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

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Prescribing Information

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


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In five clinical studies of depo-subQ provera 104^™ involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

Uterine bleeding irregularities (35%, n=75)

Increased weight (18%, n=39)

Decreased libido (11%, n=23)

Acne (10%, n=21)

Injection site reactions (6%, n=12)

Adverse reactions reported by 5% or more of all women in these clinical trials included:

Headache (9%)

Intermenstrual bleeding (7%)

Increased weight (6%)

Amenorrhea (6%)

Injection site reactions (5%)

Adverse reactions reported by 1% to <5% of all women in these clinical trials included:

General disorders: fatigue, injection site pain

Gastrointestinal disorders: abdominal distention, abdominal pain, diarrhea, nausea

Infections: bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial

Investigations: abnormal cervix smear

Musculoskeletal, connective tissue, and bone disorders: arthralgia, back pain, limb pain

Nervous system disorders: dizziness, insomnia

Psychiatric disorders: anxiety, depression, irritability, decreased libido

Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage

Skin disorders: acne

Vascular disorders: hot flushes

Postmarketing Experience
There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg).

The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104 :

General disorders: asthenia, axillary swelling, chills, chest pain, fever, excessive thirst

Blood and lymphatic system disorders: anemia, blood dyscrasia

Cardiac disorders: tachycardia

Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding

Hepato-biliary disorders: jaundice

Immune system disorders: allergic reaction

Infections: genitourinary infections

Investigations: decreased glucose tolerance

Musculoskeletal, connective tissue, and bone disorders: loss of bone mineral density, scleroderma

Neoplasms: breast cancer, cervical cancer

Nervous system disorders: convulsions, facial palsy, fainting, paralysis, paresthesia, somnolence

Psychiatric disorders: increased libido, nervousness

Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst

Respiratory disorders: asthma, dyspnea, hoarseness

Skin disorders: angioedema, dry skin, increased body odor, melasma, pruritus, urticaria

Vascular disorders: deep vein thrombosis, pulmonary embolus, thrombophlebitis

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)