Inpefa
Inpefa (sotagliflozin) is a newer medication that's approved to lessen the risk of heart-related complications in people with heart failure and in people with Type 2 diabetes, chronic kidney disease (CKD), and other heart-related conditions. This medication comes as a tablet that you take by mouth once daily. Side effects can include urinary tract infections (UTIs) and diarrhea. Inpefa (sotagliflozin) is expected to be available in the U.S. in summer 2023.
What is Inpefa (sotagliflozin)?
What is Inpefa (sotagliflozin) used for?
- Lessen the risk of heart-related death and complications in adults with:
- Heart failure, or
- Type 2 diabetes, chronic kidney disease, and other heart-related risk factors
How Inpefa (sotagliflozin) works
Inpefa (sotagliflozin) is a sodium-glucose cotransporter 1 and 2 (SGLT1/SGLT2) inhibitor. It blocks a protein in the kidneys called SGLT2. This prevents sugar and sodium (salt) from getting absorbed back into your body. This can help lower stress on your heart.
Inpefa (sotagliflozin) has the added benefit of working in the intestines (gut), where SGLT1 proteins are located. By blocking SGLT1, the medication prevents sugar and sodium absorption from the gut.
Drug facts
Side effects of Inpefa (sotagliflozin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Urinary tract infection (9-12%)
- Low fluid in the body (5-9%)
- Diarrhea (7-8%)
- Low blood sugar (4-8%)
Less Common Side Effects
- Dizziness
- Genital yeast infection
Inpefa (sotagliflozin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: swelling in the face, throat, tongue, or mouth; rash; trouble breathing
- High ketone levels in the blood: nausea, vomiting, stomach pain, tiredness, thirsty, dry mouth, fruity breath, trouble breathing
The following Inpefa (sotagliflozin) side effects have also been reported
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):
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Pros and cons of Inpefa (sotagliflozin)
Pros
- Taken just once a day
- Can lower the risk of heart-related death, heart failure (HF) hospitalizations, and urgent HF visits by up to 33%
- First-of-its-kind medication that blocks both SGLT1 and SGLT2 proteins
Cons
- Raises risk of UTIs and genital yeast infections
- Newer medication, so there's no lower-cost generic version available yet
- Unknown if safe or works well in people with severe kidney problems or are on dialysis
Pharmacist tips for Inpefa (sotagliflozin)
- Take Inpefa (sotagliflozin) within an hour before breakfast or your first meal of the day. This will help make sure your body absorbs enough medication so it works well for you.
- If you miss your Inpefa (sotagliflozin) dose by more than 6 hours, skip this missed dose. Then, take your next dose as prescribed on the next day. Don't double up to make up for a missed dose because this could lead to more side effects.
- Practice good hygiene to prevent yeast and urinary tract infections since these are common side effects of Inpefa (sotagliflozin). Change clothes and shower as soon as possible after exercising or after a hot day. Also wear underwear and clothing made from breathable, natural materials like cotton.
- Be sure to ask your provider how much fluid you should be drinking because Inpefa (sotagliflozin) can raise your risk for dehydration (low fluids in the body). If you feel dizzy, let your provider know.
- Tell your provider if you're thinking of becoming pregnant, become pregnant, or are breastfeeding while taking Inpefa (sotagliflozin). This medication isn't recommended during the second and third trimesters of pregnancy or if you're breastfeeding because it can potentially harm your baby.
Common questions about Inpefa (sotagliflozin)
SGLT2 inhibitors, like Jardiance (empagliflozin) and Invokana (canagliflozin), are common diabetes medications that can lower blood sugar levels. They can also help lower the risk of worsening heart and kidney problems for certain people. SGLT2 inhibitors target the kidneys and block the absorption of sugar and sodium (salt) back into your body. On the other hand, Inpefa (sotagliflozin), an SGLT1/SGLT2 inhibitor, blocks the absorption of sugar and sodium from the kidneys and the gut. Inpefa (sotagliflozin) isn't approved to treat diabetes, but it's meant to lower the risk of heart problems in certain people, such as those with Type 2 diabetes. Studies suggest that Inpefa (sotagliflozin) might provide greater blood sugar control and protection from heart attack, stroke, and other heart-related complications than SGLT2 inhibitors in people with Type 2 diabetes.
Take Inpefa (sotagliflozin) once a day in the morning, within an hour before breakfast. This will help keep levels of the medication consistent in your body to better help your condition. Taking Inpefa (sotagliflozin) on an empty stomach, on the other hand, will cause your body to absorb less medication.
