(soe″ ta gli floe′ zin)

Brand Name(s): Inpefa^®

WHY is this medicine prescribed?

Sotagliflozin is used to reduce the risk of a stroke, heart attack, or death or hospitalization for heart failure or urgent visits for heart failure-related concerns in adults who have heart failure or type 2 diabetes or chronic kidney disease along with heart and blood vessel disease. Sotagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works to help heart failure by causing the kidneys to get rid of sodium and glucose which helps the heart to function better. It is unclear how it works to reduce risk of heart attack or stroke or death from cardiac or vascular disease.

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?

Sotagliflozin comes as a tablet to take by mouth. It is usually taken once a day one hour before the first meal of the day. It should not be taken more than one hour before the first meal. Take sotagliflozin 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 sotagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of sotagliflozin and increase your dose after 2 weeks.

Continue to take sotagliflozin even if you feel well. Do not stop taking sotagliflozin without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking sotagliflozin,

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

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

• tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking), are on a low sodium diet, or if you have an infection. Also, tell your doctor if you have type 1 diabetes or diabetic ketoacidosis, have or have ever had low blood pressure, urinary tract infections or urinary problems, pancreatic disease including pancreatitis (swelling of the pancreas) or have had surgery on your pancreas, yeast infections in the genital area, or kidney or liver disease. If you are male, tell your doctor if you have never been circumcised. Tell your doctor if you are eating or drinking less due to illness, surgery, or a change in your diet; if you are following a ketogenic diet (a high fat, low carbohydrate diet); or have recently had diarrhea, vomiting, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sotagliflozin, call your doctor immediately. Sotagliflozin may harm the unborn child if taken during second or third trimester of pregnancy and is therefore, not recommended during pregnancy. Sotagliflozin may also cause harm to the baby if you breastfeed while taking sotagliflozin so breastfeeding is not recommended.

• ask your doctor about the safe use of alcoholic beverages while you are taking sotagliflozin. Alcohol can make the side effects from sotagliflozin worse.

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?

Take the missed dose as soon as you remember it. However, if more than 6 hours have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• diarrhea
• increased thirst
• dry mouth

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

• burning feeling when urinating, having to urinate a lot or urinate right away, pain in the lower part of the stomach, or blood in the urine.
• headache, shaky or jittery feeling, irritability, fast heartbeat, weakness, drowsiness, sweating, confusion, dizziness, hunger
• pain or tenderness around anus or genitals, swelling in this area, or redness of the skin in this area
• vaginal odor, white or yellowish vaginal discharge, vaginal itching
• redness, itching or swelling of the penis, smelly discharge from the penis, pain in the skin around the penis

Sotagliflozin 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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking sotagliflozin.

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 20, 2024.