Rosyrah
levonorgestrel and ethinyl estradiol and ethinyl estradiol · Kit · Oral
Uses
Rosyrah is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Rosyrah is indicated for use by females of reproductive age to prevent pregnancy.
Dosage and administration
Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack. ( 2 ) 2.1 How to Start and Take Rosyrah Begin Rosyrah on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first white to off-white tablet that day. For each 91-day course, take in the following order: Start the first white to off-white tablet on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Then take one white to off-white tablet once daily for a total of 42 consecutive days. Use a non-hormonal back-up method of contraception (such as condoms and spermicide) for the first 7 days of treatment. One light peach tablet once daily for 21 consecutive days. One bluish green tablet once daily for 21 days. One yellow tablet once daily for 7 days. Bleeding should occur during yellow tablet use. Begin the next and all subsequent 91-day courses of Rosyrah without interruption on the same day of the week (Sunday) on which the first dose of Rosyrah was taken. Follow the same schedule as the initial 91-day course: white to off-white tablet once daily for 42 days, light peach tablet once daily for 21 days, bluish green tablet once daily for 21 days, and yellow tablet once daily for 7 days. If the next pill pack is not started immediately, use a non-hormonal back-up method of contraception until a white to off-white tablet has been taken once daily for 7 consecutive days. Switching to Rosyrah from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant) Start on the Sunday after the patient’s next period starts. Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken 7 white to off-white pills (7 days). Starting Rosyrah after Abortion or Miscarriage First-trimester Rosyrah may be started on the Sunday after an abortion or miscarriage. The patient must use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Rosyrah following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days [see Contraindications (4 ) and Warnings and Precautions ( 5.1 )]. Starting Rosyrah after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Rosyrah following the instructions for women not currently using hormonal contraception. Use additional non-hormonal contraception (such as condoms and spermicide) until the patient has taken a white to off-white tablet for 7 days [see Contraindications (4 ) and Warnings and Precautions (5.1 )]. Rosyrah is not recommended for use in lactating women [see Use in Specific Populations ( 8.2 )] . If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Rosyrah [see Warnings and Precautions (5.1 ), Use in Specific Populations ( 8.1 )]. 2.2 Dosing Rosyrah Take one tablet by mouth at the same time every day. The dosage of Rosyrah is one white to off-white tablet once daily for 42 days, one light peach tablet once daily for 21 days, one bluish green tablet once daily for 21 days, and one yellow tablet once daily for 7 days. To achieve maximum contraceptive effectiveness, take Rosyrah exactly as directed, in the order directed, and at intervals not exceeding 24 hours. The failure rate may increase when pills are missed or taken incorrectly. 2.3 Missed Doses Table 1. Instructions for Missed Rosyrah Tablets If one white to off-white, light peach, or bluish green tablet is missed Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex. If two white to off-white, light peach, or bluish green tablets in a row are missed Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking one tablet a day until the pack is finished. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If three or more white to off-white, light peach, or bluish green tablets in a row are missed Throw away the missed tablets. Continue taking one tablet every day as indicated on the pack until the pack is finished. Bleeding may occur during the week following the missed tablets. Use additional nonhormonal contraception (such as condoms and spermicide) until tablets have been taken for 7 days after missing tablets. If any of the seven yellow tablets are missed Throw away the missed tablets. Continue taking the remaining tablets until the pack is finished. A backup birth control method is not needed. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a white to off-white, light peach or bluish green tablet, handle this as a missed tablet [see Dosage and Administration ( 2.3 )]. 2.3 Missed Doses Table 1. Instructions for Missed Rosyrah Tablets If one white to off-white, light peach, or bluish green tablet is missed Take the missed tablet as soon as possible. Take the next tablet at the regular time. Continue taking one tablet a day until the pack is finished. A back-up birth control method is not required if the patient has sex.
Dosage forms and strengths
Rosyrah consists of 91 tablets in the following order ( 3 ): 42 white to off-white tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 light peach tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, and 21 bluish green tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. Rosyrah is available as round, biconvex tablets, packaged in Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of tablets in the following order: 42 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol: debossed with 72 on one side of the tablet and plain on the other side 21 light peach tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol: debossed with 73 on one side of the tablet and plain on the other side 21 bluish green tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 74 on one side of the tablet and plain on the other side and 7 yellow tablets containing 0.01 mg of ethinyl estradiol: debossed with 65 on one side of the tablet and plain on the other side
Contraindications
4 CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 ) Rosyrah 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 females who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )]. o Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )]. o Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )]. o Have coronary artery disease [see Warnings and Precautions ( 5.1 )]. o 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 )]. o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )]. o Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions ( 5.5 )]. o Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions ( 5.7 )]. o Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions ( 5.8 )]. Current diagnosis of, or history of, breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11 )]. Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.6 )]. Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ( 5.9 )]. 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 ( 5.4 )].