Inpefa (sotagliflozin) can raise your risk for genital yeast infections. In women, symptoms can include vaginal itching; white, thick discharge; and pain in the vagina or when urinating. In men, symptoms include redness, itching, or swelling of the penis. If you experience any of these symptoms while you're taking Inpefa (sotagliflozin), contact your provider. Some ways to help prevent yeast infections from happening include changing out of wet clothes and showering as soon as possible after exercising and wearing breathable, cotton underwear.
Maybe; it depends on the type of surgery you're going to have. Make sure all of your providers know that you're taking Inpefa (sotagliflozin), and tell them ahead of time of any surgeries or procedures that require you to fast. You'll probably need to stop taking Inpefa (sotagliflozin) for at least 3 days before these types of major surgeries or procedures. Your provider will let you know when it's safe to start the medication again after your procedure.
There's not enough data to know whether Inpefa (sotagliflozin) is safe for pregnant women to take. In animal studies, Inpefa (sotagliflozin) caused harm to unborn babies during the second and third trimesters, but this doesn't always mean the same thing will happen for humans. What is known, however, is that pregnant women with untreated heart failure are at a higher risk for preterm birth and other complications. If you're pregnant or planning to become pregnant, have a discussion with your provider about the best heart failure treatment for you.
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Risks and warnings for Inpefa (sotagliflozin)
Inpefa (sotagliflozin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Ketoacidosis
- Risk factors: Diabetes | Illness | Lowered calorie intake | Insulin dose reduction | Pancreatic problems | Surgery | Alcohol abuse
Some people with diabetes taking Inpefa (sotagliflozin) have experienced a serious life-threatening condition called ketoacidosis. This can happen when your body makes too many ketones, which makes your blood acidic. Your risk might be higher if you're ill, eating less calories, drinking a lot of alcohol, or have recently had surgery or a reduction in your insulin dose. If possible, check your ketone levels if you experience dry mouth, fruity breath, tiredness, nausea, vomiting, stomach pain, or trouble breathing. If any of these symptoms happen, stop taking Inpefa (sotagliflozin) and get medical help right away.
Low fluids in the body (leading to low blood pressure or dehydration)
- Risk factors: Age 65 years or older | Kidney problems | Taking other medications that lower blood pressure, like loop diuretics (water pills) | Low-salt diet
Inpefa (sotagliflozin) can cause low levels of fluids in the body. This can lead to dehydration, low blood pressure, or kidney damage. You're more likely at risk if you already have kidney problems or take water pills known as loop diuretics. Your provider might regularly check your kidney health with blood tests. Make sure to stay hydrated while you're taking Inpefa (sotagliflozin), and ask your provider how much fluid you should be drinking. Talk to your provider if you experience dizziness, lightheadedness, or if you're urinating less than usual. Also let them know if you're vomiting or have diarrhea (you're also losing liquids from your body this way, which can lead to dehydration). Your provider can recommend ways to keep your body fluids up.
Genital and urinary tract infections
- Risk factors: History of genital yeast infections or urinary tract infections (UTIs)
Inpefa (sotagliflozin) raises the risk of genital infections, like yeast infections and UTIs. Although rare, these infections can become serious and require hospitalization. Call your provider if you experience a burning feeling when urinating; a need to urinate often; lower stomach pain; blood in your urine; an odor from your genitals; or pain, itching, swelling, redness, or tenderness around your genitals.
Low blood sugar when used with certain other diabetes medications
- Risk factors: Changes in diet and exercise | Drinking alcohol | Taking certain other medications for diabetes
When taken together with certain other diabetes medications, such as insulin and sulfonylureas like glimepiride, Inpefa (sotagliflozin) can raise your risk for low blood sugar (hypoglycemia). Very low blood sugar can be life-threatening. Symptoms of low blood sugar include feeling shaky, being nervous or anxious, having a fast heartbeat, sweating or body chills, confusion, feeling sleepy or weak, and excessive hunger. If you take other diabetes medications with Inpefa (sotagliflozin) and you experience any of these symptoms, be sure to check your blood sugar.
Inpefa (sotagliflozin) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg | 30 tablets | $338.21 | $11.27 |
| 400mg | 30 tablets | $338.21 | $11.27 |
Typical dosage for Inpefa (sotagliflozin)
The typical starting dose is 200 mg by mouth daily within an hour before breakfast (or your first meal of the day). If you're able to handle taking that dose for a couple of weeks, your provider will probably raise your dose to 400 mg daily.
How much does Inpefa (sotagliflozin) cost?
$338.21
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