Safety

hylenex recombinant safety profile

In the INFUSE PEDS 1 Study :

All subjects reported adverse events, which were resolved without residual complications.¹
- Most adverse events were mild to moderate.¹
- Most commonly reported adverse events were infusion site reactions [swelling (100%), pain (90%), and erythema (86%)].¹

In the INFUSE-LR Study :

No incidence of severe edema occurred with hylenex recombinant-facilitated Sub-Q hydration.²

Please refer to the INFUSE PEDS 1 Study and INFUSE-LR Study design details.

^1. Allen C, Etzwiler L, Miller M, Maher G, Mace S. Recombinant Human Hyaluronidase-Enabled Subcutaneous Pediatric Rehydration. PEDIATRICS Volume 124, Number 5, November 2009.
^2. 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(6):1312-1320.

Important Risk Information for Healthcare Professionals

Indications

HYLENEX recombinant (hyaluronidase human injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for subcutaneous fluid administration; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Important Risk 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 applied directly to the cornea.
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.
The most frequently reported adverse experiences have been mild local injection site reactions, such as erythema and pain.
Hyaluronidase has been reported to enhance the adverse events associated with co-administered drug products.
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.
When hyaluronidase is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidence of systemic reaction.
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.
During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion.
When solutions devoid of inorganic electrolytes are given subcutaneously, hypovolemia may occur.

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