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RX ITEM-Palynziq- Pegvaliase-Pqpz Injection Solution 2.5Mg/.5Ml

Item No.:RX883926  NDC No.RX68135005889 68135-058-89  6813505889  68135005889   UPC No.:368135058892 3-68135-05889-2 368135-058892  Item No.:RX68135-0058-89 PALYNZIQ- pegvaliase-pqpz injection, solutiBRAND: PALYNZIQ NDC: RX68135-0058-89 ,RX68135005889  UPC: 368135-058892,368135058892 PALYNZIQ- pegvaliase-pqpz injection, solution 2.5MG/.5ml
 NDC Code(s): 68135-058-89, 68135-058-90, 68135-673-39, 6Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Palynziq- Pegvaliase-Pqpz Injection Solution 2.5Mg/.5Ml

$612.00$549.00

Item No.:RX883926 NDC No.RX68135005889 68135-058-89 6813505889 68135005889 UPC No.:368135058892 3-68135-05889-2 368135-058892 Item No.:RX68135-0058-89 PALYNZIQ- pegvaliase-pqpz injection, solution 2.5MG/.5ml
NDC Code(s): 68135-058-89, 68135-0058-90 68135-058-90 6813505890 68135005890 , 68135-673-39, 68135-673-40
Packager: BioMarin Pharmaceutical Inc.
Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Biologic Licensing Application
Only Lic.

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For: Phenylketonuria Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.These highlights do not include all the information needed to use PALYNZIQ safely and effectively. See full prescribing information for PALYNZIQ. PALYNZIQ (pegvaliase-pqpz) injection, for subcutaneous use Initial U.S. Approval: 2018 WARNING: RISK OF ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has been reported after administration of Palynziq and may occur at any time during treatment. (5.1) Administer the initial dose of Palynziq under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self?injection, confirm patient competency with self?administration, and patient's and observer's (if applicable) ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed. (2.4) Prescribe auto?injectable epinephrine. Prior to first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during Palynziq treatment. (2.4, 5.1) Palynziq is available only through a restricted program called the Palynziq REMS. (5.2) INDICATIONS AND USAGE Palynziq is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. (1) DOSAGE AND ADMINISTRATION Dosage (2.1) Obtain baseline blood phenylalanine concentration before initiating treatment. The recommended initial dosage is 2.5 mg subcutaneously once weekly for 4 weeks. Titrate the dosage in a step-wise manner over at least 5 weeks based on tolerability to achieve a dosage of 20 mg subcutaneously once daily. See full prescribing information for titration regimen. Assess patient tolerability, blood phenylalanine concentration, and dietary protein and phenylalanine intake throughout treatment. Consider increasing the dosage to a maximum of 40 mg subcutaneously once daily in patients who have been on 20 mg once daily continuously for at least 24 weeks and who have not achieved either a 20% reduction in blood phenylalanine concentration from pre-treatment baseline or a blood phenylalanine concentration less than or equal to 600 micromol/L. Discontinue Palynziq in patients who have not achieved at least a 20% reduction in blood phenylalanine concentration from pre-treatment baseline or a blood phenylalanine concentration less than or equal to 600 micromol/L after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily. Reduce the dosage and/or modify dietary protein and phenylalanine intake, as needed, to maintain blood phenylalanine concentrations within a clinically acceptable range and above 30 micromol/L. Blood Phenylalanine Monitoring and Diet (2.2) Obtain blood phenylalanine concentrations every 4 weeks until a maintenance dosage is established. After a maintenance dosage is established, periodically monitor blood phenylalanine concentrations. Counsel patients to monitor dietary protein and phenylalanine intake, and adjust as directed by their healthcare provider. Premedication (2.3, 5.1, 5.3) Consider premedication for hypersensitivity reactions. Administration Instructions (2.4) Rotate injection sites. If more than one injection is needed for a single dose, the injection sites should be at least 2 inches away from each other. DOSAGE FORMS AND STRENGTHS Injection: 2.5 mg/0.5 mL, 10 mg/0.5 mL, and 20 mg/mL in a single-dose prefilled syringe. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, Other than Anaphylaxis: Management should be based on the severity of the reaction, recurrence, and clinical judgement, and may include dosage adjustment, temporary drug interruption, or treatment with antihistamines, antipyretics, and/or corticosteroids. (5.3) ADVERSE REACTIONS Most common adverse reactions (at least 20% in either treatment phase) are: injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, pruritus, nausea, abdominal pain, oropharyngeal pain, vomiting, cough, diarrhea, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Effect of Palynziq on Other PEGylated Products: Monitor for hypersensitivity reactions, including anaphylaxis, with concomitant treatment. (7.1) USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. (8.1) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 6/2018

Item No.:RX883926  NDC No.RX68135005889 68135-058-89  6813505889  68135005889   UPC No.:368135058892 3-68135-05889-2 368135-058892  Item No.:RX68135-0058-89 PALYNZIQ- pegvaliase-pqpz injection, soluti
RX ITEM-Palynziq- Pegvaliase-Pqpz Inject
Item No.:RX883926 NDC No.RX68135005889 68135-058-89 6813505889 68135005889 UPC No.:368135058892 3-68135-05889-2 368135-058892 Item No.:RX68135-0058-89 PALYNZIQ- pegvaliase-pqpz injection, soluti

BRAND: PALYNZIQ NDC: RX68135-0058-89 ,RX68135005889  UPC: 368135-058892,368135058892 PALYNZIQ- pegvaliase-pqpz injection, solution 2.5MG/.5ml
 NDC Code(s): 68135-058-89, 68135-058-90, 68135-673-39, 6
Palynziq- Pegvaliase-Pqpz Injection Solu
BRAND: PALYNZIQ NDC: RX68135-0058-89 ,RX68135005889 UPC: 368135-058892,368135058892 PALYNZIQ- pegvaliase-pqpz injection, solution 2.5MG/.5ml NDC Code(s): 68135-058-89, 68135-058-90, 68135-673-39, 6

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.