Jolessa Levonorgestrel / Ethinyl Estradiol

Brand Name: Jolessa

Generic Name: LEVONORGESTREL / ETHINYL ESTRADIOL

Drug Type: HUMAN PRESCRIPTION DRUG

Dosage Form: KIT

Data Current As Of: 2018-10-05

JOLESSA^® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.

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

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.

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:

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?

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

JOLESSA^® [joe les’ a]

(levonorgestrel and ethinyl estradiol tablets)

Important Information about taking JOLESSA

• Take 1 pill every day at the same time. Take the pills in the order directed on your pill dispenser.
• Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the pack late) you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
• If you have trouble remembering to take JOLESSA, talk to your healthcare provider.
• When you first start taking JOLESSA, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.
• You may feel sick to your stomach (nauseous), especially during the first few months of taking JOLESSA. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.
• 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 (see What should I do if I miss any JOLESSA pills? below), you could also feel a little sick to your stomach.
• It is not uncommon to miss a period. However, if you miss a period and have not taken JOLESSA according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking JOLESSA.
• If you have vomiting or diarrhea within 3-4 hours of taking a pink pill, take another pink pill as soon as possible. Continue taking one pill a day until the 91-day course is finished.
• If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider.
• Stop taking JOLESSA at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.

Before you start taking JOLESSA:

• Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
• 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 consists of 84 pink and 7 white pills. The cards in trays 1 and 2 each contain 28 pink pills (4 rows of 7 pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28 pink pills (4 rows of 7 pills) and 7 white pills (1 row of 7 pills). See Figure B.

Figure B

• Also find:
  • Where on the first tray in the pack to start taking pills (upper left corner) and
  • In what order to take the pills (follow the weeks)
• Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking JOLESSA?

If you start taking JOLESSA and you have not used a hormonal birth control method before:

• Take the first pink pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first pink pill that same day.
• Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first pink pill until the next Sunday (first 7 days).

If you start taking JOLESSA and you are switching from another birth control pill:

• Start your new JOLESSA pack on the same day that you would start the next pack of your previous birth control method.
• Do not continue taking the pills from your previous birth control pack.

If you start taking JOLESSA and previously used a vaginal ring:

• Start using JOLESSA on the day you would have reapplied the next ring.

If you start taking JOLESSA and previously used a transdermal patch:

• Start using JOLESSA on the day you would have started a new cycle (first patch application).

If you start taking JOLESSA and you are switching from a progestin-only method such as an implant or injection:

• Start taking JOLESSA on the day of removal of your implant, or on the day when you would have had your next injection.

If you start taking JOLESSA and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking JOLESSA on the day of removal of your IUD or IUS.
• You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take JOLESSA.

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 JOLESSA?” above. Follow these instructions for a Sunday Start.

Instructions for using your JOLESSA Extended-Cycle Tablet Dispenser:

Sunday Start:

• Take pill 1 on the Sunday after your period starts. To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser. See Figure C.

Figure C

• If your period starts on a Sunday, take pill “1” that same day.
• Take 1 pill at about the same time every day until you have taken the last pill in the tablet dispenser.
• After taking the last white pill on Day 91 from the pill dispenser, start taking the first pink pill from a new Extended-Cycle Tablet Dispenser on the very next day (this should be a Sunday). Take the first pill in the new pack whether or not you are having your period.
• Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take JOLESSA.

What should I do if I miss any JOLESSA pills?

If you miss 1 pink pill, follow these steps:

• 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.
• Then continue taking 1 pill every day until you finish the pack.
• You do not need to use a back-up birth control method if you have sex.

If you miss 2 pink pills in a row, follow these steps:

• Take 2 pills on the day you remember and 2 pills the next day.
• Then continue to take 1 pill every day until you finish the pack.
• You could become pregnant if you have sex in the 7 days after you miss two pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you miss 3 or more pink pills in a row, follow these steps:

• Do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. For example, if you start taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may have bleeding during the week following the missed pills.
• You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. You must use a non-hormonal birth control method (such as a condom or spermicide) as a back-up 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 white pills, call your healthcare provider because you may be pregnant.

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

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

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

JOLIFU-002

Revised August 2017