HYLENEX SUMMARY
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 (hyaluronidase human injection) 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, 1.0 mg albumin human, 0.9 mg edetate disodium, 0.3 mg calcium chloride, and sodium hydroxide added for pH adjustment.HYLENEX recombinant has an approximate pH of 7.4 and an osmolality of 290 to 350 mOsm.
HYLENEX recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
|
NEWS HIGHLIGHTS
Published Studies Related to Hylenex (Hyaluronidase Recombinant)
Randomized sibling-oocyte study using recombinant human hyaluronidase versus bovine-derived Sigma hyaluronidase in ICSI patients. [2008.08]
BACKGROUND: The enzyme hyaluronidase from bovine origin is commonly used for oocyte-cumulus cell removal in ICSI. A recombinant human hyaluronidase (rHuPH20) has been introduced as a quality-controlled and safe alternative... CONCLUSIONS: Our results indicate that rHuPH20 is not inferior to bovine hyaluronidase for oocyte denudation, with regard to oocyte survival and fertilization. rHuPH20 treatment of human oocytes is compatible with good embryo development, with positive hCG results and with live birth.
Assessing the Role of Human Recombinant Hyaluronidase in Gravity-Driven Subcutaneous Hydration: The INFUSE-LR Study. [2007.12]
Background: Subcutaneous hydration has potential advantages over intravenous. Despite studies supporting the efficacy and safety of subcutaneous hydration it has not been studied extensively to date either with or without hyaluronidase... These findings suggest that this method of hydration could potentially replace intravenous infusions in many clinical settings; further studies with rHuPH20, in patients, are warranted.
Comparison of bovine- and recombinant human-derived hyaluronidase with regard to fertilization rates and embryo morphology in a sibling oocyte model: a prospective, blinded, randomized study. [2006.05]
The objective of the present study was to compare a traditionally used bovine-derived hyaluronidase (Hyase) with the newly developed recombinant human-derived enzyme product (Cumulase) in intracytoplasmic sperm injection (ICSI) procedures using a sibling oocyte model in a prospective randomized design.
The INFUSE Morphine Study: Use of Recombinant Human Hyaluronidase (rHuPH20) to Enhance the Absorption of Subcutaneously Administered Morphine in Patients with Advanced Illness. [2009.10.09]
Morphine is often administered by the subcutaneous (SC) route when venous access is difficult to achieve. Hyaluronidase temporarily increases the permeability of SC connective tissues by degrading hyaluronan and has been shown to increase the dispersion and absorption of coadministered molecules...
Human recombinant hyaluronidase (Cumulase) improves intracytoplasmic sperm injection survival and fertilization rates. [2009.06]
The cumulus-corona-oocyte complex, composed of cumulus granulosa cells embedded in a matrix of hyaluronan oligosaccharide chains cross-linked by hyaluronan binding proteins and proteoglycans, surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI)...
Clinical Trials Related to Hylenex (Hyaluronidase Recombinant)
Phase II PK Study With Humalog and Humulin R With and Without rHuPH20 in T1DM [Recruiting]
Humalog and Humulin R are FDA approved medications for the treatment of diabetes mellitus.
Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption
and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with
both Humalog and Humulin R in order to determine if it improves the absorption of these
insulins to more closely mimic the body's natural increase in insulin in response to a meal.
Study of Immediate Post-Operative Intravesical Instillation of ChemophaseŽ in Patients With Superficial Bladder Cancer [Recruiting]
The purpose of this research study is to test the safety and tolerability of an experimental
drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational
synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial
bladder cancer when instilled intravesically immediately after TURBT (transurethral resection
of bladder tumor).
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase [Recruiting]
Liquid Meal Study With Insulin Lispro With/Without rHuPH20 and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Patients With T2DM [Recruiting]
This is a single center, phase 2, randomized, double-blind, 3-way crossover meal study in
patients with Type 2 diabetes mellitus to determine the optimum dose and compare the
pharmacokinetics and postprandial glycemic response of lispro + rHuPH20, lispro alone, and
insulin + rHuPH20 administered subcutaneously.
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone [Recruiting]
The purpose of this study is to determine the maximum tolerated concentration (MTC) of
bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate
without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at
MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20
to bisphosphonate alone.
|
|
|
|
Page last updated: 2009-10-20
|
