Nextstellis

The active ingredient in Nextstellis is drospirenone/estetrol monohydrate (a combined oral contraceptive). Nextstellis contains two hormones: drospirenone (progestin) and estetrol (estrogen). These hormones operate together to prevent pregnancy by blocking your ovaries from releasing an egg (also known as ovulation), making it more difficult for sperm to go through to fertilise an egg, and making it harder for a fertilised egg to attach to the uterus and grow.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Nextstellis. However, the following is a synopsis of the general guidelines for the use of Nextstellis:

• Take one pill from the blister card each day. Take the pill whole, with or without food.
• You can start on the first day (Day 1) of your menstrual period. If you do this, you do not need to use a backup non-hormonal birth control method.
• If you start taking Nextstellis on any day other than Day 1, use a back-up non-hormonal method of birth control (condoms) for 7 days.
• Take a pink pill every day for the first 24 days, then a white pill for the next four days. The following day, begin a new blister card for Nextstellis.
• Setting an alarm for the same time every day will help you remember to take Nextstellis. If you forget to take a tablet while sexually active, you are more likely to become pregnant by mistake. The risk increases if you miss more medications.

Some possible side effects of Nextstellis include:

• Mood changes or mood swings.
• Irregular vaginal bleeding or menstrual cycles.
• New or worsening headaches, including migraine headaches.
• Menstrual cramps.
• Weight gain.
• Increase in liver enzymes.
• Dark patches of skin on the face or other sun-exposed areas.
• Increase cholesterol or triglyceride levels.

Some individuals may experience serious side effects while using Nextstellis. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart attack symptoms include chest discomfort, arm pain, shortness of breath, and cold perspiration.
• Stroke symptoms include sudden weakness on one side of the body, drooping facial muscles, severe headaches, changes in speech or vision, and confusion.
• Deep vein thrombosis (blood clot in the leg) causes leg cramping, swelling, pain, and muscle tightness.
• Cough, chest pain, difficulty breathing, and a racing heart are symptoms of a pulmonary embolism (a blood clot in the lungs).
• Retinal vein thrombosis (blood clot in the eyes) causes difficulty seeing, vision loss, and eye pain.
• Serious liver problems include yellowing of the skin or whites of the eyes, fatigue, and abdominal pain.
• High potassium levels can cause fatigue, a racing heart, muscle weakness, and tingling or numbing sensations.
• Pancreatitis (an inflammation of the pancreas) is associated with high levels of fatty substances in your blood.
• Allergic reaction to the medication.

These are not all of the possible side effects of Nextstellis. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Nextstellis, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Surgery is scheduled as this medication increases your risk of blood clots after surgery.
• Depression.
• Breast cancer or cervical cancer.
• Liver tumors or liver disease.
• Risk of serious cardiovascular events with cigarette smoking.
• Gallbladder problems.
• Your chance of having angioedema is higher if you have a history of angioedema.
• Chloasma (a skin condition that causes dark patches on the face).

Boxed Warning

Cigarette smoking increases your risk of serious heart-related events when used with combined hormonal contraceptives (CHCs). CHCs, including Nextstellis, are contraindicated in females who are over 35 years of age and smoke.

• Adults over 35 years of age who smoke.
• You now have or have had a blood clot.
• Stroke.
• Coronary artery disease (CAD).
• Certain heart rhythm issues, such as atrial fibrillation (AFib).
• Unmanaged high blood pressure.
• Diabetes.
• Migraines with aura.
• Currently have or have had breast cancer.
• Liver tumors or diseases.
• Kidney issues.
• Low adrenal hormone levels (adrenal insufficiency).
• Abnormal vaginal bleeding that your prescriber is unaware of or has not examined yet.
• Take hepatitis C drugs that contain ombitasvir/paritaprevir/ritonavir.

Nextstellis normally begins to act to prevent pregnancy as soon as you start taking it. However, in certain cases, the tablet may take up to 7 days to properly act. In these cases, you must take a non-hormonal birth control method, such as condoms, in addition to Nextstellis for 7 days.

When Nextstellis is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• CYP inducers (aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxycarbazepine, phenytoin, rifamptin, ribatin, topiramate, St. John's wort products, and others).
• CYP inhibitors (itraconazole, voriconazole, fluconazole, ketoconazole, among others)
• HIV/hepatitis C virus protease inhibitors and non-nucleoside reverse transcriptase inhibitors (nelfinavir, ritonavir, boceprevir, telaprevir, indinavir, nevirapine, etravirine, among others).
• Lamotrigine.
• Dasabuvir.
• Potassium-sparing diuretics (Spironolactone and others).
• Potassium supplements.
• Corticosteroids.

The typical dose is one pill taken orally at the same time each day. During each cycle of birth control, take one pink active pill for the first 24 days and one white inactive (placebo) pill for the next four days.

Each active pill has 3 mg of drospirenone and 14.2 mg of estetrol. Each inactive (placebo) tablet contains no hormones.

Store at room temperature and keep out of reach of children.

Mayne Pharma is the company that manufactures Nextstellis.

There are no generic versions available of Nextstellis.

Follow the instructions and take your medication until your doctor instructs you to stop. If you want to get pregnant, you can stop taking the pill whenever you want.

Nextstellis should not be used if you are pregnant. Discontinue treatment and notify your doctor immediately if you become pregnant while taking this medication.

Nextstellis may reduce the amount of breast milk you produce and may pass through your breast milk. Consult with your healthcare practitioner about the best birth control option for you while breastfeeding.