Afaxys Pharma Logo

Afaxys Pharma provides reliable, affordable access to healthcare products for the public healthcare sector.

HEALTHCARE
PROVIDERS

Afaxys Pharma brings a strong portfolio of branded and generic oral contraceptives to the public health market. We are dedicated to offering a sustainable supply of quality, affordable women's healthcare products and services for the public health sector.

Read More
Products

Our core product line offers reliable, consistent, and affordable access to quality women's healthcare options to public health professionals and their patients.

Read More
afaxys group services

Afaxys Group Services connects its members to suppliers who provide mission-critical products and services.

Services/
Offerings

Afaxys Group Services negotiates favorable pricing across a broad base of healthcare products and services so its members have access to best-in-class suppliers and service providers. Our strategic sourcing business model enables Afaxys to secure and provide consistent and reliable access to quality products and services at an affordable price.

Read More

Our Products

Afaxys Pharma offers a broad range of contraceptive options.

previous
EContra One-Step
EContra One-Step®
(Levonorgestrel) Tablet, 1.5 mg
EContra One-Step®
(Levonorgestrel) Tablet, 1.5 mg
close
EContra One-Step® is an OTC emergency contraceptive

Other 1.5 mg levonorgestrel emergency contraceptive products which include:
Plan B One-Step®, EContra®EZ, My Way®, AfterPill®, Fallback Solo™, Opcicon™ One-Step, Fallback Solo®, and Aftera®

  • Effective up to 3 days after unprotected sex or contraceptive failure

Product Information

USAGE: EContra One-Step® (levonorgestrel 1.5 mg tablet) is a progestin-only emergency contraceptive for use in women to reduce chance of pregnancy after unprotected sex (if contraceptive failed or birth control not used). EContra One-Step® is not intended to be used in place of routine birth control.

WHO SHOULD NOT USE ECONTRA One-Step®:
  • Women who are known to be pregnant as it will not work. However, EContra One-Step® will not harm an existing pregnancy.
  • Women known to be allergic to Levonorgestrel.

Women should ask a doctor or pharmacist before using EContra One-Step® if taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

SIDE EFFECTS MAY INCLUDE:
  • Menstrual changes
  • Abdominal pain
  • Nausea or vomiting
  • Tiredness
  • Headache
  • Dizziness
  • Breast pain

Reference:
EContra One-Step® [product information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.

Please see full Product Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched March 2015
  • Effective up to three days after unprotected sex or contraceptive failure
read more
next
annovera
Annovera®
(segesterone acetate and ethinyl estradiol vaginal system),
delivers 0.15 mg / 0.013 mg per day

Afaxys is an authorized promotional partner for ANNOVERA.
Annovera®
(segesterone acetate and ethinyl estradiol vaginal system),
delivers 0.15 mg / 0.013 mg per day

Afaxys is an authorized promotional partner for ANNOVERA.
close
  • ANNOVERA is a soft and flexible, patient-controlled vaginal ring that provides contraception for 1-year (thirteen cycles) when inserted for 21 days and removed for 7 days each cycle
  • Created with a novel hormone profile, ANNOVERA releases a non-androgenic progestin (segesterone acetate) and one of the lowest doses of ethinyl estradiol (0.013 mg) daily1*
  • Each box contains one ANNOVERA individually packaged in an aluminum pouch. A black compact case is provided with the drug product for storage of ANNOVERA by patients during each 7-day vaginal system-out interval

*Based on pharmacological studies in animals and in vitro studies. The clinical significance of these data is not known.


1.Kumar N, Koide SS, Tsong YY, Sundaram K. Nestorone: A progestin with a unique pharmacological profile. Steroids, 2000;65:629-36.


IMPORTANT SAFETY INFORMATION


WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS


See full prescribing information for complete boxed warning.


Females over 35 years old who smoke should not use ANNOVERA.

Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.


CONTRAINDICATIONS

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of ANNOVERA; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.


