ELFABRIO 20 mg/10mL
pegunigalsidase alfa · INJECTION, SOLUTION, CONCENTRATE · Chiesi USA, Inc.
ELFABRIO is a injection, solution, concentrate containing pegunigalsidase alfa at 20 mg/10mL, taken intravenous. Manufactured by Chiesi USA, Inc..
Key Facts
- Brand Name
- ELFABRIO
- Generic Name
- pegunigalsidase alfa
- NDC Code (Product)
10122-160- Manufacturer
- Chiesi USA, Inc.
- Strength
- 20 mg/10mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761161
- Drug Class
- Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]
- Marketing Start
- 05/23/2023
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 ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For pretreatment recommendations, see Full Prescribing Information. ( 2.1 ) Recommended dosage is 1 mg/kg every 2 weeks administered as an intravenous infusion. ( 2.2 ) For dosage and administration modifications due to hypersensitivity reactions or infusion-associated reactions (IARs), see Full Prescribing Information. ( 2.3 ) For instructions on preparation (including dilution), storage, and administration (including rates for the initial 4-6 infusions for ERT-experienced and ERT-naïve patients), see Full Prescribing Information. ( 2.4 , 2.5 , 2.6 ) 2. 1 Recommendations Prior to ELFABRIO Treatment Pretreatment In enzyme replacement therapy (ERT)-experienced patients, if pretreatment with antihistamines, antipyretics, and/or corticosteroids was used prior to ERT administration, consider similar pretreatment with these medications before the first several ELFABRIO infusions. After 4 to 6 ELFABRIO infusions, a stepwise decrease in the pretreatment medication dose(s) and/or discontinuation of the pretreatment medication(s) may be considered if treatment with ELFABRIO was tolerated. In ERT-naïve patients, prior to ELFABRIO administration, pre-treating with …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 ) ] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 )] Membranoproliferative Glomerulonephritis [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (≥15%) are: infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 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 trial of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions From Trial 2 The safety of ELFABRIO in adults with confirmed Fabry disease who had been previously treated with agalsidase beta was evaluated in Trial 2 which included a total of 52 ELFABRIO-treated patients (2…
Frequently Asked Questions
What is ELFABRIO used for?
ELFABRIO contains pegunigalsidase alfa. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is ELFABRIO a controlled substance?
ELFABRIO is not classified as a controlled substance by the DEA.
What is the generic name for ELFABRIO?
The generic name for ELFABRIO is pegunigalsidase alfa. There are no other listed brand versions of pegunigalsidase alfa.
What is the NDC code for ELFABRIO 20 mg/10mL?
The NDC (National Drug Code) for ELFABRIO 20 mg/10mL is 10122-160, listed by Chiesi USA, Inc..
Other ELFABRIO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)