PLEASE SEE FULL PRESCRIBING INFORMATION FOR EACH PRODUCT, INCLUDING BOXED WARNINGS.
IMPORTANT SAFETY INFORMATION for Aubra EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg), Chateal EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Cyred EQ® (desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Tarina Fe 1/20 EQ® (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Tarina® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Tri-VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.250 mg/0.035 mg), Tri-VyLibra® Lo (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg), and VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.250 mg/0.035 mg).a-h
INDICATIONS
Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tri-VyLibra Lo, and VyLibra are indicated for use by women to prevent pregnancy.
Tarina 24 Fe is indicated for use by women to prevent pregnancy. The efficacy of Tarina 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m2 has not been evaluated.
Tri-VyLibra is indicated for use by women to prevent pregnancy. Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in women and girls at least 15 years of age who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tarina 24 Fe, Tri-VyLibra, Tri-VyLibra Lo, and VyLibra should not be used by women who are over 35 years of age and smoke.
Consult the Package Insert or click below for Complete Prescribing Information:
Aubra EQ
Chateal EQ
Cyred EQ
Tarina Fe 1/20 EQ
Tarina 24 Fe
Tri-VyLibra
Tri-VyLibra Lo
VyLibra
CONTRAINDICATIONS
COCs are contraindicated in women who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35
- Have deep vein thrombosis or pulmonary embolism, now or in the past
- Have inherited or acquired hypercoagulopathies
- Have cerebrovascular disease
- Have coronary artery disease
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation)
- Have uncontrolled hypertension
- Have diabetes mellitus with vascular disease
- Have headaches with focal neurological symptoms, migraine headaches with aura, or women over age 35 with any migraine headaches
- Liver tumors (benign or malignant) or liver disease
- Undiagnosed abnormal uterine bleeding
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
- Use hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular events—Stop COCs if an arterial or venous thrombotic event occurs, or at least 4 weeks before and through 2 weeks after major surgery or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (evaluate for retinal thrombosis immediately). Start COCs no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs should be used with caution in women with cardiovascular risk factors.
- Liver disease—Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinomas are associated with long-term (>8 years) COC use.
- High blood pressure—Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs.
- Malignant neoplasms—COCs are contraindicated in females who currently have or have had breast cancer because breast cancer may be hormone-sensitive.
- Other warnings and precautions include gallbladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, depression, interference with laboratory tests, drug interactions (including between Tarina Fe 1/20 EQ and/or Tarina 24 Fe and glecaprevir/pibrentasvir), hereditary angioedema, and chloasma.
ADVERSE REACTIONS
Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache. The most serious reactions include cardiovascular events, thrombotic events, and liver disease (see Warnings and Precautions).
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
IMPORTANT SAFETY INFORMATION for Jasmiel® (drospirenone and ethinyl estradiol tablets, USP 3 mg/0.02 mg)i
INDICATIONS
Jasmiel is indicated for use by women to prevent pregnancy. Jasmiel is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. Jasmiel is indicated for the treatment of moderate acne for women at least 14 years old and have achieved menarche, only if the patient desires an oral contraceptive for birth control.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.
Consult the Package Insert or click here for Complete Prescribing Information.
CONTRAINDICATIONS
Do not prescribe Jasmiel to women who are known to have the following:
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35
- Have deep vein thrombosis or pulmonary embolism, now or in the past
- Have inherited or acquired hypercoagulopathies
- Have cerebrovascular disease
- Have coronary artery disease
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation)
- Have uncontrolled hypertension
- Have diabetes mellitus with vascular disease
- Have headaches with focal neurological symptoms, migraine headaches with aura, or women over age 35 with any migraine headaches
- Undiagnosed abnormal uterine bleeding
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
- Liver tumors (benign or malignant) or liver disease
- Use hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
WARNINGS AND PRECAUTIONS
- Thrombotic and other vascular problems—Stop Jasmiel if an arterial or venous thrombotic event occurs, or at least 4 weeks before and through 2 weeks after major surgery or surgeries known to have an elevated risk of thromboembolism, or if there is an unexplained loss or change of vision (evaluate for retinal thrombosis immediately). Start Jasmiel no earlier than 4 weeks after delivery, in women who are not breastfeeding. Combined oral contraceptives (COCs) containing drospirenone (DRSP) may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing other progestins. Before initiating Jasmiel in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of the risk of a VTE.
