No

Hormone, Posterior Pituitary; Luteinizing Hormone-Releasing Hormone Analog

Treatment of endometriosis, including pain and reduction of lesions; treatment of central precocious puberty (gonadotropin-dependent precocious puberty) in children of both sexes

X

Hypersensitivity to GnRH, GnRH-agonist analogs or any components of this product; undiagnosed abnormal vaginal bleeding; pregnancy; lactation

Use with caution in patients with risk factors for decreased bone mineral content, nafarelin therapy may pose an additional risk; hypersensitivity reactions occur in 0.2% of the patients; safety and efficacy in children have not been established

>10%:

Central nervous system: Headache, emotional lability

Dermatologic: Acne

Endocrine & metabolic: Hot flashes, decreased libido, decreased breast size

Genitourinary: Vaginal dryness

Neuromuscular & skeletal: Myalgia

Respiratory: Nasal irritation

1% to 10%:

Cardiovascular: Edema, chest pain

Central nervous system: Insomnia

Dermatologic: Urticaria, rash, pruritus, seborrhea

Respiratory: Shortness of breath

<1%: Increased libido, weight loss

No data reported

Store at room temperature; protect from light

Potent synthetic decapeptide analogue of gonadotropin-releasing hormone (GnRH; LHRH) which is approximately 200 times more potent than GnRH in terms of pituitary release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Effects on the pituitary gland and sex hormones are dependent upon its length of administration. After acute administration, an initial stimulation of the release of LH and FSH from the pituitary is observed; an increase in androgens and estrogens subsequently follows. Continued administration of nafarelin, however, suppresses gonadotrope responsiveness to endogenous GnRH resulting in reduced secretion of LH and FSH and, secondarily, decreased ovarian and testicular steroid production.

Absorption: Not absorbed from GI tract

Maximum serum concentration: 10-45 minutes

Protein binding: 80% bound to plasma proteins

Endometriosis: Adults: Female: 1 spray (200 mcg) in 1 nostril each morning and the other nostril each evening starting on days 2-4 of menstrual cycle for 6 months

Central precocious puberty: Children: Males/Females: 2 sprays (400 mcg) into each nostril in the morning 2 sprays (400 mcg) into each nostril in the evening. If inadequate suppression, may increase dose to 3 sprays (600 mcg) into alternating nostrils 3 times/day.

Emotional lability is common; may cause insomnia

None reported

No information available to require special precautions

No effects or complications reported

You will begin this treatment between days 2-4 of your regular menstrual cycle. Use as directed - daily at the same time (arising and bedtime), and rotate nostrils. Maintain regular follow-up schedule. You may experience hot flashes, flushing or redness (cold clothes and cool environment may help), decreased or increased libido, emotional lability, weight gain, decreased breast size, or hirsutism. Report any breakthrough bleeding or continuing menstruation or musculoskeletal pain. Do not use a nasal decongestant within 30 minutes after nafarelin. Pregnancy/breast-feeding precautions: Consult prescriber about pregnancy. Do not breast-feed.

Do not administer to pregnant or breast-feeding patients; topical nasal decongestant should be used at least 30 minutes after nafarelin use

Solution, nasal, as acetate: 2 mg/mL (10 mL)