Medroxyprogesterone Acetate (Page 2 of 7)

5.4 Ectopic Pregnancy

Be alert to the possibility of an ectopic pregnancy among women using medroxyprogesterone acetate injectable suspension who become pregnant or complain of severe abdominal pain.

5.5 Anaphylaxis and Anaphylactoid Reaction

Anaphylaxis and anaphylactoid reaction have been reported with the use of medroxyprogesterone acetate injectable suspension. Institute emergency medical treatment if an anaphylactic reaction occurs.

5.6 Injection Site Reactions

Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions (6.2)]. Persistent injection site reactions may occur after administration of medroxyprogesterone acetate injectable suspension due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle [see Dosage and Administration (2.1)].

5.7 Liver Function

Discontinue medroxyprogesterone acetate injectable suspension use if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and medroxyprogesterone acetate injectable suspension causation has been excluded.

5.8 Convulsions

There have been a few reported cases of convulsions in patients who were treated with medroxyprogesterone acetate injectable suspension. Association with drug use or pre-existing conditions is not clear.

5.9 Depression

Monitor patients who have a history of depression and do not re-administer medroxyprogesterone acetate injectable suspension if depression recurs.

5.10 Bleeding Irregularities

Most women using medroxyprogesterone acetate injectable suspension experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment.

As women continue using medroxyprogesterone acetate injectable suspension, fewer experience irregular bleeding and more experience amenorrhea. In clinical studies of medroxyprogesterone acetate injectable suspension, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using medroxyprogesterone acetate injectable suspension.

5.11 Weight Gain

Women tend to gain weight while on therapy with medroxyprogesterone acetate injectable suspension. From an initial average body weight of 136 lb, women who completed 1 year of therapy with medroxyprogesterone acetate injectable suspension 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.

5.12 Carbohydrate Metabolism

A decrease in glucose tolerance has been observed in some patients on medroxyprogesterone acetate injectable suspension treatment. Monitor diabetic patients carefully while receiving medroxyprogesterone acetate injectable suspension.

5.13 Lactation

Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. In nursing mothers treated with medroxyprogesterone acetate injectable suspension, 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.

5.14 Fluid Retention

Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction.

5.15 Return of Fertility

Return to ovulation and fertility is likely to be delayed after stopping medroxyprogesterone acetate injectable suspension. In a large US study of women who discontinued use of medroxyprogesterone acetate injectable suspension to become pregnant, data are available for 61% of them. Of the 188 women who discontinued the study to become pregnant, 114 became pregnant. 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 medroxyprogesterone acetate injectable suspension to become pregnant and who were lost to follow-up or changed their mind.

5.16 Sexually Transmitted Diseases

Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

5.17 Pregnancy

Although medroxyprogesterone acetate injectable suspension should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. 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.

5.18 Monitoring

A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

5.19 Interference with Laboratory Tests

The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins [see Drug Interactions (7.2)].

6 ADVERSE REACTIONS

The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section (5):

  • Loss of Bone Mineral Density [see Warnings and Precautions (5.1)]
  • Thromboembolic disease [see Warnings and Precautions (5.2)]
  • Breast Cancer [see Warnings and Precautions (5.3)]
  • Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.5)]
  • Bleeding Irregularities [see Warnings and Precautions (5.10)]
  • Weight Gain [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two clinical trials with medroxyprogesterone acetate injectable suspension, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of medroxyprogesterone acetate injectable suspension. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg medroxyprogesterone acetate injectable suspension every 3-months (90 days). The median study duration was 13 months with a range of 1 to 84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months.

Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects

Body System *

Adverse Reactions [Incidence (%)]

Body as a Whole

Headache (16.5%)

Abdominal pain/discomfort (11.2%)

Metabolic/Nutritional

Increased weight > 10 lbs at 24 months (37.7%)

Nervous

Nervousness (10.8%)

Dizziness (5.6%)

Libido decreased (5.5%)

Urogenital

Menstrual irregularities:

(bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months)

* Body System represented from COSTART medical dictionary.

Table 2. Adverse Reactions that Were Reported by between 1 and 5% of Subjects

Body System *

Adverse Reactions [Incidence (%)]

Body as a Whole

Asthenia/fatigue (4.2%)

Backache (2.2%)

Dysmenorrhea (1.7%)

Hot flashes (1.0%)

Digestive

Nausea (3.3%)

Bloating (2.3%)

Metabolic/Nutritional

Edema (2.2%)

Musculoskeletal

Leg cramps (3.7%)

Arthralgia (1.0%)

Nervous

Depression (1.5%)

Insomnia (1.0%)

Skin and Appendages

Acne (1.2%)

No hair growth/alopecia (1.1%)

Rash (1.1%)

Urogenital

Leukorrhea (2.9%)

Breast pain (2.8%)

Vaginitis (1.2%)

* Body System represented from COSTART medical dictionary.

Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)

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