Nextstellis: Uses, Side Effects and Dosage

Serious warnings and precautions box

What NEXTSTELLIS is used for:

NEXTSTELLIS is used to prevent pregnancy in women who have had their first menstrual period.

How NEXTSTELLIS works:

NEXTSTELLIS is a birth control pill. It is considered to be a combination oral contraceptive. This is because it contains two female sex hormones: estetrol monohydrate and drospirenone. The hormone estetrol monohydrate is made from a plant source. NEXTSTELLIS has been shown to be effective in preventing pregnancy when taken as prescribed by your healthcare professional.

Combination hormonal contraceptives, like NEXTSTELLIS work in two ways:

• To stop the monthly release of an egg by the ovaries.
• To change the mucus produced by your cervix. This slows the movement of the sperm through the mucus and through the uterus.

Effectiveness of NEXTSTELLIS:

The results of two clinical trials show that about 1 out of 100 women may get pregnant during the first year they use NEXTSTELLIS. The chance of becoming pregnant increases if NEXTSTELLIS is not used correctly.

Women who have a Body Mass Index (BMI) above 35 kg/m² were not studied in the clinical trial. It is not known how well NEXTSTELLIS will prevent pregnancy in these women.

Other Ways to Prevent Pregnancy:

There are other methods of birth control available. These are usually less effective than birth control pills. If used properly, the other methods of birth control are effective enough for many women. The following table lists pregnancy rates for different types of birth control. A pregnancy rate is the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies per 100 Women per Year:

There are differences in these pregnancy rates. This is because not all people use birth control as carefully or as regularly as they should. This does not apply to IUDs since these are implanted in the uterus. If you are careful and use your birth control regularly, pregnancy rates should be lower. Some types of birth control will require more effort than taking a single pill every day.

The ingredients in NEXTSTELLIS are:

Medicinal ingredients: estetrol monohydrate and drospirenone

Non-medicinal ingredients:

• Pink (active) tablets: Cottonseed oil, hydrogenated, hydroxypropylcellulose, hydroxypropylmethylcellulose, iron oxide red (E172), lactose monohydrate, magnesium stearate, maize starch, povidone, sodium starch glycolate, talc, titanium dioxide (E171)
• White (inert) tablets: Cottonseed oil, hydrogenated, hydroxypropylcellulose, hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate (E572), maize starch, talc, titanium dioxide (E171)

NEXTSTELLIS comes in the following dosage forms:

• Pink tablets: 15 mg estetrol monohydrate and 3 mg drospirenone.
• White tablets: no active ingredient

Do not use NEXTSTELLIS if:

• you are allergic to any ingredients in this drug;
• you have or have had a blood clot in the legs (deep vein thrombosis), lung (pulmonary embolism) or somewhere else in your body;

• you have the following risk factors for blood clots:

  • Severe high blood pressure or high blood pressure that is not under control (hypertension);

  • Blood clot disorders such as:

    • Abnormal Factor V Leiden mutation
    • Activated protein C (APC) resistance
    • Antithrombin-III-deficiency
    • Protein C deficiency
    • Protein S deficiency
    • hyperhomocysteinemia
    • Prothrombin mutation G20210A
    • Antiphospholipid-antibodies
  • you have an unusual amount of lipoproteins in your blood;
  • you have diabetes with complications;
  • increasing age such as a woman older than 50 years old;
  • you have too much body fat (you are obese);
  • a family history of blood clot disorders;
  • you had or will have a major surgery (including to the legs, pelvis or nervous system);
  • you cannot stand or move for long periods of time, including prolonged bed rest;
  • you are a woman over age 35 and smoke;
• you had a stroke or heart attack;
• you have or had coronary artery disease (including angina) or a condition that may be a first sign of stroke (such as mini stroke, small reversible stroke, chest pains);
• you have a disease of the heart valves with complications;
• you have kidney disease;
• you have adrenal problems;
• you have or you might have breast cancer;
• you have a cancer of the uterus, or a cancer that is sensitive to hormones;
• you have unusual vaginal bleeding without a known reason;
• you have liver disease;
• you have or have a history of liver tumours (cancerous or non-cancerous);
• you have or had jaundice. This is when the skin or whites of the eyes turn yellow. This may have been related to other medicines you were taking or may have happened during pregnancy;
• you have blood vessel disease of the eye that has caused loss of vision;
• you are or think you might be pregnant;
• you have or have had migraine headaches with or without focal aura (flashes of light, blind spots and other vision changes);
• you have or have had inflammation of the pancreas (pancreatitis) and high levels of fat in your blood (triglycerides).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NEXTSTELLIS. Talk about any health conditions or problems you may have, including if you:

