Classes
DEA Class; Rx
Common Brand Names; Synarel
- Gonadotropin Releasing Hormone Agonists
Description
Intranasal synthetic analog of GnRH used for treatment of central precocious puberty in children and for endometriosis, uterine fibroids, and hirsutism in women. Maximum recommended length of therapy in women is 6 months due to risk of osteoporosis. Also used for female infertility.
Indications
Indicated for the treatment of endometriosis.
Contraindications
Pregnancy, hypersensitivity, lactation, undiagnosed abnormal vaginal bleeding
Adverse Effects
- Acne (10%)
- Breast enlargement (8%)
- Vaginal bleeding (8%)
- Seborrhea (3%)
- Emotional lability (6%)
- Vaginal discharge (3%)
- Rhinitis (5%)
- Body odor (4%)
- Increase in pubic hair (5%)
- Arthralgia
- Breast engorgement
- Chloasma
- Maculopapular rash
- Paresthesia
- Weakness
- Palpitation
- Eye pain
- Liver injury
- Pituitary apoplexy
- Seizures
- Pituitary gland changes
- Liver injury (rare)
- Ovarian hyperstimulation syndrome
Warnings
Goal in adult females is to suppress menstruation; max treatment period 6 mth
May cause increase in bone turnover & decrease in bone mineral content
Ovarian cysts may develop within first 2 months of therapy and occur more commonly in women with polycystic ovarian disease
Cases of pituitary apoplexy reported
Use caution in patients with risk factors for decreased bone mineral density
Irregular or incomplete daily doses may result in stimulation of the pituitary-gonadal axis; counsel caregivers to assure full compliance
During first month of treatment, may initially expect some signs of puberty, e.g., vaginal bleeding or breast enlargement, may occur; such changes should resolve soon after first month; if such resolution does not occur within first two months of treatment, this may be due to lack of compliance or presence of gonadotropin independent sexual precocity; if both possibilities excluded, the dose omay be increased to 1800 mcg/day administered as 600 mcg tid
Patients with intercurrent rhinitis should consult their physician for use of topical nasal decongestant; if use of topical nasal decongestant required during treatment decongestant should not be used until at least 2 hr after administering therapy; sneezing during or immediately after administering therapy should be avoided, if possible, since may impair drug absorption
Convulsions reported in patients receiving GnRH agonists; reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs; convulsions also reported in patients in the absence of any of the conditions listed
Psychiatric events reported in patients taking GnRH agonists; postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression; monitor for development or worsening of psychiatric symptoms during treatment
Pseudotumor cerebri (idiopathic intracranial hypertension) reported in pediatric patients receiving GnRH agonists, including leuprolide acetate; monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea; inform patients and caregivers that reports of pseudotumor cerebri have occurred
Pregnancy and Lactation
Pregnancy Category: X
Lactation: Excretion in milk unknown, contraindicated
Maximum Dosage
Males: 400 mcg/day SC.
Females: 800 mcg/day intranasally.
1800 mcg/day intranasally.
1800 mcg/day intranasally.
How supplied
Nafarelin Acetate
nasal spray
- 2mg/mL