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Nextstellis

Common Name:

drospirenone - estetrol

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How does this medication work? What will it do for me?

Drospirenone – estetrol is a combination medication containing two ingredients: progestin (drospirenone) and estrogen (estetrol). It is a birth control pill used to prevent pregnancy, by women between 16 and 50 years of age. This medication works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix (that makes it difficult for sperm to penetrate into the uterus) and in the endometrium (that make it difficult for an egg to implant).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each pink, round, biconvex, film-coated tablet with a drop-shaped logo embossed on one side, contains 15 mg of estetrol monohydrate and 3 mg of drospirenone. Nonmedicinal ingredients: hydrogenated cottonseed oil, hydroxypropylcellulose, hydroxypropylmethylcellulose, iron oxide red (E172), lactose monohydrate, magnesium stearate (E572), maize starch, povidone, sodium starch glycolate (Type A), talc (E553b), and titanium dioxide (E171).

Each white-to-off-white, round, biconvex, film-coated tablet with a drop-shaped logo embossed on one side contains no active ingredients. Nonmedicinal ingredients: hydrogenated cottonseed oil, hydroxypropylcellulose, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate (E572), maize starch, talc (E553b), and titanium dioxide (E171).

How should I use this medication?

Each package contains 24 pink tablets that contain the active ingredients drospirenone and estetrol. It also contains 4 white tablets that do not contain any active medication.

Take 1 pink tablet daily by mouth, for 24 days, followed by one white tablet daily for 4 days. After you have completed the package, start a new package on the next day, regardless of whether you are still experiencing menstrual bleeding.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on Day 1 or on the first Sunday after your period starts. The pills should be taken approximately the same time every day. It is a good idea to use a second method of birth control (e.g., latex condoms, or spermicidal foam or gel) for the first 7 days of the first cycle of pill use to ensure prevention of pregnancy.

Many women experience spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

If you have vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or pharmacist.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.If you miss pills at any time, the risk of becoming pregnant increases.

If you vomit after taking a pill and it is within 4 hours, take another tablet as soon as possible. The next day’s dose should be taken at the usual time.

If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during days 1 to 17 of your cycle, take the last missed tablet as soon as you remember and then take one pill a day until you finish the pack. The missed tablets will remain in the package and should be discarded at the end of the cycle. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you start your pills on Sunday and you miss 2 pills in a row during days 18 to 24 of your cycle, take the last missed tablet when you remember and the next dose at your usual time. Keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. Use another method of birth control until you have taken seven pink tablets in a row. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you start your pills on a day other than a Sunday and you miss 2 pills in a row during days 18 to 24 of your cycle, take the last missed tablet as soon as possible and then return to taking one tablet a day until you finish the pink tablets. Discard the white tablets and start a new package the next day. Use another method of birth control if you have sex in the 7 days after you miss the pills.  You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you miss any of the white pills, safely dispose of the pills you missed and keep taking one pill each day until the pack is empty. Begin a new pack as you would normally.

See the package insert for additional information on where to start and what to do if you forget to take a pill.

Store this medication at room temperature in its original packaging and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to drospirenone, estetrol, or any ingredients of the medication
  • are or may be pregnant
  • have active liver disease
  • have any eye damage resulting from vascular (blood vessel) disease of the eye, such as partial or complete loss of vision or a visual field defect
  • have had a heart attack
  • have had jaundice (yellowing of skin) with pregnancy or with prior pill use
  • have, have had, or may have an endometrial cancer (cancer of the uterus lining) or another type of tumour that needs estrogen to grow
  • have, have had, or may have breast cancer
  • have heart valve disease with complications
  • have or have had benign or malignant liver tumours
  • have or have had cerebrovascular disorders (e.g., stroke) or a condition that may be the first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
  • have or have had coronary artery disease (e.g., angina)
  • have or have had migraines with aura
  • have or have had pancreatitis associated with extremely high triglyceride levels
  • have or have had thrombophlebitis or thromboembolic (blood clotting) disorders
  • have reduced kidney function
  • have reduced liver function
  • have problems with the adrenal gland
  • have severe or multiple risk factors for blood clots:
    • diabetes with blood vessel involvement
    • are a smoker and over 35 years old
    • inherited or acquired blood clotting disorders
    • major surgery associated with an increased risk of blood clots after surgery
    • prolonged bed rest
    • severe high blood pressure
    • severe high cholesterol
    • are over 50 years old
    • have a body mass index over 30
    • have a parent or sibling who has had blood clots, especially which occurred when the family member was under age 50
    • have other medical conditions associated with blood clots
  • have undiagnosed abnormal vaginal bleeding

