HYLENEX Recombinant 150 [USP'U]/mL
Hyaluronidase · INJECTION, SOLUTION · Antares Pharma, Inc.
HYLENEX Recombinant is a injection, solution containing hyaluronidase at 150 [USP'U]/mL, taken subcutaneous. Manufactured by Antares Pharma, Inc..
Key Facts
- Brand Name
- HYLENEX Recombinant
- Generic Name
- Hyaluronidase
- NDC Code (Product)
18657-117- Manufacturer
- Antares Pharma, Inc.
- Strength
- 150 [USP'U]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA021859
- Drug Class
- Endoglycosidase [EPC]
- Marketing Start
- 12/02/2005
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP Deviations: Temperature excursion
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 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 ) 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.
Dosage & Administration
2. Dosage and administration See Full Prescribing Information for all approved routes of administration. ( 2.1 ) Subcutaneous Fluid Administration : Inject 150 USP units 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 units to 300 units (most typically 150 USP units) HYLENEX recombinant prior to drug administration. Alternatively, add 50 units to 300 units (most typically 150 USP units) HYLENEX recombinant to the injection solution. ( 2.3 ) Subcutaneous Urography : Inject 75 USP units HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. ( 2.4 ) 2.1. Important Administration Instructions HYLENEX recombinant should not be administered intravenously. Its effects relative to d…
Contraindications
4. Contraindications HYLENEX recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in HYLENEX recombinant. Discontinue HYLENEX recombinant if sensitization occurs. Hypersensitivity ( 4 )
Drug Interactions
7. Drug Interactions It is recommended that appropriate references be consulted regarding physical or chemical incompatibilities before adding HYLENEX recombinant to a solution containing another drug. 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 ) 7.1. Incompatibilities Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase. Admixture stability studies have shown that 2% lidocaine with 1:100,000 or 1:200,000 epinephrine is incompatible with hyaluronidase due to the presence of sodium metabisulfite, a common additive in anesthetic products containing epinephrine. 7.2. Drug-Specific Precautions Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha…
Adverse Reactions
6. Adverse Reactions The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions have been mild local injection site reactions such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely. Allergic and anaphylactic-like reactions have been reported, rarely. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Halozyme,ºInc. at 1-877-877-1679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is HYLENEX Recombinant used for?
HYLENEX Recombinant contains Hyaluronidase. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is HYLENEX Recombinant a controlled substance?
HYLENEX Recombinant is not classified as a controlled substance by the DEA.
What is the generic name for HYLENEX Recombinant?
The generic name for HYLENEX Recombinant is Hyaluronidase. There are 2 other brand versions of Hyaluronidase.
What is the NDC code for HYLENEX Recombinant 150 [USP'U]/mL?
The NDC (National Drug Code) for HYLENEX Recombinant 150 [USP'U]/mL is 18657-117, listed by Antares Pharma, Inc..