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DEPO-SUBQ PROVERA 104® (medroxyprogesterone acetate injectable suspension) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Loss of Bone Mineral Density

Advise the patient that the use of depo-subQ provera 104 decreases BMD [see Warnings and Precautions (5.1)].

Arterial and Venous Thromboembolic Disorders

Advise the patient that serious arterial and venous thrombotic events have been seen in women treated with depot medroxyprogesterone acetate (DMPA) [see Warnings and Precautions (5.2)].

Anaphylaxis

Counsel patients on the importance of seeking urgent medical attention if they experience symptoms of anaphylaxis [see Warnings and Precautions (5.5)].

Ectopic Pregnancy

Advise patients to tell their healthcare professional right away if they become pregnant or experience severe abdominal pain to exclude a diagnosis of ectopic pregnancy [see Warnings and Precautions (5.4)].

Bleeding Irregularities

Advise patients at the beginning of treatment that their menstrual cycle may be disrupted, resulting in irregular and unpredictable bleeding or spotting. Explain that bleeding and spotting irregularities usually decrease to the point of amenorrhea as treatment with depo-subQ provera 104 continues, and does not require other therapy [see Warnings and Precautions (5.11)].

Delayed Return of Ovulation and Fertility

Advise patients that return to ovulation and fertility is likely to be delayed after stopping depo-subQ provera 104 [see Warnings and Precautions (5.8)].

Risks of Breast Cancer

Counsel patients about the possible increased risk of breast cancer in women who use depo-subQ provera 104 [see Warnings and Precautions (5.3)].

Depression

Counsel patients about the possible risk of depression and mood disorders. Advise patients with a history of depression or who are receiving treatment for depression to be alert to any mood changes or worsening of their depression. Counsel patients to follow up with their healthcare professional accordingly [see Warnings and Precautions (5.9)].

Risk of Hyperglycemia in Patients with Diabetes

Advise diabetic patients that some patients receiving progestins may exhibit a decrease in glucose tolerance and hyperglycemia [see Warnings and Precautions (5.12)].

Liver Dysfunction

Advise patients to seek medical advice if they experience symptoms of liver problems such as jaundice [see Warnings and Precautions (5.13)].

Fluid Retention

Counsel patients with conditions that may be influenced by fluid retention to inform their healthcare professional if they experience symptoms of fluid retention [see Warnings and Precautions (5.6)].

Injection Site Reactions

Counsel patients on injection site reactions. Advise patients that dimpling or scarring may occur in 1 out of 100 patients [see Warnings and Precautions (5.10)].

Sexually Transmitted Infections

Counsel patients that depo-subQ provera 104 does not protect against HIV infection (AIDS) and other sexually transmitted infections [see Warnings and Precautions (5.14)].

Drug Interactions

Counsel patients to contact their healthcare professional if they start a medication that is a CYP3A enzyme inducer [see Drug Interactions (7)]. Advise patients that taking a medication that is a CYP3A enzyme inducer may require using a back-up or alternate contraceptive method.

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