Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Vienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) is available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side. NDC 70700-118-84, Carton containing 1 blister card. NDC 70700-118-85, Carton containing 3 blister cards. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature ]. The brands listed are the registered trademarks of their respective owners and are not trademarks of Xiromed, LLC. VIENVA ® is a registered trademark of Xiromed Pharma España, S.L. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain; PRINCIPAL DISPLAY PANEL NDC 70700-118-85 Vienva (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only
- HOW SUPPLIED Vienva (levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg) is available as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are white, round, debossed with SZ on one side and L2 on the other side. The 7 inert tablets are peach, round, debossed with SZ on one side and J1 on the other side. NDC 70700-118-84, Carton containing 1 blister card. NDC 70700-118-85, Carton containing 3 blister cards. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature ]. The brands listed are the registered trademarks of their respective owners and are not trademarks of Xiromed, LLC. VIENVA ® is a registered trademark of Xiromed Pharma España, S.L. Manufactured by Laboratorios Leon Farma S.A., Spain for Xiromed, LLC., Florham Park, NJ 07932 Product of Spain
- PRINCIPAL DISPLAY PANEL NDC 70700-118-85 Vienva (levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg Rx only
Overview
Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present in the active tablet are: corn starch, crospovidone, lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch. The inactive ingredients present in the inert tablet are: corn starch, crospovidone, FD&C Red # 40 lake, D&C Yellow #10 lake, lactose anhydrous, magnesium stearate, povidone. Structure
Indications & Usage
Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use : The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. The mean BMI of the study population was 24 kg/m 2 . Females with a BMI greater than 30 kg/m 2 accounted for 12.1% (n=179) of the study population. Females with a BMI over 35 kg/m 2 accounted for 4.3% (n=63) of the study population.
Dosage & Administration
To achieve maximum contraceptive effectiveness, Vienva (levonorgestrel and ethinyl estradiol tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Vienva (levonorgestrel and ethinyl estradiol tablet, USP) is one white tablet daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Vienva (levonorgestrel and ethinyl estradiol tablet, USP) be taken at the same time each day. During The First Cycle Of Use The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking Vienva (levonorgestrel and ethinyl estradiol tablet, USP) on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start). Sunday start The patient is instructed to begin taking Vienva (levonorgestrel and ethinyl estradiol tablet, USP) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Vienva (levonorgestrel and ethinyl estradiol tablet, USP) until a white tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days. Day 1 start During the first cycle of medication, the patient is instructed to begin taking Vienva (levonorgestrel and ethinyl estradiol tablet, USP) during the first 24 hours of her period (day one of her menstrual cycle). One white tablet should be taken daily for 21 consecutive days, followed by one peach inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If Vienva (levonorgestrel and ethinyl estradiol tablet, USP) tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Vienva (levonorgestrel and ethinyl estradiol tablet, USP) tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days. After the first cycle of use The patient begins her next and all subsequent courses of tablets on the day after taking her last peach tablet. She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on peach tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days. Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Vienva (levonorgestrel and ethinyl estradiol tablet, USP). She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Vienva (levonorgestrel and ethinyl estradiol tablet, USP) on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Vienva (levonorgestrel and ethinyl estradiol tablet, USP) the next day. If switching from an implant or injection, the patient should start Vienva (levonorgestrel and ethinyl estradiol tablet, USP) on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, implant, or intrauterine system (IUS), the patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days of the first pack. If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Risk of pregnancy if tablets are missed While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed. Although the occurrence of pregnancy is unlikely if Vienva (levonorgestrel and ethinyl estradiol tablet, USP) is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. The risk of pregnancy increases with each active (white) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below. Use after pregnancy, abortion or miscarriage Vienva (levonorgestrel and ethinyl estradiol tablet, USP) may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days. Vienva (levonorgestrel and ethinyl estradiol tablet, USP) may be initiated immediately after a first trimester abortion or miscarriage. Instruct the patient to use additional nonhormonal contraception (such as condoms) until active tablets have been taken for 7 consecutive days, unless starting Vienva on the day of surgical abortion.
