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HYLENEX: Addressing Unmet Needs in Pediatric Dehydration
As flu season approaches , Baxter is helping emergency departments to better prepare for one of the flu’s common consequences – dehydration.
Dehydration, an abnormal depletion of fluids and electrolytes from the body, often occurs as a result of an illness, especially when people are losing more fluids than they are taking in (e.g., in the case of vomiting and/or diarrhea). Dehydration can occur in people of any age, but it can be especially concerning for infants and children. They are dependent on caregivers for the provision of fluids and may have a hard time communicating thirst.
Dehydration is common in children. One of the most common causes of dehydration in children in the United States is acute gastroenteritis (or stomach flu), which is responsible for more than 1.5 million outpatient visits, 200,000 hospital stays, and approximately 300 deaths per year.1 Traditional treatment for dehydration consists of either the oral or intravenous (IV) replacement of needed fluids. Unfortunately, patients may not be able to hold down oral fluids, typically due to vomiting, limiting the utility of an oral treatment approach. Further, a study has shown that IV treatment was considered a common source of “worst pain” for children during hospitalization.2
“When children are getting their IVs, there is a lot of distress involved,” said Philip Spandorfer, M.D., emergency medicine physician at Children’s Healthcare of Atlanta at Scottish Rite. “Children are being restrained while the nurse is sticking them, and it’s just not an experience that any parent or child wants to go through.”
 Mikai Hall (HYLENEX patient) with her parents, Rekina and Mike |
Nurse and mother Rekina Hall vividly recalls the day she took her youngest daughter, Mikai, then five months old, to the hospital after she was running a fever, suffering from vomiting and diarrhea and becoming increasingly dehydrated. “ She wasn’t holding anything down, not even water,” Rekina said.
While at the hospital, Rekina learned that Mikai needed to receive IV fluids for rehydration. As Mikai was very young and had never received an IV before, Hall was uneasy about the prospect. “My experience as a nurse has taught me that sometimes it takes multiple needle sticks to actually insert and start an IV, especially when someone is dehydrated. As a nurse, you’re trained not to panic, but it’s different when you're dealing with your own kid.”
Dr. Spandorfer informed Rekina about FDA-approved HYLENEX, an alternative to IV therapy that could be used to safely and effectively facilitate rehydration in dehydrated children by delivering fluids under the skin (subcutaneously) rather than through a vein. Rekina chose subcutaneous rehydration facilitated by HYLENEX because it seemed “less invasive and less traumatic” for her child.
Baxter launched HYLENEX for use in pediatric rehydration in October 2009, and this therapy is now available at many leading U.S. children’s hospitals.
Treatment facilitated by HYLENEX is an easy-to-use and efficient alternative to IV when IV access is not practical or available and when oral therapy is not feasible. HYLENEX is injected subcutaneously without the need to start an IV or access a child’s vein, especially when fluid replacement is all that the child needs. HYLENEX also allows for injection in a child’s upper back, which may deter a young child from pulling on the catheter and from seeing the needle, which creates a more comfortable experience for parents, children and clinicians. Special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion.3 When solutions devoid of inorganic electrolytes are given subcutaneously, some complications may occur.3
“With HYLENEX we have an option that certainly will have a much higher first attempt success rate, and a much better way of rehydrating children.” Dr. Spandorfer said.
Results from Baxter’s Increased Flow Utilizing Subcutaneously-Enabled (INFUSE)-PEDS 1 study published in the latest issue of Pediatrics found HYLENEX recombinant-facilitated subcutaneous rehydration to be safe, quick and effective in mild to moderately dehydrated children ages two months to 10 years.4 Subcutaneous access was easily achieved with 90 percent of catheters successfully inserted and secured on the first attempt and a median initiation time of two minutes.4 In addition, nine out of 10 parents surveyed were satisfied or very satisfied with the procedure and reported their experience with treatment facilitated by HYLENEX was the same or better than previous IV experience.4 In the study, HYLENEX was generally safe and well tolerated. All subjects reported adverse events, which were resolved without residual complications. Most adverse events were mild to moderate. The most commonly reported adverse events were infusion site reactions [swelling (100%), pain (90%), and erythema (86%)]. No systemic adverse events due to HYLENEX or infusion fluid were reported. One serious adverse event occurred, cellulitis (a skin infection caused by bacteria) at the infusion site, but was assessed by the investigator as not related to HYLENEX.
“To have another option for rehydration is a huge deal for pediatricians because frankly, what we’ve been left with is that if we couldn’t orally rehydrate a child, we went on to IV. If we couldn’t get IV access, we had to move on to pretty invasive procedures,” said Coburn H. Allen, Assistant Professor, Department of Pediatrics, Section of Emergency Medicine and Section of Infectious Diseases, Baylor College of Medicine, Houston, Texas. “With HYLENEX , you are starting fluids into these children literally within minutes.”
 Mikai Hall (HYLENEX patient) |
For Rekina, rehydration facilitated by HYLENEX improved her daughter’s and her own hospital experience. “I was able hold Mikai in my arms as the needle was actually being inserted into her back, and it was really comforting for her. She was able to sit directly on my lap, and they were able to administer the needle and start the fluids, all within the comfort of my arms. She felt secure, I felt secure. Mikai was back to normal the next day.”
“I think the patient wins from a less painful standpoint,” Dr. Spandorfer said. “I think the parents are winning because they’re not having to witness their child being under so much distress and it’s a win for the emergency department, because we are able to get treatment started quicker and hopefully get that child discharged from the emergency department. I think it’s just an absolute win – win for everybody.”
Please see Important Risk Information for HYLENEX below.
For more about HYLENEX and for full Prescribing Information, visit www.hylenex.com.
Important Risk Information for HYLENEX
- Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.
- Discontinue HYLENEX 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.
- The most frequently reported adverse experiences have been local injection site reactions.
- 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 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.
1King C, Glass R, Bresee J, et al. Managing Acute Gastroenteritis Among Children. Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention; 2003. Nov. 21.
2Cummings EA, Reid, GJ, Finley A, et al. Prevalence and Source of Pain in Pediatric Inpatients. Pain. 1996; 68; 25-31.
3HYLENEX Full Prescribing Information.
4Baxter Healthcare Corporation. Data on File. 2009.
