Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in LUPRON DEPOT. A report of

LUPRON DEPOT is contraindicated in women who are or may become pregnant while receiving the drug.

LUPRON DEPOT may cause fetal harm when administered to a pregnant woman. Major fetal

abnormalities were observed in rabbits but not in rats after administration of LUPRON DEPOT throughout

gestation. There was increased fetal mortality and decreased fetal weights in rats and rabbits. (See

hormonal levels brought about by the drug. If this drug is used during pregnancy or if the patient becomes

pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Undiagnosed abnormal vaginal bleeding.

WARNINGS

As the effects of LUPRON DEPOT-3 Month 11.25 mg are present throughout the course of therapy, the

drug should only be used in patients who require hormonal suppression for at least three months.

Experience with LUPRON DEPOT in females has been limited to six months; therefore, exposure should

be limited to six months of therapy.

When used at the recommended dose and dosing interval, LUPRON DEPOT usually inhibits ovulation

and stops menstruation. Contraception is not insured, however, by taking LUPRON DEPOT. 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

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.

should be aware of the following information:

Since menstruation should stop with effective doses of LUPRON DEPOT, the patient should notify her

physician if regular menstruation persists. Patients missing successive doses of LUPRON DEPOT may

experience breakthrough bleeding.

Patients should not use LUPRON DEPOT if they are pregnant, breast feeding, have undiagnosed

abnormal vaginal bleeding, or are allergic to any of the ingredients in LUPRON DEPOT.

LUPRON DEPOT is contraindicated for use during pregnancy. Therefore, a non-hormonal method of

contraception should be used during treatment. Patients should be advised that if they miss successive

doses of LUPRON DEPOT, breakthrough bleeding or ovulation may occur with the potential for

conception. If a patient becomes pregnant during treatment, she should discontinue treatment and

consult her physician.

Adverse events occurring in clinical studies with LUPRON DEPOT that are associated with

hypoestrogenism include: hot flashes, headaches, emotional lability, decreased libido, acne, myalgia,

reduction in breast size, and vaginal dryness. Estrogen levels returned to normal after treatment was

discontinued.

treatment, which may not be fully reversible. In patients with major risk factors for decreased bone mineral

content such as chronic alcohol and/or tobacco use, strong family history of osteoporosis, or chronic use

of drugs that can reduce bone mass such as anticonvulsants or corticosteroids, LUPRON DEPOT therapy

may pose an additional risk. In these patients, the risks and benefits must be weighed carefully before

therapy with LUPRON DEPOT is instituted. Clinical studies suggest that the addition of hormonal

replacement therapy (estrogen and/or progestin) to LUPRON is effective in reducing loss of bone mineral

density which occurs with LUPRON, without compromising the efficacy of LUPRON in relieving symptoms

of endometriosis. The optimal drug/dose is not established.

Treatment for more than six months cannot be recommended since safety data beyond six months are

not available.

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