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Afaxys Pharma provides reliable, affordable access to healthcare products for the public healthcare sector.
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.
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Our core product line offers reliable, consistent, and affordable access to quality women's healthcare options to public health professionals and their patients.
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Afaxys Group Services connects its members to suppliers who provide mission-critical products and services.
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 MoreAfaxys Pharma offers a wide spectrum of oral and emergency contraceptives.
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.
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.; June 2018.
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.
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.
Combination oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
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.
Combination oral contraceptives should not be used in women with any of the following conditions:
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:
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.
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: Afaxys, Inc.; 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.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
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.
Combination oral contraceptives should not be used in women with any of the following conditions:
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.
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:
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.
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: Afaxys, Inc.; 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.
Cyred is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception
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 who smoke.
Do not prescribe combined oral contraceptives (COCs) to women who currently have the following conditions:
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]. Charleston, SC: Afaxys, Inc.; December 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.
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
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.
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.
Do not prescribe Tarina Fe 1/20 to women who currently have the following conditions:
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]. Charleston, SC: Afaxys, Inc.; 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.
VyLibra is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.
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.
Do not prescribe VyLibra to women who are known to have the following conditions:
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.
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.
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.
Do not prescribe Tri-VyLibra to women who are known to have the following conditions:
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.
Click on product image for safety information and warnings, including Black Box warning.
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.
