Verasafe Injection

Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. Medroxyprogesterone acetate is a progestin indicated for use by females of reproductive potential to prevent pregnancy. …

• The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle
• Prevention of Pregnancy The 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension
• The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection
• As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection
• Use for longer than 2 years is not recommended (unless other birth control methods are considered inadequate) due to the impact of long-term medroxyprogesterone acetate injectable suspension treatment on bone mineral density (BMD) [see Warnings and Precautions ]
• Dosage does not need to be adjusted for body weight [ see Clinical Studies ]
• To ensure the patient is not pregnant at the time of the first injection, the first injection should 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. …

Prefilled syringe is available packaged with 22-gauge x 1 1/2 inch Terumo SurGuard ® Needles. (3) Prefilled syringe: prefilled syringe is available packaged with 22-gauge x 1 1/2 inch Terumo SurGuard ® Needles. ( 3 )

• Medroxyprogesterone acetate injectable suspension is not indicated before menarche
• Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD
• This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion
• In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity
• It is unknown if use of medroxyprogesterone acetate injectable suspension by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. …

This product has not been studied in post-menopausal women and is not indicated in this population.

• "See FDA-approved patient labeling (Patient Information)." Advise patients 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 medroxyprogesterone acetate injectable suspension continues, without other therapy being required
• Counsel patients about the possible increased risk of breast cancer in women who use medroxyprogesterone acetate injectable suspension [ see Warnings and Precautions ]
• Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. …

• The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [ see Warnings and Precautions ]
• Known or suspected malignancy of breast [ see Warnings and Precautions ]. …

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension. ( 7.1 ) 7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. …

Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis. ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.5 ) Liver Function: Discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop. ( 5. 7) Carbohydrate Metabolism: Monitor diabetic patients carefully. …

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. …

8.1 Pregnancy Medroxyprogesterone acetate injectable suspension should not be administered during pregnancy. [ See Contraindications and Warnings and Precautions ( 5.1 7).]

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.