MYOZYME alglucosidase alfa injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALGLUCOSIDASE ALFA (UNII: DTI67O9503) (ALGLUCOSIDASE ALFA - UNII:DTI67O9503)

Available from:

Genzyme Corporation

INN (International Name):

ALGLUCOSIDASE ALFA

Composition:

ALGLUCOSIDASE ALFA 5 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

MYOZYME- ALGLUCOSIDASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYOZYME SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYOZYME.
MYOZYME (ALGLUCOSIDASE ALFA)
INJECTABLE FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2006
WARNING: ANAPHYLAXIS, SEVERE ALLERGIC AND IMMUNE MEDIATED REACTIONS
AND RISK OF
CARDIORESPIRATORY FAILURE
LIFE-THREATENING ANAPHYLACTIC, SEVERE ALLERGIC AND IMMUNE MEDIATED
REACTIONS HAVE BEEN OBSERVED IN
SOME PATIENTS DURING MYOZYME INFUSIONS. THEREFORE, APPROPRIATE MEDICAL
SUPPORT SHOULD BE
READILY AVAILABLE WHEN MYOZYME IS ADMINISTERED.
RISK OF CARDIORESPIRATORY FAILURE
PATIENTS WITH COMPROMISED CARDIAC OR RESPIRATORY FUNCTION MAY BE AT
RISK OF SERIOUS ACUTE
EXACERBATION OF THEIR CARDIAC OR RESPIRATORY COMPROMISE DUE TO
INFUSION REACTIONS, AND REQUIRE
ADDITIONAL MONITORING.
_See WARNINGS AND PRECAUTIONS (5) _
INDICATIONS AND USAGE
MYOZYME (alglucosidase alfa) is a lysosomal glycogen-specific enzyme
indicated for use in patients with Pompe disease
(GAA deficiency). MYOZYME has been shown to improve ventilator-free
survival in patients with infantile-onset Pompe
disease as compared to an untreated historical control, whereas use of
MYOZYME in patients with other forms of Pompe
disease has not been adequately studied to assure safety and efficacy.
(1)
DOSAGE AND ADMINISTRATION
The recommended dosage of MYOZYME is 20 mg/kg body weight administered
every 2 weeks as an intravenous
infusion. (2)
DOSAGE FORMS AND STRENGTHS
Dosage form: Lyophilized powder for solution for intravenous infusion.
Dosage strength: 5 mg/mL. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Life-threatening anaphylactic, severe allergic and immune mediated
reactions: Ensure that appropriate medical support
is readily available. If severe allergic or anaphylactic reactions
occur, consider immediate discontinuation of MYOZYME
and initiate appropriate medical treatm