BLISOVI FE 1.5/30
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BLISOVI FE 1.5/30 (BLISOVI FE 1.5/30).
Blisovi Fe 1.5/30 is a combination oral contraceptive containing ethinyl estradiol (estrogen) and norethindrone (progestin). It inhibits ovulation via suppression of gonadotropins (FSH and LH). Additionally, it increases cervical mucus viscosity, impeding sperm penetration, and alters endometrial development, reducing implantation likelihood.
| Metabolism | Ethinyl estradiol is metabolized primarily via CYP3A4; norethindrone is metabolized via reduction and conjugation, with some involvement of CYP3A4. |
| Excretion | Renal: ~60% (ethinyl estradiol metabolites as glucuronide/sulfate conjugates, norethindrone metabolites). Fecal: ~40% (biliary excretion of conjugates, with some enterohepatic recirculation). |
| Half-life | Ethinyl estradiol: terminal half-life ~17 hours (range 13–27 h) with single dose; for norethindrone: ~8–11 hours. Clinical context: Steady-state achieved within ~7–10 days; contraceptive efficacy maintained with once-daily dosing. |
| Protein binding | Ethinyl estradiol: ~97% bound to albumin (specifically to albumin, with some binding to SHBG). Norethindrone: ~61% bound to albumin, ~36% to SHBG. Iron: >99% bound to transferrin and ferritin. Folic acid: ~50–60% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | Ethinyl estradiol: Vd ~2.7–4.8 L/kg (large, reflecting extensive tissue distribution). Norethindrone: Vd ~3.6–4.3 L/kg. Clinical meaning: large Vd indicates extensive extravascular binding (e.g., fat stores, steroid receptors). Iron: mainly in erythrocytes and reticuloendothelial system; Vd not typically reported. Folic acid: total body folate ~500–20,000 µg, with Vd ~0.6 L/kg (reflects distribution into tissues). |
| Bioavailability | Oral ethinyl estradiol: ~38–48% (first-pass metabolism). Norethindrone: ~64% (high first-pass). Folic acid: ~76–93% (dose-dependent; reduced when taken with food). Iron (ferrous fumarate): ~10–20% (varies with iron stores; increased in deficiency). |
| Onset of Action | Oral: Full contraceptive effect after 7 consecutive days of active pills (first cycle); earlier if started on Day 1 of menses (immediate). Folate effect: onset within days for RBC folate. Iron: absorption begins within hours but clinical effect on hemoglobin takes weeks. |
| Duration of Action | Contraceptive protection: 24 hours after each active pill; failure to take pill >24 hours increases pregnancy risk. Folate: sustained with daily intake; iron: depends on iron stores and dose. |
| Molecular Weight | Drospirenone: 366.5 Da; Ethinyl estradiol: 296.4 Da |
One tablet orally once daily at the same time each day for 21 consecutive days, followed by 7 days of placebo tablets (iron-free).
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Contraindicated in severe renal impairment or acute renal failure due to potential for iron accumulation. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C). Use with caution in mild to moderate hepatic impairment; monitor liver function. |
| Pediatric use | Not indicated for use in pediatric females before menarche. Safety and efficacy in adolescents have not been established; use is generally not recommended. |
| Geriatric use | No specific dose adjustment for geriatric use. Consider increased risk of thromboembolic disorders and monitor accordingly. |
| 1st trimester | Contraindicated due to risk of congenital defects, including neural tube defects and cardiovascular malformations. |
| 2nd trimester | Contraindicated due to risk of fetal harm, including potential for virilization of female fetuses and other developmental anomalies. |
| 3rd trimester | Contraindicated due to risk of fetal harm, including potential for androgenic effects and other developmental anomalies. |
Clinical note
Comprehensive clinical and safety monograph for BLISOVI FE 1.5/30 (BLISOVI FE 1.5/30).
| Placental transfer | Both drospirenone and ethinyl estradiol cross the placenta. Ethinyl estradiol is known to cross the placental barrier, and drospirenone is expected to do so based on its molecular properties. |
| Breastfeeding | Drospirenone/ethinyl estradiol is excreted in breast milk in small amounts. Use during breastfeeding is generally not recommended, especially in the early postpartum period, due to potential effects on milk production and infant exposure to hormones. |
■ FDA Black Box Warning
Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. The risk increases with age and with heavy smoking (≥15 cigarettes per day). Women over 35 who smoke should not use this product.