Warnings and precautions
Vascular risks: Stop if a thrombotic or thromboembolic 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. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in females with well-controlled hypertension, monitor blood pressure and stop use if blood pressure rises significantly. ( 5.3 ) Gallbladder disease: May cause or worsen gallbladder disease. ( 5.6 ) Carbohydrate and lipid metabolic effects: Monitor glucose in prediabetic and diabetic women taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias. ( 5.7 ) Headache: Evaluate significant change in headaches and discontinue if indicated. ( 5.8 ) Uterine bleeding: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist. ( 5.9 ) 5.1 Thromboembolic Disorders and Other Vascular Conditions Stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if an arterial or deep venous thromboembolic event occurs. Stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. Discontinue levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets no earlier than 4 weeks after delivery, in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Before starting levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with a high risk of arterial or venous/thromboembolic diseases [see Contraindications ( 4 )]. Arterial Events COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 years of age who smoke [see Contraindications ( 4 )] . Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Venous Events Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ( 4 )] . While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued. Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE. * Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY. Use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year). In the clinical trial, three cases of deep vein thrombosis were reported. Figure 1: Likelihood of Developing a VTE 5.2 Liver Disease Elevated Liver Enzymes Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications ( 4 )]. Acute liver test abnormalities may necessitate the discontinuation of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets until liver tests return to normal and levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets causation has been excluded. Discontinue levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if jaundice develops.
Side effects
The most common adverse reactions (≥ 2%) in clinical trials for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 844-XIROMED (1-844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below are from a 12-month, US, open-label study, which enrolled women aged 18-40, of whom 3,597 took at least one dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets (2,661 woman-years of exposure) [see Clinical Studies ( 14 )] . Adverse Reactions Leading to Study Discontinuation : 13.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥1% of women) leading to discontinuation were heavy/irregular bleeding (5.0%), mood swings/alteration/affect lability (1.4%), headaches/migraines (1.3%), weight increased (1.3%) and acne (1.0%). Common Adverse Reactions (≥2% of women) : headaches (12.2%), heavy/irregular vaginal bleeding (9.7%), nausea/vomiting (8.8%), acne (5.4%), dysmenorrhea (5.4%), weight increased (4.6%), mood changes (depression, depressed mood, crying, major depression, affective disorder, depression suicidal, dysthymic disorder) (2.9%), anxiety/panic attack (2.4%), breast tenderness/pain/discomfort (2.2%), migraine (2.0%). Serious Adverse Reactions (≥2 women): abortion spontaneous, suicide attempt, cholecystitis/ cholelithiasis, deep vein thrombosis, ectopic pregnancy. 6.2 Postmarketing Experience 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 3). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). 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 3: Relevant Studies of 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 have been identified during post-approval use of extended-cycle COCs containing levonorgestrel and ethinyl estradiol. Because these reactions are 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. Gastrointestinal disorders: abdominal distension, vomiting General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain Immune system disorders: hypersensitivity reaction Investigations: blood pressure increased Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity Nervous system disorders: dizziness, loss of consciousness Psychiatric disorders: insomnia Reproductive and breast disorders: dysmenorrhea Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis Skin and subcutaneous tissue disorders: alopecia Vascular disorders: thrombosis Figure 3: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives
Drug interactions
Enzyme inducers (e.g., CYP3A4): May decrease the effectiveness of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. ( 7.1 ) The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 3 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Table 3: Significant Drug Interactions Involving Substances That Affect COCs Metabolic Enzyme Inducers Clinical effect Concomitant use of COCs with metabolic enzyme inducers may decrease the plasma concentrations of the estrogen and/or progestin component of COCs. Decreased exposure of the estrogen and/or progestin component of COCs may potentially diminish the effectiveness of COCs and may lead to contraceptive failure or an increase in breakthrough bleeding. Prevention or management Counsel females to use an alternative method of contraception or a backup method when enzyme inducers are used with COCs. Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort a , and certain protease inhibitors (see separate section on protease inhibitors below). Colesevelam Clinical effect Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. Decreased exposure of the estrogen component of COCs may potentially reduce contraceptive efficacy or result in an increase in breakthrough bleeding, depending on the strength of ethinyl estradiol in the COC. Prevention or management Administer 4 or more hours apart to attenuate this drug interaction. a Induction potency of St. John’s wort may vary widely based on preparation. Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and COCs containing ethinyl estradiol increase systemic exposure of ethinyl estradiol by approximately 20 to 25 percent. Ascorbic acid and acetaminophen may increase systemic exposure of ethinyl estradiol, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of COCs. Human immunodeficiency virus (HIV)/hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine). In contrast, significant increases in systemic exposure of the estrogen and/or progestin have been noted when COCs are co-administered with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine). 7.2 Effects of Combined Oral Contraceptives on Other Drugs Table 4 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. Table 4: Significant Drug Interaction Information for Drugs Co-Administered With COCs Lamotrigine Clinical effect Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation. Decreased systemic exposure of lamotrigine may reduce seizure control. Prevention or management Dose adjustment may be necessary. Consult the approved product labeling for lamotrigine. Thyroid Hormone Replacement Therapy or Corticosteroid Replacement Therapy Clinical effect Concomitant use of COCs with thyroid hormone replacement therapy or corticosteroid replacement therapy may increase systemic exposure of thyroid-binding and cortisol-binding globulin [see Warnings and Precautions ( 5.12 )]. Prevention or management The dose of replacement thyroid hormone or cortisol therapy may need to be increased. Consult the approved product labeling for the therapy in use [see Warnings and Precautions ( 5.12 )]. Other Drugs Clinical effect Concomitant use of COCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). Prevention or management The dosage of drugs that can be affected by this interaction may need to be increased.
