Important Safety Information

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),  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).1-7

INDICATIONS

Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tri-VyLibra Lo, and VyLibra are indicated for use by females of reproductive potential to prevent pregnancy.

Tri-VyLibra is indicated for use by females of reproductive potential to prevent pregnancy. Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females 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, combination oral contraceptives, including Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, 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
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 4 weeks before 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 hormonally 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 glecaprevir/pibrentasvir), hereditary angioedema, and chloasma.

ADVERSE REACTIONS

The most serious reactions are discussed elsewhere in the labeling and include serious cardiovascular events, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.

Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

INDICATIONS

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.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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

Tarina 24 Fe is contraindicated in females 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 problems—Stop Tarina 24 Fe if an arterial or venous thrombotic event occurs, or 4 weeks before 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 Tarina 24 Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. Combined oral contraceptives (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—Tarina 24 Fe is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive.
  • Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities, depression, interference with laboratory tests, hereditary angioedema, chloasma, and drug interactions (including between Tarina 24 Fe and glecaprevir/pibrentasvir).

ADVERSE REACTIONS

The most serious reactions are discussed elsewhere in the labeling and include serious cardiovascular events, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.

Patients should be counseled that Tarina 24 Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

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 aterial or venous thrombotic event occurs, or at least 4 weeks before 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 hormonally 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

The most serious reactions are discussed elsewhere in the labeling and include serious cardiovascular events, vascular events, and liver disease. Commonly reported adverse reactions include irregular uterine bleeding, nausea, breast tenderness, and headache.

Patients should be counseled that Jasmiel does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

INDICATIONS

Lyleq, a progestin-only oral contraceptive, 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

Progestin-only oral contraceptives (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
  • Hepatic neoplasia—Hepatic adenomas and very rare hepatocellular carcinomas are associated with combined oral contraceptive (COC) use. There is insufficient data to determine whether POP use increases the risk of developing hepatic neoplasia.
  • 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 transmission of HIV (AIDS) and other sexually transmitted diseases (STDs), such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

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). EContra One-Step is not intended to be used in place of routine birth control.

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 diseases (STDs) alert—This product does not protect against HIV/AIDS or other STDs.
  • Pregnancy alert—Do not use if you are already pregnant (because it will not work).
  • 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.

INDICATION AND USAGE

TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use:

Consider the reduced effectiveness of TWIRLA in women with a BMI ≥25 to <30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥30 kg/m2.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 kg/m2

Cigarette Smoking and Serious Cardiovascular Events

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.

Contraindicated in Women with a BMI ≥30 kg/m2
TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).

Consult the Package Insert or click here for Complete Prescribing Information.

CONTRAINDICATIONS

TWIRLA is contraindicated and should not be used in women who have or develop a high risk of arterial or venous thrombotic disease, including women with a BMI ≥30 kg/m2; headaches with focal neurological symptoms, migraine with aura, women over 35 years of age with any migraine headache; liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; current or history of breast cancer; hypersensitivity to any components of TWIRLA; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

WARNINGS AND PRECAUTIONS

  • Thromboembolic Disorders and Other Vascular Conditions –
    Women are at increased risk for a VTE when using TWIRLA.

    • Stop TWIRLA if an arterial or VTE occurs.
    • Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
    • Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery.
    • Start TWIRLA no earlier than 4 weeks after delivery in women who are not breast-feeding.
    • Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy.
  • Arterial Events – CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (>35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.
  • Liver Disease – Discontinue TWIRLA if jaundice develops.
  • Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment – Discontinue TWIRLA prior to starting therapy with the hepatitis C combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with that combination drug regimen.
  • Hypertension – Monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.
  • Gallbladder Disease – Studies suggest CHCs increase the risk of developing gallbladder disease and may also worsen existing gallbladder disease.
  • Adverse Carbohydrate and Lipid Metabolic Effects –
    • TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA.
    • Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.
  • Headache – If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA as indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).
  • Bleeding Irregularities and Amenorrhea – Women using TWIRLA may experience unscheduled bleeding, especially during the first 3 months of use, or experience absence of scheduled bleeding. If bleeding persists or occurs after previously regular cycles on TWIRLA, or if scheduled bleeding does not occur, evaluate for causes such as pregnancy or, in the case of unscheduled bleeding, malignancy.
  • Other Warnings and Precautions – Other warnings and precautions include depression, breast cancer, cervical cancer, increased serum concentrations of binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS

The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of 4 VTEs in TWIRLA-treated patients were identified in the phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.

Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA.

This is not a comprehensive list of safety information related to TWIRLA.
Please see full Prescribing Information, including BOXED WARNING.

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

  1. Aubra EQ® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; August 2023.
  2. Chateal EQ® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; August 2023.
  3. Cyred EQ® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; April 2022.
  4. Tarina Fe 1/20 EQ® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
  5. Tri-VyLibra® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; January 2024.
  6. Tri-VyLibra® Lo prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
  7. VyLibra® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
  8. Tarina 24® Fe prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; January 2024.
  9. Jasmiel® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; November 2023.
  10. Lyleq® prescribing information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
  11. EContra One-Step® product information, Charleston SC, USA: Afaxys Pharma, LLC; March 2023.
  12. Twirla® prescribing information, Princeton, NJ: Agile Therapeutics, Inc.; April 2022.

*Products with an asterisk may be discontinued

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