PALYNZIQ- pegvaliase-pqpz injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PEGVALIASE (UNII: N6UAH27EUV) (PEGVALIASE - UNII:N6UAH27EUV)

Tilgjengelig fra:

BioMarin Pharmaceutical Inc.

Administreringsrute:

SUBCUTANEOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. None. Risk Summary Based on findings in studies of pregnant animals without PKU treated with pegvaliase-pqpz, Palynziq may cause fetal harm when administered to a pregnant woman. Limited available data with pegvaliase-pqpz use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. There are risks to the fetus associated with poorly controlled phenylalanine concentrations in women with PKU during pregnancy including increased risk for miscarriage, major birth defects (including microcephaly, major cardiac malformations), intrauterine fetal growth retardation, and future intellectual disability with low IQ; therefore, phenylalanine concentrations should be closely monitored in women with PKU during pregnancy (see Clinical Considerations and Data).

Produkt oppsummering:

How Supplied Palynziq (pegvaliase-pqpz) injection is supplied as a preservative-free, sterile, clear to slightly opalescent, colorless to pale yellow solution. All dosage strengths of Palynziq are provided in a 1 mL glass syringe with a 26 gauge, 0.5 inch needle. Each carton contains 1 or 10 trays with single-dose prefilled syringe(s), Prescribing Information, Medication Guide, and Instructions for Use. The following packaging configurations are available. Pegvaliase‑pqpz 2.5 mg/0.5 mL 1 syringe/carton   1 syringe/carton 10 syringes/carton NDC 68135‑673‑40 NDC 68135‑673‑45 Storage and Handling

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

BioMarin Pharmaceutical Inc.
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MEDICATION GUIDE
Medication Guide
Palynziq® (Pal-lin-zeek)
(pegvaliase-pqpz)
Injection, for subcutaneous use
What is the most important information I should know about Palynziq?
Palynziq can cause a severe allergic reaction (anaphylaxis) that may
be life-threatening and can happen any time during treatment with
Palynziq. Severe allergic reactions are a serious but common side
effect of Palynziq.
•
You will receive your first injection of Palynziq in a healthcare
setting where you will be closely watched for at least 1 hour after
your injection for a severe allergic reaction.
•
If you have a severe allergic reaction during treatment with Palynziq,
you will need to receive an auto-injection of epinephrine immediately
and get emergency medical help right away.
•
Your healthcare provider will decide if you (or your caregiver) are
able to give the Palynziq injections, recognize the signs and symptoms
of a severe allergic reaction, give an injection of
epinephrine and call for emergency medical help, if needed.
•
Your healthcare provider may recommend that an adult observer (or your
caregiver) be with you when you give your Palynziq injection, and for
at least 1 hour after your injection to watch you
for signs and symptoms of a severe allergic reaction and, if needed,
give you an injection of epinephrine and call for emergency medical
help.
Stop injecting Palynziq and get emergency medical care right away if
you have any of the following symptoms of a severe allergic reaction
during treatment with Palynziq:
•
fainting (passing out)
•
dizziness or lightheadedness
•
sudden confusion
•
trouble breathing or wheezing
•
chest discomfort or chest tightness
•
fast heart rate
•
swelling of your face, lips, eyes, or tongue
•
throat tightness
•
flushed skin
•
skin rash, itching, or raised bumps on skin
•
nausea, vomiting, or diarrhea
•
losing control of urine or stools
•
Your healthcare provider will prescribe an auto-injectable epinephrine
for you and wil

Preparatomtale

PALYNZIQ- PEGVALIASE-PQPZ INJECTION, SOLUTION
BIOMARIN PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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)
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 10/2020
INDICATIONS AND USAGE
Palynziq is a phenylalanine (Phe)‑metabolizing enzyme indicated to
reduce blood Phe concentrations in
adult patients with phenylketonuria who have uncontrolled blood Phe
concentrations greater
than 600 micromol/L on existing management. (1)
DOSAGE AND ADMINISTRATION
Dosage (2.1)
Obtain baseline blood Phe 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 once dai