WARNINGS AND PRECAUTIONS

  • Stop ANNOVERA if a thrombotic or thromboembolic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in females who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years
  • Discontinue if jaundice occurs.
  • Stop ANNOVERA prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be restarted 2 weeks following completion of this regimen.
  • Do not prescribe ANNOVERA for females with uncontrolled hypertension or hypertension with vascular disease. Monitor blood pressure and stop use if blood pressure rises significantly in females with wellcontrolled hypertension.
  • Monitor glucose in pre-diabetic or diabetic females taking ANNOVERA. Consider an alternate contraceptive method for females with uncontrolled dyslipidemias.
  • Patients using ANNOVERA who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. ANNOVERA should be discontinued if indicated.
  • Other warnings include: gallbladder disease; depression; cervical cancer; increased serum concentrations of binding globulins; hereditary angioedema; chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using ANNOVERA); toxic shock syndrome (TSS) (if a patient exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate medical treatment); vaginal use (ANNOVERA may not be suitable for females with conditions that make the vagina more susceptible to vaginal irritation or ulceration)

ADVERSE REACTIONS

The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.


DRUG INTERACTIONS

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


INDICATION

ANNOVERA is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.


Limitations of Use: ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2


Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

ANVA-20006.5

previous
  • Launched March 2015
  • Effective up to three days after unprotected sex or contraceptive failure
read more
next
Aubra
Aubra EQ®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg
Aubra EQ®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg
close
Aubra EQ® is an AB1-rated generic oral contraceptive

Compares to: Lutera®, Aubra®, Aviane®, Orsythia®, and Falmina®

  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 21 white to off-white tablets of levonorgestrel and ethinyl estradiol
    • 7 green non–hormone-containing tablets to help ease administration
  • 28-day tablet blister pack makes dosing easy and convenient

IMPORTANT SAFETY INFORMATION


INDICATION

Combination oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.


WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.


CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Combination oral contraceptives should not be used in women with any of the following conditions:

  • Thrombophlebitis or thromboembolic disorders
  • A history of deep-vein thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease (current or past history)
  • Valvular heart disease with thrombogenic complications
  • Thrombogenic rhythm disorders.
  • Hereditary or acquired thrombophilias
  • Major surgery with prolonged immobilization
  • Diabetes with vascular involvement
  • Headaches with focal neurological symptoms
  • Uncontrolled hypertension
  • Known or suspected carcinoma of the breast or personal history of breast cancer
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas, or active liver disease
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets
  • Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

RISKS

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis.


Practitioners prescribing oral contraceptives should be familiar with information relating to these risks.



ADVERSE REACTIONS

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


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.


Reference:
Aubra EQ® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched on October 9, 2013
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
read more
next
Chateal
Chateal EQ®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg
Chateal EQ®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg
close
Chateal EQ® is an AB-rated generic oral contraceptive

Compares to: Levora®, Chateal®, Portia®, Altavera®, Marlissa®, and Kurvelo®

  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 21 orange tablets of levonorgestrel and ethinyl estradiol
    • 7 green non–hormone-containing tablets to help ease administration
  • 28-day tablet blister pack makes dosing easy and convenient

IMPORTANT SAFETY INFORMATION


INDICATION

Chateal EQ is indicated for use by females of reproductive potential to prevent pregnancy.


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 Chateal EQ, are contraindicated in women who are over 35 years of age and smoke.

CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Combined oral contraceptives are contraindicated in females who are known to have 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 current or history of deep vein thrombosis or pulmonary embolism,
    • 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 inherited or acquired hypercoagulopathies,
    • Have uncontrolled hypertension or hypertension with vascular disease,
    • Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration,
    • Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches, (Round bullet) Current or history of breast cancer or other estrogen- or progestin-sensitive cancer,
  • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis,
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations,
  • Undiagnosed abnormal uterine bleeding,
  • Pregnancy, because there is no reason to use COCs during pregnancy.

