SYLATRON- peginterferon alfa-2b kit

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

peginterferon alfa-2b (UNII: G8RGG88B68) (peginterferon alfa-2b - UNII:G8RGG88B68)

Fáanlegur frá:

Merck Sharp & Dohme Corp.

INN (Alþjóðlegt nafn):

peginterferon alfa-2b

Samsetning:

peginterferon alfa-2b 40 ug in 0.1 mL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

SYLATRON™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. SYLATRON is contraindicated in patients with: - A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b - autoimmune hepatitis - hepatic decompensation (Child-Pugh score >6 [class B and C]) Risk Summary Based on findings from animal studies, SYLATRON can cause embryo-fetal harm when administered to a pregnant woman. Available human data with SYLATRON use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Administration of nonpegylated interferon alfa-2b was abortifacient in rhesus monkeys at doses approximately 13 times higher than the recommended dose of 6 mcg/kg/week (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and

Vörulýsing:

Storage: SYLATRON should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Leyfisstaða:

Biologic Licensing Application

Upplýsingar fylgiseðill

Merck Sharp & Dohme Corp.
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This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised: 12/2018
MEDICATION GUIDE
SYLATRON™ (SY-LA-TRON)
(Peginterferon alfa-2b)
What is the most important information I should know about SYLATRON?
SYLATRON can cause serious mental health problems which can lead to
suicide.
SYLATRON may cause you to develop mood or behavior problems that may
get worse during treatment
with SYLATRON or after your last dose. Call your healthcare provider
right away if you, your family, or
caregiver notice any of the following:
•
irritability (getting upset easily)
•
depression (feeling low, feeling bad about yourself, or feeling
hopeless)
•
aggressive behavior, 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 SYLATRON and for 6 months after your last dose.
If symptoms get worse or become severe and continue, your healthcare
provider may tell you to stop
taking SYLATRON permanently. These signs or symptoms may not go away
after you stop taking
SYLATRON.
See "What are the possible side effects of SYLATRON?" for more
information about side effects.
What is SYLATRON?
SYLATRON is a prescription medicine that is used to prevent malignant
melanoma (a kind of skin
cancer) from coming back after it has been removed by surgery.
SYLATRON should be started within
84 days of surgery to remove lymph nodes containing cancer.
It is not known if SYLATRON is safe and effective in children less
than 18 years of age.
Who should not take SYLATRON?
Do not take SYLATRON if you:
•
have had a serious allergic reaction to peginterferon alfa-2b or to
interferon alfa-2b
•
have certain types of hepatitis
•
have severe liver damage
What should I tell my healthcare provider before taking SYLATRON?
Before you take SYLATRON, tell your healthcare provider about all of
your health proble

Vara einkenni

SYLATRON- PEGINTERFERON ALFA-2B
MERCK SHARP & DOHME CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYLATRON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SYLATRON.
SYLATRON™ (PEGINTERFERON ALFA-2B)
FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2011
WARNING: DEPRESSION AND OTHER NEUROPSYCHIATRIC DISORDERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE RISK OF SERIOUS DEPRESSION, WITH SUICIDAL IDEATION AND COMPLETED
SUICIDES, AND OTHER SERIOUS
NEUROPSYCHIATRIC DISORDERS ARE INCREASED WITH ALPHA INTERFERONS,
INCLUDING SYLATRON. PERMANENTLY
DISCONTINUE SYLATRON IN PATIENTS WITH PERSISTENTLY SEVERE OR WORSENING
SIGNS OR SYMPTOMS OF
DEPRESSION, PSYCHOSIS, OR ENCEPHALOPATHY. THESE DISORDERS MAY NOT
RESOLVE AFTER STOPPING SYLATRON
_[SEE WARNINGS AND PRECAUTIONS (5.1) AND ADVERSE REACTIONS (6.1)]._
INDICATIONS AND USAGE
SYLATRON is an alpha interferon indicated for the adjuvant treatment
of melanoma with microscopic or gross nodal
involvement within 84 days of definitive surgical resection including
complete lymphadenectomy. (1)
DOSAGE AND ADMINISTRATION
6 mcg/kg/week subcutaneously for 8 doses followed by;
3 mcg/kg/week subcutaneously for up to 5 years. (2.1)
DOSAGE FORMS AND STRENGTHS
200 mcg of deliverable lyophilized powder per single-dose vial (3)
300 mcg of deliverable lyophilized powder per single-dose vial (3)
600 mcg of deliverable lyophilized powder per single-dose vial (3)
CONTRAINDICATIONS
Known serious hypersensitivity reactions to peginterferon alfa-2b or
interferon alfa-2b. (4)
Autoimmune hepatitis. (4)
Hepatic decompensation (Child-Pugh score >6 [class B and C]). (4)
WARNINGS AND PRECAUTIONS
Depression and other serious neuropsychiatric adverse reactions. (5.1)
History of significant or unstable cardiac disease. (5.2)
Retinal disorders. (5.3)
Child-Pugh score >6 (class B and C). (4, 5.4)
Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that
cannot be effectively treat