Dapagliflozin

Class and Category

Pharmacologic Class: Sodium-glucose co-transporter 2 inhibitor

Therapeutic Class: Antidiabetic

Indications and Dosages

Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus

TABLETS

Adults: 

5 mg once daily in the morning, increased to 10 mg once daily in the morning, as needed.

To reduce risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established cardiovascular disease or presence of multiple cardiovascular risk factors

TABLETS

Adults: 

10mg once daily.

Mechanism of Action

Inhibits sodium-glucose co-transporter 2 in the kidneys, which prevents glucose

reabsorption. This decreases blood glucose levels.

Contraindications

Dialysis therapy, end-stage renal disease, hypersensitivity to dapagliflozin or its components, severe renal impairment (glomerular filtration rate less than 30 ml/min).

Interactions

DRUGS

Insulin, insulin secretagogues: Increased risk of hypoglycemia

Adverse Reactions

CNS: Syncope

CV: Dyslipidemia, elevated low-density lipoprotein cholesterol, hypotension

EENT: Nasopharyngitis

ENDO: Hypoglycemia, ketoacidosis

GI: Constipation, nausea

GU: Acute kidney injury, decreased glomerular filtration rate, dysuria, elevated serum creatinine levels, genital mycotic infections, impaired renal function, increased urination, necrotizing fasciitis of the perineum (Fournier’s gangrene), osmotic diuresis, potential bladder cancer, pyelonephritis, urosepsis, UTI

HEME: Elevated hematocrit level

MS: Back or extremity pain

SKIN: Severe cutaneous reactions, rash, urticaria

Other: Anaphylaxis, angioedema, dehydration, elevated serum phosphorus levels

Childbearing Considerations

PREGNANCY

• It is not known if the drug causes fetal harm.
• The drug is not recommended for use during the second and third trimesters of pregnancy because of potential adverse renal effects as seen in animal studies.

LACTATION

• It is not known if the drug is present in breast milk.
• The drug should not be used during breastfeeding because of the potential for adverse renal effects in the breastfed infant since renal maturation continues for up to 2 years after birth.

Nursing Considerations

• Use drugs cautiously in patients with chronic kidney insufficiency, congestive heart failure, decreased blood volume, and patients taking medications such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics, and NSAIDs because these conditions and treatments may predispose the patient to acute kidney injury while receiving dapagliflozin. Ensure that kidney function has been assessed prior to starting dapagliflozin therapy and then periodically thereafter.
• Know that dapagliflozin should not be given to patients with active bladder cancer, as it is not known if the drug has an effect on preexisting bladder tumors. Use cautiously in patients with a history of bladder cancer. Monitor patient throughout therapy for hematuria, as this is a potential indicator for the presence of bladder tumor.
• Assess the patient’s kidney function and volume status and correct, if needed and as prescribed, prior to starting dapagliflozin therapy, because the drug can cause intravascular volume contraction leading to acute kidney injury or symptomatic hypotension. Patients at highest risk include elderly patients, patients receiving loop diuretic therapy or drugs that interfere with the renin-angiotensin-aldosterone system, and patients who have low systolic blood pressure or impaired renal function. Expect renal function to be evaluated periodically throughout drug therapy.
• Expect the drug to be temporarily discontinued in patients who experience a reduced oral intake, such as with an acute illness or fasting, or who experience excessive fluid losses because of significant gastrointestinal illness or heat exposure, to reduce the risk of acute kidney injury.
• Monitor patient’s blood pressure and cholesterol level throughout dapagliflozin therapy.

WARNING: Monitor patient for hypersensitivity reactions. Although rare, anaphylaxis, angioedema, and severe cutaneous adverse reactions have occurred. If present, stop the drug immediately and notify the prescriber. Provide care, as prescribed, according to the standard of care until signs and symptoms subside.

• Be aware that patients receiving insulin or insulin secretagogues may require a lower dose of these agents because dapagliflozin in combination increases the risk of hypoglycemia. Monitor the patient closely for hypoglycemia. If present, treat according to the standard of care and notify the prescriber.

WARNING: Monitor the patient for a rare but serious and life-threatening necrotizing infection of the perineum called Fournier’s gangrene. Notify the prescriber immediately if a patient develops erythema, pain, swelling, or tenderness in the genital or perineal area, along with fever or malaise. Expect treatment with broad-spectrum antibiotics and, if needed, surgical debridement of the area. Know that dapagliflozin will be discontinued if this occurs. Monitor the patient’s blood glucose levels closely and expect an alternative treatment for glycemic control.

• Monitor patients for genital mycotic infections, especially those with a history of such infections. If present, notify the prescriber and treat, as prescribed.

WARNING: Monitor the patient closely for ketoacidosis that may occur despite the patient having type 2 diabetes and may be present even if a blood glucose level is less than 250 mg/dl. If signs and symptoms occur such as dehydration, fruity odor to the breath, malaise, nausea, shortness of breath, and vomiting notify the prescriber and expect the drug to be discontinued. Provide supportive care, as ordered.

Nursing Considerations

• Inform the patient that dapagliflozin therapy is not a replacement for diet and exercise therapy. 
• Instruct the patient on the signs and symptoms of hypoglycemia and how to treat it. Inform patient who is also receiving sulfonylurea or insulin that the risk of hypoglycemia is greater. Tell patient to notify prescriber if hypoglycemia occurs frequently or is severe.
• Inform the patient that dapagliflozin may have an adverse effect on the bladder, increasing the risk for bladder cancer. Tell the patient to report blood in the urine immediately to the prescriber.
• Tell the patient to monitor the blood glucose level using blood tests instead of urine tests because the drug increases urinary glucose excretion and will lead to positive urine glucose tests. Review signs and symptoms of ketoacidosis with the patient and urge her to seek immediate medical attention, if present, even if blood glucose level is less than 250 mg/dl.
• Instruct patient to stop taking a drug and seek immediate medical attention if an allergic reaction such as hives or facial or throat swelling occurs while taking dapagliflozin.
• Advise female patients to notify the prescriber if pregnancy occurs or is suspected because the drug may cause fetal harm if taken in the second or third trimester. Also, inform female patients that drugs may cause harm to infants who are breastfed. Mothers should discuss their desire to breastfeed with the prescriber prior to breastfeeding.
• Advise patient to maintain adequate fluid intake throughout dapagliflozin therapy. However, tell the patient to notify the prescriber if he is unable to take a normal amount of daily fluids due to illness or fasting or experiencing an excessive loss of fluids from excessive perspiration or gastrointestinal illnesses, as drug may need to be temporarily withheld.

WARNING: Warn the patient to stop dapagliflozin and seek immediate medical attention if pain, redness, swelling, or tenderness occur in the genital or perineal area, along with fever or malaise because, although rare, this cluster of symptoms may become life-threatening.

• Instruct the patient that if a dose is missed, to take it as soon as it is remembered unless it is almost time for the next dose. Then the patient should skip the missed dose and resume taking the drug at the next regularly scheduled time. Warn the patient never to double a dose to make up for a missed dose.