dapagliflozin

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dapagliflozin

(dap-a-gli-floe-zin),

Farxiga

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: sodium glucose co transporter 2 sglt2 inhibitors
Pregnancy Category: C

Indications

Adjunct to diet and exercise in the management of type 2 diabetes mellitus.May be used with other antidiabetic agents.

Action

Inhibits proximal renal tubular sodium-glucose co-transporter 2 (SGLT2) which determines reabsorption of glucose from the tubular lumen. Inhibits reabsorption of glucose, lowers renal threshold for glucose and increases excretion of glucose in urine.

Therapeutic effects

Improved glycemic control.

Pharmacokinetics

Absorption: 78% absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized by UGT1A9 to inactive metabolites which are primarily excreted in urine. 15% excreted in feces as unchanged drug.
Half-life: 12.9 hr

Time/action profile (decrease in HbA1c)

ROUTEONSETPEAKDURATION
POwithin 4 wk12 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Severe renal impairment/end-stage renal disease/dialysis GRF <60 mL/min/1.73 m2;Type 1 diabetes;Diabetic ketoacidosis;Active bladder cancer; Lactation: Avoid use, discontinue breastfeeding or discontinue dapagliflozin.
Use Cautiously in: eGFR <60 mL/min/1.73 m2 (monitor frequently), ↑ risk of adverse reactions related to ↓ intravascular volume; Geriatric: ↑ risk of adverse reactions related to ↓ intravascular volume; Hypotension (correct prior to treatment, especially if eGFR 30–60 mL/min, age >65 yr, or concurrent use of loop diuretics, ACE inhibitors, or ARBs; History of bladder cancer; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Cardiovascular

  • volume depletion

Genitourinary

  • genital mycotic infections
  • ↑ urination
  • renal impairment

Endocrinologic

  • hypoglycemia (with other medications)

Fluid and Electrolyte

  • hyperphosphatemia

Metabolic

  • hyperlipidemia

Interactions

Drug-Drug interaction

↑ risk of hypotension with antihypertensives or diuretics.↑ risk of hypoglycemia with other antidiabetics (dose adjustments maybe required).renal impairment

Route/Dosage

Oral (Adults) 5 mg once daily, may be increased to 10 mg once daily.

Availability

Tablets: 5 mg, 10 mg

Nursing implications

Nursing assessment

  • Observe for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety), especially in patients taking insulin or other hypoglycemic agents.
  • Monitor BP after initiating and periodically during therapy; may cause hypotension.
  • Lab Test Considerations: Monitor serum glucose and glycosylated hemoglobin periodically during therapy to evaluate effectiveness of treatment.
    • Evaluate renal function prior to starting and periodically during therapy; may cause ↑serum creatinine and ↓ eGFR.
    • May cause ↑ LDL cholesterol.
    • May cause an ↑ hematocrit and serum phosphorous.
    • Will cause urine to test positive for glucose.
  • Overdose is manifested by symptoms of hypoglycemia. Mild hypoglycemia may be treated with administration of oral glucose. Treat severe hypoglycemia with IV D50W followed by continuous IV infusion of more dilute dextrose solution at a rate sufficient to keep serum glucose at approximately 100 mg/dL.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • high alert: Accidental administration of oral hypoglycemic agents to non-diabetic adults and children has resulted in serious harm or death. Before administering, confirm that patient has Type 2 diabetes.
  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: Administer once daily in the morning without regard to food.

Patient/Family Teaching

  • Instruct patient to take medication at same time each day. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
  • Inform patient dapagliflozin may cause dehydration and hypotension. Maintain adequate hydration and notify health care professional if dizziness, fainting, weakness or orthostatic hypotension occur.
  • Advise patient to notify health care professional if signs and symptoms of genital mycotic infections; females (vaginal odor, white or yellowish vaginal discharge, vaginal itching), males (rash or redness of glans or foreskin of penis, foul smelling discharge from penis, pain in skin around penis) occur. Instruct patient on treatment options and when to notify health care professional.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to drink a glass of orange juice or ingest 2–3 tsp of sugar, honey, or corn syrup dissolved in water or an appropriate number of glucose tablets and notify health care professional.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
  • Advise patient to notify health care professional promptly if signs and symptoms of hypersensitivity reactions (rash; raised red patches on skin; swelling of face, lips, tongue, throat; difficulty breathing or swallowing) or bladder cancer (blood or red color in urine, painful urination) occur.
  • Insulin is the recommended method of controlling blood sugar during pregnancy. Counsel female patients to use a form of contraception other than oral contraceptives and to notify health care professional promptly if pregnancy is planned or suspected. May cause fetal harm in 2nd or 3rd trimester.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

  • Control of blood glucose levels without the appearance of hypoglycemic or hyperglycemic episodes.
References in periodicals archive ?
In light of the increased safety concern, Simmons Hanly Conroy is now investigating SGLT-2 drugs Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
With the acquisition, AstraZeneca possess the intellectual property and global rights for the development, manufacture, and commercialization of BMS diabetes business, which comprises Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin HCl extended release), Komboglyze (saxagliptin and metformin HCl), dapagliflozin (marketed as Forxiga outside the US and Farxiga in the US), Xigduo (dapagliflozin and metformin HCl), Byetta (exenatide), Bydureon (exenatide extended-release for injectable suspension), metreleptin, and Symlin (pramlintide acetate).
4 billion in regulatory, launch, and sales payments, and a number of sales-related royalty payments up until 2025, $600 million of which relates to the endorsement of Farxiga in the US.
Farxiga is a once-a-day tablet designed to help diabetes patients eliminate excess sugar via their urine.
The agency cleared Farxiga tablets for patients with type 2 diabetes, which affects about 24 million people in the U.
4 billion in regulatory, launch and sales payments, and various sales-related royalty payments up until 2025, $600 million of which relates to the approval of Farxiga in the US.
26, 2015 /PRNewswire/ -- Seeger Weiss LLP reports that in May 2015 the FDA issued a warning about the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin (sold under the brand names Invokana, Farxiga, and Jardiance, respectively), alerting doctors and patients about the risk of Diabetic Ketoacidosis linked to the medications.
Forxiga was the first medicine in the SGLT2 class to gain regulatory approval, having received Marketing Authorisation in the EU for type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries including the United States (available under the trade name Farxiga ) and Australia.
Insight and Analysis Provided AstraZeneca Byetta (exenatide) Onglyza (saxagliptin) Farxiga (dapagliflozin) Johnson & Johnson Invokana (canagliflozin) Merck & Co.
Farxiga (dapaglifozin) tablets has been sanctioned by the U.
Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.