WARNINGS

  • Stop COCs if an arterial or venous thrombotic/thromboembolic event occurs, if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.
  • Discontinue COCs during prolonged immobilization. If feasible, stop COCs at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism.
  • Start COCs no earlier than four weeks after delivery in females who are not breast-feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.
  • Before starting COCs evaluate any past medical history of family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. COCs are contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases.

ADVERSE REACTIONS

The most serious reactions are discussed in detail in the full product labeling and include serious cardiovascular events, vascular events, liver disease, hypertension, gallbladder disease, carbohydrate/lipid effects, headache and carcinoma of the cervix. Adverse reactions reported by COC users include bleeding irregularities and amenorrhea, mood changes, including depression, melasma/cholasma which may persist, edema/fluid retention and diminution in lactation when given immediately postpartum.

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



Reference:
Chateal EQ® [prescribing information], Charleston, SC: Afaxys Pharma, LLC; October 2019.

Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched on December 21, 2012
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
read more
next
Cyred
Cyred EQ®
Desogestrel 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
close
Cyred EQ® is an AB-rated generic oral contraceptive

Compares to: Ortho-Cept®, Cyred®, Apri®, Desogen®, Emoquette®, Reclipsen™, Enskyce™, and Isibloom™

  • A progestogen-estrogen combination oral contraception
  • Biphasic continuous administration regimen
    • 21 white active tablets containing desogestrel and ethinyl estradiol
    • 7 inactive "reminder" tablets
  • Simple 28-blister pack supports a choice of dosing schedules
    • Start on the first day of a woman's period for efficacy from day 1
    • Start on the first Sunday following the start of a woman's period for the convenience of aligning with other weekly cycles
  • First dose requires 7 days to achieve full efficacy

Important Safety Information


Indication

Cyred EQ® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.


WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING


Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive 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 Cyred EQ®, should not be used by women over 35 years of age who smoke.

Consult the Package Insert for Complete Prescribing Information


CONTRAINDICATION

Do not prescribe combined oral contraceptives (COCs) to women who currently have the following conditions:

  • A high risk of arterial or venous thrombotic disease including women who are known to smoke if over age 35, have a current or past history of deep vein thrombosis, pulmonary embolism, thrombophlebitis, thrombophilic conditions or thromboembolic disorders, have cerebrovascular or coronary artery disease (current or history), have valvular heart disease with complications, have persistent blood pressure values of greater than or equal to 160 mm Hg systolic or greater than or equal to 100 mm Hg diastolic, have headache with focal neurologic symptoms, or have diabetes with vascular involvement
  • Major surgery with prolonged immobilization
  • Known or suspected carcinoma of breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Acute or chronic hepatocellular disease with abnormal liver function, hepatic adenomas or carcinomas
  • Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of the oral contraceptive pills
  • Are receiving 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 combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries 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). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast and cervix - Women with current or past history of breast cancer should not use COCs.
  • Liver Disease - Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (>8 years use) are associated with COC use. Do not use in women receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
  • 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 gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.

ADVERSE REACTIONS

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


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


Reference:
Cyred EQ® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched in September 2015
  • A progestogen-estrogen combination oral contraception
  • Bi-phasic continuous administration regimen
read more
next
Jasmiel
Jasmiel®
Drosperinone and Ethinyl Estradiol Tablets, USP 3.0 mg/0.02 mg
Jasmiel®
Drosperinone and Ethinyl Estradiol Tablets, USP 3.0 mg/0.02 mg
close
Jasmiel® is an AB-rated generic oral contraceptive

Compares to: Yaz®, Nikki™, Loryna™, Gianvi®, and Vestura™

  • A progestin/estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 24 light pink to pink tablets, each containing 3 mg drospirenone USP (DRSP) and 0.02 mg ethinyl estradiol USP (EE)
    • 4 green non-hormone containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack

IMPORTANT SAFETY INFORMATION


INDICATION AND USAGE

Jasmiel is an estrogen/progestin combined oral contraceptive indicated for use by women to:

  • Prevent pregnancy
  • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception
  • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control

CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


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.


