HYLENEX RECOMBINANT (hyaluronidase- human recombinant injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)

Available from:

A-S Medication Solutions

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. HYLENEX recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in HYLENEX recombinant. A preliminary skin test for hypersensitivity to HYLENEX recombinant can be performed. The skin test is made by an intradermal injection of approximately 0.02 mL (3 Units) of a 150 Unit/mL solution. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. Discontinue HYLENEX recombinant if sensitization occurs. Pregnancy Category C. In an em

Product summary:

Product: 50090-4534 NDC: 50090-4534-0 1 mL in a VIAL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HYLENEX RECOMBINANT- HYALURONIDASE (HUMAN RECOMBINANT) INJECTION,
SOLUTION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYLENEX RECOMBINANT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYLENEX
RECOMBINANT.
HYLENEX RECOMBINANT (HYALURONIDASE HUMAN INJECTION) FOR INFILTRATION
USE, FOR INTERSTITIAL
USE, FOR INTRAMUSCULAR USE, FOR INTRAOCULAR USE, FOR PERIBULBAR USE,
RETROBULBAR USE, FOR SOFT
TISSUE USE AND FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
HYLENEX recombinant is an endoglycosidase indicated as an adjuvant
in subcutaneous fluid administration for achieving hydration (1.1)
to increase the dispersion and absorption of other injected drugs
(1.2)
in subcutaneous urography for improving resorption of radiopaque
agents (1.3)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for all approved routes of
administration.
Subcutaneous fluid administration:
Inject 150 U HYLENEX recombinant prior to subcutaneous fluid
administration. It will facilitate absorption
of 1,000 mL or more of solution. The dosage of subcutaneous fluids
administered is dependent upon
the age, weight, and clinical condition of the patient as well as
laboratory determinations. The rate and
volume of subcutaneous fluid administration should not exceed those
employed for intravenous
infusion. (2.2)
Increasing dispersion and absorption of injected or subcutaneously
infused drugs:
Inject 50-300 U (most typically 150 U) HYLENEX recombinant prior to
drug administration. Alternatively,
add 50-300 U (most typically 150 U) HYLENEX recombinant to the
injection solution. (2.3)
Subcutaneous Urography:
Inject 75 U HYLENEX recombinant subcutaneously over each scapula,
followed by injection of the
contrast medium at the same sites. (2.4)
DOSAGE FORMS AND STRENGTHS
150 USP units/mL single dose vials (3)
CONTRAINDICATIONS
Hypersensitivity (4)
WARNINGS AND PRECAUTIONS
Spread of Localized Infection (5.1)
Ocular Damage (5.