• have a history of depression
• have a history of kidney problems
• have a history of liver problems
• have a history of adrenal problems
• are obese
• have had or will have a major surgery
• have high blood pressure
• have or have a family history of diabetes
• have migraine headaches
• have hepatitis C and taking drugs for it
• have a family history of blot clot disorders
• have uterine fibroids. These are benign tumours of the uterus
• have inflammatory bowel disease including Crohn’s disease or ulcerative colitis
• have sickle cell disease. This is a disease that affects hemoglobin, a molecule in red blood cells that delivers oxygen throughout the body.
• have haemolytic uremic syndrome. This is when there is an abnormal breakdown of blood cells, which clogs the kidney.
• have systemic lupus erythematosus. This is a disease of the immune system.
• have cholestasis. This is a condition where the bile flow from the liver is decreased.
• have a history of seizures or have epilepsy
• have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, eyes or airway passages
• have problems with the valves in your heart and/or have an irregular heart beat
• have porphyria. This is a disease of blood pigment that is passed down in families (inherited)
• have a history of a skin condition called chloasma (hyperpigmentation)

• you are currently on daily, long-term treatment for a chronic condition with any of these drugs:

  • Non steroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems
  • Potassium-sparing diuretics
  • Potassium supplements
  • ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure
  • Heparin

Other warnings you should know about:

Blood clot in legs, lungs, heart, eyes or brain Women who use birth control that contains hormones are more likely to develop blood clots. Blood clots are the most common serious side effects of birth control pills. The risk for clots is highest during the first year a woman uses a hormonal birth control. The risk is also high if a woman restarts the same or new hormonal birth control. Clots can occur in many areas of the body and can lead to blindness or impaired vision as well as damage to or loss of a limb and death.

While you are taking NEXTSTELLIS, if you have any of the below symptoms, contact your healthcare professional right away. These are signs of blood clots.

• sharp pain in your chest
• coughing up blood
• sudden shortness of breath
• crushing chest pain or chest heaviness
• irregular heartbeat
• sudden severe or worsening headache
• feeling full
• vomiting
• dizziness, trouble walking
• fainting, seizures
• anxiety, confusion
• changes in vision
• changes in speech
• pain and / or swelling in your calf
• weakness or numbness in your face, arm or leg
• sudden pain, swelling and slight blue or red discoloration of an arm or leg
• discomfort radiating to your back, jaw, throat or stomach

Cancer: Using birth control pills may increases the risk of certain cancers including cancer of the breast, cervix and liver.

Breast cancer

The risk of breast cancer in women increases as you get older. It also increases if there is family history of breast cancer, meaning if your mother or sister have or had breast cancer. Other factors that increase your risk for breast cancer are being obese, never having children, or having your first full-term pregnancy at a late age.

If you have breast cancer now, or had it in the past, do not use birth control pills. The hormones in these pills can affect some cancers.

Some women who use birth control pills may have a higher risk of developing breast cancer before menopause. These women may have used birth control pills for a long time (more than eight years), or may have started using birth control pills at an early age.

In a few women, using of birth control pills can speed up the growth of a breast cancer that has not yet been found. Finding breast cancer early can reduce the effect of the cancer on a woman’s life expectancy. The risks for breast cancer related to using birth control pills seem to be small. You should, however, have a healthcare professional check your breasts at least once per year.

While you are taking NEXTSTELLIS, check your breasts often. See your healthcare professional if you notice any changes, such as:

• Dimpling or sinking of the skin,
• Changes in the nipple, or
• Any lumps you can see or feel.

Cervical cancer Women who use birth control pills may have a higher chance of getting cervical cancer. However, this may be due to other reasons including infection with the Human Papilloma Virus (HPV). HPV is an important risk factor for cervical cancer. However, it is possible that oral birth control pills may also cause such cancers.

Liver cancer Liver cancer (hepatocellular carcinoma) and liver tumours may be linked to oral birth control pills. The risk for liver cancer increases the longer these pills are used. However liver tumours are extremely rare. If you feel severe abdominal pain or find a lump in your abdomen, contact your healthcare professional right away.

