Enskyce (Oral)

Desogestrel and ethinyl estradiol combination is used to prevent pregnancy. It is a birth control pill that contains two hormones, desogestrel and ethinyl estradiol. When taken correctly, it prevents pregnancy by stopping a woman's egg from fully developing each month. This means the egg cannot accept sperm, which prevents fertilization (pregnancy).

No contraceptive method is 100 percent effective. Birth control methods like surgery to become sterile or abstaining from sex are more effective than birth control pills. Talk to your doctor about your birth control options.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not work as emergency contraception after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress during regular visits to ensure this medicine is working correctly and does not cause side effects. These visits will usually be every 6 to 12 months, but some doctors may require them more frequently. Your doctor may also want to check your blood pressure while you are taking this medicine.

Even though you are using this medicine to prevent pregnancy, using it while you are pregnant could harm your unborn baby. If you think you might be pregnant while using this medicine, tell your doctor immediately. Make sure your doctor knows if you have had a baby within 4 to 6 weeks before starting this medicine.

You may experience vaginal bleeding of various amounts between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when it is light, or breakthrough bleeding when it is heavier.

• If this happens, continue taking your medicine as scheduled.
• The bleeding usually stops within 1 week. Contact your doctor if the bleeding lasts more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives as directed for more than 3 months, consult your doctor.

Contact your doctor right away if you miss a menstrual period. Missed periods may happen if you skip one or more tablets and do not take your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You may need a pregnancy test.

If you think you might be pregnant, see your doctor immediately.

Do not use this medicine with any medicine for hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. Smoking while using birth control pills increases your risk of blood clots, heart attack, or stroke. Your risk is even higher if you are over age 35, have diabetes, high blood pressure, high cholesterol, or if you are overweight. Discuss ways to stop smoking with your doctor. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol levels.

Using this medicine may increase your risk of blood clotting problems. This usually happens when you first start taking this medicine, or after taking birth control pills again after not using them for a month or more. Contact your doctor right away if you experience pain in the chest, groin, or legs, especially the calves, difficulty breathing, a sudden severe headache, slurred speech, sudden unexplained shortness of breath, a sudden loss of coordination, or changes in vision while using this medicine.

Using this medicine may increase your risk of breast cancer or cervical cancer. Discuss this risk with your doctor. Contact your doctor immediately if you have abnormal vaginal bleeding.

Contact your doctor right away if you wear contact lenses or if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to examine your eyes.

Contact your doctor immediately if you have pain or tenderness in the upper stomach, dark urine, pale stools, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Using this medicine may increase your risk of needing gallbladder surgery. Discuss this risk with your doctor.

Consult your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination, and your doctor may change your prescription.

Make sure any doctor or dentist treating you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 3 to 4 weeks before and 2 weeks after major surgery.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been proper studies about how desogestrel and ethinyl estradiol combination affects children. However, there are no expected problems specific to teenagers that would limit the use of this medication. This medicine can be used for birth control in teenage females but should not be used before menstruation starts.

Geriatric

There have not been proper studies about how desogestrel and ethinyl estradiol combination affects older adults. This medicine is not meant for elderly women.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. You should either use a different medication or stop breastfeeding while taking this medicine.

Interactions with Medicines

Some medicines should not be taken together at all, while others can be used together with caution. If you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions are significant and may not be all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may choose not to prescribe this medicine or may change your other medications.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following may increase the risk of certain side effects, but it may still be the best treatment option for you. If both medicines are prescribed, your doctor may adjust the dose or how often you use one or both.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods to avoid interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant and may not be all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If used together, your doctor may adjust the dose or give you special instructions about food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to tell your doctor about any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Blood disorders (e.g., hypercoagulopathy), either inherited or acquired or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from past hormonal therapy or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hypertension (high blood pressure)—Use with caution. May worsen these conditions.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase the risk of more serious side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness, lightheadedness, fainting
• fever
• hives or welts
• itching skin or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sudden troubled breathing
• sweating
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Apri
• Caziant
• Cesia
• Cyclessa
• Desogen
• Enskyce
• Kariva
• Mircette
• Ortho-Cept
• Reclipsen
• Solia
• Velivet

In Canada

• Marvelon 21
• Marvelon 28 - White Tablet

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive

Pharmacologic Class: Progestin

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To use oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine. Treat this as a missed dose.

If you are using colesevelam, take it at least 4 hours before or after using this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, talk with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of treatment on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):For contraception (to prevent pregnancy): Adults and teenagers: Desogen®—One white tablet (active) taken at the same time each day for 21 consecutive days followed by one green tablet (inert) daily for 7 days per menstrual cycle. Ortho-Cept®—One light orange tablet (active) taken at the same time each day for 21 consecutive days followed by one green tablet (inert) daily for 7 days per menstrual cycle. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

Use a second form of birth control for 7 days after you miss a dose to prevent pregnancy.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

• If you miss one light orange or white pill: Take the pill as soon as possible and take the next pill at your regular schedule.
• If you miss two light orange or white pills in week 1 or 2: Take the two pills as soon as possible and the next two pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
• If you miss two light orange or white pills in week 3, or if you miss three or more light orange or white pills in any week: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss your menstrual period 2 months in a row, check with your doctor because you might be pregnant.
• If you miss any of the seven green pills in week 4: Throw away the pills you missed. Continue taking one pill a day until you finish the pack.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.