Depo Provera
Description
Clinical
Indications
Side Effects
Warnings
OverDosage
Patient Info


WARNING
  1. Bleeding Irregularities
    Most women using DEPO-PROVERA Contraceptive Injection experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include irregular or unpredictable bleeding or spotting, or rarely, heavy or continuous bleeding. If abnormal bleeding persists or is severe, appropriate investigation should be instituted to ruleout the possibility or organic pathology, and appropriate treatment should be instituted when necessary.
    As women continue using DEPO-PROVERA Contraceptive Injection, fewer experience irregular bleeding and more experience amenorrhea. By month 12 amenorrhea was reported by 55% of women, and by month 24amenorrhea was reported by 68% of women using DEPO-PROVERA Contraceptive Injection. 2
  2. Bone Mineral Density Changes
    Use of DEPO-PROVERA Contraceptive Injection may be considered among the risk factors for development of osteoporosis. The rate of bone loss is greatest in the early years of use and then subsequently approaches the normal rate of age related fall.
  3. Cancer Risks
    Long-term case-controlled surveillance of users of DEPO-PROVERA Contraceptive Injection found slight or no increased overall risk of breast cancer 3 and no overall increased risk of ovarian, 4 liver, 5 or cervical 6 cancer and a prolonged, protective effect of reducing the risk of endometrial 7 cancer in the population of users.
    A pooled analysis 14 from two case-control studies, the World Health Organization Study 3 and the New Zealand Study 13 , reported the relative risk (RR) of breast cancer for women who had ever used DEPO-PROVERA Contraceptive Injection as 1.1 (95% confidence interval (Cl) 0.97 to 1.4). Overall, there was no increase in risk with increasing duration of use of DEPO-PROVERA Contraceptive Injection. The RR of breast cancer for women of all ages who had initiated use of DEPO-PROVERA Contraceptive Injection within the previous 5 years was estimated to be 2.0 (95% Cl 1.5 to 2.8).
    The World Health Organization Study 3 , a component of the pooled analysis 14 described above, showed an increased RR of 2.19 (95% Cl 1.23 to 3.89) of breast cancer associated with use of DEPO-PROVERA Contraceptive Injection in women whose first exposure to drug was within the previous 4 years and who were under 35 years of age. However, the overall RR for ever-users of DEPO-PROVERA Contraceptive Injection was only 1.2 (95% Cl 0.96 to 1.52).
    [ NOTE:   A RR of 1.0 indicates neither an increased nor a decreased risk of cancer associated with the use of the drug, relative to no use of the drug. In the case of the subpopulation with a RR of 2.19, the 95% Cl is fairly wide and does not include the value of 1.0, thus inferring an increased risk of breast cancer in the defined subgroup relative to nonusers. The of 2.19 means that women whose first exposure to drug was within the previous 4 years and who are under 35 years of agvaluee have a 2.19-fold (95% Cl 1.23 to 3.89-fold) increased risk of breast cancer relative to nonusers. The National Cancer Institute 8 reports an average annual incidence rate for breast cancer for US women, all races, age 30 to 34 years of 26.7 per 100,000. A RR of 2.19, thus, increases the possible risk from 26.7 to 58.5 cases per 100,000 women. The attributable risk, thus, is 31.8 per 100,000 women per year.]
    A statistically insignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of DEPO-PROVERA Contraceptive Injection in women who were first exposed before the age of 35 years (RR 1.22 to 1.28 and 95% Cl 0.93 to 1.70). The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used DEPO-PROVERA Contraceptive Injection was estimated to be 1.11 (95% Cl 0.96 to 1.29). No trends in risk with duration of use or times since initial or most recent exposure were observed.
  4. Thromboembolic Disorders
    The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, pulmonary embolism, cerebrovascular disorders, and retinal thrombosis). Should any of these occur or be suspected, the drug should not be readministered.
  5. Ocular Disorders
    Medication should not be readministered 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 not be readministered.
  6. Unexpected Pregnancies
    To ensure that DEPO-PROVERA Contraceptive Injection is not administered inadvertently to a pregnant woman, the first injection must be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding, and if exclusively breast-feeding, ONLY at the sixth postpartum week (see DOSAGE AND ADMINISTRATION ).
    Neonates from unexpected pregnancies that occur 1 to 2 months after injection of DEPO-PROVERA Contraceptive Injection may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because such pregnancies are uncommon. 9,10
    A significant increase in incidence of polysyndactyly and chromosomal anomalies was observed among infants of users of DEPO-PROVERA Contraceptive Injection, the former being most pronounced in women under 30 years of age. The unrelated nature of these defects, the lack of confirmation from other studies, the distant preconceptual exposure to DEPO-PROVERA Contraceptive Injection, and the chance effects due to multiple statistical comparisons, make a causal association unlikely. 11
    Neonates exposed to medroxyprogesterone acetate in utero and followed to adolescence, showed no evidence of any adverse effects on their health including their physical, intellectual, sexual, or social development.
    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 (five to eight 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 because 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.
    To ensure that DEPO-PROVERA Contraceptive Injection is not administered inadvertently to a pregnant woman, it is important that the first injection be given only during the first 5 days after the onset of a normal menstrual period within 5 days postpartum if not breast-feeding and if breast-feeding, at the sixth week postpartum (see DOSAGE AND ADMINISTRATION ).
  7. Ectopic Pregnancy
    Health-care providers should be alert to the possibility of an ectopic pregnancy among women using DEPO-PROVERA Contraceptive Injection who become pregnant or complain of severe abdominal pain.
  8. Lactation
    Detectable amounts of drug have been identified in the milk of mothers receiving DEPO-PROVERA Contraceptive Injection. In nursing mothers treated with DEPO-PROVERA Contraceptive Injection, milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty. No adverse effects have been noted.
  9. Anaphylaxis and Anaphylactoid Reaction
    Anaphylaxis and anaphylactoid reaction have been reported with the use of DEPO-PROVERA Contraceptive Injection. If an anaphylactic reaction occurs appropriate therapy should be instituted. Serious anaphylactic reactions require emergency medical treatment.
PRECAUTIONS

