Inpefa (Sotagliflozin): Uses, Side Effects, and Precautions

Inpefa, containing the active ingredient sotagliflozin, is a medication used in individuals with heart failure or those with type 2 diabetes, kidney disease, and other heart disease risk factors. It reduces the risk of death from heart disease and lowers the need for hospital treatments related to heart failure. Approved by the FDA on May 26, 2023, Inpefa is a combination of SGLT-1 and SGLT-2 inhibitors, demonstrating in clinical trials a significant reduction in the risk of death and hospitalizations related to heart failure.

How Inpefa Works

Inpefa functions by blocking the effects of sodium-glucose co-transporters type 2 (SGLT2) and type 1 (SGLT1), which are proteins responsible for regulating glucose levels in the blood. SGLT-2, located in the kidneys, reabsorbs glucose back into the blood. By blocking SGLT-2, Inpefa lowers hemoglobin A1c levels and blood pressure and encourages weight loss. SGLT-1 is responsible for glucose absorption in the small intestine and reabsorption in the kidneys, especially in individuals with uncontrolled diabetes or those receiving an SGLT-2 inhibitor. Sotagliflozin enhances the removal of sugar and sodium by the kidneys.

Dosage and Administration

Inpefa is available in tablet form in strengths of 200 mg and 400 mg. It is administered orally, usually once daily, within 1 hour before the first meal of the day. The tablets should be swallowed whole and not crushed or chewed. It is important to take this medication regularly as directed by your doctor to get the most benefit from it.

What to do if you miss a dose

If you miss a dose, take it as soon as you remember unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a missed one.

Precautions and Contraindications

Before starting Inpefa, inform your healthcare provider if you:

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  • Are allergic to sotagliflozin or any of the ingredients in Inpefa.
  • Are going to have surgery or a procedure that requires fasting. Your healthcare provider may stop your Inpefa for at least 3 days before surgery.
  • Are pregnant or plan to become pregnant, as Inpefa may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if Inpefa passes into your breast milk.

It is also important to tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as Inpefa may affect how other medicines work, and vice versa.

Potential Side Effects

Like all medications, Inpefa may cause side effects.

Common Side Effects

  • Diarrhea
  • Dizziness
  • Lightheadedness

Serious Side Effects

  • Ketoacidosis: A serious condition where there is high ketones and acid in the blood. Ketoacidosis has occurred in people with type 1 or type 2 diabetes during treatment with Inpefa, even when blood sugar levels are not high. It can also occur in people who are sick or undergoing surgery. Symptoms include nausea, vomiting, trouble breathing, increased thirst or urination, and stomach pain.
  • Dehydration: Inpefa can cause dehydration, leading to dizziness, faintness, lightheadedness, or weakness, especially when standing up (orthostatic hypotension).
  • Serious Urinary Tract Infections (UTIs): UTIs that may lead to hospitalization have been reported in people taking Inpefa. Symptoms include a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine.
  • Low Blood Sugar (Hypoglycemia): If you take Inpefa with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. Symptoms of low blood sugar include behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness.
  • Necrotizing Fasciitis of the Perineum: A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This may lead to hospitalization, may require multiple surgeries, and may lead to death.
  • Vaginal Yeast Infection and Yeast Infection of the Penis: Inpefa can increase the risk of vaginal yeast infections in women and yeast infections of the penis in men.

What to do if you experience side effects

If you experience any side effects, talk to your healthcare provider. Some side effects, such as dehydration, can be managed by drinking plenty of fluids. However, serious side effects like ketoacidosis and necrotizing fasciitis require immediate medical attention.

Drug Interactions

Inpefa may interact with other medications, including:

  • Insulin
  • Sulfonylureas
  • Digoxin
  • Lithium
  • Rifampin

Always inform your healthcare provider of all medications, supplements, and herbal products you are taking to avoid potential drug interactions.

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Special Warnings

  • Diabetic Ketoacidosis (DKA): Inpefa can increase the risk of DKA, a serious condition in which high ketone levels make your blood too acidic. If you develop nausea, vomiting, stomach pain, unusual weakness or fatigue, or trouble breathing, stop taking Inpefa and call your healthcare team right away.
  • Urine Glucose Tests: Do not use urinary glucose tests in patients taking SGLT2 inhibitors because SGLT2 inhibitors increase the excretion of glucose in the urine. Use alternative testing methods to monitor glucose levels.

Storage and Disposal

Store Inpefa at room temperature between 20 and 25 degrees C (68 and 77 degrees F), away from light and moisture. Keep out of the reach of children and pets. Dispose of any unused medication after the expiration date properly.

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