ELELYSO 200 U/5mL
Taliglucerase alfa · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Pfizer Laboratories Div Pfizer Inc
ELELYSO is a injection, powder, lyophilized, for solution containing taliglucerase alfa at 200 U/5mL, taken intravenous. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- ELELYSO
- Generic Name
- Taliglucerase alfa
- NDC Code (Product)
0069-0106- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 200 U/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA022458
- Drug Class
- Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
- Marketing Start
- 05/01/2012
Recall History
Pfizer Inc.
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Pfizer Inc.
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommendations Prior to ELELYSO Treatment ( 2.1 ): • Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Recommended Dosage in Patients 4 Years and Older ( 2.2 ): • Treatment-naïve : 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion. • Patients switching from imiglucerase : Initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be based on achievement and maintenance of each patient’s therapeutic goals. Preparation and Administration ( 2.3, 2.4, 2.5 ): • Reconstitute, dilute and administer under the supervision of a healthcare professional. • See Full Prescribing Information for complete instructions. 2.1 Recommendations Prior to ELELYSO Treatment Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate ELELYSO in a healthcare setting with…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are: • Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria ( 6.1 ). • Patients who Switched from Imiglucerase, after 9 Months on Treatment (≥10%): arthralgia, headache, pain in extremity ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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. Adverse Reactions from Clinical Trials of ELELYSO as Initial Therapy • Clinical Trial in Adult Patients The safety of ELELYSO at dosages of either 30 units/kg (n=16) (50% of the recommended dosage) [see Dosage and Administration (2.1) ] or 60 units/kg (n=16) administered intravenously every other week was assessed in 32 adult treatment-naïve patients (aged 19 to 74 years) with Type 1 Gaucher disease in a 9-month double-blind, randomized cl…
Frequently Asked Questions
What is ELELYSO used for?
ELELYSO contains Taliglucerase alfa. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is ELELYSO a controlled substance?
ELELYSO is not classified as a controlled substance by the DEA.
What is the generic name for ELELYSO?
The generic name for ELELYSO is Taliglucerase alfa. There are no other listed brand versions of Taliglucerase alfa.
What is the NDC code for ELELYSO 200 U/5mL?
The NDC (National Drug Code) for ELELYSO 200 U/5mL is 0069-0106, listed by Pfizer Laboratories Div Pfizer Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)