Dapagliflozin

Dapagliflozin is a prescription medication used to treat the symptoms of Type 2 Diabetes Mellitus, Heart Failure, and Chronic Kidney Disease.

• Dapagliflozin is available under the following different brand names: Farxiga

Dosages of Dapagliflozin:

Adult dosage

• Tablet
  • 5mg
  • 10mg

Type 2 Diabetes Mellitus

• Improve glycemic control: 
  • Initial: 5mg orally once daily in the morning
  • May increase to 10mg once daily in patients tolerating 5 mg/day who require additional glycemic control

Reduce the risk of hospitalization for heart failure:

• 10mg orally once daily in the morning

Heart Failure

• 10mg orally once daily

Chronic Kidney Disease

• 10mg orally once daily 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Dapagliflozin include:

• genital yeast infection, 
• urinating more than usual, 
• sore throat, and
• runny or stuffy nose

Serious side effects of Dapagliflozin include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area, 
• fever, 
• not feeling well, 
• little or no urination, 
• dizziness, 
• weakness, 
• lightheadedness, 
• swelling in the feet or ankles, 
• tiredness, 
• shortness of breath, 
• nausea, 
• vomiting, 
• stomach pain, 
• confusion, 
• unusual drowsiness, 
• pain or burning during urination, 
• increased urination, 
• blood in the urine, 
• fever, and
• pain in the pelvis or back

Rare side effects of Dapagliflozin include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dapagliflozin has severe interactions with no other drugs.
• Dapagliflozin has serious interactions with no other drugs.
• Dapagliflozin has moderate interactions with at least 24 other drugs.
• Dapagliflozin has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Serious hypersensitivity to dapagliflozin (eg, anaphylaxis, angioedema)
• Patients on dialysis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dapagliflozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dapagliflozin?”

Cautions

• Genital mycotic infections may occur; patients with a history of genital mycotic infections and uncircumcised males are more susceptible
• Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors
• Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness or swelling of the genitals, or area from the genitals to the rectum, and have a fever over 100.4ºF or generally feeling unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

Intravascular volume contraction

• Patients with diabetes and renal impairment may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion
• Symptomatic hypotension may occur after initiating, particularly in patients with renal impairment (eGFR over 60 mL/min/1.73 m2), with low systolic blood pressure, taking loop diuretics, or who are elderly
• Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients to acute kidney injury, including hypovolemia, chronic renal insufficiency, CHF, and concomitant medications (eg, diuretics, ACE inhibitors, ARBs, NSAIDs); consider temporarily discontinuing dapagliflozin in any setting of reduced oral intake or fluid loss; monitor for signs and symptoms of acute kidney injury, and, if evident, discontinue drug promptly and institute treatment

Ketoacidosis

• Sodium-glucose cotransporter 2 (SGLT2) inhibitors increase the risk of ketoacidosis in patients with type 1 and type 2 diabetes mellitus
• Before initiating therapy, consider factors that may predispose patients to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
• Consider temporarily discontinuing dapagliflozin for at least 3 days before undergoing scheduled surgery to avoid euglycemic ketoacidosis
• Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery); ensure risk factors for ketoacidosis are resolved before resumption

Drug interactions overview

• Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required

Laboratory testing

• Increase in LDL-cholesterol compared with placebo
• Urine glucose tests are not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
• The 1,5-AG assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control

Pregnancy and Lactation

• Based on animal data showing adverse renal effects, the drug is not recommended during the second and third trimesters of pregnancy. 
• Limited data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy. 
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
• There is no information regarding the presence of dapagliflozin in human milk, effects on the breastfed infant, or milk production; the drug is present in the milk of lactating rats; however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear
• Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be a risk to developing human kidney; because of the potential for serious adverse reactions in breastfed infants, advise women that therapy is not recommended while breastfeeding.