CONTRAINDICATIONS

  • Renal impairment
  • Adrenal insufficiency
  • A high risk of arterial or venous thrombotic diseases
  • Undiagnosed abnormal uterine bleeding
  • Breast cancer or other estrogen- or progestin-sensitive cancer
  • Liver tumors or liver disease
  • Pregnancy
  • Co-administration with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir

WARNINGS AND PRECAUTIONS

  • Vascular risks—Stop Jasmiel if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some 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 her 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.
  • Liver disease—Discontinue Jasmiel if jaundice occurs.
  • High blood pressure—Do not prescribe Jasmiel for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Jasmiel. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache—Evaluate significant change in headaches and discontinue Jasmiel if indicated.
  • Uterine bleeding—Evaluate irregular bleeding or amenorrhea

ADVERSE REACTIONS

The most frequent adverse reactions (≥2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%), and mood changes (2.2%).

The most frequent adverse reactions (≥2%) in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).


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


Reference:
Jasmiel® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
read more
next
Tarina 24 Fe
Tarina® 24 Fe
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg
Tarina® 24 Fe
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.0 mg/0.02 mg and 75 mg
close
Tarina® 24 Fe is an AB-rated generic oral contraceptive

Compares to: Junel® Fe 24, Larin™ 24 Fe, Lomedia® 24 Fe, Blisovi™ 24 Fe, and Loestrin® 24 Fe

  • A progestin/estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 24 light yellow to yellow tablets, each containing 1 mg norethindrone acetate USP and 20 mcg ethinyl estradiol USP
    • 4 brown non-hormone containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack

IMPORTANT SAFETY INFORMATION


INDICATION AND USAGE

Tarina 24 Fe is a progestin/estrogen combined oral contraceptive 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.


WARNINGS:

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 FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Do not prescribe Tarina 24 Fe to women who currently have the following conditions:


  • A high risk of arterial or venous thrombotic disease
  • Breast cancer or other estrogen- or progestin-sensitive cancer
  • Undiagnosed abnormal uterine bleeding
  • Liver tumors or liver disease
  • Pregnancy
  • Are receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

WARNINGS AND PRECAUTIONS

  • Thrombotic disorders and other vascular problems—Stop Tarina 24 Fe if a thrombotic event occurs. Stop at least 4 weeks before and 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding.
  • Liver disease—Discontinue Tarina 24 Fe if jaundice occurs.
  • High blood pressure—If used in women with wellcontrolled hypertension, monitor blood pressure and stop Tarina 24 Fe if blood pressure rises significantly.
  • Carbohydrate and lipid metabolic effects—Monitor prediabetic and diabetic women taking Tarina 24 Fe. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache—Evaluate significant change in headaches and discontinue Tarina 24 Fe if indicated.
  • Bleeding irregularities and amenorrhea—Evaluate irregular bleeding or amenorrhea

ADVERSE REACTIONS

The most common adverse reactions reported (greater than or equal to 2%) include headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain


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


Reference:
Tarina® 24 Fe [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
read more
next
Tarina
Tarina Fe 1/20 EQ®
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg
Tarina Fe 1/20 EQ®
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg
close
Tarina Fe 1/20 EQ® is an AB-rated generic oral contraceptive

Compares to: Loestrin® Fe 1/20, Tarina® Fe 1/20, Gildess® Fe 1/20, Junel® Fe 1/20, Larin® Fe 1/20, and Microgestin® Fe 1/20

  • A progestogen-estrogen combination oral contraception
  • Single-phase continuous administration regimen
    • 21 light yellow to yellow tablets of norethindrone acetate and ethinyl estradiol tablets
    • 7 brown non–hormone-containing tablets of ferrous fumarate to help ease administration
  • 28-day tablet blister pack makes dosing easy and convenient

IMPORTANT SAFETY INFORMATION


Indication

Tarina Fe 1/20 EQ® is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.


WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Consult the Package Insert for Complete Prescribing Information


Contraindications

Do not prescribe Tarina Fe 1/20 EQ® to women who currently have the following conditions:

  • Thrombophlebitis or thromboembolic disorders
  • A past history of deep-vein thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease
  • Known or suspected carcinoma of the breast
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Hepatic adenoma or carcinoma
  • Cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
  • Known or suspected pregnancy
  • Hypersensitivity to any of the components of Tarina Fe 1/20 EQ®
  • Are receiving 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 Tarina Fe 1/20 EQ® if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries 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.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast - Women with current or past history of breast cancer should not use Tarina Fe 1/20 EQ®.
  • Liver Disease - Discontinue Tarina Fe 1/20 EQ® if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use.
  • Do not use in women receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
  • High Blood pressure - Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use Tarina Fe 1/20 EQ®.
  • Other warnings and precautions include gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.

ADVERSE REACTIONS

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


Patients should be counseled that Tarina Fe 1/20 EQ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference:
Tarina Fe 1/20 EQ® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched in January 2015
  • A progestogen-estrogen combination oral contraception
  • Single-phase continuous administration regimen
read more
next
Tri-VyLibra
Tri-VyLibra®
Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg
Tri-VyLibra®
Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg
close
Tri-VyLibra® is an AB-rated generic oral contraceptive

Compares to: Ortho Tri-Cyclen®, Tri-Estarylla®, Tri-Linyah™, Tri-Previfem®, and Tri-Sprintec®

  • A progestin-estrogen combination oral contraceptive
  • Triphasic continuous administration
    • 7 white tablets with 0.18 mg/0.035 mg norgestimate/ethinyl estradiol
    • 7 light blue tablets with 0.215 mg/0.035 mg norgestimate/ethinyl estradiol
    • 7 dark blue tablets with 0.25 mg/0.035 mg norgestimate/ethinyl estradiol
    • 7 green non–hormone-containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack

IMPORTANT SAFETY INFORMATION


INDICATION and USAGE OF TRI-VYLIBRA®

Tri-VyLibra is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Tri-VyLibra is also 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.


WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Do not prescribe Tri-VyLibra to women who are known to have 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 or 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
  • Pregnancy, because there is no reason to use COCs during pregnancy
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Are receiving 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 combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries 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.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast and cervix — Women with current or past history of breast cancer should not use COCs.
  • Liver Disease — Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use. Do not use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
  • 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 gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.

ADVERSE REACTIONS

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


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


Reference:
Tri-VyLibra® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched in March 2018
  • A progestin-estrogen combination oral contraceptive
  • Tri-phasic continuous administration
read more
next
Tri-VyLibra Lo
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
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
close
Tri-VyLibra® is an AB-rated generic oral contraceptive

Compares to: Ortho Tri-Cyclen® Lo, Tri-Lo-Estarylla™, Tri-Lo-Marzia™, Tri-Lo-Sprintec®, and Trinessa® Lo

  • A progestin-estrogen combination oral contraceptive
  • Tri-phasic continuous administration regimen
    • 7 white to off white tablets each containing 0.180 mg norgestimate and 0.025 mg ethinyl estradiol
    • 7 pale blue to bluish white tablets each containing 0.215 mg norgestimate and 0.025 mg ethinyl estradiol
    • 7 blue to light blue tablets each containing 0.250 mg norgestimate and 0.025 mg ethinyl estradiol
    • 7 green non-hormone containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack

IMPORTANT SAFETY INFORMATION


INDICATION and USAGE OF TRI-VYLIBRA® LO

Tri-VyLibra Lo is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.


WARNINGS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive 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 Tri-VyLibra Lo, should not be used by women who are over 35 years of age and smoke.

CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Do not prescribe Tri-VyLibra Lo to women who are known to have 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 or 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
  • Pregnancy, because there is no reason to use COCs during pregnancy
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Are receiving 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 combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries 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.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast and cervix — Women with current or past history of breast cancer should not use COCs.
  • Liver Disease — Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use. Do not use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
  • 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 gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.

