Leuprolide / Norethindrone Dosage

Usual Adult Dose for Endometriosis

1-Month Depot Formulation:

• Initial dose: leuprolide: 3.75 mg IM once a month plus norethindrone 5 mg orally once a day

3-Month Depot Formulation:

• Initial dose: leuprolide: 11.25 mg IM every 3 months plus norethindrone 5 mg orally once a day

Maximum Initial Duration of Therapy: 6 months

• If symptoms of endometriosis recur after the initial course of therapy, may consider retreatment for up to another 6 months; bone density should be assessed before retreatment begins

Maximum Duration of Therapy: 12 months

Comments:

• Leuprolide should be administered by a healthcare provider.
• Duration of treatment is limited to 2 six-month courses due to concerns about adverse impact on bone mineral density.
• Leuprolide 1-month depot and 3-month depot formulations are not interchangeable due to release characteristics; 3 doses of the 3.75 mg formulation should not be used to mimic the effect of the 11.25 mg 3-month formulation.

Uses: For the management of initial and recurrent painful symptoms of endometriosis.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Contraindicated in women with liver disease or liver tumors

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to GnRH agonist analogs, either of the active substances or any product ingredients
• Undiagnosed abnormal uterine bleeding
• Known, suspected or planned pregnancy during therapy
• Lactating women
• Known, suspected or history of breast cancer or other hormone-sensitive cancer
• Current or history of thrombotic or thromboembolic disorder
• Liver tumors or liver disease.

Safety and efficacy have not been established in patients younger than 18 years or older than 65 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Leuprolide acetate for depot suspension: For IM administration into the gluteal area, anterior thigh, or deltoid; alternate injection sites; this should be administered by a healthcare professional

Norethindrone tablets: Take orally once a day

Reconstitution/preparation techniques:

• The 3.75 mg once-monthly depot injection is not interchangeable with the 11.25 mg three-month depot injection
• Suspension should be reconstituted and administered within 2 hours
• To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn; hold the syringe upright and release diluent by slowly pushing the plunger (over 6 to 8 seconds) until the first middle stopper is at the blue line in the middle of the barrel
• Mix the microspheres by gently shaking until the powder forms a uniform suspension which will appear milky; do not use if the powder has not gone into suspension
• The manufacturer's product information may be consulted for more detailed instructions with illustrations.

General:

• Duration of therapy is limited due to concerns about adverse impact on bone mineral density (BMD).
• For women with major risk factors for decreased BMD, the benefits of therapy must be carefully weighed against the risk of increased loss of BMD.

Monitoring:

• Assess and manage cardiovascular risk factors prior to therapy; closely monitor women with risk factors
• Assess bone mineral density (BMD) prior to treatment
• Rule out pregnancy prior to treatment
• Monitor for clinical depression, especially in women with a history of depression
• Ocular exam should be performed immediately with any sudden or partial loss of vision

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be advised that this drug may cause fetal harm and should not be used if they are pregnant or planning to become pregnant or breastfeeding; nonhormonal contraception is advised while receiving this drug.
• Patients should be instructed to report new or worsening symptoms during treatment; they should be instructed seek immediate medical attention if they develop sudden loss of vision, double vision, or sudden migraine.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer