FDA label 3737b5dd-6816-4df6-ad81-761eae67918e

WARNINGS 1. Pregnancy The use of progestational drugs during the first four months of pregnancy is not recommended. Progestational agents have been used beginning with the first trimester of pregnancy in attempts to prevent abortion but there is no evidence that such use is effective. Furthermore, the use of progestational agents, with their uterine-relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. 2. Intrauterine Exposure Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias (5 to 8 per 1,000 male births in the general population) may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but insofar as some of these drugs induce mild virilization of the external genitalia of the female fetus, and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy. If the patient is exposed to DEPO-PROVERA Sterile Aqueous Suspension during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus. 3. Thromboembolic Disorders The physician should be alert to the earliest manifestations of thrombotic disorder (thrombophlebitis, cerebrovascular disorder, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. 4. Ocular Disorders Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. 5. Lactation Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined. 6. Multi-dose Use Multi-dose use of DEPOPROVERA Sterile Aqueous Suspension from a single vial requires special care to avoid contamination. Although initially sterile, any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed.

ADVERSE REACTIONS –(See WARNINGS for possible adverse effects on the fetus) –breakthrough bleeding –spotting –change in menstrual flow –amenorrhea –headache –nervousness –dizziness –edema –change in weight (increase or decrease) –changes in cervical erosion and cervical secretions –cholestatic jaundice, including neonatal jaundice –breast tenderness and galactorrhea –skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash –acne, alopecia and hirsutism –rash (allergic) with and without pruritis –anaphylactoid reactions and anaphylaxis –mental depression –pyrexia –fatigue –insomnia –nausea –somnolence In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess. A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: –rise in blood pressure in susceptible individuals –premenstrual syndrome –changes in libido –changes in appetite –cystitis-like syndrome –headache –nervousness –fatigue –backache –hirsutism –loss of scalp hair –erythema multiforma –erythema nodosum –hemorrhagic eruption –itching –dizziness The following laboratory results may be altered by the use of estrogen-progestin combination drugs: –increased sulfobromophthalein retention and other hepatic function tests –coagulation tests: increase in prothrombin factors VII, VIII, IX, and X –metyrapone test –pregnanediol determinations –thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T 3 uptake values