GENERAL
  1. Physical Examination
    It is good medical practice for all women to have annual history and physical examinations, including women using DEPO-PROVERA Contraceptive Injection. The physical examination, however, may be deferred until after initiation of DEPO-PROVERA if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
  2. Fluid Retention
    Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.
  3. Weight Changes
    There is a tendency for women to gain weight while on therapy with DEPO-PROVERA Contraceptive Injection. From an initial average body weight of 136 lb, women who completed 1 year of therapy with DEPO-PROVERA Contraceptive Injection gained an average of 5.4 lb. Women who completed 2 years of therapy gained an average of 8.1 lb.
    Women who completed 4 years gained an average of 13.8 lb. Women who completed 6 years gained an average of 16.5 lb. Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain.
  4. Return of Fertility
    DEPO-PROVERA Contraceptive Injection has a prolonged contraceptive effect. In a large US study of women who discontinued use of DEPO-PROVERA Contraceptive Injection to become pregnant, data are available for 61% of them. Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued DEPO-PROVERA Contraceptive Injection to become pregnant and who were lost to follow-up or changed their mind.
  5. CNS Disorders and Convulsions
    Patients who have a history of psychic depression should be carefully observed and the drug not be readministered if the depression recurs.
    There have been a few reported cases of convulsions in patients who were treated with DEPO-PROVERA Contraceptive Injection. Association with drug use or pre-existing conditions is not clear.
  6. Carbohydrate Metabolism
    A decrease in glucose tolerance has been observed in some patients on DEPO-PROVERA Contraceptive Injection treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.
  7. Liver Function
    If jaundice develops, consideration should be given to not readministering the drug.
  8. Protection Against Sexually Transmitted Diseases
    Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
  DRUG INTERACTIONS

Aminoglutethimide administered concomitantly with the DEPO-PROVERA Contraceptive Injection may significantly depress the serum concentrations of medroxyprogesterone acetate. 12 Users of DEPO-PROVERA Contraceptive Injection should be warned of the possibility of decreased efficacy with the use of this or any related drugs. LABORATORY TEST INTERACTIONS

The pathologist should be advised of progestin therapy when relevant specimens are submitted.

The following laboratory tests may be affected by progestins including DEPO-PROVERA Contraceptive Injection:
  1. Plasma and urinary steroid levels are decreased (eg, progesterone, estradiol, pregnanediol, testosterone, cortisol).
  2. Gonadotropin levels are decreased.
  3. Sex-hormone-binding-globulin concentrations are decreased.
  4. Protein-bound iodine and butanol extractable protein-bound iodine may increase.
    T 3 -uptake values may decrease.
  5. Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
  6. Sulfobromopthalein and other liver function test values may be increased.
  7. The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.
CARCINOGENESIS

See " WARNINGS " section 3.

PREGNANCY

Pregnancy Category X. See " WARNINGS " section 6.

NURSING MOTHERS

See " WARNINGS " section 8.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established. See " WARNINGS " section 6.

INFORMATION FOR THE PATIENT

See Patient Labeling.

Patient labeling is included with each single-dose vial and prefilled syringe of DEPO-PROVERA Contraceptive Injection to help describe its characteristics to the patient. It is recommended that prospective users be given this labeling and be informed about the risks and benefits associated with the use of DEPO-PROVERA Contraceptive Injection, as compared with other forms of contraception or with no contraception at all. It is recommended that physicians or other health-care providers responsible for those patients advise them at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with DEPO-PROVERA Contraceptive Injection continues, without other therapy being required.
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