ADVERSE REACTIONS

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


Patients should be counseled that Tri-VyLibra Lo does not protect against HIV infection (AIDS) and other sexually transmitted diseases.


Reference:
Tri-VyLibra® Lo prescribing information. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
read more
next
Tulana
Tulana™
Norethindrone Tablets, USP 0.35 mg
Tulana™
Norethindrone Tablets, USP 0.35 mg
close
Tulana™ is an AB1-rated generic oral contraceptive

Compares to: Nor-QD®, Camila®, Heather®, and Incassia™

  • A progestin-only oral contraceptive
  • Single-phase continuous administration regimen
    • 28 tablets of norethindrone
    • 7 brown non–hormone-containing tablets of ferrous fumarate to help ease administration
  • 28-day tablet blister pack makes dosing easy and convenient

Important Safety Information


Indication

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

WARNINGS

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 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 this product
  • Benign or malignant liver tumors
  • Acute liver disease


1. ECTOPIC PREGNANCY
Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.

2. 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. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.

3. IRREGULAR GENITAL BLEEDING
Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy, or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.

4. CARCINOMA OF THE BREAST AND REPRODUCTIVE ORGANS
Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives, and there is insufficient data to determine whether the use of POPs similarly increases the risk.

Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.

However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. HEPATIC NEOPLASIA
Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intraabdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

INFORMATION FOR THE PATIENT

Counseling Issues
The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:
  • The necessity of taking pills at the same time every day, including throughout all bleeding episodes.
  • The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.
  • The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.
  • The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea, or severe abdominal pain.
  • The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Tulana™ must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs.

Reference:
Tulana™ [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.

Please see full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched on June 13, 2013
  • A progestin only oral contraceptive
  • Single-phase continuous administration regimen
read more
next
VyLibra
VyLibra®
Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg
VyLibra®
Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg
close
VyLibra® is an AB-rated generic oral contraceptive

Compares to: Ortho-Cyclen®, Estarylla®, Mono-Linyah®, Previfem®, Sprintec®, and MonoNessa®

  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 21 dark blue tablets containing norgestimate and ethinyl estradiol
    • 7 green non–hormone-containing tablets to help ease administration
    • Combined in a 28-day tablet blister pack

IMPORTANT SAFETY INFORMATION


INDICATION AND USAGE OF VYLIBRA®

VyLibra is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.


WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

CONSULT THE PACKAGE INSERT FOR COMPLETE PRESCRIBING INFORMATION


CONTRAINDICATIONS

Do not prescribe VyLibra to women who are known to have the following conditions:

  • 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 or migraine headaches with aura
  • Women over age 35 with any migraine headaches
  • Have liver tumors, benign or malignant, or liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy, because there is no reason to use COCs during pregnancy
  • Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
  • Are receiving 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 combined oral contraceptives if an arterial or venous thrombotic event occurs, 4 weeks before and 2 weeks after major surgeries 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.). Combined oral contraceptives should be used with caution in women with cardiovascular risk factors.
  • Carcinoma of the breast and cervix — Women with current or past history of breast cancer should not use COCs.
  • Liver Disease — Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use. Do not use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  • 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 gall bladder disease, carbohydrate and lipid metabolic effects, headache, bleeding irregularities including amenorrhea, COC use before and during pregnancy, depression, and interference with laboratory tests.

ADVERSE REACTIONS

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


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


Reference:
VyLibra® [prescribing information]. Charleston, SC: Afaxys Pharma, LLC; October 2019.


Please see full Prescribing Information here.


To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.

previous
  • Launched on March 2018
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
read more
next

Click on product image for safety information and warnings, including Boxed Warnings

next

Drug Quality and Safety

Afaxys Pharma is focused on product safety by working with our manufacturing suppliers and assuring ongoing safety monitoring and evaluation of its products. Our suppliers have FDA-approved manufacturing plants.

We are committed to the safe and effective use of our products.