Do not use NEXTSTELLIS if you have a history of liver tumors (cancerous or non-cancerous).

Gallbladder disease The risk for gallbladder disease that needs surgery is higher in women using birth control pills. The risk is highest in the first year of use and increases the longer these pills are used.

Vaginal bleeding Breakthrough bleeding or spotting sometimes happens in women using birth control pills including NEXTSTELLIS. This is blood coming from the vagina between periods. It is most likely to happen in the first months of starting a birth control pill. If the bleeding is heavy or does not stop, contact your healthcare professional.

While you are taking NEXTSTELLIS you may not get your period each month. If you were not taking NEXTSTELLIS as directed by your healthcare professional, you should have a pregnancy test. This will rule out if the missed period is because you are pregnant.

Pregnancy, Breastfeeding, Miscarriage and Abortions:

Use in pregnancy

Birth control pills should not be taken by pregnant women. Stop taking NEXTSTELLIS if you get pregnant. You should check with your healthcare professional about risks to your unborn child from any medication taken during pregnancy.

Use after pregnancy, miscarriage or an abortion Your healthcare professional will tell you when to start using NEXTSTELLIS after childbirth, miscarriage or an abortion.

Pregnancy after stopping NEXTSTELLIS You will have a menstrual period when you stop using NEXTSTELLIS. Wait until after your next period before getting pregnant. This will help to better date the pregnancy. Speak to your healthcare professional about other forms of birth control you can use during this time. Breast feeding If you are breastfeeding, talk to your healthcare professional before starting the birth control pill. Other types of birth control, instead of a birth control pill, are recommended until your baby has stopped breastfeeding. The hormones in the pill may lower the amount and quality of your breast milk. This may not happen, however, if you wait until after nursing is established.

Skin conditions Chloasma may develop while you are using NEXTSTELLIS. This appears as yellowish-brown patches on the skin, particularly of the face. It is more likely to happen if you have previously had chloasma gravidarum. This is when these patches appear on the skin of the face during pregnancy. This is commonly known as “the mask of pregnancy”. If you have or had chloasma, avoid too much exposure to the sun while using NEXTSTELLIS. Surgery Tell your healthcare professional if you are scheduled for surgery. You may need to stop using NEXTSTELLIS one month before surgery and during prolonged bedrest. You may need to wait for at least two weeks after surgery before restarting NEXTSTELLIS. Check-ups and tests Before starting NEXTSTELLIS, you will need to have examinations and tests. Your healthcare professional will conduct a physical exam. He or she will examine your breasts, liver, arms and legs. They will conduct a pelvic exam which includes a PAP smear. Your healthcare professional will also ask you some questions about your personal health history and that of your close relatives. He or she will also measure your blood pressure and do blood tests.

While you are taking NEXTSTELLIS, you will need to have regular check-ups with your healthcare professional. Your first check up should be about three months after starting NEXTSTELLIS. Afterward, you will see your healthcare professional about once per year. At these visits, your healthcare professional will conduct physical and internal exams. He or she will also measure your blood pressure and do blood tests.

If you are scheduled for any laboratory tests, be sure to tell your healthcare professional that you are taking NEXTSTELLIS. This is because birth control pills can affect some blood tests

NEXTSTELLIS may not work as well as it should to prevent pregnancy if you:

• miss pills,
• don’t take your pills as directed by your healthcare professional,
• have gastrointestinal problems, or
• are taking certain medicines.

If this happens, you should use another method of birth control, like condoms (barrier method). Do this while taking NEXTSTELLIS until you start a new pack of NEXTSTELLIS.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NEXTSTELLIS:

