Cyclessa

(Desogestrel/Ethinyl Estradiol)

The active ingredients in Cyclessa are ethinyl estradiol (estrogen) and desogestrel (progestin). It is a combined oral contraceptive that works mainly by suppressing ovulation. The hormones inhibit the release of FSH and LH from the pituitary gland, which prevents the ovary from releasing an egg. It also thickens cervical mucus, making it difficult for sperm to enter the uterus, and alters the uterine lining, reducing the chance of implantation. Together, these actions effectively prevent pregnancy.

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

• Take one tablet every day at the same time, following the order on the blister card.
• Start the first cycle as directed, often on the first day of the menstrual period or the first Sunday after bleeding begins.
• If a dose is missed, follow the missed-dose instructions in the patient guide to reduce the chance of pregnancy.
• Use a backup method, such as spermicides, if pills are missed or taken late.
• Do not skip tablets, even if breakthrough bleeding occurs during the cycle.
• If vomiting or severe diarrhea occurs, use additional birth control until the next cycle.

Some mild or common side effects of Cyclessa seen in clinical trials include:

• Nausea and vomiting.
• Breast tenderness.
• Headache.
• Breakthrough bleeding or spotting.
• Bloating
• Edema (fluid retention).
• Mood changes.
• Changes in the menstrual cycle, such as amenorrhea.
• Hypertension (high blood pressure).
• Weight gain.

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

• Heart attack: chest pain, stomach discomfort, sweating, nausea, and dizziness.
• Stroke: sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, and difficulty walking.
• Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, and muscle tightness.
• Pulmonary embolism (blood clot in the lung): cough, chest pain, shortness of breath, and racing heart.
• Liver disease: yellowing of the skin or the whites of the eyes, tiredness, and stomach pain.
• Increased risk of breast cancer and cervical cancer.
• Severe headache or migraine headache.

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

• A history of thromboembolic disorders or blood clots.
• High blood pressure, cardiovascular disease, or heart valve disorders.
• Liver disease, including tumors or hepatitis.
• Kidney disease.
• A history of breast cancer.
• Gallbladder disease.
• A recent major surgery or immobilization.
• Risk factors for hypertension or high cholesterol.
• Smoking habits, especially if 35 years of age or older.
• If you have any cancers, such as breast cancer or endometrial cancer.

Boxed Warning

Cigarette smoking increases the risk of cardiovascular disease and significantly raises the chance of serious cardiovascular adverse effects in women who use combination hormonal contraceptives. This risk becomes even greater with increasing age, particularly in women over 35 years, and with heavy smoking of 15 or more cigarettes per day. For this reason, women who use hormonal oral contraceptives should be strongly advised not to smoke.

Cyclessa should not be used in individuals who:

• Are pregnant or think they may be pregnant.
• Heavy smoking (15 or more cigarettes per day) and over age 35.
• Have a history of blood clots, stroke, or heart attack.
• Have certain heart or cardiovascular conditions.
• Have liver disease or liver tumors.
• Have breast cancer or estrogen-dependent cancer.
• Have unexplained vaginal bleeding.
• Diabetes with blood vessel problems.
• Certain types of headaches.
• Major surgery where you weren't able to move for a long time.
• Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir.

Cyclessa may begin working within the first cycle, but backup contraception is recommended for the first 7 days unless started on the first day of the menstrual period.

When Cyclessa 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:

• Carbamazepine, topiramate, or felbamate may lower contraceptive effectiveness.
• Atorvastatin.
• Griseofulvin, which may reduce hormone levels.
• St. John’s wort, which increases the chance of breakthrough bleeding.
• Ritonavir and other inhibitors that may alter hormone exposure.
• Cyclosporine and theophylline, because hormone changes may affect drug levels.
• Certain hepatitis C medicines, such as dasabuvir or ombitasvir combinations, may increase liver-related risks.

Cyclessa is supplied as a triphasic oral contraceptive tablet pack containing desogestrel and ethinyl estradiol in varying mcg strengths across the three phases.

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

Cyclessa is manufactured by the company listed on the official FDA-approved label.

Yes, there are generic formulations of Cyclessa that contain the same active ingredients, desogestrel and ethinyl estradiol. Common generic names and authorized versions include Velivet and Cesia.

You can stop Cyclessa at the end of a pill pack or as directed by your healthcare provider. Sudden discontinuation may cause menstrual cycle changes. If you stop taking oral contraceptives and do not get a menstrual period, tell your doctor so they can rule out pregnancy.

Cyclessa should not be used during pregnancy. If you become pregnant or suspect you might be pregnant while taking Cyclessa, you should stop taking the medication right away and contact your doctor.

Cyclessa can lower the amount and quality of breast milk you produce. It can also pass into breast milk, which might lead to larger breasts and jaundice (yellowing of the skin and whites of the eyes) in your breastfed baby. Because of this, it is recommended to use an alternative form of birth control until you have stopped breastfeeding.