Canagliflozin

What is Canagliflozin?

• Canagliflozin (Invokana) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to treat type 2 diabetes.

What are the uses of this medicine?

This medicine is used:

• along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes.
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes who have known cardiovascular disease.
• to reduce the risk of end stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.

Limitations of Use:

• Invokana is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
• Invokana is not used to lower blood sugar (glucose) in adults with type 2 diabetes with severe kidney problems(eGFR less than 30 mL/min/1.73 m2).

How does this medicine work?

• Canagliflozin is an inhibitor of SGLT2.
• By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG), and thereby increases urinary glucose excretion (UGE).
• Canagliflozin increases the delivery of sodium to the distal tubule by blocking SGLT2-dependent glucose and sodium reabsorption.
• This is believed to increase tubuloglomerular feedback and reduce intraglomerular pressure.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to canagliflozin or any of the ingredients in Invokana.

Symptoms of allergic reaction to Invokana may include:

• rash
• raised red patches on your skin (hives)
• swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing

• are on kidney dialysis

What drug interactions can this medicine cause?

• Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
• Monitoring glycemic control with 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.

Avoid coadministrartion of Invokana with:

• UGT inducers (e.g., rifampin)
• Digoxin

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

• Assess renal function before initiating Invokana.
• In patients with volume depletion, correct this condition before initiating Invokana.

Recommended Dosage:

• The recommended starting dose is 100 mg once daily, taken before the first meal of the day.
• Dose can be increased to 300 mg once daily in patients tolerating Invokana 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control.
• eGFR 30 to less than 60: 100 mg once daily.
• eGFR less than 30: Initiation is not recommended, however patients with albuminuria greater than 300 mg/day may continue 100 mg once daily to reduce the risk of ESKD, doubling of serum creatinine, CV death, and hospitalization for heart failure
• On dialysis: Contraindicated

• Adjust dose when taken concomitantly with UGT inducer.

Administration

• Take Invokana by mouth 1 time each day exactly as your doctor tells you to take it.
• Your doctor will tell you how much Invokana to take and when to take it. Your doctor may change your dose if needed.
• It is best to take Invokana before the first meal of the day.
• Your doctor may tell you to take Invokana along with other diabetes medicines. Low blood sugar can happen more often when Invokana is taken with certain other diabetes medicines. See "WHAT ARE THE POSSIBLE SIDE EFFECTS OF Invokana?"
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of Invokana at the same time. Talk to your doctor if you have questions about a missed dose.
• If you take too much Invokana, call your doctor or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Stay on your prescribed diet and exercise program while taking Invokana.
• Check your blood sugar as your doctor tells you to.
• Invokana will cause your urine to test positive for glucose.
• Your doctor may do certain blood tests before you start Invokana and during treatment as needed. Your doctor may change your dose of Invokana based on the results of your blood tests.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg, 300 mg

This medicine is available in fallowing brand namesː

• Invokana

What side effects can this medication cause?

The most common side effects of this medicine include:

• vaginal yeast infections and yeast infections of the penis
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

Invokana may cause serious side effects including:

• Amputations
• Dehydration
• Ketoacidosis (increased ketones in your blood or urine)
• Vaginal yeast infection
• Yeast infection of the skin around the penis (balanitis or balanoposthitis)
• serious urinary tract infections
• low blood sugar (hypoglycemia)
• a rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum)
• serious allergic reaction
• broken bones (fractures)

What special precautions should I follow?

• An increased risk of lower limb amputations associated with Invokana. Consider factors that may increase the risk of amputation before initiating Invokana. Monitor patients for infection or ulcers of lower limb and discontinue if these occur.
• Invokana can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. May result in acute kidney injury. Before initiating Invokana, assess and correct volume status in patients with renal impairment, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.
• Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in clinical trials. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue Invokana, evaluate and treat promptly. Before initiating Invokana, consider risk factors for ketoacidosis. Patients on Invokana may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including Invokana. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• Invokana may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with Invokana.
• Reports of necrotizing fasciitis of the perineum (Fournier's gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including Invokana. Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
• Invokana increases the risk of genital mycotic infections. Monitor and treat appropriately.
• Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with Invokana. If hypersensitivity reactions occur, discontinue use of Invokana; treat and monitor until signs and symptoms resolve.
• An increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using Invokana. Consider factors that contribute to fracture risk before initiating Invokana.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of an overdose, contact the Poison Control Center.
• It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient's clinical status.
• Canagliflozin was negligibly removed during a 4-hour hemodialysis session.
• Canagliflozin is not expected to be dialyzable by peritoneal dialysis.

Can this medicine be used in pregnancy?

• Based on animal data showing adverse renal effects, Invokana is not recommended during the second and third trimesters of pregnancy.
• Limited data with Invokana in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of Invokana in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: canagliflozin
• Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. In addition, the tablet coating contains iron oxide yellow E172 (100 mg tablet only), macrogol/PEG, polyvinyl alcohol, talc, and titanium dioxide.

Who manufactures and distributes this medicine?

• Active ingredient made in Belgium

• Manufactured for:

Janssen Pharmaceuticals, Inc. Titusville, NJ

• Licensed from Mitsubishi Tanabe Pharma Corporation

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)

• Dailymed label info on Canagliflozin
• FDA Canagliflozin

Canagliflozin Resources
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