KURVELO
- levonorgestrel and ethinyl estradiol
LUPIN LIMITED
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Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 Kurvelo, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)].
Kurvelo™ (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 light-orange active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 pink inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel C21H28O2 MW: 312.4
Levonorgestrel is chemically (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one).
Ethinyl Estradiol C20H24O2 MW: 296.4
Ethinyl Estradiol is (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol).
Each light-orange active tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.
Each pink inert tablet contains the following inactive ingredients: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.
Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.
Kurvelo is contraindicated in females who are known to have the following conditions:
1.Thromboembolic Disorders and Other Vascular Conditions
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 tablet is contraindicated in women over 35 years of age who smoke (see CONTRAINDICATIONS). 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). 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. Based on results from a few studies, there is some evidence that this is true for non-oral products as well. 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, for pregnant females, 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.
Figure 1: Likelihood of Developing a VTE
Elevated Liver Enzymes
Levonorgestrel and ethinyl estradiol tablet is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of liver (see CONTRAINDICATIONS). Discontinue levonorgestrel and ethinyl estradiol tablet if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of COC use until the liver tests return to normal and COC causation has been excluded.
Liver Tumors
Levonorgestrel and ethinyl estradiol tablet is contraindicated in females with benign or malignant liver tumors (see CONTRAINDICATIONS). COCs increase the risk of hepatic adenomas. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death from abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. The attributable risk of liver cancers in COC users is less than one case per million users.
3.Hypertension
Levonorgestrel and ethinyl estradiol tablet is contraindicated in females 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 tablet if blood pressure rises significantly.
An increase in blood pressure has been reported in females using COCs, and this increase is more likely in older women with extended duration of use. The effect of COCs on blood pressure may vary according to the progestin in the COC.
4.Age-related Considerations
The risk for cardiovascular disease and prevalence of risk factors for cardiovascular disease increase with age. Certain conditions, such as smoking and migraine headache without aura, that do not contraindicate COC use in younger females, are contraindications to use in women over 35 years of age [see CONTRAINDICATIONS and WARNINGS (1)]. Consider the presence of underlying risk factors that may increase the risk of cardiovascular disease or VTE, particularly before initiating a COC for women over 35 years, such as:
5.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 tablet prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see CONTRAINDICATIONS).
Levonorgestrel and ethinyl estradiol tablet can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
6.Gallbladder Disease
Studies suggest an increased risk of developing gallbladder disease among COC users. Use of COCs may also worsen existing gallbladder disease.
A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Females with a history of pregnancy-related cholestasis may be at an increased risk for COC- related cholestasis.
7.Adverse Carbohydrate and Lipid Metabolic Effects
Hyperglycemia
Levonorgestrel and ethinyl estradiol tablet is contraindicated in diabetic women over age 35, or females who have diabetes with hypertension, nephropathy, retinopathy, neuropathy, other vascular disease, or females with diabetes of > 20 years duration (see CONTRAINDICATIONS). Levonorgestrel and ethinyl estradiol tablet may decrease glucose tolerance. Carefully monitor prediabetic and diabetic females who are using levonorgestrel and ethinyl estradiol tablet.
Dyslipidemia
Consider alternative contraception for females with uncontrolled dyslipidemia. Levonorgestrel and ethinyl estradiol tablet may cause adverse lipid changes.
Females with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using levonorgestrel and ethinyl estradiol tablet, which may increase the risk of pancreatitis.
8.Headache
Levonorgestrel and ethinyl estradiol tablet 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 headaches with or without aura (see CONTRAINDICATIONS).
If a woman using levonorgestrel and ethinyl estradiol tablet develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue levonorgestrel and ethinyl estradiol tablet if indicated. Consider discontinuation of levonorgestrel and ethinyl estradiol tablet if there is an increased frequency or severity of migraines during COC use (which may be prodromal of a cerebrovascular event).
9.Bleeding Irregularities and Amenorrhea
Unscheduled Bleeding and Spotting
Females using levonorgestrel and ethinyl estradiol tablet may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy.
In two clinical trials of levonorgestrel and ethinyl estradiol tablet (1084 subjects reporting for a total of 8186 treatment cycles and 238 subjects reporting for a total of 1102 treatment cycles), breakthrough bleeding occurred in 6.9% and 8.1% of reported cycles, and spotting occurred in 8.6% and 7.9% of reported cycles over the total study duration, respectively. In the two trials, intermenstrual bleeding (i.e.,breakthrough bleeding and/or spotting) occurred in 13.1% and 12.9% of reported cycles over the total study duration, respectively. In one trial, 33 subjects out of 1084 (3.0%) discontinued due to bleeding irregularities (i.e., breakthrough bleeding and spotting); in the other trial, 6 subjects out of 238 (2.5%) discontinued due to bleeding irregularities.
