Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
peginterferon alfa-2b (UNII: G8RGG88B68) (peginterferon alfa-2b - UNII:G8RGG88B68)
Merck Sharp & Dohme Corp.
peginterferon alfa-2b
peginterferon alfa-2b 40 ug in 0.1 mL
PRESCRIPTION DRUG
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
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.
Biologic Licensing Application
Merck Sharp & Dohme Corp. ---------- 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 Læs hele dokumentet
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 Læs hele dokumentet