Warnings & Precautions
WARNINGS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined 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, including levonorgestrel and ethinyl estradiol, are contraindicated in women who are over 35 years of age and 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 (see CONTRAINDICATIONS ). Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral-contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods. 1. Thromboembolic Disorders and Other Vascular Problems Cardiovascular and Cerebrovascular Events Use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk of these events with CHC use is greater in females with concomitant risk factors: age 35 years and older, smoking, hypertension, dyslipidemia, diabetes, or obesity. The risk increases with increasing age and with increasing number of cigarettes smoked. Venous Thromboembolism Use of CHCs also increases the risk of VTE, such as deep vein thrombosis and pulmonary embolism. The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years. The VTE risk should be considered in the context of relevant subpopulations of females of reproductive potential who are not taking CHCs (see ADVERSE REACTIONS ). Risk factors for VTE with CHC use include smoking, obesity, family history of VTE, and prolonged immobilization, in addition to other factors that contraindicate use of CHCs (see CONTRAINDICATIONS ). The presence of multiple risk factors for VTE with CHC use may further increase the risk. The risk of VTE is highest during the first year of CHC use and when restarting hormonal contraception after a break of four weeks or longer. The risk of VTE returns to baseline approximately 3 months after CHC use is discontinued. Postpartum Venous Thromboembolism The risk of VTE is increased during the first six weeks postpartum. The risk is highest up to four weeks postpartum but remains higher than baseline until at least six weeks postpartum. The presence of multiple risk factors for VTE may further increase the risk. Obstetric complications may extend the elevated risk up to 12 weeks postpartum. 2. Malignant Neoplasms Breast Cancer Levonorgestrel and ethinyl estradiol is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive (see CONTRAINDICATIONS ). Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use (see ADVERSE REACTIONS ). Cervical Cancer Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia or invasive cervical cancer 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. 3. Hepatic Neoplasia Benign hepatic adenomas are associated with oral-contraceptive use, although the incidence of these benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use. Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral-contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral-contraceptive users approaches less than one per million users. 4. Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue levonorgestrel and ethinyl estradiol prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see CONTRAINDICATIONS ). Levonorgestrel and ethinyl estradiol can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen. 5. Ocular Lesions There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives that may lead to partial or complete loss of vision. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately. 6. Oral-Contraceptive Use Before or During Early Pregnancy Extensive epidemiological studies have revealed no increased risk of birth defects in infants born to women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy (see CONTRAINDICATIONS ). It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral-contraceptive use should be discontinued if pregnancy is confirmed. 7. Gallbladder Disease Combination oral contraceptives may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women. Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral-contraceptive users may be minimal. The recent findings of minimal risk may be related to the use of oral-contraceptive formulations containing lower hormonal doses of estrogens and progestogens. 8. Carbohydrate and Lipid Metabolic Effects Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Carefully monitor females with prediabetes and diabetes who are using levonorgestrel and ethinyl estradiol. Levonorgestrel and ethinyl estradiol may decrease glucose tolerance. A small proportion of women will have persistent hypertriglyceridemia while on COCs. As discussed earlier (see WARNINGS and PRECAUTIONS ), changes in serum triglycerides and lipoprotein levels have been reported in oral-contraceptive users. 9. Elevated Blood Pressure Levonorgestrel and ethinyl estradiol is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease (see CONTRAINDICATIONS ). For all females, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop levonorgestrel and ethinyl estradiol if blood pressure rises significantly. An increase in blood pressure has been reported in females using CHCs, and this increase is more likely in older women with extended duration of use. The effect of CHCs on blood pressure may vary according to the progestin in the CHC. 10. Headache Levonorgestrel and ethinyl estradiol is contraindicated in females who have headaches with focal neurological symptoms or have migraine headaches with aura, and in women over age 35 years who have migraine head aches with or without aura. The onset or exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause. Consider discontinuation of levonorgestrel and ethinyl estradiol if there is an increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event; see WARNINGS and CONTRAINDICATIONS .) 11. Bleeding Irregularities Unscheduled bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. The type and dose of progestogen may be important. If bleeding persists or recurs, nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea (possibly with anovulation), especially when such a condition was preexistent. In the clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, unscheduled bleeding was defined as bleeding or spotting that occurred: During cycle 1 on pill-pack Days 4 to 21, inclusive of a 28-day cycle. In subsequent cycles, on Days 5 to 21 inclusive or on pill-pack Days 1 to 4 inclusive if preceded by 2 consecutive days without bleeding or spotting. Based on subject diaries, the proportion of subjects reporting unscheduled bleeding or spotting per 28-day cycle decreased over time: 30.5% at Cycle 1 versus 18.2% at Cycle 12. 12. Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 13. Chloasma Chloasma may occur, especially in women with a history of chloasma gravidarum. Advise women with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while taking levonorgestrel and ethinyl estradiol . 14. Effect on Binding Globulins The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. Monitor thyroid-stimulating hormone (TSH) levels for females receiving levonorgestrel and ethinyl estradiol and thyroid hormone replacement therapy concomitantly. Follow the recommendation for the thyroid hormone in accordance with its 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 Prolonged immobilization (especially with major surgery) Diabetes with vascular involvement Headaches with focal neurological symptoms or migrane with aura Women with migrane who are 35 years or older Uncontrolled hypertension Known or suspected carcinoma of the breast or personal history of breast cancer Known or suspected estrogen- or progesterone sensitive malignancy Undiagnosed abnormal vaginal bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas, or active liver disease Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see WARNINGS , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
Adverse Reactions
An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine. Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 2: Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis. Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site conditions: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Pyschiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.