• drugs used to treat epilepsy including felbamate, lamotrigine, oxcarbazepine, phenytoin, primidone, barbiturates, carbamazepine, topiramate, rufinamide, ethosuximide, phenobarbital;
• drugs used to treat tuberculosis including rifampin, rifabutin;
• drugs used to treat HIV infections including efavirenz, atazanavir/ritonavir,ritonavir darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, etravirine, nelfinavir, neviparine;
• alpha-II adrenoreceptor agents including clonidine;
• drugs for Hepatitis C virus including ombitasvir, paritaprevir, ritonavir, with or without dasabuvir, telaprevir;
• drugs used to treat bacterial infections like erythromycin, ampicillin, cotrimoxazole, penicillins, chloramphenicol, neomycin, nitrofurantoin, sulfonamides, tetracyclines, troleandomycin metronidazole;
• drugs used to treat fungal infections like fluconazole, itraconazole, ketoconazole, voriconazole, clarithromycin)
• drugs used to treat fungal infections including griseofulvin;
• drugs used to lower cholesterol levels including clofibrate;
• drugs used to prevent blood clots;
• St. John’s Wort, an herbal product used to treat depression and other conditions;
• drugs used to treat diabetes including insulin and oral drugs that lower blood sugar;

• drugs used to help you relax or sleep including benzodiazepines, chlordiazepoxide, lorazepam, oxazepam, diazepam, phenothiazines, reserpine, barbiturates, chloral hydrate,

  • glutethimide, meprobamate;
• drugs used to treat depression including clomipramine;
• drugs used to treat fever, pain or inflammation including acetaminophen, ASA, antipyrine, meperidine, prednisone, phenylbutazone;
• drugs used to treat allergies
• drugs used to treat migraine headaches;
• Folic acid and vitamins E and B₁₂;
• drugs used to help prevent organ rejection including cyclosporine;
• a drug used to help treat bleeding called aminocaproic acid;
• drugs used to treat lung diseases such as asthma and COPD (bronchitis, emphysema) including theophylline;
• drugs used to slow the heart rate including isoproterenol;
• drugs used to treat high blood pressure including guanethidine, methyldopa, beta blockers, reserpine, diltiazem and verapamil;
• drugs used to treat high blood pressure in the blood vessels between the heart and the lungs (pulmonary hypertension) including bosentan;
• drugs used to help prevent nausea and vomiting after chemotherapy including aprepitant;
• grapefruit juice

Antacids may affect how NEXTSTELLIS is absorbed in your body. If you need to use antacids, like TUMS, take them 2 hours before or 2 hours after taking NEXTSTELLIS.

The effects of caffeine and alcohol may also be increased. This is because birth control pills affect how these are metabolized.

How to take NEXTSTELLIS:

1. 1.

   Be sure to read these directions:

   1. • before you start taking your pills, and
   2. • anytime you are not sure what to do.
2. 2. Decide with your healthcare professional what is the best day for you to start taking your first pill. Pick a time of day that will be easy to remember.
3. 3.

   Look at your pill pack:

   • The NEXTSTELLIS pill pack has:

     • 24 pink pills. These pills contain hormones to be taken for 24 days.
     • 4 white pills. These do not contain any hormones and are considered inert. These pills are to be taken for 4 days.

   • Check the pill pack for:

     • where to start taking pills; and
     • the order to take the pills. Follow the arrows.
4. 4. The first day of your menstrual period (bleeding) is day 1 of your cycle. Your healthcare professional may tell you to start taking the pills on Day 1 or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
5. 5.

   Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS. Your period should occur during the last four days of

   1. using that pill pack.
6. 6. For Day 1 starters, pick the Day Label sticker that corresponds with the first day of your period. This is the day you start bleeding or spotting. If you are a Sunday starter (your healthcare professional has told you to start NEXTSTELLIS on the Sunday after your period begins), pick the day label sticker that starts with Sunday.

1. 7. Place the Day Label sticker on the top edge of the blister card. This sticker will go over the words: “Place day label here”. Labelling the card with the days of the week will help remind you to take your pill everyday.

1. 8.

   Taking NEXTSTELLIS:

   • Take NEXTSTELLIS exactly as directed by your healthcare professional.
   • Take one pill each day at about the same time.

   • Take NEXTSTELLIS with or without food.

   • Start taking NEXTSTELLIS on either:

     • Day 1 of your period. This is called “Day 1 start”; or
     • The first Sunday after your period starts. This is called “Sunday start”. If your period starts on Sunday, start that same day.

   • Take NEXTSTELLIS according to this schedule:

     1. i. Take 1 pink tablet each day for 24 days in a row. You should always begin a pack by a pink tablet. You should always take all the pink tablets first.
     2. ii. Then, take 1 white tablet each day for 4 days in row.
     1. iii. Start the next pack on the day after your last white tablet. Take one tablet every day. Do not wait any days between packs. Follow the above schedule with each pack of NEXTSTELLIS.
   • Be sure to use all the tablets in each pack.
   • Do not skip any days. There is no need to stop taking NEXTSTELLIS for a rest period.
   • Do not skip tablets even if you are spotting or bleeding between monthly periods or feel sick to your stomach.
   • Do not skip tablets even if you do not have sex very often.

