SUPPRELIN® LA
This product information is intended for U.S. residents only.
SUPPRELIN® LA (histrelin acetate is a gonadotropin releasing
hormone (GnRH) agonist indicated for the treatment of children with central
precocious puberty (CPP).
SUPPRELIN LA is an under-the-skin (subcutaneous) implant that contains the
medicine histrelin, which blocks the action of the gonadotropin releasing
hormone (GnRH). SUPPRELIN LA is used for treatment of children with central
precocious puberty (CPP). CPP makes puberty come early in girls (before 8
years of age) and in boys (before 9 years of age). Signs of early puberty
include breast enlargement in girls and the appearance of hair in genital
area in boys and girls. SUPPRELIN LA works by reducing the amount of sex
hormones in the blood to delay early puberty.
Visit
www.supprelinla.com to learn more
- SUPPRELIN® LA (histrelin acetate) subcutaneous
implant is indicated for the treatment of children with central
precocious puberty (CPP).
- Important Safety Information
- SUPPRELIN LA is contraindicated in women who are or may become
pregnant, and in patients who are hypersensitive to GnRH or GnRH agonist
analogs. Safety and effectiveness in pediatric patients under the age of
2 years has not been established.
- SUPPRELIN LA, like other GnRH agonists, initially causes a transient
increase in serum concentrations of estradiol in females and testosterone in
both sexes during the first week of treatment, with worsening or onset of
new symptoms during this period. Within 4 weeks of therapy, gonadal steroid
suppression occurs and manifestations of puberty decrease.
- Implant insertion and removal is a surgical procedure and should
utilize aseptic technique. Careful adherence to the recommended
insertion and removal procedures is recommended. On occasion, localizing
and/or removal of implant products have been difficult and imaging
techniques were used, including ultrasound, CT, or MRI (this implant is
not radiopaque). Rare events of spontaneous extrusion have been observed
in clinical trials.
- LH, FSH and estradiol or testosterone should be monitored at 1 month
post implantation then every 6 months. Every 6-12 months, height and
bone age should also be assessed.
- In clinical trials, the most common adverse reactions involved the
implant site and included bruising, pain, soreness, erythema and
swelling.
-
Please see the accompanying
Full Prescribing Information for SUPPRELIN LA.
SUPPRELIN® LA is a registered trademark of
Endo Pharmaceuticals
*By clicking on the link(s) on this page you will leave the Endo.com website and move to an external website(s) independently operated and not managed by Endo Pharmaceuticals. Because Endo Pharmaceuticals does not control the content of the website(s) you are about to visit, and due to its constantly changing nature, we cannot be responsible for its content, accuracy, practices, or standards.
