Usual Adult Dose for Endometriosis

200 mcg (as 1 spray into 1 nostril) intranasally 2 times a day

• Maximum dose: 800 mcg/day (as 1 spray into each nostril 2 times a day)
• Duration of therapy: 6 months

• Doubling the recommended dose should be considered in compliant patients who experience menstruation for 2 months after starting treatment.
• Treatment should begin between days 2 and 4 of the menstrual cycle.
• Patients receiving the recommended dose should alternate nostrils, with administration into one nostril in the morning and the other nostril in the evening.

Usual Pediatric Dose for Precocious Puberty

800 mcg (as 2 sprays into each nostril) intranasally 2 times a day

• Maximum dose: 1800 mcg/day (as 3 sprays into alternating nostrils 3 times a day)

• If patients do not have symptom resolution within the first 2 months of treatment, compliance and gonadotropin independent sexual precocity should be evaluated; the dose may be increased to 1800 mcg/day if both etiologies are excluded.
• Signs of puberty may occur early in treatment, but should resolve after the first month.
• Treatment may continue until the resumption of puberty is appropriate.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established for the treatment of endometriosis in female patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Patients should tilt their heads slightly back during administration.
• If multiple sprays are required in one nostril, doses should be separated by 30 seconds.
• Patients who sneeze during/immediately after administration should consider repeating the dose.

• Protect from light and freezing; store upright when not in use.

• When used to treat endometriosis, this drug produces a menopause-like state via induction of chronic pituitary desensitization.
• Controlled ovulation stimulation should be supervised by an infertility specialist.
• Alternative etiologies should be ruled out in patients with central precocious puberty prior to beginning treatment (e.g., hypothalamic/pituitary/testicular tumors, increased intracranial pressure, congenital adrenal hyperplasia, testotoxicosis, autonomous feminizing/masculinizing disorders).

• Pregnancy tests prior to treatment and in any patient who misses a dose
• Bone density, especially in patients with a high risk of reduced bone mass and/or receiving 2 or more courses of therapy
• Estradiol and progesterone levels, especially in patients on treatment for controlled ovulation or precocious puberty
• Luteinizing hormone, especially patients on treatment for precocious puberty
• Growth and bone age velocity in patients on treatment for precocious puberty
• Development/worsening of psychiatric symptoms

• Patients should be advised to speak to their healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding; patients should be told to use non-hormonal, barrier contraceptives during treatment.
• Patients and/or caregivers should be instructed to maintain complete compliance during treatment; if included, the informational pamphlet should be read prior to use.
• Patients should be told to contact their healthcare providers if doses are missed or menstruation occurs despite compliance.
• Patients should contact their healthcare provider if nasal congestion or rhinitis occurs to determine appropriate treatments. Topical nasal decongestants should be separated by at least 30 minutes.