If you start NEXTSTELLIS after Day 1 of your period (Sunday starter):

• Use an extra barrier method of birth control (e.g. condoms) for the first 7 days of your first cycle of NEXTSTELLIS.

You might notice bleeding 2 to 4 days after the last pink tablet. The bleeding might not finish before you start the next pack. This is normal. If this happens, do not stop taking NEXTSTELLIS. These symptoms will usually go away. If they remain for a long time, check with your healthcare professional.

You may miss your period while you are taking NEXTSTELLIS. If you have been having regular periods and then do not have a period for two or more cycles, you may be pregnant. Contact your healthcare professional if this happens.

If you vomit within 4 hours after taking a pink tablet, take a new tablet as soon as possible. A new tablet should be taken within 24 hours of the usual dose time. Take the next tablet at the usual dose time. If it has been more than 24 hours since the last tablet was taken, see "Missed Dose" below for more instructions.

Switching to NEXTSTELLIS from a different type of birth control:

• For any switch, always use a second method of birth control (e.g. condoms) for the first 7 days of taking NEXTSTELLIS.
• If you are switching from another combined oral birth control pill, talk to your healthcare professional about when to start taking NEXTSTELLIS.
• If you are switching from minipill (progestogen only) birth control, start taking NEXTSTELLIS on the next day.
• If you are switching from a type of birth control that is implanted, start taking NEXTSTELLIS on the day the implant is taken out.
• If you switch from a type of birth control that is injected into your body, start taking NEXTSTELLIS on the day the next injection would happen.

Usual dose:

Take one (1) tablet per day, starting with the pink tablets. Then, when all the 24 pink tablets are done, take one white tablet per day for 4 days.

Overdose:

If too many birth control pills are taken at one time, nausea, vomiting and vaginal bleeding in women are possible.

Missed dose:

If you miss pink pills, you could get pregnant. The more pills you miss, the more likely you are to get pregnant. This is especially true if you miss taking the first few or the last few pink pills in a pack.

Missing pills can cause you to have some spotting or light bleeding, even if you take the missed pills.

The following chart tells you what to do if you miss taking one or more birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack. If you miss one or more pink pills and do not have a period that month, you may be pregnant. If this happens, contact your healthcare professional.

If you are not sure about the number or the colour of pills missed:

• Use a barrier method of birth control (such as a condom) until you have taken the pink pills for 7 days.

Always be sure you have on hand:

• An extra full pack of pills;
• Back-up methods of birth control. These are types that do not include hormones, like latex or polyurethane condoms and spermicidal foam or gel. You will need back-up birth control if you miss pills and in some other situations. Always talk to your healthcare professional if you are not sure whether you need to use back-up birth control.

Possible side effects from using NEXTSTELLIS:

These are not all the possible side effects you may feel when taking NEXTSTELLIS. If you experience any side effects not listed here, tell your healthcare professional.

• Headache
• Acne
• Skin colour changes, red skin lumps
• Burning, prickling skin feeling
• Excess hair on face, chest, abdomen or legs
• Breast colour change, pain, swelling or tenderness
• Decreased libido
• Weight change
• Nausea and vomiting
• Abdominal or back pain
• Sleep disorder like insomnia or somnolence
• Dizziness
• Hot flush
• Constipation
• Diarrhea
• Black or bloody stools
• Heart burn
• Urinary tract infection
• Flu-like symptoms
• Respiratory tract infections including bronchitis, runny nose, stuffy nose, sore throat
• Dry eyes
• Hair loss
• Bruising
• Bladder spasm
• High or low blood pressure

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

• Store NEXTSTELLIS at room temperature (15 - 30°C). Keep the tablets in their original package.
• Keep out of reach and sight of children.
• Do not throw away any drugs via wastewater or household waste. Ask your pharmacist how to throw away drugs you no longer use. These measures will help to protect the environment.

If you want more information about NEXTSTELLIS:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.searchlightpharma.com), or by calling 1-800-667-4708.

Date of Authorization: 2026-09-14