HALOETTE Dosage & Rx Info | Uses, Side Effects

Haloette Generic Name & Formulations

Legal Class

General Description

Etonogestrel 0.12mg/day, ethinyl estradiol 0.015mg/day; vaginal ring; latex-free.

Pharmacological Class

Hormonal vaginal contraceptive (progestin + estrogen).

How Supplied

Rings—3

Manufacturer

Mayne Pharma US

Generic Availability

YES

Mechanism of Action

Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary effect of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Haloette Indications

Indications

Contraception.

Haloette Dosage and Administration

Adult

Insert 1 ring vaginally and leave in place for 3 weeks, then remove for 1 ring-free week; repeat; backup method (eg, condoms) recommended during first week. Switching from combination oral contraceptives: insert 1 ring any time within 7 days after last tab and no later than the day a new cycle of pills was to start (no back-up method needed). Switching from progestin-only contraceptives or after abortion, miscarriage or childbirth: see full labeling.

Children

Premenarchal: not applicable.

Haloette Contraindications

Contraindications

High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or PE, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis with valvular disease, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy. Current diagnosis or history of breast cancer, which may be hormone-sensitive. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Haloette Boxed Warnings

Boxed Warning

Cigarette smoking increases risk of serious cardiovascular events.

Haloette Warnings/Precautions

Warnings/Precautions

Increased risk of cardiovascular events (eg, stroke, MI) esp. in smokers >35yrs. Discontinue if thrombotic event, unexplained visual changes, severe headaches, depression, jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Gallbladder disease. Pregnancy-related cholestasis. Hypertriglyceridemia. Malignant neoplasms. Diabetes. Prediabetes. Hereditary angioedema. History of chloasma gravidarum; avoid sun or UV radiation exposure. Uncontrolled dyslipidemia; consider alternative therapy. Predisposition to vaginal irritation or ulceration. May need barrier contraception with postpartum use (see full labeling). Monitor BP annually. Do regular complete physical exams. Postmenopausal women. Nursing mothers.

Haloette Pharmacokinetics

Absorption

Etonogestrel released by Haloette is rapidly absorbed. The bioavailability of etonogestrel after vaginal administration is ~100%.

Ethinyl estradiol released by Haloette is rapidly absorbed. The bioavailability of ethinyl estradiol after vaginal administration is ~56%, which is comparable to that with oral administration of ethinyl estradiol.

Distribution

Etonogestrel is ~32% bound to sex hormone-binding globulin (SHBG) and ~66% bound to albumin in blood.

Ethinyl estradiol is highly but not specifically bound to serum albumin (98.5%) and induces an increase in the serum concentrations of SHBG.

Metabolism

Hepatic (CYP3A4).

Elimination

Renal, bile, fecal. Half-life: 29.3 hours (etonogestrel); 44.7 hours (ethinyl estradiol).

Haloette Interactions

Interactions

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Haloette prior to starting HCV regimen and restart 2wks after completion. Do not use with female barrier methods (eg, diaphragm, cervical cap, female condom); ring device may interfere with their placement and position. Antagonized by hepatic enzyme inducing drugs (eg, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort); use non-hormonal method or a backup contraception. May be potentiated by atorvastatin, acetaminophen, ascorbic acid, vaginal miconazole, or strong/moderate CYP3A4 inhibitors (eg, itraconazole, ketoconazole, voriconazole, fluconazole, grapefruit juice). May be affected by HIV/HCV protease inhibitors or NNRTIs. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid, lamotrigine. May potentiate cyclosporine, prednisolone, theophylline, tizanidine, voriconazole. May need dose adjustment of thyroid hormones. May affect lab tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins, hormone binding globulins).

Haloette Adverse Reactions

Adverse Reactions

Vaginitis, headache, mood changes, nausea, vomiting, vaginal discomfort/discharge, weight gain, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, decreased libido, ring device related events (eg, expulsion/discomfort/foreign body sensation, inadvertent bladder insertion, ring breakage), increased BP; toxic shock syndrome, chloasma, amenorrhea, breakthrough bleeding, hypersensitivity reactions (discontinue if suspected).

Haloette Clinical Trials

See Literature

Haloette Note

Not Applicable

Haloette Patient Counseling