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Hyaluronidase (Human Recombinant) (Hylenex Recombinant)

Trade Name : HYLENEX Recombinant

Halozyme, Inc.

INJECTION, SOLUTION

Strength 150 [USP'U]/mL

HYALURONIDASE (HUMAN RECOMBINANT) Endoglycosidase [EPC],Glycoside Hydrolases [CS]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hyaluronidase (Human Recombinant) (Hylenex Recombinant) which is also known as HYLENEX Recombinant and Manufactured by Halozyme, Inc.. It is available in strength of 150 [USP'U]/mL per ml. Read more

Hyaluronidase (Human Recombinant) (Hylenex Recombinant) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • HYLENEX recombinant is an endoglycosidase indicated as an adjuvant
  • in subcutaneous fluid administration for achieving hydration ()
  • to increase the dispersion and absorption of other injected drugs ()
  • in subcutaneous urography for improving resorption of radiopaque agents ()
  • No data
  • 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. ()
  • 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. ()
  • Subcutaneous Urography:Inject 75 U HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. ()
  • 150 USP units/mL single dose vials
  • 150 USP units/mL single dose vials ()
  • 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.
  • Hypersensitivity ()
  • No data
  • Spread of Localized Infection ()
  • Ocular Damage ()
  • Enzyme Inactivation with Intravenous Administration ()
  • 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Halozyme Therapeutics, Inc. at 1-877-877-1679 or FDA at 1-800-FDA-1088 or .
  • Allergic and anaphylactic-like reactions have been reported, rarely. ()
  • 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. ()
  • Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha agonist drugs. ()
  • Local anesthetics: Hyaluronidase hastens onset and shortens duration of effect, increases incidence of systemic reactions. ()
  • Large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect. ()
  • No data
  • 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. (, , )
  • HYLENEX recombinant is a purified preparation of the enzyme recombinant human hyaluronidase. HYLENEX recombinant is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). The purified hyaluronidase glycoprotein contains 447 amino acids with an approximate molecular weight of 61,000 Daltons.
  • HYLENEX recombinant is supplied as a sterile, clear, colorless, nonpreserved, ready-for-use solution. Each mL contains 150 USP units of recombinant human hyaluronidase with 8.5 mg sodium chloride, 1.4 mg dibasic sodium phosphate, 1 mg albumin human, 1.5 mg L-methionine, 0.2 mg polysorbate 80, and hydrochloric acid and sodium hydroxide added for pH adjustment.
  • HYLENEX recombinant has an approximate pH of 7.0 and an osmolality of 280 to 340 mOsm/kg.
  • No data
  • Hyaluronidase is found in most tissues of the body. Long-term animal studies have not been performed to assess the carcinogenic or mutagenic potential of hyaluronidase.
  • Human studies on the effect of intravaginal hyaluronidase in sterility due to oligospermia indicated that hyaluronidase may have aided conception. Thus, it appears that hyaluronidase may not adversely affect fertility in females. In addition, when recombinant human hyaluronidase was administered to cynomolgus monkeys for 39 weeks at dose levels up to 220,000 U/kg, no evidence of toxicity to the male or female reproductive system was found through periodic monitoring of in-life parameters, e.g., semen analyses, hormone levels, menstrual cycles, and also from gross pathology, histopathology and organ weight data.
  • HYLENEX recombinant facilitated the administration of subcutaneous fluids in pediatric patients with mild to moderate dehydration in an open-label, multicenter, single arm study in fifty-one (51) patients. A subcutaneous injection of 1 mL (150 U) of HYLENEX recombinant was immediately followed by subcutaneous infusion of isotonic fluids in either the mid-anterior thigh or the inter-scapular area of the upper back.
  • The safety and flow rate of subcutaneously administered Lactated Ringer's (LR) solution with and without HYLENEX recombinant was evaluated in a prospective, randomized, double-blinded, placebo-controlled, within-subject, single-center study in fifty-four (54) healthy volunteers. The mean HYLENEX recombinant facilitated infusion rate was 464 mL/hr versus 118 mL/hr for the saline control (p < 0.001, paired t-test).
  • HYLENEX recombinant is supplied sterile as 150 USP units of nonpreserved recombinant human hyaluronidase per mL in a single-use glass vial.
  • 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 2u00b0 to 8u00b0C (36u00b0 to 46u00b0 F).
  • DO NOT FREEZE.
  • No data
  • Hylenex, the Hylenex logo and Halozyme Therapeutics are trademarks of Halozyme, Inc.
  • U.S. Patent Nos. 7,767,429, 8,202,517, 8,431,124 and 8,431,380
  • Manufactured for and Marketed by: Halozyme Therapeutics, Inc., San Diego, CA 92121
  • For Product Inquiry: 1 855 495-3639
  • Rev. February 2016LBL301-05
  • NDC 18657-117-04
  • Hylenexn recombinant 4 x 1 mL (hyaluronidasehuman injection)
  • 150 USP units/mL NOT FOR IV USE REFRIGERATE
  • Rx only
  • Single Dose VialsHALOZYME THERAPEUTICS

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

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