HYALURONIDASE

HYALURONIDASE- hyaluronidase (human recombinant) injection, solution
HF Acquisition Co LLC, DBA HealthFirst

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 ( 5.2)
Enzyme Inactivation with Intravenous Administration ( 2.1)

ADVERSE REACTIONS

Allergic and anaphylactic-like reactions have been reported, rarely. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Halozyme Therapeutics, Inc. at 1-877-877-1679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Furosemide, the benzodiazepines and phenytoin are incompatible with hyaluronidase. ( 7.1)
Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha agonist drugs. ( 7.2)
Local anesthetics: Hyaluronidase hastens onset and shortens duration of effect, increases incidence of systemic reactions. ( 7.3)
Large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect. ( 7.4)

USE IN SPECIFIC POPULATIONS

Pediatric Use: The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight, and the rate of administration should not be greater than 2 mL per minute. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion. ( 2.2, 8.4, 14)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2016

TABLE OF CONTENTS

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Subcutaneous Fluid Administration
1.2 Dispersion and Absorption of Injected Drugs
1.3 Subcutaneous Urography
2. DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Subcutaneous Fluid Administration
2.3 Dispersion and Absorption of Injected Drugs
2.4 Subcutaneous Urography
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Spread of Localized Infection
5.2 Ocular Damage
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Incompatibilities
7.2 Drug-Specific Precautions
7.3 Local Anesthetics
7.4 Salicylates, Cortisone, ACTH, Estrogens and Antihistamines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Important Precautions Regarding HYLENEX recombinant
17.2 What Patients Should Know About Adverse Reactions
17.3 Patients Should Inform Their Doctors If Taking Other Medications

* Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

1.1 Subcutaneous Fluid Administration

HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

1.2 Dispersion and Absorption of Injected Drugs

HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.

1.3 Subcutaneous Urography

HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

2 DOSAGE & ADMINISTRATION

2.1 Important Administration Instructions

HYLENEX recombinant should not be administered intravenously. Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.

HYLENEX recombinant may be administered for infiltration use, interstitial use, intramuscular use, intraocular use, peribulbar use, retrobulbar use, soft tissue use or subcutaneous use.

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration.

Always use aseptic precautions. Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space. Inject HYLENEX recombinant through the catheter hub or injection port closest to the needle/catheter. Begin administration of solution. Solution should start in readily.

2.2 Subcutaneous Fluid Administration

Inject 150 U of HYLENEX recombinant prior to start of subcutaneous fluid administration to facilitate absorption of up to 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer’s, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.

HYLENEX recombinant may be added to small volumes of solution, such as fluid replacement solutions or solutions of drugs for subcutaneous injection. Subcutaneous fluids should be administered as directed by a physician. 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. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg and the rate of administration should not be greater than 2 mL per minute.

2.3 Dispersion and Absorption of Injected Drugs

Hylenex can be used to enhance the dispersion and absorption of other injected or subcutaneously infused drugs by pre-administration of HYLENEX recombinant or by adding 50-300 U, most typically 150 U hyaluronidase, to the injection solution prior to infiltration use, interstitial use, intramuscular use, intraocular use, retrobulbar use, soft tissue use or subcutaneous use.

2.4 Subcutaneous Urography

The subcutaneous route of administration of urographic contrast media may be considered when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, inject 75 U of HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.

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