Select therapeutic use:

Anemias:

Indications for LUPRON DEPOT 3.75mg:

Preoperative improvement of patients with anemia due to uterine leiomyomata (fibroids), with iron therapy if iron therapy alone is inadequate.

Adult:

Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. ≥18yrs: 3.75mg once a month for up to 3 months.

Children:

<18yrs: not applicable.

Contraindications:

Undiagnosed abnormal vaginal bleeding. Pregnancy. Nursing mothers. When coadministered with norethindrone acetate, its contraindications also apply to this combination regimen.

Warnings/Precautions:

Exclude pregnancy prior to initiation; advise to use nonhormonal contraception during therapy; discontinue if pregnancy occurs. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, family history of osteoporosis, anticonvulsants, corticosteroids); consider concomitant norethindrone acetate and supplemental calcium in endometriosis; assess BMD before retreatment. History of depression. Missing successive doses may cause breakthrough bleeding or ovulation. Elderly.

Pharmacologic Class:

GnRH analogue.

Adverse Reactions:

Hot flashes/sweats, headache, decreased libido, depression/emotional lability, dizziness, nausea/vomiting, pain, weight gain/loss, vaginitis, amenorrhea, acne, skin reactions; bone density loss, convulsions, hypersensitivity reactions; rare: anaphylaxis, asthma.

How Supplied:

Kit—1 (prefilled dual-chamber syringe w. supplies)

Endometriosis:

Indications for LUPRON DEPOT 3.75mg:

Endometriosis management, including pain relief and reduction of endometriotic lesions. With norethindrone acetate: for initial management and recurrent symptoms.

Adult:

Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. ≥18yrs: 3.75mg once a month for up to 6 months. May repeat one 6-month cycle; give with norethindrone acetate 5mg daily when retreating (do not use leuprolide alone for retreatment). Max total treatment: 12 months.

Children:

<18yrs: not applicable.

Contraindications:

Undiagnosed abnormal vaginal bleeding. Pregnancy. Nursing mothers. When coadministered with norethindrone acetate, its contraindications also apply to this combination regimen.

Warnings/Precautions:

Exclude pregnancy prior to initiation; advise to use nonhormonal contraception during therapy; discontinue if pregnancy occurs. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, family history of osteoporosis, anticonvulsants, corticosteroids); consider concomitant norethindrone acetate and supplemental calcium in endometriosis; assess BMD before retreatment. History of depression. Missing successive doses may cause breakthrough bleeding or ovulation. Elderly.

Pharmacologic Class:

GnRH analogue.

Adverse Reactions:

Hot flashes/sweats, headache, decreased libido, depression/emotional lability, dizziness, nausea/vomiting, pain, weight gain/loss, vaginitis, amenorrhea, acne, skin reactions; bone density loss, convulsions, hypersensitivity reactions; rare: anaphylaxis, asthma.

How Supplied:

Kit—1 (prefilled dual-chamber syringe w. supplies)

Miscellaneous Ob/Gyn conditions:

Indications for LUPRON DEPOT 3.75mg:

Preoperative improvement of patients with anemia due to uterine leiomyomata (fibroids), with iron therapy if iron therapy alone is inadequate.

Adult:

Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. ≥18yrs: 3.75mg once a month for up to 3 months.

Children:

<18yrs: not applicable.

Contraindications:

Undiagnosed abnormal vaginal bleeding. Pregnancy. Nursing mothers. When coadministered with norethindrone acetate, its contraindications also apply to this combination regimen.

Warnings/Precautions:

Exclude pregnancy prior to initiation; advise to use nonhormonal contraception during therapy; discontinue if pregnancy occurs. Risk factors for decreased bone mineral density (eg, chronic alcohol, tobacco, family history of osteoporosis, anticonvulsants, corticosteroids); consider concomitant norethindrone acetate and supplemental calcium in endometriosis; assess BMD before retreatment. History of depression. Missing successive doses may cause breakthrough bleeding or ovulation. Elderly.

Pharmacologic Class:

GnRH analogue.

Adverse Reactions:

Hot flashes/sweats, headache, decreased libido, depression/emotional lability, dizziness, nausea/vomiting, pain, weight gain/loss, vaginitis, amenorrhea, acne, skin reactions; bone density loss, convulsions, hypersensitivity reactions; rare: anaphylaxis, asthma.

How Supplied:

Kit—1 (prefilled dual-chamber syringe w. supplies)