Pronunciation:

droe-SPYE-re-none, es-TE-trol

Brand Names:

• Nextstellis

Dosage Forms:

• Tablet

Warnings:

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including drospirenone and estetrol tablets, are contraindicated in women who are over 35 years of age and smoke .

Classifications:

Therapeutic—

Biphasic Contraceptive Combination

Pharmacologic—

Progestin

Uses of This Medicine:

Drospirenone and estetrol combination is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of drospirenone and estetrol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Older adults—

Appropriate studies on the relationship of age to the effects of drospirenone and estetrol combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Boceprevir
• Cobicistat
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Selegiline
• Temazepam
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Adrenal disease or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Blood disorders (eg, hypercoagulopathy) or
• Breast cancer, active or history of or
• Diabetes with high blood pressure or kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Kidney disease or
• Liver disease, including tumors or cancer or
• Migraine headache, new or worse or a new kind of headache or
• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or
• Chloasma gravidarum (skin disorder during pregnancy), history of or
• Cholestasis (bile problem) during pregnancy, history of or
• Depression, history of or
• Diabetes or
• Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
• Gallbladder disease or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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 make using 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. Each blister pack contains 28 tablets with different colors (pink and white) that need to be taken in the same order as directed on the blister pack.

Take this medicine at the same time each day. You may take it with or without food. 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 have light bleeding or spotting when you first take the pill.

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.

If you are switching from another birth control method (eg, pill, transdermal patch, vaginal ring) to using Nextstellis™, take the medicine on the day you would have usually taken your next pill. Do not continue taking the pills from your previous birth control pack. If you have used a vaginal ring, or patch, take the pill on the day the ring, or patch is reapplied.

If you are switching from another birth control method (eg, intrauterine device or intrauterine system) to using Nextstellis™, take the medicine on the day your IUD or IUS are removed. You must also use a second method of birth control (eg, condom, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (eg, implant, injection) to using Nextstellis™, take the medicine on the day you would have removed your implant or on the day you would have your next injection.

If you have a miscarriage or abortion after the second trimester or if you gave birth and chose not to breastfeed, you may start using this medicine after 4 weeks to prevent the risk of having blood clots. You must also use a second method of birth control (eg, condom, spermicide) for the first 7 days you take this medicine.

If you have a miscarriage or abortion after the second trimester or less, you must also use a second method of birth control (eg, condom, spermicide) for the first 7 days you take this medicine.

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 will ask you to begin your dose on the first day of your menstrual period (called Day 1 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, check with your doctor about changing it. If you cannot start taking the pills on the first day of your menstrual period, you need to use another form of birth control (eg, condom, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy 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—One pink tablet (active) taken at the same time each day for 24 days in a row followed by one white (inert) tablet once a day for 4 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.

If you miss 1 pink pill, take it as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Continue taking 1 pill every day until you finish the pack.

If you miss 2 or more pink pills on week 1 or 2, take a pill as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Throw away the other missed pills. Continue taking 1 pill every 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 2 or more pink pills on week 3, take a pill as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Throw away the other missed pills. Continue taking 1 pill every day until you finish the pink pills in the pack. Throw out the rest of the white pills in the pack and start a new pack the next day. Use a second form of birth control (including condom, spermicide) for 7 days after you miss a dose.

If you miss 1 or more white pills, skip the missed pill and continue taking 1 pill every day until you finish the pack.

If you vomit or have diarrhea within 3 to 4 hours of taking the pills, treat this as a missed dose and take a new pill as soon as you can. Then take your next pill within 12 hours of the regular time. If you miss 2 or more pills, follow the instructions in the patient leaflet or call your doctor or you may use another form of birth control.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may also be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. You might need a pregnancy test.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using drospirenone and estetrol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Using this medicine may increase your risk of having cervical cancer. Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding, discharge, or pain.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

You might have some light bleeding or spotting, especially during the first 4 months of using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats 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 if you are having a surgery that requires inactivity for a long time.

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

Side Effects of This Medicine:

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:

Less common

Absent, missed, or irregular menstrual periods

anger

anxiety

breast discomfort, enlargement, fullness, pain, soreness, swelling, or tenderness

chest pain or discomfort

confusion about identity, place, and time

cramps

difficulty in speaking

discouragement

dizziness or lightheadedness

double vision

dry mouth

fainting

fast or pounding heartbeat

feeling sad or empty

headache

headache, severe and throbbing

heavy bleeding

heavy non menstrual vaginal bleeding

inability to move the arms, legs, or facial muscles

inability to speak

irregular heartbeat

irritability

lack of appetite

longer or heavier menstrual periods

loss of interest or pleasure

lower stomach cramps or pain

nausea

nervousness

nipple pain

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

pain, redness, or swelling in the arm or leg

pain in the chest, groin, or legs, especially the calves

pain or discomfort in the arms, jaw, back, or neck

painful or tender cysts or lumps in the breasts

pelvic discomfort or pain

restlessness

shaking

slurred speech

stopping of menstrual bleeding

sudden, severe weakness or numbness in the arm or leg

sudden loss of coordination

sweating

thoughts of killing oneself changes in behavior

tiredness

trouble breathing

trouble concentrating

trouble sleeping

unexpected or excess milk flow from the breasts

unusually heavy or unexpected menstrual bleeding

vaginal bleeding or spotting

vision changes

vomiting

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:

Less common

Blemishes on the skin

decreased interest in sexual intercourse

loss in sexual ability, desire, drive, or performance

pimples

weight increased

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.