Steglujan

Steglujan is a prescription medication used to lower blood sugar in adults with type 2 diabetes. 

It is a single product containing 2 medications: ertugliflozin and sitagliptin.

Ertugliflozin belongs to a group of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. These work to lower blood sugar by stopping the reabsorption of sugar by the kidney and causing the kidneys to get rid of more sugar in the urine. Sitagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors which help to lower blood sugar levels by increasing insulin production and decreasing sugars that are made in the liver.

This medication comes in tablet form and is taken once daily in the morning, with or without food.

Common side effects of Steglujan include yeast infections of the genitals, upper respiratory infection, and headache.

Steglujan is a prescription medication used with diet and exercise to lower blood sugar in adults with type 2 diabetes. 

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

Serious side effects have been reported with Steglujan. See the “Steglujan Precautions” section.

Common side effects of Steglujan include the following:

• yeast infections of the genital areas
• upper respiratory infection
• stuffy or a runny nose
• sore throat
• headache
• upset stomach
• diarrhea

This is not a complete list of Steglujan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• insulin or medications that help your pancreas to produce insulin such as glipizide (Glucotrol), glimepiride (Amaryl), repaglinide (Prandin), and nateglinide (Starlix). When these medications are used with Steglujan, there is a higher risk for hypoglycemia (low blood sugar). 
• digoxin (Lanoxin)

This is not a complete list of Steglujan drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Steglujan including the following:

• pancreatitis (inflammation of the pancreas). Tell your healthcare provider if you have stomach pain that may radiate to the back, nausea, vomiting, worsening pain after eating, fever, and chills.
• heart failure. Tell your healthcare provider if you have any symptoms of heart failure including sudden weight gain, increased swelling, worsening shortness of breath, needing to use more pillows to go to sleep, and new or increasing irregularities in your heart rate.
• dehydration. You may cause you to feel dizzy, weak or like you are going to faint. This can happen especially when you stand up (orthostatic hypotension). You may be at risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, are on a low salt diet, or are 65 years of age or older. 
• ketoacidosis (ketones in the blood or urine). Tell your healthcare provider if you experience any symptoms including nausea, vomiting, stomach pain, generalized feeling bad, and shortness of breath.
• kidney problems. Your healthcare provider will monitor your kidney function.
• serious urinary tract infections that can go into the blood or damage the kidney. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection including burning while urinating, increased frequency of urination, pain in the lower part of the stomach, or blood in the urine.
• amputation. This medication can increase the risk of a lower limb amputation. Tell your healthcare provider if you have signs of ulcers (sores) or infections such as redness, swelling, and warmth on the lower limb.
• hypoglycemia (low blood sugar). Tell your healthcare provider if you have signs of low blood sugar including hunger, shakiness, dizziness, confusion, difficulty speaking, and feeling anxious or weak.
• increased cholesterol level. Your healthcare provider will monitor for this.
• vaginal yeast infection. Tell your healthcare provider if you have symptoms of a vaginal yeast infection including vaginal odor, vaginal itching, and white or yellowish vaginal discharge that may be lumpy.
• yeast infection of the penis. Tell your healthcare provider if you have symptoms of yeast infection of the penis including redness, itching, swelling, rash, pain, and bad smelling discharge from the penis.
• severe allergic reaction. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include chest pain, rash, difficulty breathing or swallowing, and swelling of the face, eyes, lips, tongue, arms, or legs.
• severe joint pain. Tell your healthcare provider if you have new or worsening joint pain.
• skin reaction. Some people taking medications called DPP-4 inhibitors, which is one of the medicines in Steglujan, may experience a skin reaction called bullous pemphigoid that may require treatment in a hospital. This type of skin reaction is an autoimmune disorder that causes rashes and blistering. Tell your healthcare provider if you develop any rashes or blisters on the legs, arms, or abdomen.

When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.

Do not take Steglujan if you:

• are allergic to Steglujan or to any of its ingredients
• have severe renal (or kidney) impairment, have end-stage renal disease, or on dialysis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Steglujan, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Steglujan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Steglujan or to any of its ingredients
• have kidney problems
• have liver problems
• have type 1 diabetes or have had diabetic ketoacidosis
• have or have had pancreas problems
• have a history of stones in your gallbladder (gallstones)
• have a history of urinary tract infections or problems with urinating
• are eating less
• have had an amputation
• have neuropathy, or nerve problems in the legs
• have had blocked or narrowed blood vessels
• have diabetic foot ulcers or sores
• are planning on having surgery
• drink alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. There is limited data with the use of Steglujan in pregnant women

Based on animal data that showed kidney problems in babies from ertugliflozin, one of the medicines in Steglujan, it is not recommended to use Steglujan during the second and third trimesters of pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Steglujan crosses into human milk. Because of the possibility for adverse reactions in nursing infants from Steglujan, it is not recommended to use this medication while breastfeeding.

Take Steglujan exactly as prescribed.

This medication comes in tablet form and is taken once daily, in the morning, with or without food.

Your doctor may tell you to take this medication along with other diabetes medicines. Low blood sugar can happen more often when this medication is taken with certain other diabetes medicines.

Stay on your prescribed diet and exercise program while taking this medication.

Be sure to check your blood sugar as your doctor tells you to.

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Steglujan at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting dose of Steglujan (ertugliflozin and sitagliptin) for the treatment of type 2 diabetes is 5 mg of ertugliflozin/100 mg of sitagliptin once daily, in the morning. The maximum dose of Steglujan is 15 mg of ertugliflozin/100 mg of sitagliptin. 

If you take too much Steglujan, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Steglujan tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Steglujan in a dry place to protect from moisture.
• Keep this and all medicines out of the reach of children.