PEGASYS- peginterferon alfa-2a injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGINTERFERON ALFA-2A (UNII: Q46947FE7K) (PEGINTERFERON ALFA-2A - UNII:Q46947FE7K)

Available from:

Genentech, Inc.

INN (International Name):

peginterferon alfa-2a

Composition:

peginterferon alfa-2a 180 ug in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adult Patients: PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with CHC and compensated liver disease. For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS monotherapy is only indicated for the treatment of patients with CHC and compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs. Pediatric Patients: PEGASYS in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease. Limitations of Use : - PEGASYS alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa. - PEGASYS is not recommended for treatment of patients with CHC who have had solid

Product summary:

PEGASYS (peginterferon alfa-2a) injection is a sterile, preservative-free, colorless to slightly yellowish solution administered subcutaneously. Storage and Handling Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light. Vials and prefilled syringes are for single use only. Discard any unused portion remaining in the vial, prefilled syringe. Disposal Instructions If home use is prescribed, a puncture-resistant container for the disposal of used needles and syringes should be supplied to the patients. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of any needles and syringes. The full container should be disposed of according to the directions provided by the physician [see FDA-Approved Medication Guide] .

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Genentech, Inc.
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: October 2020
Medication Guide
PEGASYS® (PEG-ah-sis)
(peginterferon alfa-2a)
Injection
for Subcutaneous Use
Important: If you are taking PEGASYS with other medicines for
treatment of hepatitis C, you should
also read the Medication Guides or Patient Information that comes with
the other medicines.
What is the most important information I should know about PEGASYS?
Ribavirin in combination with PEGASYS may cause birth defects or death
of your unborn baby. If you
are pregnant or your sexual partner is pregnant or plans to become
pregnant, do not take PEGASYS and
Ribavirin combination therapy. You or your sexual partner should not
become pregnant during treatment
with PEGASYS and Ribavirin combination therapy and for 6 months after
treatment is over. You must
use 2 effective forms of birth control, one of which should be a
condom with spermicide during treatment
with PEGASYS and Ribavirin combination therapy, and for the 6 months
after you stop treatment.
•
Females must have a pregnancy test before starting PEGASYS and
Ribavirin combination
therapy, every month while being treated, and every month for the 6
months after stopping
treatment with PEGASYS and Ribavirin combination therapy.
•
If you or your female sexual partner becomes pregnant during treatment
with PEGASYS and
Ribavirin or within 6 months after you stop taking PEGASYS and
Ribavirin, tell your
healthcare provider right away. You or your healthcare provider should
contact the Ribavirin
Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy
Registry collects
information about the health of you and your baby if you take PEGASYS
and Ribavirin during
pregnancy or if you become pregnant within 6 months after you stop
taking PEGASYS and
Ribavirin.
Mental health problems and suicide. PEGASYS may cause you to develop
mood or behavioral problems,
including:
•
irritability (getting upset easily)
•
depression (feeling low, feel

Summary of Product characteristics

PEGASYS- PEGINTERFERON ALFA-2A INJECTION, SOLUTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEGASYS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PEGASYS.
PEGASYS® (PEGINTERFERON ALFA-2A) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2002
WARNING: RISK OF SERIOUS DISORDERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
RISK OF SERIOUS DISORDERS
MAY CAUSE OR AGGRAVATE FATAL OR LIFE-THREATENING NEUROPSYCHIATRIC,
AUTOIMMUNE,
ISCHEMIC, AND INFECTIOUS DISORDERS. MONITOR CLOSELY AND WITHDRAW
THERAPY WITH
PERSISTENTLY SEVERE OR WORSENING SIGNS OR SYMPTOMS OF THE ABOVE
DISORDERS (5)
RECENT MAJOR CHANGES
Dosage and Administration, Preparation and Administration (2.7)
03/2021
INDICATIONS AND USAGE
PEGASYS is an inducer of the innate immune response indicated for the
treatment of
Chronic Hepatitis C (CHC) (1.1)
Adult Patients: In combination therapy with other hepatitis C virus
drugs for adults with compensated
liver disease. PEGASYS monotherapy is indicated only if patient has
contraindication or significant
intolerance to other HCV drugs.
Pediatric Patients: In combination with ribavirin for pediatric
patients 5 years of age and older with
compensated liver disease
Chronic Hepatitis B (CHB) (1.2)
Adult Patients: Treatment of adults with HBeAg-positive and
HBeAg-negative chronic hepatitis B (CHB)
infection who have compensated liver disease and evidence of viral
replication and liver inflammation
Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3
years of age and older with HBeAg-
positive CHB and evidence of viral replication and elevations in serum
alanine aminotransferase (ALT)
DOSAGE AND ADMINISTRATION
PEGASYS is administered by subcutaneous injection (2)
In adult patients with CHC, PEGASYS is dosed as 180 mcg per week and
the duration of treatment
depends on indication, genotype, and whether it is administered with
other HCV antiviral drugs (2.2).
In adult patients with CH