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

Please see full Prescribing Information here.

Tri-VyLibra
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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
Product Gallery
NDC # package size order numbers
50102-233-13 Carton Containing 3 Packages
NDC # 50102-233-13
package size Carton Containing 3 Packages
order numbers

ORDER Tri-VyLibra ®

AmerisourceBergen

1-610-727-7000
www.amerisourcebergen.com
10185559

ANDA

1-800-331-2632 (Ext. 74591)
www.andanet.com
328026

Cardinal

1-800-326-6457
www.cardinal.com
5423181

R&S Northeast

1-800-262-7770
www.rsnortheast.com
023313

Seacoast Medical LLC

1-877-410-0811
www.seacoastmedical.com/afaxys
112407

Smith Medical Partners LLC

1-800-292-9653
340B 1-877-445-7970
www.smpspecialty.com
570-7294

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.

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, 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.


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; November 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.