Teva

Levonorgestrel + ethinyl estradiol

Generic

Generic for Camrese

ID: 00093313482

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LEVONORGESTREL ETHINYL ESTRADIOL 015 MG 30 MCG 10 MCG TABLET 0093313482

📜 Prescription Required

FORM

Tablet

STRENGTH

0.15 mg/30 mcg-10 mcg

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Key facts from the full medication guide below

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 How to Start and Take CAMRESE 2.2 Dosing CAMRESE

🩺What it's for

CAMRESE is indicated for use by females of reproductive potential to prevent pregnancy. CAMRESE is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

💊How to take it

Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack.

ℹ️Common side effects

Hyperglycemia CAMRESE 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 ( 4 )]. CAMRESE may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are taking CAMRESE. Dyslipidemia Consider alternative contraception for women with uncontrolled dyslipidemia.

⚠️Serious risks

Cigarette smoking increases the risk of serious cardiovascular events from combination 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 CAMRESE, are contraindicated in women who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1)].

📋Interactions & cautions

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.

📦Storage & missed dose

How Supplied CAMRESE tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers (NDC 0093-3134-82), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. Table 1. Instructions for Missed CAMRESE Tablets If one light blue-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 backup birth control method is not required if the patient has sex. If two light blue-green tablet in a row are missed Take the two missed tablets as soon as possible, and the next two tablets the next day.

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Begin CAMRESE on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the first light blue-green tablet that day. For each 91-day course, take in the following order: 1. Start the first light blue-green tablet on the first Sunday after onset of menstruation. Then take one light blue-green tablet daily for 84 consecutive days. Use a non-hormonal backup method of contraception (such as condoms and spermicide) until a light blue-green tablet has been taken daily for 7 consecutive days. 2. Then take one yellow tablet for 7 consecutive days. Bleeding should occur during the 7 days that the yellow tablets are taken. Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of CAMRESE, following the same schedule: 84 days taking a light blue-green tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal backup method of contraception until she has taken a light blue-green tablet daily for 7 consecutive days. Switching to CAMRESE 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 a light blue-green tablet for 7 consecutive days. Starting CAMRESE after Abortion or Miscarriage First-trimester CAMRESE 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 light blue-green tablet for 7 consecutive 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 CAMRESE 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 light blue-green tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)]. Starting CAMRESE after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with CAMRESE 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 light blue-green tablet for 7 consecutive days [see Contraindications (4) and Warnings and Precautions (5.1)]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of CAMRESE [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

CAMRESE 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: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]. Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ( 5.1 )]. Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] Have coronary artery disease [see Warnings and Precautions ( 5.1 )]. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ( 5.1 )]. Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )]. Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.3)]. 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)]. 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)]. A high risk of arterial or venous thrombotic diseases (4) Undiagnosed abnormal uterine bleeding (4) Breast cancer (4) Liver tumors or liver disease, acute viral hepatitis or decompensated cirrhosis (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.(4)

Stop CAMRESE if an arterial or deep venous thrombotic/thromboembolic event occurs. Stop CAMRESE if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. Discontinue CAMRESE during prolonged immobilization. If feasible, stop CAMRESE at least 4 weeks before and through 2 weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. Start CAMRESE no earlier than 4 weeks after delivery, in women 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 CAMRESE evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. CAMRESE is contraindicated in women 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. CAMRESE is 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 CHCs [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 women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE. Use of CAMRESE 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).

