Hylenex

Clinician Resource Library

Bibliography

The bibliography is provided to direct you to further published information regarding hyaluronidase and related topics. It contains a selection but not a comprehensive list of the available published literature.

Hylenex recombinant (hyaluronidase human injection)

Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, et al. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatr. 2009;124(5):e858-e867.

Bookbinder LH, Hofer A, Haller MF, et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114:230-241.

Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4:427-440.

Haller MF. Converting intravenous dosing to subcutaneous dosing with recombinant humanhyaluronidase. Pharm Tech. 2007;10:861-864.

Pirrello RD, Ting Chen C, Thomas SH. Initial experiences with subcutaneous recombinant human hyaluronidase. J Palliat Med. 2007;10:861-864.

Thomas JR, Yocum RC, Haller MF, von Gunten CF. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007;10:1312-1320.

Yocum RC, Kennard D, Heiner LS. Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs. 2007;30:293-299.

Hyaluronidase

Dudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med. 2008;358:843-849.

Ebo DG, Goossens S, Opsomer F, Bridts CH, Stevens WJ. Flow-assisted diagnosis of anaphylaxis to hyaluronidase. Allergy. 2005;60:1333-1334.

Jaworski A, Farley JE Jr. Hyaluronidase in administration of fluids. Am J Dis Child. 1950;79:59-64.

Schwartzman J. Hyaluronidase: a review of its therapeutic use in pediatrics. J Pediatr. 1951;39:491-502.

World Health Organization. WHO Guidelines on Transmissible Spongiform Encephalopathies in Relation to Biological and Pharmaceutical Products. 2003. Available at: http://www.who.int/bloodproducts/publications/en/WHO_TSE_2003.pdf. Accessed July 18, 2011.

Subcutaneous Hydration

Frisoli A Jr, de Paula AP, Feldman D, and Nasri F. Subcutaneous hydration by hypodermoclysis. A practical and low cost treatment for elderly patients. Drugs Aging. 2000;16:313-319.

Lipschitz S, Campbell AJ, Roberts MS, Wanwimolruk S, McQueen EG, Firth LA. Subcutaneous fluid administration in elderly subjects: Validation of an under-used technique. Am J Geriatr Soc. 1991;29:6-9.

Lybarger EH. Hypodermoclysis in the home and long-term care settings. J Infus Nurs. 2009;32:40-44.

Remington R, Hultman T. Hypodermoclysis to treat dehydration: a review of the evidence. J Am Geriatr Soc. 2007;55(12):2051-2055.

Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004;291:2746-2754.

Thomas DR, Cote TR, Lawhorne L, et al and Dehydration Council. Understanding clinical dehydration and its treatment. J Am Med Dir Assoc. 2008;9:292-301.

Walsh G. Hypodermoclysis: an alternate method for rehydration in long-term care. J Infus Nurs. 2005;28:123-129.

Pediatric IV Considerations

Spandorfer PR, Alessandrini EA, Joffe MD, Localio R, Shaw KN. Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. Pediatr. 2005;115:295-301.

Wathen JE, MacKenzie T, Bothner JP. Usefulness of the serum electrolyte panel in the management of pediatric dehydration treated with intravenously administered fluids. Pediatrics. 2004;114:1227-1234.

Zempsky WT. Pharmacologic approaches for reducing venous access pain in children. Pediatrics. 2008;122:S140-S153.

Absorption and Dispersion of Other Injected Drugs

Anderson DM. et al, eds. Dorland's Medical Dictionary. 27th ed. Philadelphia, PA: W.B. Saunders; 1988.

Alwitry A, Chaudhary S, Gopee K, Butler TK, Holden R. Effect of hyaluronidase on ocular motility in sub-Tenon’s anesthesia: randomized controlled trial. J Cataract Refract Surg. 2002;28:1420-1423.

Dempsey GA, Barrett PJ, Kirby IJ. Hyaluronidase and peribulbar block. Br J Anaesth. 1997;78:671-674.

Eberhart AH, Weiler CR, Erie JC. Angioedema related to the use of hyaluronidase in cataract surgery. Am J Ophthalmol. 2004;138:142-143.

Guise P, Laurent S. Sub-Tenon’s block: the effect of hyaluronidase on speed of onset and block quality. Anaesth Intensive Care. 1999;27:179-181.

Kallio H, Paloheimo M, Maunuksela EL. Hyaluronidase as an adjuvant in bupivacaine-lidocaine mixture for retrobulbar/peribulbar block. Anesth Analg. 2000;91:934-937.

Mantovani C, Bryant AE, Nicholson G. Efficacy of varying concentrations of hyaluronidase in peribulbar anesthesia. Br J Anaesth. 2001;86:876-878.

Rowley SA, Hale JE, Finlay RD. Sub-Tenon’s local anaesthesia: the effect of hyaluronidase. Br J Ophthalmol. 2000;84:435-436.

Please see Important Safety Information and accompanying package insert for Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication

Hylenex recombinant (hyaluronidase human injection) is a tissue modifier indicated as an adjuvant in subcutaneous fluid administration for achieving hydration, to increase the dispersion and absorption of other injected drugs, and in subcutaneous urography for improving resorption of radiopaque agents.

Important Safety Information

Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.
Discontinue Hylenex recombinant (hyaluronidase human injection) if sensitization occurs.
Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
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.
Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.
Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
Hyaluronidase should not be applied directly to the cornea.

The most frequently reported adverse experiences have been local injection site reactions, such as erythema and pain. Hyaluronidase has been reported to enhance the adverse events associated with co-administered drug products.

Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect, since these drugs apparently render tissues partly resistant to the action of hyaluronidase.

Edema has been reported most frequently in association with subcutaneous fluid administration.

The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. As with all parenteral fluid therapy, use the same precautions for restoring fluid and electrolyte balance. Special care must be taken in pediatric patients to avoid overhydration by controlling the rate and total volume of infusion. When solutions devoid of inorganic electrolytes are given subcutaneously, hypovolemia may occur.