Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
ELOSULFASE ALFA (UNII: ODJ69JZG85) (ELOSULFASE ALFA - UNII:ODJ69JZG85)
BioMarin Pharmaceutical Inc.
ELOSULFASE ALFA
ELOSULFASE ALFA 5 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Vimizim (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). None Pregnancy Exposure Registry There is a Morquio A Registry that collects data on pregnant women with MPS IVA who are treated with Vimizim. Contact MARS@bmrn.com or call 1-800-983-4587 for information and enrollment. Risk Summary Available data from published case reports and postmarketing experience with Vimizim use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development were observed in rats given daily administration of elosulfase alfa up to 33 times the human steady-state AUC (area under the concentration-time curve) at the recommended human weekly dose premating and through the period of organogenesis. No effects on embryo-fetal development were observed in rabbits given daily administration of elosulfase alfa at doses up
Vimizim is supplied as a concentrated solution for infusion (1 mg per mL) requiring dilution. One vial of 5 mL contains 5 mg Vimizim. NDC 68135-100-01, 5 mL single-dose vial Store Vimizim under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Diluted Vimizim should be used immediately. If immediate use is not possible, diluted Vimizim may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F) followed by up to 24 hours at 23°C to 27°C (73°F to 81°F) during administration.
Biologic Licensing Application
VIMIZIM- ELOSULFASE ALFA INJECTION, SOLUTION, CONCENTRATE BIOMARIN PHARMACEUTICAL INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VIMIZIM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIMIZIM. VIMIZIM (ELOSULFASE ALFA) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2014 WARNING: RISK OF ANAPHYLAXIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. LIFE-THREATENING ANAPHYLACTIC REACTIONS HAVE OCCURRED IN SOME PATIENTS DURING VIMIZIM INFUSIONS. ANAPHYLAXIS, PRESENTING AS COUGH, ERYTHEMA, THROAT TIGHTNESS, URTICARIA, FLUSHING, CYANOSIS, HYPOTENSION, RASH, DYSPNEA, CHEST DISCOMFORT, AND GASTROINTESTINAL SYMPTOMS IN CONJUNCTION WITH URTICARIA, HAVE BEEN REPORTED TO OCCUR DURING INFUSIONS, REGARDLESS OF DURATION OF THE COURSE OF TREATMENT. CLOSELY OBSERVE PATIENTS DURING AND AFTER VIMIZIM ADMINISTRATION AND BE PREPARED TO MANAGE ANAPHYLAXIS. INFORM PATIENTS OF THE SIGNS AND SYMPTOMS OF ANAPHYLAXIS AND HAVE THEM SEEK IMMEDIATE MEDICAL CARE SHOULD SYMPTOMS OCCUR. PATIENTS WITH ACUTE RESPIRATORY ILLNESS MAY BE AT RISK OF SERIOUS ACUTE EXACERBATION OF THEIR RESPIRATORY COMPROMISE DUE TO HYPERSENSITIVITY REACTIONS, AND REQUIRE ADDITIONAL MONITORING (5.1, 5.2, 6). INDICATIONS AND USAGE Vimizim is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) (1). DOSAGE AND ADMINISTRATION 2 mg per kg body weight administered once every week as an intravenous infusion over a minimum of 3.5 to 4.5 hours, based on infusion volume (2.1, 2.3). DOSAGE FORMS AND STRENGTHS Injection: 5 mg/5 mL (1 mg/mL) in single-dose vials (3). CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS · Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during treatment with Vimizim. If anaphylaxis or severe hypersensitivity reactions occur, immediately stop the infusion an Lue koko asiakirja