Invokana

The recommended starting dose for Invokana (Canagliflozin) is 100 mg taken by mouth once a day. Your doctor may adjust the dose up or down, depending on how effective it is and how well it is tolerated. The maximum recommended dose is 300 mg daily.

Invokana (Canagliflozin) should be taken at the same time every day, preferably before the first meal of the day. The tablets should be swallowed whole with some fluid and may be taken with food or on an empty stomach.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Invokana (Canagliflozin) exactly as prescribed by your doctor. Do not stop using the medication because you feel better. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Invokana (Canagliflozin) at room temperature, protect from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it could make you more prone to urinary tract infections and infections of the genital organs; it can cause dizziness; it may increase urination; it may cause low blood sugar levels, which could make you feel dizzy, shaky or weak; it may lower your blood pressure, which could cause weakness and/or dizziness - use caution when getting up from a lying or sitting position and when driving. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 mg
Each yellow, capsule-shaped, film-coated tablet with "CFZ" on one side and "100" on the other, contains Invokana (Canagliflozin) hemihydrate equivalent to 100 mg of Invokana (Canagliflozin). Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose; film coating: iron oxide yellow, Macrogol (polyethylene glycol), polyvinyl alcohol, talc, and titanium dioxide.

300 mg
Each white, capsule-shaped, film-coated tablet with "CFZ" on one side and "300" on the other, contains Invokana (Canagliflozin) hemihydrate equivalent to 300 mg of Invokana (Canagliflozin). Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose; film coat: Macrogol (polyethylene glycol), polyvinyl alcohol, talc, and titanium dioxide.

Do not use Invokana (Canagliflozin) if you:

• are allergic to Invokana (Canagliflozin) or any ingredients of Invokana (Canagliflozin)
• are receiving dialysis

Invokana (Canagliflozin) should not be used to treat Type 1 Diabetes.

There may be an interaction between Invokana (Canagliflozin) and any of the following:

• acetylsalicylic acid (Asa)
• Aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Buserelin
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Danazol
• other diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Digoxin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dofetilide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Glucagon
• Goserelin
• Hepatitis C direct antivirals (e.g., daclatasvir, ledipasvir, paritaprevir, sofosbuvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• Leuprolide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• Pasireotide
• Pegvisomant
• phenobarbital
• Phenytoin
• primidone
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• somatotropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• testosterone
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Invokana (Canagliflozin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Invokana (Canagliflozin).

HEALTH CANADA ADVISORY

September 6, 2017

Health Canada has issued new information concerning the use of Invokana (Canagliflozin) (Invokana). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

Previous advisories on Invokana (Canagliflozin) were issued on May 16, 2016, and on June 22, 2015.

Amputation: There may be an increased risk for lower leg or toe amputations in people taking Invokana (Canagliflozin), especially if you are at high risk for heart disease. Good foot care is very important for people with diabetes. Contact your doctor as soon as possible if you notice symptoms of leg pain; poor circulation; bluish, cold skin; and poor hair or toenail growth.

Cholesterol: Invokana (Canagliflozin) can cause increased blood cholesterol levels, particularly low-density lipoprotein. If you are at risk of developing High Cholesterol or you have high cholesterol levels before starting Invokana (Canagliflozin), discuss with your doctor how Invokana (Canagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invokana (Canagliflozin), and whether any special monitoring is needed.

Diabetic ketoacidosis: If blood sugar levels are too high (hyperglycemia), a condition known as diabetic ketoacidosis may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma or death. Your risk of developing diabetic ketoacidosis may be increased if you are on a low carbohydrate diet, drink a lot of alcohol, have a severe illness or infection, or have problems with your pancreas. There have been reports of diabetic ketoacidosis in people taking Invokana (Canagliflozin).

If you develop symptoms of diabetic ketoacidosis such as difficulty breathing, feeling very thirsty, vomiting, abdominal pain, nausea, loss of appetite, confusion, and unusual tiredness, seek urgent medical attention.

Dizziness: Some people taking Invokana (Canagliflozin) may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing Low Blood Pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how Invokana (Canagliflozin) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Invokana (Canagliflozin), and whether any special monitoring is needed.

Fractures: There is a small increase in the risk of bone fractures for people taking Invokana (Canagliflozin). If you are at risk of Osteoporosis or are taking medications that may decrease the strength of your bones, discuss with your doctor how Invokana (Canagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invokana (Canagliflozin), and whether any special monitoring is needed.

Glucose control: When Invokana (Canagliflozin) is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking Invokana (Canagliflozin). If you take other medications for diabetes, discuss with your doctor how Invokana (Canagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invokana (Canagliflozin), and whether any special monitoring is needed.

Kidney function: Invokana (Canagliflozin) may cause a decrease in kidney function. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Invokana (Canagliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invokana (Canagliflozin), and whether any special monitoring is needed.

Potassium levels: Increases in blood levels of potassium may occur when taking Invokana (Canagliflozin). This is more likely to happen to people who are taking other medications that prevent potassium from being removed from the body, or those who have moderately reduced kidney function. This doesn't often cause problems, but potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness or tingling sensations, contact your doctor.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking Invokana (Canagliflozin) as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: Invokana (Canagliflozin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Invokana (Canagliflozin), contact your doctor immediately.

Breast-feeding: It is not known if Invokana (Canagliflozin) passes into breast milk. If you are a breast-feeding mother and are taking Invokana (Canagliflozin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Invokana (Canagliflozin) have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to experience side effects with Invokana (Canagliflozin) and may require lower doses.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. Like all individuals with diabetes, you should monitor your blood sugar levels regularly using the appropriate device. If you remember missing a dose within 12 hours of the time it is usually taken, take it as soon as you remember, then take the next dose at the regularly scheduled time. If the dose is missed by more than 12 hours, skip the missed dose. Do not double the next dose to catch up. It is preferable to take this medication before the first meal of the day.