Unscheduled Bleeding and Spotting Women using CAMRESE may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first 3 months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If unscheduled bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy. When prescribing CAMRESE, the occurrence of fewer planned menses (4 per year instead of 13 per year) should be weighed against the occurrence of increased unscheduled bleeding and/or spotting. The primary clinical trial (PSE-301) that evaluated the efficacy of CAMRESE also assessed unscheduled bleeding. The participants in the 12-month clinical trial (N=1,006) completed the equivalent of 8,681 28-day cycles of exposure and were composed primarily of women who had used oral contraceptives previously (89%) as opposed to new users (11%). A total of 82 (8.2%) of the women discontinued CAMRESE, at least in part, due to bleeding or spotting. Scheduled (withdrawal) bleeding and/or spotting remained fairly constant over time, with an average of 3 days of bleeding and/or spotting per each 91-day cycle. Unscheduled bleeding and unscheduled spotting decreased over successive 91-day cycles. Table 1 below presents the number of days with unscheduled bleeding in treatment cycles 1 and 4. Table 2 presents the number of days with unscheduled spotting in treatment cycles 1 and 4. Table 2: Total Number of Days with Unscheduled Bleeding 91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval Q1 Median Q3 Mean Mean 1st 1 4 10 6.9 1.7 4th 0 1 4 3.2 0.8 Q1=Quartile 1: 25% of women had this number of days of unscheduled bleeding Median: 50% of women had this number of days of unscheduled bleeding Q3=Quartile 3: 75% of women had this number of days of unscheduled bleeding Table 3: Total Number of Days with Unscheduled Spotting 91-Day Treatment Cycle Days per 84-Day Interval Days per 28-Day Interval Q1 Median Q3 Mean Mean 1st 1 4 11 7.4 1.9 4th 0 2 7 4.4 1.1 Q1=Quartile 1: 25% of women had this number of days of unscheduled spotting Median: 50% of women had this number of days of unscheduled spotting Q3=Quartile 3: 75% of women had this number of days of unscheduled spotting Figure 2 shows the percentage of CAMRESE subjects participating in trial PSE-301 with 7 days or 20 days of unscheduled bleeding and/or spotting, or only unscheduled bleeding, during each 91-day treatment cycle. Figure 2: Percent of Women Taking CAMRESE who Reported Unscheduled Bleeding and/or Spotting or only Unscheduled Bleeding If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider. Amenorrhea and Oligomenorrhea Women who use CAMRESE may experience absence of scheduled (withdrawal) bleeding, even if they are not pregnant. If scheduled bleeding does not occur, consider the possibility of pregnancy. After discontinuation of CAMRESE, amenorrhea or oligomenorrhea may occur, especially if these conditions were pre-existent.

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 CAMRESE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency of 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

Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs: Table 4 includes substances that demonstrated an important drug interaction with CAMRESE. Table 4: 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 worta, 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 CHC. 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. CYP3A 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).

Absorption Ethinyl estradiol and levonorgestrel are absorbed with maximum plasma concentrations occurring within 2 hours after CAMRESE administration. Levonorgestrel is completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism. Ethinyl estradiol is absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of ethinyl estradiol is approximately 43%. The daily exposure to levonorgestrel and ethinyl estradiol on Day 21, corresponding to the end of a typical 3-week contraceptive regimen, and on Day 84, at the end of an extended cycle regimen, were similar. There was no additional accumulation of ethinyl estradiol after dosing a 0.03 mg ethinyl estradiol tablet during Days 84-91. The mean plasma pharmacokinetic parameters of CAMRESE following a single dose of one levonorgestrel/ethinyl estradiol combination tablet, for 84 days, in normal healthy women are reported in Table 6. Table 6: Mean Pharmacokinetic Parameters for CAMRESE during Daily One Tablet Dosing for 84 Days AUC0-24 hr (mean SD) Cmax (mean SD) Tmax (mean SD) Levonorgestrel Day 1 18.2 6.1 ng hr/mL 3.0 1.0 ng/mL 1.3 0.4 hours Day 21 64.4 25.1 ng hr/mL 6.2 1.6 ng/mL 1.3 0.4 hours Day 84 60.2 24.6 ng hr/mL 5.5 1.6 ng/mL 1.3 0.3 hours Ethinyl Estradiol Day 1 509.3 172.0 pg hr/mL 69.8 26 pg/mL 1.5 0.3 hours Day 21 837.1 271.2 pg hr/mL 99.6 31 pg/mL 1.5 0.3 hours Day 84 791.5 215.0 pg hr/mL 91.3 32 pg/mL 1.6 0.3 hours The effect of food on the rate and the extent of levonorgestrel and ethinyl estradiol absorption following oral administration of CAMRESE has not been evaluated. Distribution The apparent volume of distribution of levonorgestrel and ethinyl estradiol are reported to be approximately 1.8 L/kg and 4.3 L/kg, respectively. Levonorgestrel is about 97.5 - 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinyl estradiol is about 95 - 97% bound to serum albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis, which leads to decreased levonorgestrel clearance. Following repeated daily dosing of levonorgestrel/ethinyl estradiol oral contraceptives, levonorgestrel plasma concentrations accumulate more than predicted based on single-dose pharmacokinetics, due in part, to increased SHBG levels that are induced by ethinyl estradiol, and a possible reduction in hepatic metabolic capacity. Metabolism Following absorption, levonorgestrel is conjugated at the 17 -OH position to form sulfate and to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3 ,5 -tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3 ,5 -tetrahydrolevonorgestrel and 16 -hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users. First-pass metabolism of ethinyl estradiol involves formation of ethinyl estradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed ethinyl estradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of ethinyl estradiol hydroxylation. Hydroxylation at the 4-, 6-, and 16- positions may also occur, although to a much lesser extent than 2-hydroxylation. The various hydroxylated metabolites are subject to further methylation and/or conjugation. Excretion About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for levonorgestrel after a single dose of CAMRESE was about 34 hours. Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of ethinyl estradiol after a single dose of CAMRESE was found to be about 18 hours. Race The effect of race on the pharmacokinetics of CAMRESE has not been evaluated.