- Hyperkalemia—DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
- Malignant neoplasms—Jasmiel is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormone-sensitive.
- Liver disease—Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinomas are associated with long-term (>8 years) COC use.
- High blood pressure—Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs.
- Other warnings and precautions include gallbladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities, depression, interference with laboratory tests, hereditary angioedema, and chloasma.
ADVERSE REACTIONS
Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache. The most serious reactions include cardiovascular events, thrombotic events, and liver disease (see Warnings and Precautions).
Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
IMPORTANT SAFETY INFORMATION for Lyleq® (norethindrone tablets, USP 0.35 mg)j
INDICATIONS
Lyleq, a progestin-only oral contraceptive (POP), is indicated for the prevention of pregnancy.
WARNING
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
Consult the Package Insert or click here for Complete Prescribing Information.
CONTRAINDICATIONS
POPs should not be used by women who currently have the following conditions:
- Known or suspected pregnancy
- Known or suspected carcinoma of the breast
- Undiagnosed abnormal genital bleeding
- Hypersensitivity to any component of Lyleq
- Benign or malignant liver tumors
- Acute liver disease
WARNINGS AND PRECAUTIONS
- Ectopic pregnancy—Up to 10% of pregnancies reported in clinical studies of POP users are extrauterine. Healthcare providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on POPs.
- Delayed follicular atresia/ovarian cysts—If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Rarely, these may twist or rupture, requiring surgical intervention.
- Irregular genital bleeding
- Benign and malignant tumors —Hepatic adenomas and very rare hepatocellular carcinomas are associated with combined oral contraceptive (COC) use. Breast and cervical cancers have been associated with COCs in some studies. There are insufficient data to determine whether POP use increases the risk of developing these tumors.
- Other warnings and precautions include carbohydrate and lipid metabolic effects, drug interactions, lactation, headache, and interference with laboratory tests.
ADVERSE REACTIONS
Commonly reported adverse reactions include irregular bleeding, dizziness, nausea, breast tenderness, headache, acne, gastrointestinal effects, hirsutism, and weight gain.
Patients should be counseled that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
PRODUCT INFORMATION for EContra® (levonorgestrel tablet, 1.5 mg)k
INDICATIONS
EContra One-Step is a progestin-only emergency contraceptive pill for use in women to reduce the chance of pregnancy after unprotected sex (if contraceptive failed or birth control was not used). It should be taken as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better it will work.
Consult the Package Insert or click here for Drug Label Information.
WARNINGS
- Allergy alert—Do not use if you have ever had an allergic reaction to levonorgestrel.
- Sexually transmitted infections (STIs) alert—This product does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
- Pregnancy alert—Do not use if you are already pregnant (because it will not work).
- Contraception—Do not use as a regular birth control because it is not as effective as regular birth control.
- Interaction with other medications—Women should ask a doctor or pharmacist before using EContra One-Step if taking efavirenz (HIV medication), rifampin (tuberculosis treatment), or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.
ADVERSE REACTIONS
Commonly reported adverse reactions include menstrual changes, abdominal pain, nausea, vomiting, tiredness, headache, dizziness, and breast pain.
To report SUSPECTED ADVERSE REACTIONS for any of these products, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.
References:
- Aubra EQ prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; August 2023.
- Chateal EQ prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; August 2023.
- Cyred EQ prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; November 2024.
- Tarina Fe 1/20 EQ prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
- Tarina 24 Fe prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; November 2023.
- Tri-VyLibra prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; January 2024.
- Tri-VyLibra Lo prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
- VyLibra prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; December 2024.
- Jasmiel prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; November 2023.
- Lyleq prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
- EContra One-Step product information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
