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 longer than a total of 12 months due to concerns about adverse impact on bone mineral density.
LUPANETA PACK 1-Month 3.75 mg and 3-Month 11.25 mg are contraindicated in:
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 pre-existing 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.
Reference: 1. LUPANETA PACK [package insert]. North Chicago, IL: AbbVie Inc.