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 CAMRESE [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 interruption in intake) the same or a different COC [see Warnings and Precautions ( 5.1 )]. Use during Pregnancy Instruct females to stop further intake of CAMRESE if pregnancy is confirmed during treatment. Sexually Transmitted Infections CAMRESE does not protect against HIV-infection (AIDS) 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, What to do if you miss pills section of FDA-Approved Instructions for Use [see Dosage and Administration (2.3)]. Need for Additional Contraception Postpartum females who have not yet had a period when they start CAMRESE need to use an additional method of contraception until they have taken a light blue-green tablet for 7 consecutive days [see Dosage and Administration (2.1)]. There is a need to use a backup or alternative method of contraception when enzyme inducers are used with CAMRESE [see Drug Interactions (7.1)]. Lactation CAMRESE 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. Advise patients to contact a healthcare provider in the event of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.9)]. Fertility Following Discontinuation of CAMRESE Resumption of pre-treatment ovarian function is expected, generally within 8 weeks after discontinuation of CAMRESE. 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)]. Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 CAMPI-003 Rev. 10/2024 2024 Teva Pharmaceuticals, Inc.

PATIENT INFORMATION CAMRESE (levonorgestrel/ethinyl estradiol and ethinyl estradiol) WARNING TO WOMEN WHO SMOKE Do not use CAMRESE if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from 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 the most important information I should know about CAMRESE? Do not use CAMRESE if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from 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 CAMRESE? CAMRESE is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. CAMRESE does not protect against HIV infection (AIDS) and other sexually transmitted infections. How Does CAMRESE Work for contraception? Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant. Based on the results of a single clinical study lasting 12 months, 1 to 3 women, out of 100 women, may get pregnant during the first year they use CAMRESE. 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 CAMRESE? Do not take CAMRESE if you: smoke and are over 35 years of age have or had blood clots in your arms, legs, eyes or lungs had a stroke had a heart attack have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart have or had a problem with your blood that makes it clot more than normal have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems have diabetes and are over the age of 35; have diabetes with high blood pressure; kidney, eye, nerve, or blood vessel damage; or for more than 20 years have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over the age of 35 have or had breast cancer have liver disease, including liver tumors have unexplained vaginal bleeding take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood. Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy. If any of these conditions happen to you while you are taking CAMRESE, stop taking CAMRESE right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking CAMRESE. What should I tell my healthcare provider before taking CAMRESE? Tell your healthcare provider if you: are pregnant or think you may be pregnant are scheduled for surgery. CAMRESE may increase your risk of blood clots after surgery. You should stop taking CAMRESE at least 4 weeks before you have surgery and not restart CAMRESE until at least 2 weeks after your surgery. are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed. CAMRESE may decrease the amount of breast milk you make. A small amount of the hormones in CAMRESE may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding. Tell your healthcare provider if you have ever had any of the conditions listed in, Who should not take CAMRESE above. Your healthcare provider may recommend another method of birth control. Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John s wort topiramate Use a backup or alternative birth control method when you take medicines that may make birth control pills less effective. Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone. 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 CAMRESE? Read the Instructions for Use at the end of this Patient Information. What are the most serious risks of taking birth control pills? Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age over 35 years old. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the: Legs (thrombophlebitis) Lungs (pulmonary embolus) Eyes (loss of eyesight) Heart (heart attack) Brain (stroke) Women who take birth control pills may get: High blood pressure. You should see your healthcare provider to check your blood pressure regularly. Gallbladder problems Rare cancerous or noncancerous liver tumors All of these events are uncommon in healthy women. Call your healthcare provider right away if you have: Persistent leg pain Sudden shortness of breath Sudden blindness, partial or complete Severe pain in your chest Sudden, severe headache unlike your usual headaches Weakness or numbness in an arm or leg, or trouble speaking Yellowing of the skin or eyeballs What are common side effects of birth control pills? The most common side effects of birth control pills are: Spotting or bleeding between menstrual periods Nausea Breast tenderness Headache These side effects are usually mild and usually disappear with time. Less common side effects are: Acne Less sexual desire Bloating or fluid retention Blotchy darkening of the skin, especially on the face High blood sugar, especially in women who already have diabetes High fat levels in the blood Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself. Problems tolerating contact lenses Weight changes This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1 800-FDA-1088. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. What else should I know about taking CAMRESE? If you are scheduled for any lab tests, tell your healthcare provider you are taking CAMRESE. Certain blood tests may be affected by CAMRESE. Do not skip any pills, even if you do not have sex often. Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects. You should stop CAMRESE at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots. If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like CAMRESE, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk. If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider. How should I store CAMRESE? Store CAMRESE at room temperature between 68 F to 77 F (20 C to 25 C). Keep CAMRESE and all medicines out of the reach of children. General information about CAMRESE Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CAMRESE for a condition for which it was not prescribed. Do not give CAMRESE to anyone else. This Patient Information summarizes the most important information about CAMRESE. If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare providers for a more detailed label written for medical professionals. Do birth control pills cause cancer? It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use. If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones. Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. What if I want to become pregnant? You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill. What should I know about my period when taking CAMRESE? When you take CAMRESE, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 3 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. During the first CAMRESE 91-day treatment cycle, about 3 in 10 women may have 20 or more days of unplanned bleeding or spotting. This bleeding or spotting tends to decrease with time. Do not stop taking CAMRESE because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider. What if I miss my scheduled period when taking CAMRESE? You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow tablets). Since scheduled periods are less frequent when you are taking CAMRESE, notify your healthcare provider that you have missed your period and that you are taking CAMRESE. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking CAMRESE if it is determined that you are pregnant. What are the ingredients in CAMRESE? Active ingredients: Light blue-green tablets: levonorgestrel and ethinyl estradiol Yellow tablets: ethinyl estradiol Inactive ingredients: Light blue-green tablets: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Yellow tablets: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. INSTRUCTIONS FOR USE CAMRESE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) How do I take CAMRESE? 1. Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 2. Many women have spotting or light bleeding or may feel sick to their stomach during the first few months of taking CAMRESE. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider. 3. Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 4. If you have trouble remembering to take CAMRESE, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control. Before you start taking CAMRESE 1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day. 2. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 light blue-green and 7 yellow pills. Trays 1 and 2 each contain 28 light blue-green pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 light blue-green pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills). 3. Also find: Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and In what order to take the pills (follow the weeks and arrow). 4. Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a backup in case you miss pills. If you are switching from another birth control method: If you have been using a different hormonal method of birth control (such as a different pill, the patch, or the vaginal ring ), you need to use another method of birth control (such as condoms or spermicide) each time you have sex after stopping your old method of birth control until you have taken CAMRESE for 7 days. If you have recently given birth and have not yet had a period, use another method of birth control if you have sex (such as condoms and spermicide) as a backup method until you have taken CAMRESE for 7 days. When to start CAMRESE 1. Take the first light blue-green pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first light blue-green pill that same day. 2. Use another method of birth control (such as condoms or spermicide) as a backup method if you have sex anytime from the Sunday you start your first light blue-green pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the patch, or the vaginal ring ), you need to use another method of birth control (such as condoms or spermicide) each time you have sex after stopping your old method of birth control until you have taken CAMRESE for 7 days. How to take CAMRESE 1. Take one pill at the same time every day until you have taken the last pill in the tablet dispenser. Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2. When you finish a tablet dispenser After taking the last yellow pill, start taking the first light blue-green pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started. 3. If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking CAMRESE. What to do if you miss pills If you MISS 1 light blue-green pill: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. 2. You do not need to use a backup birth control method if you have sex. If you MISS 2 light blue-green pills in a row: 1. Take 2 pills on the day you remember, and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a backup for the 7 days after you restart your pills. If you MISS 3 OR MORE light blue-green pills in a row: 1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under Thursday and do not take the missed pills. You may experience bleeding during the week following the missed pills. 2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. 3. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a backup when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the yellow pills, call your healthcare provider because you may be pregnant. If you MISS ANY of the 7 yellow pills: 1. Throw away the missed pills. 2. Keep taking the scheduled pills until the pack is finished. 3. You do not need a backup method of birth control. Finally, if you are still not sure what to do about the pills you have missed Use a backup method anytime you have sex. Keep taking one pill each day until you contact your healthcare provider. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 CAMPL-003 Revised: 10/2024 2024 Teva Pharmaceuticals, Inc.