Femolife®
Hydroxyprogesterone Caproate
250 & 500 mg Ampoule
- Reducing the risk of preterm birth
- Management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
- Production of secretory endometrium and desquamation
- Test for endogenous estrogen production
- Treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV)
Mechanism of Action:
Femolife® is a progestin medication which is used to prevent preterm birth in pregnant women with a history of the condition and to treat gynecological disorders.
Method of Administration:
| Disease | Dose | |
|---|---|---|
| 1 | Preterm birth | IM (vial): 250 mg once weekly (every 7 days). |
| 2 | Amenorrhea (primary and secondary) or abnormal uterine bleeding due to hormonal imbalance | 250 mg on day 15 of each 28-day cycle for 4 cycles (in combination with estradiol valerate) |
| 3 | Production of secretory endometrium and desquamation |
Patients not on estrogen therapy: Cyclic therapy schedule: 250 mg on day 15 of each 28-day cycle (in combination with estradiol valerate); may begin at any time; continue until cyclic therapy is no longer required. Patients currently on estrogen therapy: Single dose therapy: 375 mg as a single dose; begin at any time or; Cyclic therapy schedule: 250 mg on day 15 of each 28-day cycle (in combination with estradiol valerate); begin cyclic therapy schedule after 4 days of desquamation. If there is no bleeding, begin cyclic therapy schedule 21 days after the 375 mg single dose schedule. |
| 4 | Test for endogenous estrogen production | 250 mg as a single dose (bleeding 7 to 14 days after administration indicates endogenous estrogen); may repeat once 4 weeks after initial dose. |
| 5 | Uterine adenocarcinoma (advanced) | 1,000 mg one or more times a week (1,000 to 7,000 mg/week); discontinue upon relapse |
Notes
Contraindications
Hypersensitivity to hydroxyprogesterone caproate or any component of the formulation; current or history of thrombosis or thromboembolic disorders; breast cancer or other hormone-sensitive cancer (known, suspected, or history of); undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; liver tumors (benign or malignant) or active liver disease; missed abortion; uncontrolled hypertension; as a diagnostic test for pregnancy.
Interactions:
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors).
Pregnancy and Lactation:
PREGNANCY: Adverse events were not observed in human studies following second or third trimester exposure; use not studied during first trimester. LACTATION: Progestins are present in milk following maternal use and have not been found to adversely affect breastfeeding, health, growth, or development of the infant. Use of Femolife® is not indicated following delivery.
Warning and Precaution:
Thromboembolic Disorders, Allergic reactions including urticaria, pruritus and angioedema, consider discontinuing the drug if such reactions occur. A decrease in glucose tolerance has been observed in some patients on progestin treatment. Carefully monitor prediabetic and diabetic women. Because progestational drugs may cause some degree of fluid retention, carefully monitor women with conditions that might be influenced by this effect (e.g., preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction). Monitor women who have a history of clinical depression and discontinue if clinical depression recurs. Carefully monitor women who develop jaundice while receiving Femolife® and consider whether the benefit of use warrants continuation. Carefully monitor women who develop hypertension.
Adverse Reactions:
Urticaria (12%), Pain at injection site (7% to 35%), swelling at injection site (17%), Preeclampsia (≤9%), Pruritus (8%), Gestational diabetes (6%), Nausea (6%), diarrhea (2%).
Storage:
Store below 30 and protect from light and moisture.