Dapagliflozin

💊 What is Dapagliflozin used for?

• •To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who have either established cardiovascular disease or multiple cardiovascular risk factors
• •As an add-on to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes

How it works

The label describes dapagliflozin as an SGLT2 inhibitor. It states that SGLT2 inhibitors increase the amount of glucose (sugar) removed through the urine. The label does not describe its mechanism in more detail.

How it is usually taken

• •The label says dapagliflozin is taken by mouth once a day. The tablet is swallowed. Follow the instructions from your prescriber or pharmacist about how and when to take it. The label says to withhold the medicine for at least 3 days before surgery or procedures that involve prolonged fasting, if possible.

Comes as

• •5 mg yellow, round, film-coated tablets
• •10 mg yellow, oval, film-coated tablets

⚠️ Dapagliflozin side effects

🛑 Who should not take Dapagliflozin, and who should be careful

The label says not to take it if

• 🚨The label says not to use it if you have had a serious allergic reaction to dapagliflozin or any of its ingredients.
• 🚨The label says it is not for improving blood sugar control in people with type 1 diabetes.
• 🚨The label says it is not recommended for improving blood sugar control in people with type 2 diabetes whose eGFR is less than 45 mL/min/1.73 m2. The label says it is likely to be ineffective in this situation.

Tell your doctor before taking it if

• •Tell your provider if you have type 1 diabetes or have had diabetic ketoacidosis.
• •Tell your provider if your insulin dose has been decreased.
• •Your provider will assess your kidney function before you start and then as needed.
• •Your provider will check your fluid (volume) status. If you have volume depletion, the label says it should be corrected before you start.
• •Your provider may ask you to check ketones in your urine or blood from time to time.
• •The label lists several other conditions and situations to discuss with your provider, but the full list is not included in the text provided.

🔀 Dapagliflozin with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

• •Insulin or insulin secretagogues (such as sulfonylureas): the label says the risk of low blood sugar (hypoglycemia) may increase. It says a lower dose of insulin or the secretagogue may be needed.
• •Lithium: the label says an SGLT2 inhibitor may decrease lithium levels. It advises monitoring lithium levels more often when dapagliflozin is started or its dose is changed.
• •Urine glucose tests: the label says these are not recommended for monitoring blood sugar, because SGLT2 inhibitors cause positive urine glucose tests.
• •1,5-anhydroglucitol (1,5-AG) tests: the label says these are unreliable for monitoring blood sugar in people taking SGLT2 inhibitors.
• •Water pills (diuretics) and medicines to lower blood pressure: the label says these can increase the risk of dehydration.

Alcohol and food

The label lists drinking too much alcohol as a risk factor for ketoacidosis. It also lists a ketogenic diet (high in fat and low in carbohydrates) and a low-salt diet as factors to discuss with your provider, since they may affect ketoacidosis or dehydration risk. The label says to talk with your provider about how much fluid you should drink each day.

🤰 Dapagliflozin in pregnancy and breastfeeding

Pregnancy

The label says dapagliflozin is not recommended during the second and third trimesters of pregnancy, based on animal studies that showed kidney effects in young animals. Data in pregnant women are not enough to determine risk for birth defects or miscarriage. The label also notes risks to the mother and fetus from poorly controlled diabetes and untreated heart failure during pregnancy. Talk with your provider about your options.

Breastfeeding

The label does not say.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store at 20°C to 25°C (68°F to 77°F). Brief excursions between 15°C and 30°C (59°F and 86°F) are permitted.

If a dose is missed

The label does not say.

If too much is taken

The label says there were no reports of overdose during clinical development. If an overdose occurs, the label suggests contacting the Poison Help line at 1-800-222-1222 or a medical toxicologist, and using supportive measures based on the patient's condition. The label says removal of dapagliflozin by hemodialysis has not been studied.

🗒️ Questions to ask about Dapagliflozin

• Am I a candidate for dapagliflozin, given my type of diabetes and my kidney function?
• How often should I check my ketones, and what should I do if I notice them?
• How much fluid should I drink each day while taking this medicine?
• Should I stop taking this medicine before surgery or a procedure, and for how long?
• Could this medicine affect my insulin, sulfonylurea, lithium, or water pill doses?
• What symptoms of a genital or urinary infection should I report to you right away?
• Will you check my kidney function, and how often?

❓ Dapagliflozin: frequently asked questions