Nextstellis (Drospirenone/Estetrol) - Uses, Side Effects, and More

Who should not use Nextstellis?

Allergies to Ingredients. People who are allergic to any of the following should not take Nextstellis.

• Nextstellis
• Drospirenone
• Estetrol
• Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Nextstellis.

Drug Interactions. Nextstellis should not be taken while you are using certain other medicines. Before taking Nextstellis, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Smoking. Nextstellis should not be taken if you smoke and are 35 years of age or older.

Blood Clots. Nextstellis should not be taken if you currently have or have had blood clots, such as deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attack, or have had blood clots/blood vessel damage from diabetes.

Heart and Blood Vessel Problems. Nextstellis should not be taken if you have a condition that makes you more likely to get blood clots (hypercoagulation). Nextstellis should not be taken if you have plaque buildup in the blood vessels of your heart (coronary artery disease) or if you have a condition that affects the blood flow to your brain (cerebrovascular disease). Nextstellis should not be taken if you have heart rhythm problems (such as atrial fibrillation) or heart valve problems, as these may increase your chances of having a blood clot.

Increased Blood Pressure (Hypertension). Nextstellis should not be taken if you have high blood pressure that is not controlled or high blood pressure with a condition that affects your blood vessels (vascular disease).

Diabetes. Nextstellis should not be taken if you have diabetes with high blood pressure or diabetes with kidney, eye, nerve, or blood vessel damage. Nextstellis should not be taken if you have had diabetes for more than 20 years.

Migraines. Nextstellis should not be taken if you have migraines with vision or hearing changes, muscle weakness, tingling, or trouble speaking (aura), as this can increase your risk of having a stroke. 

Breast Cancer. Nextstellis should not be taken if you have or have had breast cancer.

Liver Tumors or Problems. Nextstellis should not be used if you have hepatic adenoma (a non-cancerous tumor on your liver), hepatocellular carcinoma (cancerous tumor on the liver), acute hepatitis (inflammation of the liver), or decompensated cirrhosis (scar tissue on your liver).

Spotting. Nextstellis should not be taken if you are bleeding between your monthly periods without a known cause. Tell your health care provider if you are bleeding between your monthly periods while on Nextstellis. Your health care provider will find out why this is happening and may do tests to see if you are able to take this medicine.

Kidney Problems. Nextstellis should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your health care provider may do tests to check if they are working well enough to take this medicine.

Reduced Adrenal Function. Nextstellis should not be taken if you have adrenal insufficiency, which is when your adrenal glands do not make enough cortisol (the stress hormone). 

What should I know about Nextstellis before using it?

Do not take Nextstellis unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Nextstellis with other people, even if they have the same condition as you. It may harm them.

Keep Nextstellis out of the reach of children.

Read the Instructions for Use when taking Nextstellis for the first time and for instructions on what to do if you miss a dose.

Do not take Nextstellis if you smoke and are 35 years of age or older. Smoking while taking Nextstellis can increase your chances of having heart and blood vessel problems, which can include blood clots, heart attack, or stroke. Your risk increases as you get older and the number of cigarettes you smoke.

Nextstellis does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).

Nextstellis comes in a blister pack with 28 tablets that are separated into different colors. Take tablets in order (from left to right) at the same time every day until the pack is finished. Swallow the tablets whole. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack. Talk to your health care provider about backup contraception options (condoms, spermicide).

Your periods may be irregular, lighter, and/or shorter than usual while you are taking Nextstellis. If you miss your period and have not taken Nextstellis as directed, call your health care provider right away.

You may also have spotting or light bleeding between your periods, which can last a few months. Call your health care provider if this does not go away after a few months.

What should I tell my health care provider before using Nextstellis?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Nextstellis is right for you.

In particular, make sure that you discuss any of the following.

Immobilization. Talk to your health care provider if you are unable to walk for an extended period of time (immobile). Taking Nextstellis while you are immobile may increase your risk of having blood clots.

Major Surgeries. Talk to your health care provider about any upcoming surgeries. Taking Nextstellis may increase your risk of blood clots after surgery.  Your health care provider may stop Nextstellis if you are about to have major surgery and may not start you on it right away after your surgery. If your health care provider decides to stop Nextstellis because of an upcoming surgery, your health care provider will talk to you about other forms of contraception to use during that time.

Skin Issues. Talk to your health care provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma) as this may increase your chances of getting chloasma while taking Nextstellis. Tell your health care provider if you have sensitivity to the sun or to ultraviolet (UV) rays from tanning booths or sun lamps.

Angioedema. Talk to your health care provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body including your lips, face, tongue, or throat. Taking Nextstellis may increase your chances of having angioedema or make your symptoms worse if you have had this condition. 

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

• Liver or gallbladder problems, including jaundice or cholestasis (slowed flow of bile from the liver)
• Depression
• Diabetes
• High triglyceride levels, which is a type of fat in your blood
• Blood clots or blood vessel problems
• Heart problems or high blood pressure
• Migraine or headaches
• Unexplained spotting
• Cancer

Pregnancy. Nextstellis may cause harm to a fetus. Tell your health care provider if you are or plan to become pregnant. If you become pregnant, stop taking Nextstellis right away and contact your health care provider.

Breastfeeding. Nextstellis passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Nextstellis may decrease the amount of breastmilk you make. Your health care provider will let you know if you should take Nextstellis while breastfeeding. 

How can I get more information about Nextstellis?

For more information about Nextstellis, you can visit the drugmaker’s website at www.nextstellis.com or call them at 844-825-8500.