"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
recombinant (hyaluronidase human injection)
HYLENEX recombinant (hyaluronidase human injection) is a purified preparation of the enzyme recombinant human hyaluronidase. HYLENEX recombinant (hyaluronidase human injection) 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 edentate disodium, 0.3 mg calcium chloride, and sodium hydroxide added for pH adjustment.
HYLENEX recombinant (hyaluronidase human injection) has an approximate pH of 7.4 and an osmolality of 290 to 350 mOsm.
What are the possible side effects of hyaluronidase (Amphadase, Hylenex, Vitrase)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include pain, itching, redness, or swelling where the medication was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...
Last reviewed on RxList: 12/29/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Hylenex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.