Amenorrhea and Oligomenorrhea
Females who use levonorgestrel and ethinyl estradiol tablet may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. In two clinical trials of levonorgestrel and ethinyl estradiol tablet, one including 8186 reported treatment cycles, and the other including 1102 reported treatment cycles, amenorrhea occurred in 1.5% of treatment cycles in each trial.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
After discontinuation of a COC, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.
10.Depression
Carefully observe females with a history of depression and discontinue levonorgestrel and ethinyl estradiol tablet if depression recurs to a serious degree. Data on the association of COCs with onset of depression or exacerbation of existing depression are limited.
11. Malignant Neoplasms
Breast Cancer
Levonorgestrel and ethinyl estradiol tablet is contraindicated in female 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, Postmarketing Experience].
Cervical Cancer
Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. There is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.
12.Effect on Binding Globulins
The estrogen component of levonorgestrel and ethinyl estradiol tablet may raise the serum concentrations of thyroxine- binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.
13.Hereditary Angioedema
In females with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
14.Chloasma
Chloasma may occur with levonorgestrel and ethinyl estradiol tablet use, especially in females with a history of chloasma gravidarum. Advise females with a history of chloasma to avoid exposure to the sun or ultraviolet radiation while using levonorgestrel and ethinyl estradiol tablet.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult [see WARNINGS (7)].
In patients with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
2.Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
3.Gastrointestinal Motility
Diarrhea and/or vomiting may reduce hormone absorption (see DOSAGE AND ADMINISTRATION).
4.Drug Interactions
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 tablet.
4.1Effects of Other Drugs on Combined Oral Contraceptives
Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs:
Table 1 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablet.
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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*, 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. |
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. CYP3A inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice7, 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).
4.2Effects of Combined Oral Contraceptives on Other Drugs
Table 2 provides significant drug interaction information for drugs co-administered with levonorgestrel and ethinyl estradiol tablet.
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
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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, EFFECT ON BINDING GLOBULINS). |
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, EFFECT ON BINDING GLOBULINS). |
Other Drugs
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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. Consult the approved product labeling for the concomitantly used drug. |
4.3 Concomitant Use with Hepatitis C Virus (HCV) Combination Therapy – Liver Enzyme Elevation
Do not co-administer levonorgestrel and ethinyl estradiol tablet with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, [see Warnings (5)], and glecaprevir/pibrentasvir due to potential for ALT elevations.
4.4 Effect on Laboratory Tests
The use of COCs may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
5.Carcinogenesis
See WARNINGS (11).
6.Pregnancy
Risk Summary
Discontinue levonorgestrel and ethinyl estradiol tablet if pregnancy occurs because there is no reason to use COCs in pregnancy. Epidemiologic studies and meta- analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. Animal studies to evaluate embryo/fetal toxicity were not conducted.
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.
7.Lactation
Risk Summary
Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. (see DOSAGE AND ADMINISTRATION). The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for levonorgestrel and ethinyl estradiol tablet and any potential adverse effects on the breast-fed child from levonorgestrel and ethinyl estradiol tablet or from the underlying maternal condition.
8.Pediatric Use
Safety and efficacy of levonorgestrel and ethinyl estradiol tablet have been established in females of reproductive potential. Use of levonorgestrel and ethinyl estradiol tablet before menarche is not indicated.
9.Geriatric Use
Levonorgestrel and ethinyl estradiol tablet has not been studied in postmenopausal women and is not indicated in this population.
10.PATIENT COUNSELING INFORMATION
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions reported by COC users and described elsewhere in the labeling are:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.
There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.
1.How to Start and Take Kurvelo
Kurvelo is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED). Kurvelo may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Starting Kurvelo in females with no current use of hormonal contraception
| Day 1 start
• Take first tablet without regard to meals on the first day of menses • Take subsequent tablets once daily at the same time each day • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) |
Sunday start
• Take first tablet without regard to meals on the first Sunday after the onset of menstrual period • Take subsequent tablets once daily at the same time each day • Use additional nonhormonal contraception for the first seven days of product use • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) |
|
Switching from another contraceptive method
• A COC | Start Kurvelo: • On the day when the new pack of the previous COC would have been started |
• Transdermal patch
| • On the day when next application would have been scheduled |
• Vaginal ring
| • On the day when next insertion would have been scheduled |
• Injection
| • On the day when next injection would have been scheduled |
• Intrauterine contraceptive
| • On the day of removal |
• Implant
| • On the day of removal |
Starting Kurvelo after Abortion or Miscarriage
First-trimester
Starting Kurvelo after Childbirth
Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Kurvelo as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.
3.Missed doses
Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.
