© Copyright 2016 AbbVie Inc.
 Disclaimer: The information contained in this site is intended for U.S. healthcare professionals only.
Project # 2031986-1896603
© Copyright 2016 AbbVie Inc.
 Disclaimer: The information contained in this site is intended for U.S. healthcare professionals only.
Project # 2031986-1896603
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Important Safety Information

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Indications1

Endometriosis

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and 3-month 11.25 mg are indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with daily norethindrone acetate 5 mg is also indicated for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.

Uterine Leiomyomata (Fibroids)

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and 3-month 11.25 mg concomitantly with iron therapy are indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a 1-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. LUPRON DEPOT may be added if the response to iron alone is considered inadequate. Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to 3 months. The 3-month 11.25 mg dosage form is indicated only for women for whom 3 months of hormonal suppression is deemed necessary.

Experience with LUPRON DEPOT in females with endometriosis or uterine fibroids has been limited to women 18 years of age and older.

Important Safety Information1

General Information

  • LUPRON DEPOT 3.75 mg for 1-month and 11.25 mg for 3-month administration are contraindicated in:
    • patients who are hypersensitive to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, or any of the excipients in LUPRON DEPOT
    • undiagnosed abnormal vaginal bleeding
    • females who are or may become pregnant while receiving the drug. LUPRON DEPOT may cause fetal harm when administered to pregnant women. If used during pregnancy, the patient should be apprised of the potential hazard to a fetus, and that spontaneous abortion may occur. Before starting treatment with LUPRON DEPOT, pregnancy must be excluded
    • women who are breast-feeding
  • Used at the recommended dose, LUPRON DEPOT usually inhibits ovulation and stops menstruation. Patients should use non-hormonal methods of contraception.
  • An increase in clinical signs and symptoms may be observed during the initial days of therapy due to a temporary rise in sex steroids, but will dissipate with continued therapy.
  • Patients should be counseled on the possibility of the development or worsening of depression and the occurrence of memory disorders. Patients who have a history of depression should be carefully observed during treatment.
  • Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy, including patients with and without concurrent medications and comorbid conditions.

Endometriosis

  • Norethindrone acetate as add-back therapy in endometriosis is contraindicated in women with thrombophlebitis, thromboembolic disorders, cerebral apoplexy, or a past history of these conditions; markedly impaired liver function or liver disease; and known or suspected carcinoma of the breast.
  • Assessment and management of risk factors for cardiovascular disease is recommended prior to initiation of add-back therapy with norethindrone acetate. Norethindrone acetate should be used with caution in women with risk factors, including lipid abnormalities or cigarette smoking.
  • LUPRON DEPOT plus norethindrone acetate treatment should be discontinued if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
  • Induced hypoestrogenic state results in bone loss over the course of treatment, some of which may not be reversible. In controlled clinical trials in patients with endometriosis, at the end of 6 months of therapy with LUPRON DEPOT, vertebral bone density decreased by an average of 3.2% compared with the pretreatment values.
  • In patients with major risk factors for loss of bone mineral content, risks and benefits of LUPRON DEPOT alone must be weighed carefully before therapy is instituted, and concomitant treatment with daily norethindrone acetate 5 mg should be considered. Treatment with LUPRON DEPOT beyond an initial 6-month course is not advisable in these patients. In patients that are candidates for retreatment, it is recommended that bone density be assessed before retreatment. Retreatment with LUPRON DEPOT alone is not recommended.
  • Due to suppression of the pituitary-gonadal system by LUPRON DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment, and for up to 3 months after discontinuation of LUPRON DEPOT, may be affected.
  • In controlled clinical trials of endometriosis patients, with or without add-back therapy with norethindrone acetate, adverse events occurring in >20% of patients were headache, vasomotor flushes, depression/emotional lability, vaginitis, pain, nausea/vomiting, and insomnia/sleep disorder.
  • LUPRON DEPOT plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL ratios in clinical trials. After discontinuation of treatment, mean serum lipid levels in clinical trial patients with follow-up data returned to pretreatment values.