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne (usually less common after 3 months of treatment, and may improve if acne already exists)
  • back pain
  • breast pain, tenderness, or swelling
  • changed interest in sexual activity
  • constipation
  • darkening skin on the face
  • diarrhea
  • difficulty wearing contact lenses
  • dizziness
  • dry eyes
  • hair loss
  • headache
  • heartburn
  • hot flushes
  • increased eating
  • nausea
  • prickling or burning skin sensation
  • trouble sleeping
  • unusual hair growth on face, chest, abdomen, or legs
  • vomiting
  • weight change

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal bloating or swelling
  • blood pressure changes
  • breast lumps
  • changes in your bleeding pattern during periods or between periods, such as:
    • breakthrough bleeding or spotting between periods
    • complete stopping of menstrual bleeding several months in a row
    • decreased bleeding during periods
    • occasional stopping of menstrual bleeding
    • prolonged bleeding during periods
  • cold symptoms (e.g., runny nose, stuffy nose, sore throat)
  • flu-like symptoms
  • increased blood pressure
  • mood swings including agitation, aggressive behaviour, or hostility
  • painful bowel movements
  • painful intercourse
  • pelvic pain
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of a liver problem (e.g., yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
  • unusual bruising
  • vaginal yeast infection with vaginal itching or irritation, or thick, white, or curd-like discharge

 

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of an allergic reaction (e.g., difficulty breathing, hives, swelling of the face or throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • sudden loss of vision (partly or completely)
  • signs of stroke (e.g., sudden severe or worsening headache; vomiting; dizziness; fainting; vision or speech problems; weakness or numbness in the face, arm, or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: All hormonal contraceptives can increase the risk of developing blood clots. Some studies show that birth control pills containing drospirenone have a higher risk of blood clots compared to other birth control pills. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Tell your doctor if you are planning an upcoming surgery or if you will be immobilized or inactive for a prolonged period of time (i.e., due to an accident or illness), as there is an increased risk of blood clot formation when using combination hormone contraceptives. If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision or speech changes, sudden severe headache, weakness or numbness in an arm or leg, or are coughing blood, get immediate medical attention as these symptoms could indicate a possible blood clot.

Blood pressure: This medication may increase blood pressure, increasing the risks of other heart problems. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to visit your doctor more frequently to have your blood pressure checked while using this medication. Occasionally, high blood pressure that develops with the use of hormone contraceptives may require stopping this medication.

Cigarette smoking and heart disease: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as a woman gets older. Women over 35 years of age who are smokers should not use the birth control pill. Other factors that increase your risk of heart disease include diabetes, high blood pressure, high cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk. For women who have a low risk of heart disease and do not smoke, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease, regardless of age. These women may continue to use birth control pills up to the age of menopause.

Depression: This medication, like other birth control medications, may contribute to feelings of depression. If you have a history of depression or other emotional problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Women with a history of depression or other emotional problems may be more likely to have a recurrence while taking oral birth control medications.

Diabetes: If you have diabetes or a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have diabetes, it may be necessary to test your blood sugar more often to detect any worsening of blood sugar control after starting birth control pills.

Epilepsy: If you have a history of epileptic seizures, speak to your doctor about the possibility of this medication increasing the numbers of epileptic seizures you may experience. If you experience a change in the frequency of seizures, contact your doctor as soon as possible.

Electrolytes: This medication contains the progesterone drospirenone, which may increase potassium levels for women who are at high risk for this condition. Women with reduced kidney or liver function or inadequate production of adrenal hormones are at increased risk. Women who receive other medications that can increase their potassium should have their potassium levels checked by their doctor when they first start this medication.

Eye problems: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye, which may cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

Fibroid tumours: This medication may worsen fibroid tumours (noncancerous growths in the uterus), causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gallbladder problems: The use of hormonal contraceptives increases the risk of gallbladder problems. If you experience symptoms of gallbladder problems, such as severe stomach or back (between the shoulder blades) pain, nausea or vomiting, contact your doctor.

