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Prescribing Information
DEPO-SUBQ PROVERA 104™ (medroxyprogesterone acetate injectable suspension) 104 mg/0.65 mL How Supplied
Return to the depo_subq Product Center

depo-subQ provera 104® for subcutaneous use (medroxyprogesterone acetate injectable suspension 104 mg/0.65 mL) is available as a pre-filled syringe, pre-assembled with an UltraSafe Passive Needle Guard* device, and packaged with a 26-gauge x 3/8 inch needle in the following presentation:

NDC 0009-4709-01 0.65 mL single-use, disposable syringe

Store at controlled room temperature 20° to 25° C (68° to 77°F) [see USP].

*UltraSafe Passive Needle Guard is a trademark of Safety Syringes, Inc.

Rx only

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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%).

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