Afaxys Pharma Logo

Afaxys' Pharma Division provides reliable, affordable access to healthcare products for the public health care sector.

HEALTH CARE
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 Purchasing Organization 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 wide spectrum of oral and emergency contraceptives.

previous
E Contra
EContra® EZ
(Levonorgestrel) Tablet, 1.5 mg
EContra® EZ
(Levonorgestrel) Tablet, 1.5 mg
close
EContra® EZ is an AB-Rated emergency contraceptive

Reference Drug: Plan B One-Step®
Compares to: Take Action®, Next Choice One Dose®, My Way®, AfterPill®, Fallback Solo®, Opcicon® One-Step and Aftera™

  • Launched March 2015
  • Effective up to three days after unprotected sex or contraceptive failure

visit econtraez.com

Product Information

USAGE: EContra® EZ (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 EZ is not intended to be used in place of routine birth control.

WHO SHOULD NOT USE ECONTRA EZ: Women who are known to be pregnant as it will not work. However, EContra EZ will not harm an existing pregnancy. Women known to be allergic to levonorgestrel.

SIDE EFFECTS MAY INCLUDE:
  • Menstrual changes. After EContra EZ women may experience heavier or lighter bleeding. If the next period is more than a week late, consider pregnancy.
  • Abdominal pain. Ectopic pregnancy should be considered in cases of severe abdominal pain.
  • Nausea or vomiting. If women vomit within 2 hours of taking the medication, consider recommending a second dose.
  • Tiredness
  • Headaches
  • Dizziness
  • Breast Pain

Reference: EContra® EZ product information. Charleston, SC: Afaxys Inc. February 2017.

Please see full product information here.
previous
  • Launched March 2015
  • Effective up to three days after unprotected sex or contraceptive failure
read more
next
ella
ella®
ulipristal acetate tablet 30 mg
ella®
ulipristal acetate tablet 30 mg
close
ella®

Next-Generation Prescription Strength Emergency Contraceptive

  • The only 30 mg ulipristal acetate tablet currently available
  • The only emergency contraceptive product that is FDA approved for use up to 5 days after unprotected sex or a known contraceptive failure1,2
  • Safety and tolerability established in more than 1.4 million women worldwide3
  • Convenient, single-tablet dosing
  • Affordable product, reliable supply
  • Not an abortifacient

References:
  1. Glasier A, Cameron S, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta analysis. The Lancet. 2010; 375: 555–562.
  2. Moreau C, Trussel J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012; 86: 673–680.
  3. Levy D, Jager M, et al. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women. Contraception. 2014; 89: 431–433.

INDICATION


ella® is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.


Important Safety Information


The most common side effects of ella (ulipristal acetate) tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. ella is not recommended for use in breastfeeding women. A rapid return of fertility is likely following treatment with ella, therefore, a reliable barrier method of contraception should be used with subsequent acts of intercourse in that same menstrual cycle. Because ella and the progestin component of hormonal contraceptives both bind to the progesterone receptor, using them together could reduce their contraceptive effectiveness. After using ella, if a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake of ella. Repeated use of ella within the same menstrual cycle is not recommended. Drugs or herbal products that induce CYP3A4 decrease the effectiveness of ella. ella does not protect against STI/HIV.


Reference: ella® prescribing information. Charleston, SC: Afaxys, Inc. September 2017.


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.


References:


  1. Glasier A, Cameron S, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta analysis. The Lancet. 2010; 375: 555–562.
  2. Moreau C, Trussel J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012; 86: 673–680.
  3. Levy D, Jager M, et al. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women. Contraception. 2014; 89: 431–433.
previous
  • The only 30 mg ulipristal acetate tablet currently available
  • The only emergency contraceptive product that is FDA approved for use up to 5 days after unprotected sex or a known contraceptive failure1,2
read more
next
Aubra
Aubra®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg
Aubra®
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg
close
Aubra® is an AB-Rated generic oral contraceptive

Reference Drug: Lutera®
Compares to: Aviane®, Orsythia®, Sronyx® and Falmina®

  • Launched on October 9, 2013
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 21 white to off-white tablets of levonorgestrel and ethinyl estradiol
    • brown non-hormone containing tablets to help ease administration
  • 28-day tablet blister pack makes dosing easy and convenient

IMPORTANT SAFETY INFORMATION


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 AND USAGE


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


SELECTED SAFETY INFORMATION


WARNINGS


Cigarette smoking increases the risk of serious cardiovascular side effects from combination 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.


