INPEFA tablets contain the active ingredient sotagliflozin, which is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. These tablets are formulated for oral administration in strengths of 200 mg and 400 mg. Key inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The drug is intended to lower blood glucose levels by inhibiting glucose reabsorption in the kidneys.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take this medication no more than one hour before the first meal of the day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Diabetic ketoacidosis (DKA)—increased thirst or amount of urine, dry mouth, fatigue, fruity odor to breath, trouble breathing, stomach pain, nausea, vomiting
• Genital yeast infection—redness, swelling, pain, or itchiness, odor, thick or lumpy discharge
• Infection or redness, swelling, tenderness, or pain in the genitals, or area from the genitals to the back of the rectum
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Change in diet, eating less
• Dehydration
• Diet low in salt
• Frequently drink alcohol
• Having surgery
• History of diabetic ketoacidosis (DKA)
• History of genital infections
• History of pancreatitis or pancreas problems
• History of urinary tract infections (UTI)
• Kidney disease
• Liver disease
• Serious infection
• Trouble passing urine
• Type 1 diabetes
• An unusual or allergic reaction to sotagliflozin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Digoxin
• Lithium
• Rifampin

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Using this medication with insulin or a sulfonylurea may increase your risk of low blood sugar. Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

This medication may increase the risk of diabetic ketoacidosis (DKA), a serious condition in which high ketone levels make your blood too acidic. Your care team may ask you to check for ketones in your urine or blood while you are taking this medication. If you develop nausea, vomiting, stomach pain, unusual weakness or fatigue, or trouble breathing, stop taking this medication and call your care team right away.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

If you have diabetes, you may get a false-positive result for sugar in your urine. Check with your care team.

If you are going to need surgery or other procedure, tell your care team that you are on this medication.