Use in specific populations
Pregnancy: Discontinue use if pregnancy occurs. ( 8.1 ) Lactation: Advise use of another method. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are not recommended for nursing mothers; may decrease milk production. ( 8.2 ) 8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. 8.2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [See Dosage and Administration (2.1 )] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets and any potential adverse effects on the breastfed child from levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets or the underlying maternal condition. 8.4 Pediatric Use Safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets before menarche is not indicated. 8.6 Hepatic Impairment No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females with acute hepatitis or severe decompensated cirrhosis. [See Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )].
Pregnancy
8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Pediatric use
8.4 Pediatric Use Safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets before menarche is not indicated.
Overdosage
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Description
Rosyrah is an extended-cycle oral contraceptive. Rosyrah consists of 42 white to off-white tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 light peach tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 bluish green tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17α)-(-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each white to off-white tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium and magnesium stearate. Each light peach tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate. Each bluish green tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, lactose monohydrate, povidone K-25 and dl -α-tocopherol. Meets USP Dissolution Test 2 for Ethinyl Estradiol 0.01 mg Levonorgestrel Structural Formula Ethinyl Estradiol Structural Formula
Mechanism of action
12.1 Mechanism of Action CHCs prevent pregnancy primarily by suppressing ovulation.
How supplied
How Supplied Rosyrah is available as round, unscored, biconvex tablets, packaged in an Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of the tablets in the following order: 42 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.02 mg ethinyl estradiol: debossed with 72 on one side of the tablet and plain on the other side 21 light peach tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol: debossed with 73 on one side of the tablet and plain on the other side 21 bluish green tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 74 on one side of the tablet and plain on the other side 7 yellow tablets containing 0.01 mg of ethinyl estradiol: debossed with 65 on one side of the tablet and plain on the other side Pouch of 1 Extended-Cycle Tablet Blister Pack NDC 70700-312-87 Carton for 1 pouch of 1 Extended-Cycle Tablet Blister Pack NDC 70700-312-87 Storage and Handling Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use. Women who are over 35 years old and smoke should not use levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Venous Thromboembolism Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ( 5.1 )] . Use during Pregnancy Instruct females to stop levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets if pregnancy is confirmed during treatment. Sexually Transmitted Infections Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets do not protect against HIV infection and other sexually transmitted infections. Dosing and Missed Pill Instructions Patients should take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See [see Dosage and Administration ( 2.3 )]. Instruct patients to see, “What to do if you miss pills” section of the FDA-Approved Instructions for Use. Need for Additional Contraception Postpartum females who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets need to use an additional method of contraception until they have taken a white to off-white tablet for 7 consecutive days [see Dosage and Administration (2.2 )] . There is a need for a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Drug Interactions ( 7.1 )] . Lactation Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets may reduce breast milk production. This is less likely to occur if breastfeeding is well established. When possible, nursing women should use other methods of contraception until they have discontinued breastfeeding [see Use in Specific Populations ( 8.2 )] . Amenorrhea and Possible Symptoms of Pregnancy Amenorrhea may occur [see Warnings and Precautions (5.9 )] . Advise the patient to contact a healthcare provider in the event of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see Use in Specific Populations ( 8.1 ] . Depression Depressed mood and depression may occur. Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [see Warnings and Precautions ( 5.10 )] .
Label text from the FDA structured product label by Xiromed, LLC (revised Nov 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Rosyrah NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70700-312 | Kit | Xiromed, LLC | ANDA |
Frequently asked questions
What is Rosyrah used for?
Rosyrah is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Rosyrah is indicated for use by females of reproductive age to prevent pregnancy.
What are the side effects of Rosyrah?
The most common adverse reactions (≥ 2%) in clinical trials for levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 844-XIROMED… See the full label for the complete list.
Who makes Rosyrah?
Rosyrah is listed by 1 labeler in the FDA NDC directory, including Xiromed, LLC.