Luprolex Warnings

As the effects of Leuprorelin (Luprolex) are present throughout the course of therapy, the drug should only be used in patients who require hormonal suppression for at least one month (for 1.88 mg and 3.75 mg) or three months (for 11.25 mg).
During the early phase of therapy, sex steroids temporarily rise above baseline because of the physiologic effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed during the initial days of therapy, but these will dissipate with continued therapy.
Symptoms consistent with an anaphylactoid or asthmatic process have been rarely reported post-marketing.
The safety of Leuprorelin (Luprolex) in prematures, newborns, and nursing infants has not been established.
The following applies to Females: Leuprorelin (Luprolex) is contraindicated for use during pregnancy. Safe use of leuprorelin [or norethindrone acetate (see as follows)] in pregnancy has not been established clinically. Before starting treatment with leuprorelin acetate (Luprolex) pregnancy must be excluded.
When used at the recommended dose and dosing interval, Leuprorelin (Luprolex) usually inhibits ovulation and stops menstruation. Contraception is not ensured, however, by taking Leuprorelin (Luprolex). Therefore, patients should use non-hormonal methods of contraception.
Patients should be advised to see their physician if they believe they may be pregnant. If a patient becomes pregnant during treatment, the drug must be discontinued and the patient must be apprised of the potential risk to the fetus. (See Contraindications.)
Experience with Leuprorelin (Luprolex) 11.25 mg monotherapy in females has been limited to six months; therefore, monotherapy exposure should be limited to six months of therapy.
The following applies to co-treatment with Leuprorelin (Luprolex) and norethindrone acetate in the treatment of Endometriosis: Since a decrease in bone mass may occur, the recommended duration of administration of this drug should be limited to 6 months. However, when necessary, the treatment period can be extended to 12 months, if norethindrone acetate 5 mg daily is given concurrently with Leuprorelin (Luprolex) ('add-back therapy') under careful observation of bone mass.
When considering add-back therapy with norethindrone acetate, refer also to Warnings and Precautions in the norethindrone acetate prescribing information.
The following applies to treatment of Uterine fibroids: Since a decrease in bone mass may occur, the recommended duration of administration of this drug should be limited to 6 months.