than or equal to 600 micromol/L.
• If a patient does not show a better response or any improvement after 16 weeks of maximum dose (40mg once daily), treatment should be discontinued and the patient should be further evaluated clinically.
• Dose reduction and advice regarding the intake of dietary protein and phenylalanine must be given to the patient if the phenylalanine concentrations go below 30 micromol/L.
• Initial administration and readministration of pegvaliase-pqpz after an anaphylaxis should be supervised by a healthcare provider for at least a period of 60 minutes after an injection.
• Allergy to pegvaliase-pqpz
• Pregnancy and breastfeeding
• Children below 18 years of age and patients above 65 years (due to the lack of safety and effectiveness data in these groups)
Caution is required to use the drug in patients with severe arthritis and other joint disorders.
• Injection should be inspected for the presence of particulate matter or any discoloration before administration and should be discarded immediately if such things are present.
• The preferred sites for pegvaliase-pqpz injection are front middle thigh, abdomen, buttocks, and back of the upper arm. Inject 2 inches away from the navel area.
Dosage & When it is to be taken
• The recommended initial dose of pegvaliase-pqpz is 2.5 mg taken once a week for four weeks.• The initial dose should be administered only under the supervision of the physician to manage any unexpected allergic or hypersensitivity reactions.
• The dose of pegvaliase-pqpz injection can be increased gradually based on the patient's tolerability to pegvaliase-pqpz for at least five weeks.
• The maintenance dose of pegvaliase-pqpz injection is 20 mg once daily for 24 weeks.
• The maximum dose of pegvaliase-pqpz injection is 40 mg once a day for 16 weeks.
• The maximum dose should be prescribed only to patients who have been kept on a maintenance dose and have not shown a decrease of either 20% of phenylalanine in blood or a concentration less than or equal to 600 micromol/L.
• If a patient does not show a better response or any improvement after 16 weeks of maximum dose (40mg once daily), treatment should be discontinued and the patient should be further evaluated clinically.
• Dose reduction and advice regarding the intake of dietary protein and phenylalanine must be given to the patient if the phenylalanine concentrations go below 30 micromol/L.
• Initial administration and readministration of pegvaliase-pqpz after an anaphylaxis should be supervised by a healthcare provider for at least a period of 60 minutes after an injection.
When it is not to be taken (Contraindications)
Pegvaliase-pqpz should not be used in patients with-• Allergy to pegvaliase-pqpz
• Pregnancy and breastfeeding
• Children below 18 years of age and patients above 65 years (due to the lack of safety and effectiveness data in these groups)
Caution is required to use the drug in patients with severe arthritis and other joint disorders.
