Supprelin LA, Xyzal tablets.
(histrelin acetate, Indevus Pharmaceuticals Inc.)
The Food and Drug Administration approved Supprelin LA (histrelin acetate subcutaneous implant) 50 mg for treatment of central precocious puberty in children.
* Recommended Dosage: The once-yearly implant continuously releases approximately 65 mcg/day of the gonadotropin-releasing hormone analog histrelin. The implant is inserted in the upper aspect of the arm.
* Special Considerations: Implant site bruising, pain, soreness, erythema, and swelling were the most commonly reported adverse events in two studies. An initial transient increase in estradiol and/or testosterone that temporarily worsens symptoms is possible. Other adverse events related to suppression of endogenous sex steroid secretion may occur.
Use in children younger than 2 years is not recommended. Use of the implant is contraindicated in women who are or may become pregnant.
* Comment: Safety and efficacy of Supprelin LA was based on two clinical trials with a total of 47 children aged 4-11 years. Duration of implant use ranged from 9 months to 18 months. There were 24 reported implant site reactions. Two serious adverse events were reported--one patient coincidentally had Stargardt's disease and experienced amblyopia. Another participant had a benign pituitary adenoma. One patient withdrew from the study because of an injection site infection. A long-term follow-up study is underway.
"I think it's a unique and exciting development," Dr. William Clarke said in an interview. "The treatment of central precocious puberty has required children to receive either daily or every-4-month injections of another medication, Lupton Depot. This has worked well, but has been associated with significant pain, which means a little less compliance than you would like.
"Even though the new drug may require conscious sedation to get it implanted, it looks like it works for more than 1 year," said Dr. Clarke, the Robert M. Blizzard professor of pediatric endocrinology at the University of Virginia, Charlottesville.
It may lead to more referrals to pediatric endocrinologists for evaluation of precocious puberty. "Treatment will be seen as less onerous," said Dr. Clarke, who was an investigator for one of the multicenter trials that led to approval. He has no affiliation with Indevus Pharmaceuticals.
A potential criticism is that the product is a "one-dose-fits-all" therapy. "That may be legitimate [criticism], but it did not seem to be a problem in the studies," Dr. Clarke said.
The subcutaneous product is palpable but not visible. The implant is 3.5 cm long and 3 mm thick--about the same width as angel hair pasta, Dr. Clarke said.
(levocetirizine dihydrochloride, UCB/Sanofi Aventis)
The FDA approved Xyzal (levocetirizine dihydrochloride) for relief of symptoms of seasonal and perennial allergic rhinitis, as well as for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria, in patients 6 years and older.
* Recommended Dosage: One 5-mg tablet once daily in the evening for patients 12 years and older. The tablets are scored, and half a tablet (2.5 mg) once daily in the evening is recommended for children 6-11 years.
* Special Considerations: Somnolence, fatigue, and asthenia have been associated with use of Xyzal. Nasopharyngitis, dry mouth, and pharyngitis also occurred in clinical trial participants. Caution patients against activities that require mental alertness after taking this medication.
* Comment: Short-term safety data in pediatric patients are based on two clinical trials that included 243 children aged 6-12 years. Participants were treated with Xyzal 5 mg once daily for 4-6 weeks. Pyrexia, cough, somnolence, and epistaxis were reported by more than 2% of the 243 patients taking Xyzal and their incidence was greater compared with a placebo group of 240 patients.
The effectiveness of Xyzal 2.5 mg once daily in children aged 6-11 years is extrapolated from efficacy data among patients 12 years and older taking the 5-mg dose.
"I don't see why this is great news, to tell you the truth. It doesn't sound like it's any great advantage over other similar medications that we already have; however, it is always good to have alternatives," Dr. Vincent Bonagura said. "I've used Allegra in kids this age. We also have a syrup, Zyrtec, with a little more likelihood to make kids sleepy, and Clarinex is also once a day, as is Claritin.
"Some people respond to similar drugs differently and, therefore, having another drug is not a bad thing. It's another alternative," said Dr. Bonagura, chief and director of the division of allergy and immunology at Schneider Children's Hospital of the North Shore-Long Island Jewish (LIJ) Health System, New Hyde Park, N.Y.
Dr. Bonagura does not have an affiliation with Xyzal or UCB/Sanofi Aventis. He said he has no affiliation with makers of the other drugs mentioned.
BY DAMIAN McNAMARA, MIAMI BUREAU
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|Title Annotation:||New & Approved|
|Article Type:||Drug overview|
|Date:||Jul 1, 2007|
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