Names and pronunciation
(dap′a-gli-floe′zin) Farxiga
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Individual generic drug information
Extracted information for dapagliflozin only.
(dap′a-gli-floe′zin) Farxiga
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Func. class.: Oral antidiabetic
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Chem. class.: Sodium-glucose co- transporter 2 (SGLT 2) inhibitor
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Do not confuse: Farxiga/Fetzima
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ACTION: Blocks reabsorption of glucose by the kidney, increases glucose excretion, low- ers blood glucose concentrations D
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USES: Type 2 diabetes mellitus, with diet and exercise
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Extracted information for dapagliflozin only.
CONTRAINDICATIONS: Dialy- sis, renal failure (eGFR <30 mL/min/1.73 m2) or ESRD (dialysis), hypersensitivity, breastfeeding, diabetic ketoacidosis, active bladder cancer Precautions: Pregnancy, children, renal/hepatic disease, hypothyroidism, hyperglycemia, hypotension, bladder cancer, hypercholesterolemia, pituitary insufficiency, type 1 diabetes mellitus, malnutrition, fever, dehydration, adrenal insufficiency, geriatrics, genital fungal infections, hypoglycemia
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SIDE EFFECTS GI: Pancreatitis, constipation, nausea GU: Cystitis, candidiasis, urinary fre- quency, polydipsia, polyuria, increased serum creatinine; renal impairment/fail- ure; infections INTEG: Photosensitivity, rash, pruritus META: Hypercholesterolemia, lipidemia, hypoglycemia, hyperkalemia, hypomag- nesemia, hypo/hyperphosphatemia MISC: Bone fractures, hypotension; dehydration; orthostatic hypotension; hypersensitivity; new bladder cancer
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INTERACTIONS Increase: hypoglycemia—sulfonylureas, insulin, MAOIs, salicylates, fibric acid derivatives, bile acid sequestrates, ACE inhibitors, angiotensin II receptor antag- onists, beta-blockers; adjust antidiabetics Increase or decrease: glycemic con- trol—androgens, lithium, bortezomib, quinolones Decrease: effect, hyperglycemia—diges- tive enzymes, intestinal absorbents, thia- zide diuretics, loop diuretics, corticoste- roids, estrogen, progestins, oral contraceptives, sympathomimetics, iso- niazid, phenothiazines, protease inhibi- tors, atypical antipsychotics, carbonic anhydrase inhibitors, cycloSPORINE, tacrolimus, baclofen Drug/Lab Test Increase: Hct, LDL Decrease: eGFR
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Extracted information for dapagliflozin only.
DOSAGE AND ROUTES Type 2 diabetes mellitus in combination with diet and exercise • Adult: PO 5 mg daily, increase dose to 10 mg daily in those who require addi- tional glycemic control Reduction of HF hospitalizations in type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors • Adult: PO 10 mg once daily. HF with reduced ejection fraction (NYHA class II to IV) to reduce the risk of cardiovascular death and hospitalization for HF • Adult: PO 10 mg once daily Chronic kidney disease to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for HF in those at risk of disease progression • Adult: PO 10 mg once daily Renal dose • Adult: PO eGFR ≥45 mL/min/1.73 m2 no change, eGFR <45 mL/min, do not use
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Available forms: Tablets 5, 10 mg
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Administer: PO route • Once daily in AM without regard to food • Store at room temperature
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Extracted information for dapagliflozin only.
Assess: • Hypoglycemia (weakness, hunger, dizziness, tremors, anxiety, tachycardia, sweating) when used with other agents even though product does not cause hypoglycemia; if patient is on sul- fonylureas or insulin, hypoglycemia may be additive; if hypoglycemia occurs, treat with dextrose or, if severe, with IV gluca- gon; monitor HbA1c, lipid panel, blood glucose, BUN, creatinine; if renal func- tion is reduced, discontinue; monitor volume status, B/P, usually in those with eGFR <60 mL/min/1.73m2; more fre- quent in those with poor renal function • Necrotizing fasciitis of the perineum: may occur in both females and males and require surgical intervention; assess perineum for swelling, pain, fever; if present, discontinue and start antibiotics • Bone fracture risk: avoid use in those at increased risk of fractures; renal im- pairment increases fracture risk • Mycotic infections: increased risk of mycotic infections, especially genital; caution in those with previous infections or in uncircumcised males • Hypersensitivity: discontinue immedi- ately • Ketoacidosis: increased urine/serum ketone levels, may occur without in- creased glucose levels; may occur more frequently in those with reduced intake of food, fluids, or in serious conditions • Renal function: baseline and peri- odically; discontinue if renal function is reduced; assess for signs of UTIs (seri- ous) • Pregnancy/breastfeeding: avoid use in pregnancy; do not breastfeed
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Evaluate: • Therapeutic response: improved signs/ symptoms of diabetes mellitus (decreased polyuria, polydipsia, polyphagia); clear sensorium, absence of dizziness, stable gait; HbA1c WNL
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • The symptoms of hypo/hyperglycemia, what to do about each • That medication must be taken as prescribed; explain consequences of dis- continuing medication abruptly; that insulin may need to be used for stress, including trauma, fever, surgery • To avoid OTC medications and herbal supplements unless approved by health care provider • That diabetes is a lifelong illness; that the diet and exercise regimen must be followed; that this product is not a cure • To carry emergency ID and glucose source • That blood glucose monitoring and periodic lab tests are required to assess product effect • That GI side effects may occur • That there is a risk of renal impair- ment, dehydration, and bladder cancer • To report immediately fever, itching, change in urine output, light headedness or feeling faint, other signs of UTI • To ensure adequate fluid intake to avoid dehydration and/or hypotension; to report symptoms to provider • Necrotizing fasciitis of the perineum: Teach patient to report imme- diately pain, swelling of perineum, fever • Candidiasis (yeast infection): Have patient report itching, discharge, inflammation, redness, burning; discuss dietary ways of preventing • Ketoacidosis: to report immediately confusion, abdominal pain, fatigue, trouble breathing, nausea, vomiting, food intolerance HIGH ALERT
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Extracted information for dapagliflozin only.
PHARMACOKINETICS 91% protein binding, primary excretion in urine, half-life 12.9 hr; primarily metabo- lized by O-glucuronidation by UGT1A9; minor CYP3A4; Cmax is less than 2 hr
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Filter the extracted dose blocks for this individual drug.
Type 2 diabetes mellitus in combination with diet and exercise
• Adult: PO 5 mg daily, increase dose to 10 mg daily in those who require addi- tional glycemic control Reduction of HF hospitalizations in type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
Candidate age grouping · source pages 345, 346
Type 2 diabetes mellitus in combination with diet and exercise
• Adult: PO 10 mg once daily. HF with reduced ejection fraction (NYHA class II to IV) to reduce the risk of cardiovascular death and hospitalization for HF
Candidate age grouping · source pages 345, 346
Type 2 diabetes mellitus in combination with diet and exercise
• Adult: PO 10 mg once daily Chronic kidney disease to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for HF in those at risk of disease progression
Candidate age grouping · source pages 345, 346
Type 2 diabetes mellitus in combination with diet and exercise
• Adult: PO 10 mg once daily Renal dose
Candidate age grouping · source pages 345, 346
Type 2 diabetes mellitus in combination with diet and exercise
• Adult: PO eGFR ≥45 mL/min/1.73 m2 no change, eGFR <45 mL/min, do not use
Candidate age grouping · source pages 345, 346