Hylenex Recombinant

HYLENEX recombinant is an endoglycosidase indicated as an adjuvant

• in subcutaneous fluid administration for achieving hydration (
  1.1. Subcutaneous Fluid Administration

  HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
  )
• to increase the dispersion and absorption of other injected drugs (
  1.2. Dispersion and Absorption of Injected Drugs

  HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
  )
• in subcutaneous urography for improving resorption of radiopaque agents (
  1.3. Subcutaneous Urography

  HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
  )

• See Full Prescribing Information for all approved routes of administration. (
  2.1. Important Administration Instructions

  HYLENEX recombinant should not be administered intravenously. Its effects relative to dispersion and absorption of other drugs are not produced when it is administered intravenously because the enzyme is rapidly inactivated.

  HYLENEX recombinant may be administered for infiltration use, interstitial use, intramuscular use, intraocular use, peribulbar use, retrobulbar use, soft tissue use or subcutaneous use. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration.
  )
• Subcutaneous Fluid Administration
  : Inject 150 USP units 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. (
  2.2. Subcutaneous Fluid Administration

  Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space. Inject 150 USP units of HYLENEX recombinant prior to start of subcutaneous fluid administration to facilitate absorption of up to 1,000 mL or more of solution. Inject HYLENEX recombinant through the catheter hub or injection port closest to the needle/catheter. Begin administration of solution. Solution should start in readily. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.

  HYLENEX recombinant may be added to small volumes of solution, such as fluid replacement solutions or solutions of drugs for subcutaneous injection. Subcutaneous fluids should be administered as directed by a physician. 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. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg and the rate of administration should not be greater than 2 mL per minute.
  )
• Increasing Dispersion and Absorption of Injected or Subcutaneously Infused Drugs
  : Inject 50 units to 300 units (most typically 150 USP units) HYLENEX recombinant prior to drug administration. Alternatively, add 50 units to 300 units (most typically 150 USP units) HYLENEX recombinant to the injection solution. (
  2.3. Dispersion and Absorption of Injected Drugs

  Hylenex can be used to enhance the dispersion and absorption of other injected or subcutaneously infused drugs by pre-administration of HYLENEX recombinant or by adding 50 units to 300 units, most typically 150 USP units hyaluronidase, to the injection solution prior to infiltration use, interstitial use, intramuscular use, intraocular use, retrobulbar use, soft tissue use or subcutaneous use.
  )
• Subcutaneous Urography
  : Inject 75 USP units HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. (
  2.4. Subcutaneous Urography

  The subcutaneous route of administration of urographic contrast media may be considered when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, inject 75 USP units of HYLENEX recombinant subcutaneously over each scapula, followed by injection of the contrast medium at the same sites.
  )

Injection: 150 USP units/mL as a clear and colorless solution in a single-dose vial.

• 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. (
  2.2. Subcutaneous Fluid Administration

  Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space. Inject 150 USP units of HYLENEX recombinant prior to start of subcutaneous fluid administration to facilitate absorption of up to 1,000 mL or more of solution. Inject HYLENEX recombinant through the catheter hub or injection port closest to the needle/catheter. Begin administration of solution. Solution should start in readily. As with all parenteral fluid therapy, observe effect closely, with the same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's, etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are administered subcutaneously, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration.

  HYLENEX recombinant may be added to small volumes of solution, such as fluid replacement solutions or solutions of drugs for subcutaneous injection. Subcutaneous fluids should be administered as directed by a physician. 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. For premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg and the rate of administration should not be greater than 2 mL per minute.
  ,
  8.4. Pediatric Use

  Clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with HYLENEX recombinant.

  The dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. The potential for chemical or physical incompatibilities should be kept in mind [see Drug Interactions (7)].

  The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. 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.

  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 [see Dosage and Administration (2.1)].
  ,
  14 Clinical Studies

  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 USP units) 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).
  )

• Spread of Localized Infection (
  5.1. Spread of Localized Infection

  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.
  )
• Ocular Damage (
  5.2. Ocular Damage

  Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
  )