Vericiguat

IMPORTANT WARNING:

Do not take vericiguat if you are pregnant or plan to become pregnant. Vericiguat may harm the fetus. If you are sexually active and able to become pregnant, you should not begin taking vericiguat until a pregnancy test has shown that you are not pregnant. You must use reliable methods of birth control during treatment and for 1 month after your final dose of vericiguat. Talk to your doctor about birth control methods that are effective and will work for you. If you become pregnant while taking vericiguat, call your doctor immediately.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to vericiguat.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vericiguat and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Vericiguat is used to reduce the risk of death and need for hospitalization in certain adults with heart failure. Vericiguat is in a class of medications called soluble guanylate cyclase (sGC) stimulators. It works by relaxing the blood vessels in the lungs to allow blood to flow easily.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vericiguat comes as a tablet to take by mouth. It is usually taken with food once a day. Take vericiguat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vericiguat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you cannot swallow the tablet whole, you can crush the tablet and mix the contents with a small amount of water. Swallow the mixture right after you mix it.

Your doctor will probably start you on a low dose of vericiguat and gradually increase your dose, not more than once every 2 weeks. Your doctor may decrease your dose if you experience side effects.

What SPECIAL PRECAUTIONS should I follow?

Before taking vericiguat,

• tell your doctor and pharmacist if you are allergic to vericiguat, any other medications, or any of the ingredients in vericiguat tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking riociguat (Adempas). Your doctor will probably tell you not to take vericiguat if you are taking this medication.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking vericiguat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had any medical conditions.

• tell your doctor if you are breast-feeding or plan to breastfeed. Do not breastfeed while taking vericiguat.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you remember the missed dose that same day, take the missed dose with food as soon as you remember it. However, if you do not remember until the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose or two doses in one day to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Vericiguat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• lightheadedness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• pale skin, tiredness, or shortness of breath

Vericiguat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• dizziness
• lightheadedness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to vericiguat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.