VIMIZIM 5 mg/5mL
elosulfase alfa · INJECTION, SOLUTION, CONCENTRATE · BioMarin Pharmaceutical Inc.
Vimizim (elosulfase alfa) is an enzyme replacement therapy given by intravenous injection to treat Morquio A syndrome, a rare inherited disorder that affects bone and cartilage development. This medication works by replacing a missing enzyme that the body cannot produce on its own.
Key Facts
- Brand Name
- VIMIZIM
- Generic Name
- elosulfase alfa
- NDC Code (Product)
68135-100- Manufacturer
- BioMarin Pharmaceutical Inc.
- Strength
- 5 mg/5mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125460
- Drug Class
- Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
- Marketing Start
- 02/14/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administration of VIMIZIM should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. ( 2.1 ) 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. ( 2.2 , 2.4 ) See the full prescribing information for administration modifications due to hypersensitivity reactions. ( 2.3 ) 2.1 Important Administration Instructions Administration of VIMIZIM should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate VIMIZIM in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation [see Warnings and Precautions (5.1) ] . This product must be diluted prior to administration and administered using a low-protein binding infusion set equipped with a low-protein binding 0.2 micrometer (µm) in-line filter. Consider pre-medicating with antihistamines, with or without antipyretics, 30 to 60 minutes prior to the start of the infusion […
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] . Risk of Acute Respiratory Complications [see Warnings and Precautions (5.2) ] . Spinal or Cervical Cord Compression [see Warnings and Precautions (5.3) ] . Most common adverse reactions (≥10%) are: pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioMarin at 1-866-906-6100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A 24-week, randomized, double-blind, placebo-controlled clinical trial of VIMIZIM was conducted in 176 patients with MPS IVA, ages 5 to 57 years old. Approximately half of the patients (49%) were male. Of the 176 patients, 65% were White, 23% Asian, 3% Black, and 10% Other race. The majority of patie…
Frequently Asked Questions
What is VIMIZIM used for?
Vimizim (elosulfase alfa) is an enzyme replacement therapy given by intravenous injection to treat Morquio A syndrome, a rare inherited disorder that affects bone and cartilage development. This medication works by replacing a missing enzyme that the body cannot produce on its own.
Is VIMIZIM a controlled substance?
VIMIZIM is not classified as a controlled substance by the DEA.
What is the generic name for VIMIZIM?
The generic name for VIMIZIM is elosulfase alfa. There are no other listed brand versions of elosulfase alfa.
What is the NDC code for VIMIZIM 5 mg/5mL?
The NDC (National Drug Code) for VIMIZIM 5 mg/5mL is 68135-100, listed by BioMarin Pharmaceutical Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)