Jolessa (Page 6 of 8)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[see Warnings and Precautions (5.2, 5.10) and Use in Specific Populations (8.1)].

14 CLINICAL STUDIES

In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18-40 were studied to assess the safety and efficacy of JOLESSA, completing 809 91-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (77%), African-American (11%), Hispanic (7%), Asian (2%), and Other (3%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 84 to 304 pounds, with a mean weight of 157 pounds and a median weight of 147 pounds. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 29% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 8% were new starts.

The pregnancy rate (Pearl Index [PI]) in the 397 women aged 18-35 years was 1.98 pregnancies per 100 women-years of use (95% CI: 0.54 to 5.03), based on 4 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of back-up contraception, were not included in the calculation of the PI.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

JOLESSA (levonorgestrel and ethinyl estradiol tablets) are available as round, film-coated, biconvex, unscored tablets with a debossed stylized b on one side, packaged in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets in the following order:

  • 84 pink tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 992 on the other side
  • 7 white inert tablets debossed with 208 on the other side

Box of 3 Extended-Cycle Tablet Dispensers NDC 0555-9123-66

16.2 Storage Conditions

  • Store at 20° to 25° C (68° to 77° F), excursions permitted to 15º to 30ºC (59º to 86º F) [See USP Controlled Room Temperature].
  • Protect from light.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Counsel patients on the following information:

  • Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
  • 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)].
  • JOLESSA does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
  • JOLESSA is not to be used during pregnancy; if pregnancy occurs during use of JOLESSA, instruct the patient to stop further use [see Warnings and Precautions (5.9)].
  • Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed [see Dosage and Administration (2.3) ].
  • Use a back-up or alternative method of contraception when enzyme inducers are used with JOLESSA [see Drug Interactions (7.1)].
  • COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3)].
  • Women who start on COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken a pink tablet for 7 consecutive days [see Dosage and Administration (2.2)].
  • Amenorrhea may occur. Because women using JOLESSA will likely have scheduled bleeding only 4 times per year, rule out pregnancy at the time of any missed menstrual period [see Warnings and Precautions (5.8)].

Manufactured by:

TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, INC
North Wales, PA 19454

JOL-002

Patient Information

JOLESSA® [joe les’ a]

(levonorgestrel and ethinyl estradiol tablets)

What is the most important information I should know about JOLESSA?

Do not use JOLESSA 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 JOLESSA?

JOLESSA is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does JOLESSA 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 JOLESSA.

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.

chart
(click image for full-size original)

Who should not take JOLESSA?

Do not take JOLESSA if you:

  • smoke and are over 35 years of age
  • had blood clots in your arms, legs, lungs, or eyes
  • had a problem with your blood that makes it clot more than normal
  • have certain heart valve problems or irregular heart beat
  • had a stroke
  • had a heart attack
  • have high blood pressure that cannot be controlled by medicine
  • have diabetes with kidney, eye, nerve, or blood vessel damage
  • have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
  • have liver problems, including liver tumors
  • take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
  • have any unexplained vaginal bleeding
  • are pregnant
  • had breast cancer or any cancer that is sensitive to female hormones

If any of these conditions happen while you are taking JOLESSA, stop taking JOLESSA right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking JOLESSA.

What should I tell my healthcare provider before taking JOLESSA?

Tell your healthcare provider if you:

  • are pregnant or think you may be pregnant
  • are depressed now or have been depressed in the past
  • had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
  • are breastfeeding or plan to breastfeed. JOLESSA may decrease the amount of breast milk you make. A small amount of the hormones in JOLESSA may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

JOLESSA may affect the way other medicines work, and other medicines may affect how well JOLESSA 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 JOLESSA?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of JOLESSA?

  • Like pregnancy, JOLESSA may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.
  • Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
    • first start taking birth control pills
    • restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

  • leg pain that will not go away
  • a sudden, severe headache unlike your usual headaches
  • sudden severe shortness of breath
  • weakness or numbness in your arm or leg
  • sudden change in vision or blindness
  • trouble speaking
  • chest pain


Other serious side effects include:

  • liver problems, including:
    • rare liver tumors
    • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
  • high blood pressure. You should see your healthcare provider for a yearly check of your blood pressure.
  • gallbladder problems
  • changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
  • new or worsening headaches including migraine headaches
  • irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking JOLESSA.
  • depression
  • possible cancer in your breast and cervix
  • swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
  • dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking JOLESSA. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of JOLESSA?

  • headache (migraine)
  • acne
  • heavier or longer periods, pain with periods
  • breast tenderness
  • nausea
  • increase in weight


These are not all the possible side effects of JOLESSA. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking JOLESSA?

  • If you are scheduled for any lab tests, tell your healthcare provider you are taking JOLESSA. Certain blood tests may be affected by JOLESSA.
  • JOLESSA does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store JOLESSA?

  • Store JOLESSA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Protect from light.

General information about the safe and effective use of JOLESSA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use JOLESSA for a condition for which it was not prescribed. Do not give JOLESSA to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about JOLESSA. You can ask your pharmacist or healthcare provider for information about JOLESSA that is written for health professionals.

For more information, call 1-888-483-8279 (1-888-4Teva-RX).

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 JOLESSA?

When you take JOLESSA, which has a 91-day extended dosing cycle, you should have 4 scheduled periods a year (bleeding when you are taking the 7 white pills). 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 JOLESSA 91-day treatment cycle, about 1 in 3 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 JOLESSA because of this bleeding or spotting. If the spotting continues for more than 7 days in a row or if the bleeding is heavy, call your healthcare provider.

What are the ingredients in JOLESSA?

Active ingredients: Each pink pill contains levonorgestrel and ethinyl estradiol.

Inactive ingredients:

Pink pills: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP.

White pills: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.

JOLPL-002

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