Kariva

(Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol)

Kariva works to prevent pregnancy by using synthetic hormones that mimic estrogen (ethinyl estradiol) and progestin (desogestrel). These hormones stop ovulation (the release of an egg from an ovary), thicken mucus in your cervix to block sperm from reaching the egg, and thin the lining of the uterus to make implantation unlikely. Together, these actions make pregnancy much less likely when the pill is taken correctly and consistently.

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 Kariva. However, the following is a synopsis of the general guidelines for the use of Kariva:

• Kariva is taken by mouth once daily, at the same time each day.
• The blister pack contains 28 tablets, which are taken in order without skipping days.
• Active tablets containing hormones are taken first, followed by inactive tablets at the end of the cycle.
• A menstrual period typically occurs during the days the inactive tablets are taken.
• If a dose is missed, back-up birth control may be required depending on when the missed dose occurred.
• Kariva should be started exactly as instructed by a healthcare provider, especially when switching from another birth control method.
• Taking Kariva consistently and correctly is important for maintaining contraceptive effectiveness. Missing doses or taking tablets late can increase the risk of pregnancy.

Some mild or common side effects of Kariva include:

• Nausea.
• Breast tenderness.
• Breakthrough bleeding or spotting between menstrual periods.
• Headache.
• Weight gain or fluid retention (edema).
• Changes in the menstrual cycle, including amenorrhea.

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

• Blood clots in the legs, lungs, heart, or brain.
• Chest pain or shortness of breath.
• Severe headache or sudden vision changes.
• Swelling or pain in one leg.
• Signs of a heart attack or stroke.
• Severe allergic reactions, including angioedema.
• Vision problems or trouble wearing your contact lenses.

These are not all of the possible side effects of Kariva. 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 Kariva, 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:

• High blood pressure or hypertension.
• Heart disease or coronary artery disease.
• A history of blood clots or increased risk of blood clots.
• Breast cancer or estrogen-sensitive cancers.
• Gallbladder disease.
• Liver disease or hepatitis C.
• High cholesterol or triglyceride levels.
• Kidney disease.
• A history of migraine with aura.

Boxed Warning

Smoking while using combination oral contraceptives (COCs) increases the risk of serious cardiovascular events, especially in people over 35 years of age. For this reason, COCs, including Kariva, are contraindicated in women who are over 35 years of age and smoke.

Kariva should not be used in individuals who are pregnant or who have a history of blood clots, certain heart conditions, uncontrolled hypertension, breast cancer, severe liver disease, or unexplained vaginal bleeding. A healthcare provider will review contraindications before prescribing this medication.

If Kariva is started on the first day of the menstrual period, pregnancy protection begins immediately. If started at another time, back-up birth control such as condoms or spermicide may be needed for the first 7 days. Full effectiveness depends on consistent daily use.

When Kariva 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:

• Rifampin may reduce contraceptive effectiveness.
• Carbamazepine, phenytoin, phenobarbital, or topiramate may lower hormone levels.
• Griseofulvin may reduce birth control effectiveness.
• Ritonavir, which may alter hormone levels.
• St. John’s wort may decrease contraceptive reliability.
• Lamotrigine may have reduced blood levels when taken with hormonal birth control.
• Back-up birth control may be required when certain interacting medications are used.

Kariva is available as an oral tablet in a 28-day blister pack containing active and inactive tablets.

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

Kariva is manufactured by Teva Pharmaceuticals.

Yes. Generic name versions containing desogestrel and ethinyl estradiol are available.

Kariva can be stopped at any time, but pregnancy may occur shortly after discontinuation. If you plan to stop Kariva, talk to your healthcare provider about alternative birth control options if pregnancy prevention is still desired.

Kariva should not be used during pregnancy. If pregnancy occurs while taking Kariva, contact your healthcare provider right away.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Hormonal birth control may reduce breast milk production, especially early after childbirth. Your healthcare provider will help determine the best option.