Desogestrel-Ethinyl-Estradiol

Desogestrel/Ethinyl Estradiol is a prescription medication used as contraception to prevent pregnancy. 

• Desogestrel/Ethinyl Estradiol is available under the following different brand names: Ortho-Cept, Desogen, Apri, Caziant, Cyclessa, Emoquette, Enskyce, Kariva, Mircette, Reclipsen, Solia, Velivet, Viorele, Azurette, Kimidess, Pimtrea, Bekyree, Cyred, Cyred EQ, Isibloom, Juleber

Common side effects of Desogestrel/Ethinyl Estradiol include:

• nausea,
• vomiting (especially when taking the medicine for the first time),
• breast tenderness,
• breakthrough bleeding,
• acne,
• darkening of facial skin,
• weight gain, and
• problems with contact lenses

Serious side effects of Desogestrel/Ethinyl Estradiol include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• sudden numbness or weakness (especially on one side of the body),
• sudden severe headache,
• slurred speech,
• problems with vision or balance,
• sudden vision loss,
• stabbing chest pain,
• feeling short of breath,
• coughing up blood,
• pain or warmth in one or both legs,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• loss of appetite,
• upper stomach pain,
• tiredness,
• fever,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• severe headache,
• blurred vision,
• pounding in the neck or ears,
• swelling in the hands, ankles, or feet,
• changes in the pattern or severity of migraine headaches,
• breast lump,
• sleep problems,
• weakness,
• tired feeling, and
• mood changes

Rare side effects of Desogestrel/Ethinyl Estradiol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult  dosage

Tablet, monophasic

• 0.15 mg/0.03 mg

Tablet, biphasic

• 0.15 mg/0.02 mg x 21 days, then inert tabs x 2 days, then 0 mg/0.01 mg x 5 days

Tablet, triphasic

• 0.1 mg/0.025 mg (7 tabs), plus
• 0.125 mg/0.025 mg (7 tabs), plus
• 0.15 mg/0.025 mg (7 tabs)

Contraception

Adult dosage

Monophasic (Apri, Cyred, Cyred EQ, Desogen, Emoquette, Enskyce, Isibloom, Juleber, Ortho-Cept, Reclipsen, Solia)

• 1 tablet orally every day for 28 days, then start a new pack
• Days 1-21: Each tablet contains desogestrel 0.15 mg/Ethinyl Estradiol (EE) 0.03 mg
• Days 22-28: Inactive tablets

Biphasic (Azurette, Bekyree, Kariva, Kimidess, Mircette, Pimtrea, Viorele)

• 1 tablet orally every day for 28 days in the order indicated on the package, then start a new pack
• Days 1-21, Each tablet contains 0.15 mg desogestrel/0.02 mg EE
• Days 22-23: Inactive tablets
• Days 24-28: Each tablet contains 0.01 mg of Ethinyl Estradiol

Triphasic (Cyclessa, Velivet, Caziant)

• 1 tablet orally every day for 28 days in the order indicated on the package, then start new pack Day 1-7, each tablet contains 0.025 mg Ethinyl Estradiol and 0.1 mg desogestrel
• Days 8-14, each tablet contains 0.025 mg Ethinyl Estradiol and 0.125 desogestrel
• Days 15-21, each tablet contains 0.025 mg Ethinyl Estradiol and 0.15 desogestrel
• Days 22-28: Inactive tablets

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Desogestrel/Ethinyl Estradiol has severe interactions with the following drugs:
  • cabotegravir
• ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
• Desogestrel/Ethinyl Estradiol has serious interactions with at least 62 other drugs.
• Desogestrel/Ethinyl Estradiol has moderate interactions with at least 132 other drugs.
• Desogestrel/Ethinyl Estradiol has minor interactions with at least 27 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension (ie, persistent BP values above 160 mm Hg systolic or more than 100 mg Hg diastolic)
• Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use
• Inherited or acquired hypercoagulopathies
• Smoke, if age above 35 years
• Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Desogestrel/Ethinyl Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Desogestrel/Ethinyl Estradiol?”

Cautions

• Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (e.g., migraine, asthma, epilepsy)
• Women with a history of hypertension or hypertension-related diseases or renal disease should be encouraged to use another method of contraception
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• Increased risk of cervical cancer with OCP use, however, HPV remains the main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• The risk of venous thromboembolism (VTE) is highest in the first year of use and when a combination oral contraceptive is started or restarted after a break in the use of four weeks or more
• CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease the risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)
• Discontinue hormonal therapy before starting therapy with a combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with a combination drug regimen
• Breast cancer
  • Epidemiology studies have not found a consistent association between the use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer
  • Some studies report a small increase in the risk of breast cancer among current or recent users(below 6 months since last use) and current users with a longer duration of COC use
  • A woman's risk depends on conditions where naturally high hormone levels persist for long periods including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity

Pregnancy & Lactation

• Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives before pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy
• Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy; oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion
• It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use; if the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period; oral contraceptive use should be discontinued if pregnancy is confirmed
• Lactation
  • Small amounts of oral contraceptive steroids were identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given during the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk
  • If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child