Patient Information

                                                           MARLISSA® (MĀR-LIS-SĂ)

                              (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)

What is the most important information I should know about MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

Do not use MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets).

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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

Do not take MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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
• •had breast cancer or any cancer that is sensitive to female hormones
• •have liver problems, including liver tumors
• •have any unexplained vaginal bleeding
• •are pregnant
• •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.

If any of these conditions happen while you are taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets), stop taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets).

What should I tell my healthcare provider before taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

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. MARLISSA® (levonorgestrel and ethinyl estradiol tablets) may decrease the amount of breast milk you make. A small amount of the hormones in MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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.

MARLISSA® (levonorgestrel and ethinyl estradiol tablets) may affect the way other medicines work, and other medicines may affect how well MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

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

What are the possible serious side effects of MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

• •Like pregnancy, MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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

• •sudden change in vision or blindness

• •sudden severe shortness of breath

• •chest pain

• •a sudden, severe headache unlike your usual headaches

• •weakness or numbness in your arm or leg

• •trouble speaking

Other serious side effects include:

• • liver problems, including:
  • orare liver tumors
  • ojaundice (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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets).
• • 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 if 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets). Use sunscreen if you have to be in the sunlight.

What are the most common side effects of oral contraceptives?

• •nausea

• •weight gain

• •vomiting

• •breast tenderness

• •bleeding between menstrual periods

• •difficulty wearing contact lenses

These are not all the possible side effects of MARLISSA® (levonorgestrel and ethinyl estradiol tablets). 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

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

How should I store MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

• •Store MARLISSA® (levonorgestrel and ethinyl estradiol tablets) 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets).

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MARLISSA® (levonorgestrel and ethinyl estradiol tablets) for a condition for which it was not prescribed. Do not give MARLISSA® (levonorgestrel and ethinyl estradiol tablets) to other people, even if they have the same symptoms that you have.

This Patient Information Leaflet summarizes the most important information about MARLISSA® (levonorgestrel and ethinyl estradiol tablets). You can ask your pharmacist or healthcare provider for information about MARLISSA® (levonorgestrel and ethinyl estradiol tablets) that is written for health professionals.

For more information, call 1 (888) 721-7115.

Do birth control cause cancer?

There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more.

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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets), 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 MARLISSA® (levonorgestrel and ethinyl estradiol tablets)?

Active ingredients: Each light orange to orange pill contains levonorgestrel and ethinyl estradiol.

Inactive ingredients:

Light orange to orange pills: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol.

Light pink to pink inert tablets: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc.

Distributed by:

Glenmark Pharmaceuticals Inc., USA

Elmwood Park, NJ 07407

Questions? 1 (888) 721-7115

www.glenmarkpharma-us.com

April 2025