| Serious Effects |
Pregnancy or suspected pregnancyHistory of or current thromboembolic disorders (e.g., deep vein thrombosis, pulmonary embolism)Cerebrovascular or coronary artery diseaseKnown or suspected breast cancer or other estrogen-dependent neoplasiaActive liver disease or hepatic adenomasUncontrolled hypertension (blood pressure > 160/100 mmHg)Diabetes mellitus with vascular involvementMigraine with focal neurological symptoms (including aura) in women > 35 years of ageMajor surgery with prolonged immobilizationUndiagnosed abnormal uterine bleedingRenal impairment (e.g., renal failure, adrenal insufficiency) due to drospirenone's potassium-sparing propertiesKnown hypersensitivity to any component of the product
| Precautions | Thrombotic disorders (thrombophlebitis, pulmonary embolism, cerebrovascular accidents, myocardial infarction), Hepatic neoplasia (benign and malignant), Gallbladder disease, Hypertension, Carbohydrate and lipid metabolism effects, Headache/migraine, Irregular bleeding, Ectopic pregnancy risk if used for emergency contraception, Ocular lesions (retinal thrombosis), Depression, Hereditary angioedema, Chloasma |
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| Lactation Rating | L4 - Possibly Hazardous |
| Teratogenic Risk | FDA Pregnancy Category X. Use is contraindicated in pregnant women because drospirenone/ethinyl estradiol can cause fetal harm. There is no indication for use in pregnancy. If pregnancy occurs during treatment, the drug should be discontinued immediately. Epidemiologic studies have not revealed an increased risk of birth defects in infants born to women who inadvertently used oral contraceptives early in pregnancy. However, drospirenone is a progestin with antiandrogenic activity, and animal studies have shown teratogenic effects including urogenital tract abnormalities at high doses. |
| Fetal Monitoring | Before starting therapy, rule out pregnancy with a sensitive test. Monitor for signs of thromboembolic events (e.g., DVT, PE, stroke) as pregnancy increases risk. Blood pressure should be checked regularly due to potential for hypertension. In patients with conditions such as migraine with aura, monitor for new onset or worsening headaches. Evaluate liver function if symptoms of hepatotoxicity occur. Monitor glucose in diabetic patients, as hormonal contraceptives can impair glucose tolerance. During pregnancy, standard prenatal monitoring applies; discontinued drug if pregnancy is confirmed. |
| Fertility Effects | BLISOVI FE 1.5/30 is indicated for contraception and suppresses ovulation. After discontinuation, return to fertility may be delayed but is typically not prolonged; most women ovulate within 1-3 months. No permanent effects on fertility have been demonstrated. In some cases, resumption of regular menstrual cycles and fertility may take several cycles. |
| Food/Dietary | Food does not significantly affect absorption of the hormonal components. Grapefruit juice may inhibit metabolism and increase estrogen levels; avoid large amounts. No specific dietary restrictions. Iron tablets may cause gastrointestinal upset; taking with food may help. |
| Clinical Pearls | BLISOVI FE 1.5/30 is a combination oral contraceptive containing ethinylestradiol and norethindrone acetate. It is primarily used for contraception and acne treatment. The iron component (ferrous fumarate) is not intended for contraceptive effect but to offset menstrual blood loss. Monitor for thromboembolic events, especially in smokers over 35. Use caution in patients with migraine with aura, hypertension, or liver disease. Drug interactions with rifampin, certain anticonvulsants, and St. John's wort may reduce contraceptive efficacy. |
| Patient Advice | Take one tablet daily at the same time each day. The first 21 tablets are active hormones; the last 7 are iron tablets. · If you miss a dose, refer to the package instructions. Missing pills increases risk of pregnancy. · Do not smoke while taking this medication, especially if over 35 years old, due to increased risk of blood clots. · Contact your healthcare provider if you experience severe headaches, chest pain, leg pain, vision changes, or jaundice. · This medication does not protect against HIV or other sexually transmitted infections. · Inform your doctor about all medications you are taking, including over-the-counter drugs and supplements. · The iron tablets may cause black or dark stools; this is harmless. · If you experience persistent vomiting or diarrhea, use additional contraception. |