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
  • rombogenic 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.


Risk information described in the full Prescribing Information includes:


  1. Thromboembolic Disorders and Other Vascular Problems
  2. Estimates of Mortality from Contraceptive Use
  3. Carcinoma of the Reproductive Organs and Breasts
  4. Hepatic Neoplasia
  5. Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  6. Ocular Lesions
  7. Oral Contraceptive Use Before or During Early Pregnancy
  8. Gallbladder Disease
  9. Carbohydrate and Lipid Metabolic Effects
  10. Elevated Blood Pressure
  11. Headache
  12. Bleeding Irregularities
  13. Ectopic Pregnancy

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.


DOSAGE AND ADMINISTRATION


To achieve maximum contraceptive effectiveness, Aubra (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours.


Reference: Aubra® prescribing information, Charleston SC USA August 2017


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.


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.

Risk information described in the full Prescribing Information includes:

  1. Thromboembolic Disorders and Other Vascular Problems
  2. Estimates of Mortality from Contraceptive Use
  3. Carcinoma of the Reproductive Organs and Breasts
  4. Hepatic Neoplasia
  5. Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  6. Ocular Lesions
  7. Oral Contraceptive Use Before or During Early Pregnancy
  8. Gallbladder Disease
  9. Carbohydrate and Lipid Metabolic Effects
  10. Elevated Blood Pressure
  11. Headache
  12. Bleeding Irregularities
  13. Ectopic Pregnancy

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.

DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Aubra (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours.

Reference: Aubra® prescribing information, Charleston SC USA August 2017

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

Reference Drug: Levora®
Compares to: Portia®, Altavera®, Marlissa ® and Kurvelo®

  • Launched on December 21, 2012
  • A progestin-estrogen combination oral contraceptive
  • Single-phase continuous administration regimen
    • 1 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 and Usage of Chateal®


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


INDICATIONS AND USAGE


INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.


CONTRAINDICATIONS


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


  • Thrombophlebitis or thromboembolic disorders.
  • A past history of deep-vein thrombophlebitis or thromboembolic disorders.
  • Cerebral-vascular or coronary artery disease.
  • Thrombogenic valvulopathies.
  • Thrombogenic rhythm disorders.
  • Uncontrolled hypertension.
  • Diabetes with vascular involvement.
  • Known or suspected carcinoma of the breast.
  • 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, as long as liver function has not returned to normal.
  • Known or suspected pregnancy.
  • Hypersensitivity to any component of CHATEAL (levonorgestrel and ethinyl estradiol tablets, USP).
  • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevat

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.


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.


Risk information described in the full Prescribing Information includes:


  1. Thromboembolic Disorders and Other Vascular Problems
  2. Estimates of Mortality from Contraceptive Use
  3. Carcinoma of the Reproductive Organs and Breasts
  4. Hepatic Neoplasia
  5. Use in women receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations
  6. Ocular Lesions
  7. Oral Contraceptive Use Before or During Early Pregnancy
  8. Gallbladder Disease
  9. Carbohydrate and Lipid Metabolic Effects
  10. Elevated Blood Pressure
  11. Headache
  12. Bleeding Irregularities

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.


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


DOSAGE AND ADMINISTRATION


To achieve maximum contraceptive effectiveness, CHATEAL must be taken exactly as directed and at intervals not more than 24 hours apart.

Reference: Chateal® prescribing information, Charleston SC USA, August 2017

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®
Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg
Cyred®
Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg
close
Cyred® is an AB-Rated generic oral contraceptive

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

  • Launched in September 2015
  • A progestogen-estrogen combination oral contraception
  • Bi-phasic 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 one
    • 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 seven days to achieve full efficacy

Important Safety Information


Indication and Usage of Cyred®


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


SELECTED SAFETY INFORMATION about Cyred


WARNINGS: CIGARETTE SMOKING AND SERIOUS CARDIOVASCLAR EVENTS


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 Cyred, should not be used by women over 35 years of age and smoke.


