Hyaluronidase
Generic Name: hyaluronidase
Brand Names:
Hylenex Recombinant
11 Description Hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has an approximate molecular weight of 61 kDa.
Overview
11 Description Hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has an approximate molecular weight of 61 kDa.
Uses
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
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.
Side Effects
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.
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.
Warnings
5. Warnings and Precautions Spread of Localized Infection ( 5.1 ) Ocular Damage ( 5.2 ) 5.1. Spread of Localized Infection Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings. 5.2. Ocular Damage Hyaluronidase should not be applied directly to the cornea. It is not for topical use. 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 )
Pregnancy
8.1. Pregnancy Risk Summary There are no adequate and well-controlled studies of HYLENEX recombinant administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of HYLENEX recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. Administration of HYLENEX recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses. Human Data Limited available data with HYLENEX recombinant in pregnant women have not identified any potential risks.
Storage
HYLENEX recombinant is supplied in the following packaging: 1 mL single-dose vial (NDC 18657-117-01) available in boxes of 4 (NDC 18657-117-04) Store unopened in a refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.
Frequently Asked Questions
What is Hyaluronidase used for?▼
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.
What are the side effects of Hyaluronidase?▼
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.
Can I take Hyaluronidase during pregnancy?▼
8.1. Pregnancy Risk Summary There are no adequate and well-controlled studies of HYLENEX recombinant administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of HYLENEX recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. Administration of HYLENEX recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses. Human Data Limited available data with HYLENEX recombinant in pregnant women have not identified any potential risks.
What are the important warnings for Hyaluronidase?▼
5. Warnings and Precautions Spread of Localized Infection ( 5.1 ) Ocular Damage ( 5.2 ) 5.1. Spread of Localized Infection Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings. 5.2. Ocular Damage Hyaluronidase should not be applied directly to the cornea. It is not for topical use. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.