Inflammatory Bowel Disease: Some women who have Crohn’s disease or ulcerative colitis may experience worsening symptoms when they take birth control pills. This may cause a decrease in effectiveness of this medication. If you have Crohn’s disease or colitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: Drospirenone – estretrol has not been studied for use by patients with kidney problems. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to have regular blood tests while taking this medication. Women with moderate to severely decreased kidney function should not take this medication.

Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems, including liver cancer. See your doctor as soon as possible if you develop signs of liver problems such as yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin.

Migraine and headache: Women with migraines should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed. Tell your doctor if you notice the development of worsening migraine headaches or new types of headaches that are recurrent, persistent, or severe.

Regular checkups: Your doctor may want a follow-up visit 3 months after starting this medication. After this, you should visit your doctor yearly for a physical examination and follow-up while you are taking this medication.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Risk of cancer: The use of hormone contraceptives may increase the risk of breast and cervical cancer for women before menopause (around age 50). If you have been using hormone contraceptives for a long time (more than 8 years), started using them at an early age, or have a family history of cancer (mother or sister), you may be at an increased risk of developing cancer. Talk to your doctor about whether any special monitoring is needed.

If you are taking birth control pills, you should learn how to do a breast self-exam. Notify your doctor anytime you detect a lump. For some women, the use of birth control pills may speed up the growth of a breast cancer that has not yet been diagnosed. A yearly clinical breast examination is also recommended because, if breast cancer should develop, medications that contain estrogen may cause the cancer to grow quickly.

Sexually transmitted infections (STIs): Birth control pills do not protect against HIV/AIDS and other sexually transmitted infections (STIs; formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with this medication to protect against these infections.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: The hormones in this medication pass into breast milk. These hormones may reduce the quantity and quality of the breast milk. Breast-feeding women should use another form of birth control until they are no longer breast-feeding. Talk to your doctor about your options.

Children: The safety and effectiveness of using this medication have not been established for children less than 16 years of age.

What other drugs could interact with this medication?

There may be an interaction between drospirenone-estetrol and any of the following:

  • acetaminophen
  • acetylsalicylic acid (ASA)
  • aliskiren
  • anastrozole
  • angiotensin converting enzyme inhibitors (ACE inhibitors; e.g., ramipril, lisinopril, or enalapril)
  • angiotensin-II receptor blockers (e.g., candesartan, losartan)
  • antacids (when taken within 2 hours of the medication)
  • antibiotics (e.g., ampicillin, cotrimoxazole, erythromycin, metronidazole, penicillin, nitrofurantoin, rifampin, sulfonamides, tetracyclines)
  • anticonvulsants (e.g., carbamazepine,  lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate)
  • apalutamide
  • apixaban
  • aprepitant
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., phenobarbital)
  • benzodiazepines (e.g., lorazepam, diazepam, chlordiazepoxide)
  • beta-blockers (e.g., propranolol, metoprolol, atenolol)
  • bosentan
  • caffeine
  • cannabis
  • celecoxib
  • cholestyramine
  • clonidine
  • cobicistat
  • conivaptan
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dabigatran
  • deferasirox
  • dehydroepiandrosterone
  • diabetes medications (e.g., acarbose, canagliflozin, glyburide, linagliptin, liraglutide, insulin, metformin, rosiglitazone)
  • diltiazem
  • dronedarone
  • edoxaban
  • elagolix
  • exemestane
  • flibanserin
  • folic acid
  • grapefruit juice
  • heparin
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hyaluronidase
  • lenalidomide
  • letermovir
  • lixisenatide
  • lumacaftor and ivacaftor
  • mifepristone
  • mitotane
  • modafinil
  • mycophenolate
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
  • octreotide
  • pomalidomide
  • potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene)
  • potassium supplements or potassium- containing salt substitutes
  • protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib, nilotinib, ribociclib, sunitinib)
  • retinoic acid medications (e.g., acitretin, etretinate, isotretinoin)
  • rifabutin
  • rifampin
  • rivaroxaban
  • ropinirole
  • St. John’s wort
  • sarilumab
  • selegiline
  • siltuximab
  • smoked tobacco
  • somatropin
  • thalidomide
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • thyroid replacements (e.g., desiccated thyroid, levothyroxine)
  • tocilizumab
  • tranexamic acid
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine)
  • ursodiol
  • verapamil
  • vitamin C
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Nextstellis

Last Updated: 30/11/2022