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.
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NEWS HIGHLIGHTS
Published Studies Related to Hylenex (Hyaluronidase Recombinant)
Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. [2010.02]
CONCLUSIONS: Ceftriaxone AUC did not differ significantly between the three administration routes. C(max) was higher and t(max) shorter with rHuPH20-facilitated SC than SC preceded by placebo. rHuPH20-facilitated SC ceftriaxone was generally well tolerated. This study is limited by evaluation of healthy adults and absence of repeated-dose groups.
Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or
without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone
administration in adult volunteers. [2010]
CONCLUSIONS: Ceftriaxone AUC did not differ significantly between the three
The INFUSE-Morphine IIB study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneous morphine in healthy volunteers. [2009.11]
Morphine is usually given intravenously (IV) for the treatment of moderate-to-severe pain, but subcutaneous (SC) administration is a viable alternative for parenteral delivery. The pharmacokinetics of SC morphine may be enhanced by coadministration with a hyaluronidase product... Compared with SC morphine alone, rHuPH20 shortens morphine T(max) and raises C(max) in healthy adults, without changing the extent of exposure.
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.
Clinical Trials Related to Hylenex (Hyaluronidase Recombinant)
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers [Recruiting]
Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients [Recruiting]
The overall aim of this study is to find out whether Hylenex recombinant (for short,
Hylenex) in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids
in hospice patients. Specifically, this study proposes to compare the level of self-reported
pain in hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid)
over the initial 8 hours of opioid infusion with and without the preceded co-injection of
Hylenex. Hospice patients include both home-bound patients as well as those under intensive
care in hospice houses.
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]
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