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(Ethinyl Estradiol/Levonorgestrel)

The active ingredients in Aviane are levonorgestrel and ethinyl estradiol.

These hormones work together to prevent pregnancy in several ways. They stop ovulation, meaning the ovaries do not release an egg. They also thicken cervical mucus, making it harder for sperm to reach the egg, and change the lining of the uterus, which reduces the chance of implantation. This combined mechanism of action makes Aviane an effective oral contraceptive when taken correctly.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Aviane. However, the following is a synopsis of the general guidelines for the use of Aviane:

• Take Aviane exactly as prescribed by your healthcare provider.
• Take one tablet daily at the same time each day.
• Follow the order of the pill pack carefully, including active pills and reminder pills.
• Aviane packs typically include 21 active tablets and 7 reminder pills.
• You may start taking Aviane on the first day of your menstrual period or as directed.
• Swallow tablets whole with water.
• If you miss pills, follow the instructions in your medication guide.
• Missing pills may increase the risk of pregnancy.
• Use backup contraception, such as spermicide, if advised.
• If vomiting or diarrhea occurs, effectiveness may be reduced.
• Continue taking the pills even if you experience breakthrough bleeding.

Some mild or common side effects of Aviane include:

• Nausea.
• Breast tenderness.
• Bloating.
• Mood changes.
• Weight gain.
• Breakthrough bleeding or spotting.

Some individuals may experience serious side effects while using Aviane. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of blood clots such as chest pain, leg pain, or shortness of breath.

-Severe headache or vision changes.

• Symptoms of a heart attack such as chest pain or discomfort.
• Signs of stroke such as weakness or trouble speaking.
• Yellowing of the skin or eyes (jaundice), which may indicate liver problems.
• Severe abdominal pain.
• Signs of an allergic reaction, such as hives, swelling, or trouble breathing.

These are not all of the possible side effects of Aviane. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Aviane, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of blood clots or increased risk of clotting.
• High blood pressure or heart disease.
• Liver disease or liver tumors.
• Breast cancer or hormone-sensitive conditions.
• Kidney disease or gallbladder disease.
• High cholesterol or triglycerides.
• Obesity or prolonged bed rest.
• Additional precautions:
• Smoking increases the risk of serious cardiovascular events, especially in women over 35 years of age.
• Hormonal birth control may increase the risk of blood clots, heart attack, or stroke.
• Monitor for changes in vision or discomfort when wearing contact lenses.
• Regular check-ups with your healthcare provider are recommended.
• This medication does not protect against sexually transmitted diseases.

Boxed Warning

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives.

This risk increases with age and the number of cigarettes smoked.

The risk is especially significant in women over 35 years of age.

Aviane should not be used in the following situations:

• Known hypersensitivity to levonorgestrel and ethinyl estradiol or any component.
• History of blood clots or thromboembolic disorders.
• Certain types of heart disease or stroke.
• Liver disease or liver tumors.
• Known or suspected breast cancer.
• Undiagnosed abnormal vaginal bleeding.

Aviane may begin to prevent pregnancy within the first cycle if started correctly. However, backup contraception may be needed during the first 7 days, depending on when you start taking the pills. Consistent daily use is important for effectiveness.

When Aviane is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ritonavir, which may affect hormone levels and reduce effectiveness.
• St. John’s wort, which may decrease contraceptive effectiveness.
• Griseofulvin, which may reduce hormone levels and effectiveness.
• Modafinil, which may decrease the effectiveness of hormonal contraceptives.
• Certain antiviral combinations, such as ombitasvir-containing regimens, which may increase liver-related risks.

Aviane is available in blister packs containing:

• 21 light-green active tablets with levonorgestrel and ethinyl estradiol.
• 7 reminder pills without active hormones.
• The daily dose is one tablet per day following the pill pack schedule.

It should be stored at room temperature, away from the reach of children or pets.

Aviane is manufactured by Teva Pharmaceuticals.

Yes, Aviane is available as a generic medication. The generic name is levonorgestrel and ethinyl estradiol tablets.

Aviane can be stopped at any time, but you should consult your healthcare provider first.

• Stopping may lead to the return of ovulation and possible pregnancy.
• Your menstrual period may take time to return to normal.
• Discuss alternative contraceptive options with your healthcare provider.

You should not take Aviane if you are planning to become pregnant or are already pregnant.

It is generally recommended not to use Aviane while breastfeeding, particularly in the first few weeks or months after childbirth.

Aviane is a combined oral contraceptive (containing both estrogen and progestin) that can interfere with your breast milk supply and may have undesirable effects on a nursing infant.