BRIEF SUMMARY: Consult the Package Insert for Complete Prescribing Information


CONTRAINDICATIONS


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 carcinoma
  • 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. with cardiovascular risk factors.
  • Liver Disease - Discontinue COCs if jaundice develops. Hepatic adenomas and very rare hepatocellular carcinoma (> 8 years use) are associated with COC use. with cardiovascular risk factors. 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 with cardiovascular risk factors.
  • High Blood pressure - Women with well-controlled hypertension should be monitored closely. Women with uncontrolled hypertension should not use COCs. with cardiovascular risk factors.
  • 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. with cardiovascular risk factors.

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 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.


Reference: Cyred® prescribing information. Afaxys Inc., Charleston, SC, USA, June 2017


Please see full prescribing information here.


To report a Suspected Adverse Reaction to Cyred, please contact the Afaxys Health and Safety team at 1-855-888-2467.

previous
  • Launched in September 2015
  • A progestogen-estrogen combination oral contraception
  • Bi-phasic continuous administration regimen
read more
next
Lyza
Lyza®
Norethindrone Tablets, USP 0.35 mg
Lyza®
Norethindrone Tablets, USP 0.35 mg
close
Lyza® is an AB-Rated generic oral contraceptive

Reference Drug: Nor-QD®, Nora-BE®, Errin ®, Heather ®, Jolivette®, Camila®, Jencycla ® and norethindrone

  • Launched on June 13, 2013
  • A progestin only oral contraceptive
  • Single-phase continuous administration regimen
    • 28 yellow 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

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

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

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

WARNINGS
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.

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, Lyza 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: Lyza® prescribing information. Charleston, SC: Afaxys Inc. March 2017.

Please see full prescribing information here.
previous
  • Launched on June 13, 2013
  • A progestin only oral contraceptive
  • Single-phase continuous administration regimen
read more
next
Tarina
Tarina® Fe 1/20
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg
Tarina® Fe 1/20
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets,
1 mg/20 mcg/75 mg
close
Tarina® Fe 1/20 is an AB-Rated generic oral contraceptive

Reference Drug: Loestrin® Fe 1/20 Tablets
Compares to: Gildess® Fe 1/20, Junel® Fe 1/20, Larin® Fe 1/20 and Microgestin® Fe 1/20

  • Launched in January 2015
  • A progestogen-estrogen combination oral contraception
  • Single-phase continuous administration regimen
    • 21 white to off-white 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 and Usage of Tarina® Fe 1/20


IMPORTANT SAFETY INFORMATION about Tarina® Fe 1/20 (Norethindrone Acetate and ethinyl estradiol tablets USP and Ferrous Fumarate Tablets, (1.0/0.02 mg and75 mg), including Black Box Warning


Indication and Usage of Tarina Fe 1/20


Tarina Fe 1/20 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.


Selected Safety Information


WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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


BRIEF SUMMARY: Consult the Package Insert for Complete Prescribing Information Contraindications


Contraindications


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


  • Thrombophlebitis or thromboembolic disorders,
  • A past history of deep vein thrombophlebitis or thromboembolic disorders,
  • Cerebral vascular 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
  • 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 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.
  • Liver Disease- Discontinue Tarina Fe 1/20 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 /120.
  • 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 does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference: Tarina® Fe 1/20 prescribing information. Afaxys Inc., Charleston, SC, USA, November 2017


To report a Suspected Adverse Reaction to Tarina Fe 1/20, please contact the Afaxys Health and Safety team at 1-855-888-2467.


Please see full prescribing information here.

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

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

  • Launched on March 2018
  • 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.


WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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 VyLibra, should not be used by women who are over 35 years of age and smoke.


BRIEF SUMMARY: 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, Inc. November 2017.


To report a Suspected Adverse Reaction to VyLibra™, please contact the Afaxys Health and Safety team at 1-855-888-2467.


Please see full prescribing information here.

previous
  • Launched on March 2018
  • A progestin-estrogen combination oral contraceptive
  • 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

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

  • Launched on March 2018
  • A progestin-estrogen combination oral contraceptive
  • Tri-phasic 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 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.


WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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, should not be used by women who are over 35 years of age and smoke.


BRIEF SUMMARY: 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, Inc. November 2017.


To report a Suspected Adverse Reaction to TriVylibra™, please contact the Afaxys Health and Safety team at 1-855-888-2467.


Please see full prescribing information here.

previous
  • Launched on March 2018
  • A progestin-estrogen combination oral contraceptive
  • Tri-phasic continuous administration
read more
next

Click on product image for safety information and warnings, including Black Box warning.

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.