DailyMed Label: VyLibra

DailyMed Label: VyLibra

2023

DailyMed Prescription

VyLibra

norgestimate and ethinyl estradiol

Afaxys Pharma, LLC

NDC: 50102-235

NDC: 50102-235

NDC: 50102-235

NDC: 50102-235

VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active dark blue coated tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green placebo tablet containing only inert ingredients, as follows: Anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.

VyLibra is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1)

Take one tablet daily by mouth at the same time every day.  (2.2) Take tablets in the order directed on the blister pack.  (2.2) Do not skip or delay tablet intake.  (2.2)

VyLibra tablets are available in blister packs. Each blister pack contains 28 tablets in the following order: 21 dark blue, round, biconvex, coated tablet debossed with “S” on one side and “22” on other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 green round, mottled biconvex, uncoated tablets (non-hormonal placebo) debossed with “S” on one side and “24” on other side of the tablet contains inert ingredients

VyLibra is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see  Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see  Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Pregnancy, because there is no reason to use COCs during pregnancy [see  Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11 )]. Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3) ]

Thromboembolic Disorders and Other Vascular Problems : Stop VyLibra 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) Liver disease : Discontinue VyLibra if jaundice occurs.  (5.2) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop VyLibra if blood pressure rises significantly. ( 5.4 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking VyLibra. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.6 ) Headache : Evaluate significant change in headaches and discontinue VyLibra if indicated. ( 5.7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea. ( 5.8 )

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:

Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with VyLibra.

Nursing mothers: Not recommended; can decrease milk production.  (8.3)

VyLibra   ( norgestimate and ethinyl estradiol tablets USP 0.250 mg/0.035 mg) are available in a blister pack. Each blister pack (28 tablets) contains in the following order: 21 dark blue, round, biconvex, coated tablet debossed with “S” on one side and “22” on other side of the tablet contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol 7 green round, mottled, biconvex, uncoated tablets, debossed with “S” on one side and “24” on other side of the tablet contains inert ingredients The blister packs are available in the following packages: The Blister Packs are packaged in mono cartons Carton of 1 Blister Pack                                                         NDC 50102-235-11 Carton of 3 Blister Packs packaged in mono cartons             NDC 50102-235-13

•         Oral Contraception          COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

[See Warnings and Precautions (5.2 ,  5.11 ) and Use in Specific Populations (8.1) .]

In three U.S. clinical trials with VyLibra, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to 13% African-American, 6 to 14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.

VyLibra (Norgestimate and Ethinyl Estradiol Tablets USP 0.250 mg/0.035 mg) What is the most important information I should know about VyLibra ? Do not use VyLibra if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. What is VyLibra ?  VyLibra is a birth control pill (oral contraceptive) used by women to prevent pregnancy. How does  VyLibra work for contraception? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use VyLibra. The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Who should not take VyLibra? Do not take VyLibra if you: smoke and are over 35 years of age had blood clots in your arms, legs, lungs, or eyes had a problem with your blood that makes it clot more than normal have certain heart valve problems or irregular heart beat that increases your risk of having blood clots had a stroke had a heart attack have high blood pressure that cannot be controlled by medicine have diabetes with kidney, eye, nerve, or blood vessel damage have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age have liver problems, including liver tumors take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.  have any unexplained vaginal bleeding are pregnant had breast cancer or any cancer that is sensitive to female hormones If any of these conditions happen while you are taking VyLibra, stop taking VyLibra right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking VyLibra. What should I tell my healthcare provider before taking VyLibra ? Tell your healthcare provider if you: are pregnant or think you may be pregnant are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed. VyLibra may decrease the amount of breast milk you make. A small amount of the hormones in VyLibra may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. VyLibra may affect the way other medicines work, and other medicines may affect how well VyLibra works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take VyLibra ? Read the Instructions for Use at the end of this Patient Information . What are the possible serious side effects of VyLibra? Like pregnancy,  VyLibra may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: first start taking birth control pills restart the same or different birth control pills after not using them for a month or more Call your healthcare provider or go to a hospital emergency room right away if you have: leg pain that will not go away sudden severe shortness of breath sudden change in vision or blindness chest pain a sudden, severe headache unlike your usual headaches weakness or numbness in your arm or leg trouble speaking Other serious side effects include: liver problems, including: rare liver tumors jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes. high blood pressure. You should see your healthcare provider for a yearly check of your blood pressure. gallbladder problems changes in the sugar and fat (cholesterol and triglycerides) levels in your blood new or worsening headaches including migraine headaches irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking VyLibra. depression possible cancer in your breast and cervix swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema. dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking VyLibra. Use sunscreen if you have to be in the sunlight. What are the most common side effects of VyLibra? headache (migraine) breast pain or tenderness, enlargement or discharge stomach pain, discomfort, and gas vaginal infections and discharge mood changes, including depression nervousness changes in weight skin rash These are not all the possible side effects of VyLibra. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088 . What else should I know about taking VyLibra? If you are scheduled for any lab tests, tell your healthcare provider you are taking VyLibra. Certain blood tests may be affected by VyLibra. VyLibra does not protect against HIV infection (AIDS) and other sexually transmitted infections. How should I store VyLibra? Store VyLibra at room temperature between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep VyLibra and all medicines out of the reach of children. Store away from light. General information about the safe and effective use of VyLibra . Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VyLibra for a condition for which it was not prescribed. Do not give VyLibra to other people, even if they have the same symptoms that you have. This Patient Information summarizes the most important information about VyLibra. You can ask your pharmacist or healthcare provider for information about VyLibra that is written for health professionals . For more information, call Afaxys Pharma, LLC at 1-855-888-2467 Does hormonal birth control cause cancer? It is not known if hormonal birth control pills causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.  If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. What if I want to become pregnant? You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. What should I know about my period when taking VyLibra ? Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking VyLibra, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy. What are the ingredients in VyLibra ? Active ingredients: Each dark blue pill contains norgestimate and ethinyl estradiol. Inactive ingredients: Dark blue pills: croscarmellose sodium, FD&C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Green pills: Anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.

NDC 50102-235-11 afaxys ® pharma VyLibra ® Norgestimate and Ethinyl Estradiol Tablets, USP 0.250 mg/0.035 mg Each dark blue coated tablet contains norgestimate USP 0.250 mg and ethinyl estradiol USP 0.035 mg. Each green tablet contains inert ingredients. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 1 Blister Card of 28 tablets each                                    Rx only