Uterine Leiomyomata (Fibroids)

  • Induced hypoestrogenic state results in bone loss over the course of treatment, some of which may not be reversible. In controlled clinical trials in patients with fibroids, after 3 months of therapy, vertebral bone density decreased by an average of 2.7% compared with the pretreatment values.
  • In patients with major risk factors for decreased bone mineral content, LUPRON DEPOT therapy may pose an additional risk.
  • In controlled clinical trials of fibroid patients, adverse events occurring in >10% of patients were headache, vasomotor flushes, depression/emotional lability and vaginitis.
  • In controlled clinical trials of fibroid patients, mean changes in cholesterol, LDL, HDL, and the LDL/HDL ratios were observed.

Indication2

LUPANETA PACK™ (leuprolide acetate for depot suspension and norethindrone acetate tablets) 1- Month 3.75 mg and 3-Month 11.25 mg are indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. The initial treatment course is limited to 6 months. If symptoms recur, a single treatment course of not more than 6 months may be administered. Use is not recommended for longer than a total of 12 months due to concerns about adverse impact on bone mineral density.

Important Safety Information2

  • LUPANETA PACK 1-Month 3.75 mg and 3-Month 11.25 mg are contraindicated in:
    • Patients who are hypersensitive to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, any of the excipients in leuprolide acetate for depot suspension, or norethindrone acetate
    • Undiagnosed abnormal uterine bleeding
    • Known, suspected, or planned pregnancy during the course of 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
  • Leuprolide acetate for depot suspension induces a hypoestrogenic state resulting in loss of bone mineral density (BMD), some of which may not be reversible. In patients that are candidates for retreatment, it is recommended that bone density be assessed before retreatment. Retreatment with leuprolide acetate for depot suspension alone is not recommended.
  • In patients with major risk factors for loss of bone mineral content, risks and benefits of LUPANETA PACK must be weighed carefully before therapy is instituted, as use in this population may pose additional risks.
  • Leuprolide acetate may cause fetal harm if administered to a pregnant woman. Exclude pregnancy before initiating treatment with LUPANETA PACK. Use at the recommended dose usually inhibits ovulation and stops menstruation. Patients should use non-hormonal methods of contraception. Discontinue LUPANETA PACK if a patient becomes pregnant during treatment and inform the patient of potential risk to the fetus.
  • Discontinue norethindrone acetate tablets, pending examination, if there is a sudden partial or complete loss of vision or sudden onset of proptosis, diplopia, or migraine. Discontinue LUPANETA PACK if examination reveals papilledema or retinal vascular lesions
  • Depression may occur or worsen during treatment with LUPANETA PACK. Carefully observe patients with a history of clinical depression and discontinue if the depression recurs to a serious degree.
  • In clinical trials of LUPANETA PACK, adverse events of asthma were reported in women with preexisting histories of asthma, sinusitis, and environmental or drug allergies. Postmarketing reports of symptoms consistent with an anaphylactoid or asthmatic process have been reported.
  • Assess and manage risk factors for cardiovascular disease before starting LUPANETA PACK. Closely monitor women on norethindrone acetate who have risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (e.g., family history of VTE, obesity, and smoking).
  • An increase in clinical signs and symptoms may be observed during the initial days of therapy due to a temporary rise in sex steroids, but these should dissipate with continued therapy.
  • Norethindrone acetate may cause some degree of fluid retention; therefore, carefully observe women with conditions that might be influenced by this effect, such as epilepsy, migraines, or cardiac or renal dysfunctions.
  • Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy, including patients with and without concurrent medications and comorbid conditions.
  • Experience with LUPANETA PACK for treatment of endometriosis has been limited to women 18 years of age and older.
  • In controlled clinical trials, adverse events occurring in >10% of patients were hot flashes/sweats, headache/migraine, depression/emotional lability, nausea/vomiting, nervousness/anxiety, insomnia, pain, acne, asthenia, vaginitis, weight gain, constipation/diarrhea.

References:

  1. LUPRON DEPOT GYN 3.75 mg and 3 Month 11.25 mg [package insert]. North Chicago, IL: AbbVie Inc.
  2. LUPANETA PACK [package insert]. North Chicago, IL: AbbVie Inc.






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