PLEGRIDY- peginterferon beta-1a injection, solution PLEGRIDY PEN- peginterferon beta-1a injection, solution PLEGRIDY- peginter

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGINTERFERON BETA-1A (UNII: I8309403R0) (PEGINTERFERON BETA-1A - UNII:I8309403R0)

Available from:

Biogen Inc.

INN (International Name):

PEGINTERFERON BETA-1A

Composition:

PEGINTERFERON BETA-1A 94 ug in 0.5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PLEGRIDY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY [see Warnings and Precautions ( 5.3)] . Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data). In a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion (see Data ). In the U.S. general population, the estimated backgro

Product summary:

PLEGRIDY (peginterferon beta-1a) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution supplied as a 0.5 mL single-dose prefilled pen or a 0.5 mL single-dose prefilled syringe. Subcutaneous Administration PLEGRIDY (peginterferon beta-1a) injection for subcutaneous use is supplied as a single-dose prefilled pen or single-dose prefilled syringe with a rubber stopper and a 29-gauge, 0.5-inch staked needle with a rigid needle shield in the following packaging configurations: Intramuscular Administration PLEGRIDY (peginterferon beta-1a) injection for intramuscular use is supplied as a single-dose prefilled syringe with a rubber stopper and a 23-gauge, 1.25-inch staked needle provided separately with the syringe in the following packaging configurations: Store PLEGRIDY prefilled pens and prefilled syringes in a refrigerator between 2°C to 8°C (36°F to 46°F) in the closed original carton to protect from light until ready for injection. Do not freeze. Discard if frozen. If refrigeration is unavailable, PLEGRIDY may be stored at room temperature up to 25°C (77°F) for a period up to 30 days, protected from light. PLEGRIDY can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days. PLEGRIDY prefilled syringe for intramuscular administration contains natural rubber latex which may cause allergic reactions. Dispose in a sharps-bin container or other hard plastic or metal sealable container. Always follow local regulations for disposal.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

PLEGRIDY PEN - PEGINTERFERON BETA-1A INJECTION, SOLUTION
PLEGRIDY- PEGINTERFERON BETA-1A
PLEGRIDY PEN - PEGINTERFERON BETA-1A
Biogen Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 7/2023
Medication Guide
PLEGRIDY® (PLEGG-rih-dee)
(peginterferon beta-1a)
injection, for subcutaneous or intramuscular use
Read this Medication Guide before you start using PLEGRIDY, and each
time you get a refill. There may be
new information. This information does not take the place of talking
with your healthcare provider about
your medical condition or your treatment.
What is the most important information I should know about PLEGRIDY?
PLEGRIDY can cause serious side effects, including:
•
Liver problems or worsening of liver problems, including liver failure
and death. Symptoms may
include: yellowing of your skin or the white part of your eye, nausea,
loss of appetite, tiredness,
bleeding more easily than normal, confusion, sleepiness, dark colored
urine, and pale stools.
During your treatment with PLEGRIDY you will need to see your
healthcare provider and have
regular blood tests to check for these possible side effects.
•
Depression or suicidal thoughts. Symptoms may include: new or
worsening depression (feeling
hopeless or bad about yourself), thoughts of hurting yourself or
suicide, irritability (getting upset
easily), nervousness, or new or worsening anxiety.
•
Call your healthcare provider right away if you have any of the
symptoms listed above.
What is PLEGRIDY?
•
PLEGRIDY is a prescription medicine used to treat relapsing forms of
multiple sclerosis (MS), to
include clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive
disease, in adults.
•
It is not known if PLEGRIDY is safe and effective in people under 18
or over 65 years of age.
Do not take PLEGRIDY if you:
•
are allergic to interferon beta or peginterferon, or any of the other
ingredients in PLEGRIDY. See the
end of this Medication Guide for a complete list of

Summary of Product characteristics

PLEGRIDY- PEGINTERFERON BETA-1A INJECTION, SOLUTION
PLEGRIDY PEN - PEGINTERFERON BETA-1A INJECTION, SOLUTION
PLEGRIDY- PEGINTERFERON BETA-1A
PLEGRIDY PEN - PEGINTERFERON BETA-1A
BIOGEN INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PLEGRIDY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLEGRIDY.
PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, FOR SUBCUTANEOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Warnings and Precautions (5.8)
7/2023
INDICATIONS AND USAGE
PLEGRIDY is an interferon beta indicated for the treatment of
relapsing forms of multiple sclerosis (MS), to
include clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive
disease, in adults (1)
DOSAGE AND ADMINISTRATION
For subcutaneous or intramuscular use only (2.1)
Recommended dose: 125 micrograms every 14 days (2.1)
PLEGRIDY dose should be titrated, starting with 63 micrograms on day
1, 94 micrograms on day 15,
and 125 micrograms (full dose) on day 29 (2.1)
A healthcare professional should train patients in the proper
technique for self-administering
subcutaneous injections using the prefilled pen or syringe or
intramuscular injections using the prefilled
syringe (2.2)
Analgesics and/or antipyretics on treatment days may help ameliorate
flu-like symptoms (2.3)
DOSAGE FORMS AND STRENGTHS
Subcutaneous Administration:
Injection: 125 mcg/0.5 mL in a single-dose prefilled pen or
single-dose prefilled syringe (3)
Injection: 63 mcg/0.5 mL in a single-dose prefilled pen or single-dose
prefilled syringe (3)
Injection: 94 mcg/0.5 mL in a single-dose prefilled pen or single-dose
prefilled syringe (3)
Intramuscular Administration:
Injection: 125 mcg/0.5 mL solution in a single-dose prefilled syringe
(3)
CONTRAINDICATIONS
History of hypersensitivity to natural or recombinant interferon beta
or peginterferon, or any other
component of PLEGRIDY (4)
WARNINGS AND PRECAUTIONS
Hepatic injury: monitor liver function tests; mon