No

Gonadotropin Releasing Hormone Analog; Luteinizing Hormone-Releasing Hormone Analog

Treatment of central idiopathic precocious puberty; treatment of estrogen-associated gynecological disorders such as acute intermittent porphyria, endometriosis, leiomyomata uteri, and premenstrual syndrome

X

Hypersensitivity to histrelin, pregnancy, breast-feeding

The site of injection should be varied daily; the dose should be administered at the same time each day. In precocious puberty, changing the dosage schedule or noncompliance may result in inadequate control of the pubertal process.

>10%:

Cardiovascular: Vasodilation

Central nervous system: Headache

Gastrointestinal: Abdominal pain

Genitourinary: Vaginal bleeding, vaginal dryness

Local: Skin reaction at injection site

1% to 10%:

Central nervous system: Mood swings, headache, pain

Dermatologic: Rashes, urticaria

Endocrine & metabolic: Breast tenderness, hot flashes

Gastrointestinal: Nausea, vomiting

Genitourinary: Increased urinary calcium excretion

Neuromuscular & skeletal: Joint stiffness

No data reported

Refrigerate at 2°C to 8°C (36°F to 46°F) and protect from light; allow vial to reach room temperature before injecting contents

Histrelin is a synthetic long-acting gonadotropin-releasing hormone analog; with daily administration, it desensitizes the pituitary to endogenous gonadotropin-releasing hormone (ie, suppresses gonadotropin release by causing down regulation of the pituitary); this results in a decrease in gonadal sex steroid production which stops the secondary sexual development

Precocious puberty: Onset of hormonal responses: Within 3 months of initiation of therapy

Acute intermittent porphyria associated with menses: Amelioration of symptoms: After 1-2 months of therapy

Treatment of endometriosis or leiomyomata uteri: Onset of responses: After 3-6 months of treatment

Central idiopathic precocious puberty: S.C.: Usual dose is 10 mcg/kg/day given as a single daily dose at the same time each day

Acute intermittent porphyria in women: S.C.: 5 mcg/day

Endometriosis: S.C.: 100 mcg/day

Leiomyomata uteri: S.C.: 20-50 mcg/day or 4 mcg/kg/day

Precocious puberty: Prior to initiating therapy: Height and weight, hand and wrist x-rays, total sex steroid levels, beta-hCG level, adrenal steroid level, gonadotropin-releasing hormone stimulation test, pelvic/adrenal/testicular ultrasound/head CT; during therapy monitor 3 months after initiation and then every 6-12 months; serial levels of sex steroids and gonadotropin-releasing hormone testing; physical exam; secondary sexual development; histrelin may be discontinued when the patient reaches the appropriate age for puberty

May cause mood swings

None reported

No information available to require special precautions

No effects or complications reported

Use as directed - daily at the same time. Maintain regular follow-up schedule. You may experience headache and GI distress (analgesics may help), vaginal bleeding, pain, irritation (during first weeks of therapy), nausea or anorexia (small frequent meals may help), flushing or redness (cold clothes and cool environment may help). Report irregular or rapid heartbeat, unresolved nausea or vomiting, difficulty breathing, or infection at injection sites. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant 1 month before, during, or for 1 month following therapy. Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not donate blood during or for 1 month following therapy (same reason). Do not breast-feed.

Parenteral: S.C.: Vary the injection site daily

Injection: 7-day kits of single use: 120 mcg/0.6 mL; 300 mcg/0.6 mL; 600 mcg/0.6 mL