REMS
Contraindicated in:
Pregnancy
;Use Cautiously in:
CV: edema, DEEP VEIN THROMBOSIS
Derm: acne, hirsutism, oiliness
EENT: deepening of voice
Endo: ↓breast size (women), amenorrhea, anovulation, ↓libido
GI:
hepatitis (cholestatic jaundice)
GU: amenorrhea, clitoral enlargement, testicular atrophy
Neuro: emotional lability, STROKE
Drug-drug:
Endometriosis
Fibrocystic Breast Disease
Hereditary Angioedema
(disease response)
ROUTE | ONSET | PEAK | DURATION |
PO (endometriosis) | unknown | 68 wk | 6090 days |
PO (fibrocystic disease) | 1 mo | 26 mo | 1 yr |
PO (angioedema) | unknown | 13 mo | unknown |
Advise patient to report the signs or symptoms of intracranial hypertension (headache, blurred vision, diplopia, vision loss, nausea, vomiting).
May cause fetal harm. Advise patient to use a nonhormonal form of contraception and avoid breastfeeding during therapy. Inform patient that amenorrhea is expected with higher doses. Instruct patient to notify health care provider if regular menstruation does not occur within 6090 days after discontinuation of therapy or if pregnancy is suspected.
NDC Code