DEPO-SUBQ PROVERA 104® Use in Specific Populations

(medroxyprogesterone acetate)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

There is no use for depo-subQ provera 104 in pregnancy and therefore depo-subQ provera 104 should be discontinued during pregnancy. There appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual, or social development.

8.3 Nursing Mothers

Although medroxyprogesterone acetate is detectable in the milk of mothers receiving DMPA-IM, milk composition, quality, and amount do not appear to be adversely affected. Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery. Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted.

8.4 Pediatric Use

Depo-subQ provera 104 is indicated for the prevention of pregnancy and management of endometriosis-associated pain in females of reproductive age. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older.

Use of depo-subQ provera 104 is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence, a critical period of bone accretion. It is unknown if use of depo-subQ provera 104 by female adolescents will reduce peak bone mass and increase the risk for osteoporotic fractures in later life. In a study of adolescent females (12–18 years of age) receiving DMPA-IM for contraception, mean BMD 2 years after starting DMPA-IM decreased 1.9% (spine), 4.3% (total hip), and 4.2% (femoral neck). In those adolescents who used DMPA-IM for more than 2 years, mean BMD at total hip and femoral neck did not return to baseline within 5 years.

Depo-subQ provera 104 is not indicated before menarche.

8.5 Geriatric Use

Depo-subQ provera 104 is not indicated in post-menopausal women.

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Use in Specific Populations

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

There is no use for depo-subQ provera 104 in pregnancy and therefore depo-subQ provera 104 should be discontinued during pregnancy. There appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual, or social development.

8.3 Nursing Mothers

Although medroxyprogesterone acetate is detectable in the milk of mothers receiving DMPA-IM, milk composition, quality, and amount do not appear to be adversely affected. Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery. Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted.

8.4 Pediatric Use

Depo-subQ provera 104 is indicated for the prevention of pregnancy and management of endometriosis-associated pain in females of reproductive age. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older.

Use of depo-subQ provera 104 is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence, a critical period of bone accretion. It is unknown if use of depo-subQ provera 104 by female adolescents will reduce peak bone mass and increase the risk for osteoporotic fractures in later life. In a study of adolescent females (12–18 years of age) receiving DMPA-IM for contraception, mean BMD 2 years after starting DMPA-IM decreased 1.9% (spine), 4.3% (total hip), and 4.2% (femoral neck). In those adolescents who used DMPA-IM for more than 2 years, mean BMD at total hip and femoral neck did not return to baseline within 5 years.

Depo-subQ provera 104 is not indicated before menarche.

8.5 Geriatric Use

Depo-subQ provera 104 is not indicated in post-menopausal women.
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