PEGINTRON- peginterferon alfa-2b injection, powder, lyophilized, for solution PEGINTRON- peginterferon alfa-2b kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Peginterferon alfa-2b (UNII: G8RGG88B68) (Interferon alfa-2b - UNII:43K1W2T1M6)

זמין מ:

Merck Sharp & Dohme Corp.

INN (שם בינלאומי):

Peginterferon alfa-2b

הרכב:

Peginterferon alfa-2b 50 ug in 0.5 mL

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

PEGINTRON® , as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease. - PEGINTRON in combination with ribavirin and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients with HCV genotype 1 infection (see labeling of the specific HCV NS3/4A protease inhibitor for further information). - PEGINTRON in combination with ribavirin is indicated in patients with genotypes other than 1, pediatric patients (3-17 years of age), or in patients with genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors. PEGINTRON monotherapy should only be used in the treatment of CHC in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. Combination therapy provides substantially better respons

leaflet_short:

PEGINTRON REDIPEN PEGINTRON Vials Storage PEGINTRON REDIPEN single-dose pre-filled pen PEGINTRON REDIPEN pre-filled pen should be stored at 2-8°C (36-46°F). After reconstitution, the solution should be used immediately, but may be stored up to 24 hours at 2-8°C (36-46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE. Keep away from heat. PEGINTRON Vials PEGINTRON should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. After reconstitution with supplied diluent, the solution should be used immediately but may be stored up to 24 hours at 2-8°C (36-46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE. Keep away from heat. Disposal Instructions Patients should be thoroughly instructed in the importance of proper disposal. After preparation and administration of PEGINTRON for Injection, patients should be advised to use a puncture-resistant container for the disposal of used syringes, needles, and the REDIPEN pre-filled pen. The full container should be disposed of in accordance with state and local laws. Patients should also be cautioned against reusing or sharing needles, syringes, or the REDIPEN pre-filled pen.

מצב אישור:

Biologic Licensing Application

עלון מידע

PEGINTRON- PEGINTERFERON ALFA-2B
Merck Sharp & Dohme Corp.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised 08/2019
MEDICATION GUIDE
PEGINTRON® (peg-In-tron)
(Peginterferon alfa-2b)
for injection, for subcutaneous use
Important: When taking PEGINTRON in combination with ribavirin, you
should also read the ribavirin
Medication Guide. If your healthcare provider also prescribes an
approved hepatitis C virus (HCV)
medicine for you, also read the Medication Guide that comes with that
medicine.
What is the most important information I should know about PEGINTRON?
PEGINTRON can cause serious side effects that:
•
may cause death, or
•
may worsen certain serious diseases that you may already have.
Tell your healthcare provider right away if you have any of the
symptoms listed below while taking
PEGINTRON. If symptoms get worse, or become severe and continue, your
healthcare provider may tell
you to stop taking PEGINTRON permanently. In many, but not all,
people, these symptoms go away
after they stop taking PEGINTRON.
Mental health problems, including suicide. PEGINTRON may cause you to
develop mood or behavior
problems that may get worse during treatment with PEGINTRON or after
your last dose, including:
•
irritability (getting upset easily)
•
depression (feeling low, feeling bad about yourself, or feeling
hopeless)
•
acting aggressive, being angry or violent
•
thoughts of hurting yourself or others, or suicide
•
former drug addicts may fall back into drug addiction or overdose
If you have these symptoms, your healthcare provider should carefully
monitor you during treatment
with PEGINTRON and for 6 months after your last dose.
Heart problems. Some people who take PEGINTRON may get heart problems,
including:
•
low blood pressure
•
fast heart rate or abnormal heart beat
•
trouble breathing or chest pain
•
heart attacks or heart muscle problems (cardiomyopathy)
Stroke or symptoms of a stroke. Symptoms may include weakness, loss of
coordination, and

מאפייני מוצר

PEGINTRON- PEGINTERFERON ALFA-2B INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
PEGINTRON- PEGINTERFERON ALFA-2B
MERCK SHARP & DOHME CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEGINTRON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PEGINTRON.
PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
WARNING: RISK OF SERIOUS DISORDERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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)
INDICATIONS AND USAGE
PEGINTRON is an antiviral indicated for treatment of Chronic Hepatitis
C (CHC) in patients with compensated liver
disease. (1.1)
DOSAGE AND ADMINISTRATION
PEGINTRON is administered by subcutaneous injection. (2)
PEGINTRON DOSE (ADULTS)*
PEGINTRON DOSE (PEDIATRIC
PATIE NTS)
PEGINTRON Combination Therapy
(2.1)
1.5 mcg/kg/ week
60 mcg/m / week
PEGINTRON is used in combination with other products including
ribavirin and HCV direct-acting antivirals. For further
information on dosing and administration, refer to the respective
prescribing information.
Dose reduction is recommended in patients experiencing certain adverse
reactions or renal dysfunction. (2.3, 2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL,
150 mcg per 0.5 mL in single-dose vial (with 5 mL
diluent) and single-dose pre-filled pens (3)
CONTRAINDICATIONS
Known hypersensitivity reactions, such as urticaria, angioedema,
bronchoconstriction, anaphylaxis, Stevens-Johnson
syndrome, and toxic epidermal necrolysis to interferon alpha or any
other product component. (4)
Autoimmune hepatitis. (4)
Hepatic decompensation (Child-Pugh score greater than 6 [class B and
C]) in cirrhotic CHC patients before or during
treatment. (4)
If PEGINTRON is adm