DEPO-SUBQ PROVERA 104™ (medroxyprogesterone acetate injectable suspension) 104 mg/0.65 mL Description

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Prescribing Information

DEPO-SUBQ PROVERA 104™ (medroxyprogesterone acetate injectable suspension) 104 mg/0.65 mL Description


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depo-subQ provera 104^™ contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205° and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is 17-hydroxy-6α-methylpregn-4-ene-3,20-dione 17-acetate. The structural formula is as follows:

depo-subQ provera 104^™ for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Each 0.65 mL contains:

Medroxyprogesterone acetate	104 mg
Methylparaben	1.040 mg
Propylparaben	0.098 mg
Sodium Chloride	5.200 mg
Polyethylene Glycol	18.688 mg
Polysorbate 80	1.950 mg
Monobasic Sodium Phosphate H₂O	0.451 mg
Dibasic Sodium Phosphate 2H₂O	0.382 mg
Methionine	0.975 mg
Povidone	3.250 mg
Water for Injection	qs

When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

PRINTER-FRIENDLY

depo-subQ Safety Information

Important Safety Information

Women who use depo-subQ provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. depo-subQ provera 104 should be used long-term (e.g., longer than 2 years) only if other methods of birth control are inadequate.

depo-subQ provera 104 does not protect patients from HIV/AIDS or other sexually transmitted diseases.

depo-subQ provera 104 is contraindicated in patients with known or suspected pregnancy or with undiagnosed vaginal bleeding, known or suspected breast malignancy, active thrombophlebitis, current or past thromboembolic or cerebral vascular disorders, significant liver disease, or known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients.

The most common side effects (occurring in 5% of subjects) were headache (9%), intermenstrual bleeding (7%), increased weight (6%), amenorrhea (6%), and injection-site reactions (5%).

Among 212 women, the most common reasons for discontinuation were uterine bleeding irregularities (35%), increased weight (18%), decreased libido (11%), acne (10%) and injection site reactions (6%).

Please see full prescribing information.

depo-subQ provera 104^™ (medroxyprogesterone acetate injectable suspension)