Lupron Depot-3 Month 11.25mg

— THERAPEUTIC CATEGORIES —
  • Anemias
  • Endometriosis
  • Miscellaneous Ob/Gyn conditions
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lupron Depot-3 Month 11.25mg Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Leuprolide acetate 11.25mg; depot susp for IM inj; preservative-free.

    Pharmacological Class

    GnRH analogue.

    See Also

    How Supplied

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

    Manufacturer

    AbbVie

    Lupron Depot-3 Month 11.25mg Indications

    Indications

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

    Lupron Depot-3 Month 11.25mg Dosage and Administration

    Adult

    Give as single IM inj into gluteal area, anterior thigh or deltoid. ≥18yrs: 11.25mg once (3-month course). Do not split doses.

    Children

    <18yrs: not established.

    Lupron Depot-3 Month 11.25mg Contraindications

    Contraindications

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

    Lupron Depot-3 Month 11.25mg Boxed Warnings

    Not Applicable

    Lupron Depot-3 Month 11.25mg Warnings/Precautions

    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.

    Lupron Depot-3 Month 11.25mg Pharmacokinetics

    See Literature

    Lupron Depot-3 Month 11.25mg Interactions

    Not Applicable

    Lupron Depot-3 Month 11.25mg Adverse Reactions

    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.

    Lupron Depot-3 Month 11.25mg Clinical Trials

    See Literature

    Lupron Depot-3 Month 11.25mg Note

    Not Applicable

    Lupron Depot-3 Month 11.25mg Patient Counseling

    See Literature

    Lupron Depot-3 Month 11.25mg Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Leuprolide acetate 11.25mg; depot susp for IM inj; preservative-free.

    Pharmacological Class

    GnRH analogue.

    See Also

    How Supplied

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

    Manufacturer

    AbbVie

    Lupron Depot-3 Month 11.25mg Indications

    Indications

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

    Lupron Depot-3 Month 11.25mg Dosage and Administration

    Adult

    Give as single IM inj into gluteal area, anterior thigh or deltoid; rotate inj sites. ≥18yrs: 11.25mg once every 3 months; treat 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. Do not split doses.

    Children

    <18yrs: not established.

    Lupron Depot-3 Month 11.25mg Contraindications

    Contraindications

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

    Lupron Depot-3 Month 11.25mg Boxed Warnings

    Not Applicable

    Lupron Depot-3 Month 11.25mg Warnings/Precautions

    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.

    Lupron Depot-3 Month 11.25mg Pharmacokinetics

    See Literature

    Lupron Depot-3 Month 11.25mg Interactions

    Not Applicable

    Lupron Depot-3 Month 11.25mg Adverse Reactions

    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.

    Lupron Depot-3 Month 11.25mg Clinical Trials

    See Literature

    Lupron Depot-3 Month 11.25mg Note

    Not Applicable

    Lupron Depot-3 Month 11.25mg Patient Counseling

    See Literature

    Lupron Depot-3 Month 11.25mg Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Leuprolide acetate 11.25mg; depot susp for IM inj; preservative-free.

    Pharmacological Class

    GnRH analogue.

    See Also

    How Supplied

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

    Manufacturer

    AbbVie

    Lupron Depot-3 Month 11.25mg Indications

    Indications

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

    Lupron Depot-3 Month 11.25mg Dosage and Administration

    Adult

    Give as single IM inj into gluteal area, anterior thigh or deltoid. ≥18yrs: 11.25mg once (3-month course). Do not split doses.

    Children

    <18yrs: not established.

    Lupron Depot-3 Month 11.25mg Contraindications

    Contraindications

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

    Lupron Depot-3 Month 11.25mg Boxed Warnings

    Not Applicable

    Lupron Depot-3 Month 11.25mg Warnings/Precautions

    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.

    Lupron Depot-3 Month 11.25mg Pharmacokinetics

    See Literature

    Lupron Depot-3 Month 11.25mg Interactions

    Not Applicable

    Lupron Depot-3 Month 11.25mg Adverse Reactions

    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.

    Lupron Depot-3 Month 11.25mg Clinical Trials

    See Literature

    Lupron Depot-3 Month 11.25mg Note

    Not Applicable

    Lupron Depot-3 Month 11.25mg Patient Counseling

    See Literature

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