• If one active tablet is missed in Weeks 1, 2, or 3 | Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. |
• If two active tablets are missed in Week 1 or Week 2 | Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
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• If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 | Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
4.Advice in Case of Gastrointestinal Disturbances
If vomiting occurs within 3 to 4 hours after taking Kurvelo, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.
Kurvelo Tablets (levonorgestrel and ethinyl estradiol tablets USP) (3 x 28) are available in packages of 3 blisters, each containing 28 tablets as follows:
Each blister strip contains 21 light orange tablets, each containing of 0.15 mg levonorgestrel and 30 mcg ethinyl estradiol, debossed with "LU" on one side and "U31" on the other side.
7 inert pink, round, biconvex tablets, debossed with "LU" on one side and "U32" on the other side.
They are supplied as follows:
Kurvelo tablets are available in a blister (NDC 68180-844-71) containing 28 tablets, such 3 blisters are packed in a carton (NDC 68180-844-73).
Store at 25°C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].
Lupin Pharmaceuticals, Inc.
Naples, FL 34108
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
INDIA
Revised: September 2024
(levonorgestrel 0.15 mg and ethinyl estradiol tablets USP, 30 mcg tablets)
What is the most important information I should know about Kurvelo?
Do not use Kurvelo 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 Kurvelo?
Kurvelo is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does Kurvelo 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 to 5 out of 100 women may get pregnant during the first year they use Kurvelo.
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 Kurvelo? Do not take Kurvelo if you:
If any of these conditions happen while you are taking Kurvelo, stop taking Kurvelo right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Kurvelo.
What should I tell my healthcare provider before taking Kurvelo?
Tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Kurvelo may affect the way other medicines work, and other medicines may affect how well Kurvelo 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 Kurvelo?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of Kurvelo?
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:
Call your healthcare provider or go to a hospital emergency room right away if you have:
Other serious side effects include:
What are the most common side effects of oral contraceptives?
These are not all the possible side effects of Kurvelo. For more information, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
What else should I know about taking Kurvelo?
General information about the safe and effective use of Kurvelo.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Kurvelo for a condition for which it was not prescribed. Do not give Kurvelo to other people, even if they have the same symptoms that you have.
This Patient Information Leaflet summarizes the most important information about Kurvelo. You can ask your pharmacist or healthcare provider for information about Kurvelo that is written for health professionals.
For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
Do birth control pills cause cancer?
Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills 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 Kurvelo?
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 Kurvelo, 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 Kurvelo?
Active ingredients: Each light-orange pill contains levonorgestrel and ethinyl estradiol.
Inactive ingredients:
Light-orange pills: croscarmellose sodium, FD&C Yellow #6, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.
Pink pills: croscarmellose sodium, D & C Red #30, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
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Lupin Pharmaceuticals, Inc.
Naples, FL 34108
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
INDIA
Revised: September 2024
Instructions For Use Kurvelo™
(levonorgestrel 0.15 mg and ethinyl estradiol tablets USP, 30 mcg)
Important Information about taking Kurvelo
Before you start taking Kurvelo:
When should I start taking Kurvelo?
If you start taking Kurvelo and you have not used a hormonal birth control method before:
If you start taking Kurvelo and you are switching from another birth control pill:
If you start taking Kurvelo and previously used a vaginal ring:
If you start taking Kurvelo and previously used a transdermal patch:
If you start taking Kurvelo and you are switching from a progestin-only method such as an implant or injection:
If you start taking Kurvelo and you are switching from an intrauterine device or system (IUD or IUS):
Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, "When should I start taking Kurvelo?" above. Follow these instructions for either a Sunday Start or a Day 1 Start.
Instructions for using your Kurvelo Pill Dispenser: Sunday Start:
You will use a Sunday Start if your healthcare provider told you to take your first pill on Sunday.
You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period.
What should I do if I miss any Kurvelo pills?
If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:
If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Lupin Pharmaceuticals, Inc.
Naples, FL 34108
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) - 454 775
INDIA
Revised: September 2024 ID#: 277628
KurveloTM [levonorgestrel and ethinyl estradiol tablets USP] 0.15 mg and 30 mcg
NDC 68180-844-71
Blister Label: 28 Tablets
KurveloTM [levonorgestrel and ethinyl estradiol tablets USP] 0.15 mg and 30 mcg
Rx Only
NDC 68180-844-73
Carton: 3 Blister of 28 Tablets Each
KURVELO
levonorgestrel and ethinyl estradiol kit |
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Labeler - LUPIN LIMITED (675923163) |
Registrant - LUPIN LIMITED (675923163) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LUPIN LIMITED | 650582310 | MANUFACTURE(57297-844, 57297-841, 57297-842) , PACK(57297-844, 57297-841, 57297-842) |