Patient Medication Information: uses, side effects, how to take - Invokamet XR
What is INVOKAMET XR used for?
INVOKAMET XR is used along with diet and exercise to improve blood sugar levels in adults with type 2 diabetes.
Serious Warnings and Precautions
Lactic Acidosis
Diabetic Ketoacidosis (DKA)
Lower Limb Amputation
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INVOKAMET XR can be used in patients:
whose diabetes is not controlled on:
- metformin alone
- metformin in combination with a sulfonylurea
- metformin in combination with pioglitazone
- metformin in combination with insulin
who are currently taking combination of separate tablets of:
- metformin and INVOKANA (canagliflozin)
- metformin, INVOKANA and a sulfonylurea
- metformin, INVOKANA and pioglitazone
- metformin, INVOKANA and insulin
How does INVOKAMET XR work?
INVOKAMET XR contains two medicines canagliflozin and metformin. These medicines work together to help you better control your blood sugar level.
Canagliflozin is in a class of medicines called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to remove more sugar from the body through the urine.
Metformin is a class of medicines called biguanides. It helps your body respond better to insulin, a natural chemical that manage the amount of sugar in the blood. This lowers the amount of sugar made by the liver and the amount of sugar that moves from the food you eat to the blood.
What are the ingredients in INVOKAMET XR?
Medicinal ingredients: canagliflozin and metformin hydrochloride
Non-medicinal ingredients: croscarmellose sodium, hypromellose, hydroxypropyl cellulose, iron oxide black (50/1000 mg and 150/1000 mg tablets), iron oxide red (50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg tablets), iron oxide yellow (50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg, and 150 mg/1000 mg tablets), lactose anhydrous, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol (partially hydrolyzed), polyethylene oxide, silicified microcrystalline cellulose, talc, and titanium dioxide
INVOKAMET XR comes in the following dosage forms:
Tablets:
- 50 mg canagliflozin/500 mg metformin hydrochloride
- 50 mg canagliflozin /1000 mg metformin hydrochloride
- 150 mg canagliflozin /500 mg metformin hydrochloride
- 150 mg canagliflozin /1000 mg metformin hydrochloride
Do not use INVOKAMET XR if you:
- are allergic (hypersensitive) to canagliflozin, metformin or any other ingredients in INVOKAMET XR.
- have kidney problems.
- have or have had a condition called metabolic acidosis (including diabetic ketoacidosis or lactic acidosis – too much acid in the blood).
- have type 1 diabetes (your body does not produce any insulin).
- drink alcohol very often or drink a lot of alcohol in a short-term “binge” drinking.
- have liver problems.
- have serious heart problems or heart failure.
- have lost a lot of water from your body (seriously dehydrated)
- are under stress, have a serious infection, have recently had an injury.
- are going to have major surgery or are recovering from surgery.
- are going have an exam or other tests such as an X-ray or scan with injectable dye or contrast agents. You will need to stop taking this medicine around the time of your check-up.
are pregnant or are planning to become pregnant.
- are breastfeeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take INVOKAMET XR. Talk about any health conditions or problems you may have, including if you:
have any of the following conditions
- are malnourished.
- problems with your adrenal or pituitary glands (adrenal or pituitary insufficiency).
- low vitamin B12.
- history of yeast infections of the vagina or penis.
- low blood pressure.
- are taking any of the medicines listed in the drug interactions section (see The following may interact with INVOKAMET XR).
have risk of DKA, such as if you:
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- are on a very low carbohydrate (sugar) diet.
- have been fasting for a while.
- are eating less, or there is a change in your diet.
- drink a lot of alcohol.
- have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
- are hospitalized for major surgery, or are about to have major surgery.
- are hospitalized for serious infection or serious medical illnesses.
- have an acute illness.
- have sudden reductions in insulin dose.
- have a history of DKA.
have risk of an amputation, such as if you:
- have a history of amputation.
- have heart disease or are at risk for heart disease.
- have had blocked or narrowed blood vessels, usually in your leg.
- have damage to the nerves (neuropathy) in your leg.
- have had diabetic foot ulcers or sores.
- have a lower limb infection are dehydrated.
Other warnings you should know about:
Children and adolescents (under 18 years of age):
INVOKAMET XR is not recommended for use in patients under 18 years of age.
Adults aged 65 years of age and older
You could have more side effects with INVOKAMET XR.
Check-ups and testing
You will have regular visits with your healthcare professional before and during treatment with INVOKAMET XR to monitor your health. They may check:
- your blood sugar levels. INVOKAMET XR will cause your urine to test positive for sugar.
- the level of red cells in your body.
- that your kidneys are working properly.
- the level of blood fat.
- the potassium levels in your blood.
- ketone levels in your blood or urine. Ketones are a type of chemical that your liver produces when it breaks down fats for energy.
Broken bone (fracture): INVOKAMET XR may raise the chance of a broken bone. Talk with your healthcare professional.
Surgery and illnesses
Tell your healthcare professional if you:
- are going to have a surgery.
- are hospitalized for a serious infection.
- have a serious medical illness.
- had major surgery.
Your healthcare professional may tell you to stop taking INVOKAMET XR:
- before or after certain types of surgery.
- when you are sick or injured.
If INVOKAMET XR is stopped, your healthcare professional will:
- continue to monitor for signs or symptoms of DKA.
- tell you when to start taking INVOKAMET XR again.
Driving and using machinery
INVOKAMET XR may cause dizziness or light-headedness. DO NOT drive or use machines until you know how the medicine affects you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with INVOKAMET XR:
- digoxin, used to treat heart problems.
- furosemide or other diuretics (water pills), used to treat high blood pressure and other heart problems.
- insulin or a sulfonylurea (such as glimepiride, gliclazide, or glyburide), used to help control blood sugar.
- carbamazepine, or phenobarbital, used to treat seizures.
- barbituates, used as sedatives and sleep-aids.
- efavirenz or ritonavir, used to treat HIV infection
- rifampin, an antibiotic used to treat bacterial infections such as Tuberculosis.
- St. John’s wort, an herbal product used to treat depression.
- Angiotensin-Converting Enzyme (ACE) inhibitors, Angiotensin Receptor Blockers (ARB) used to treat high blood pressure.
- phenprocoumon and other drugs used prevent blood clots and thin the blood.
other medicines that may cause high blood sugar and may lead to a loss of blood sugar control such as:
- corticosteroids medicines such as prednisone, used to treat a broad range of diseases.
- isoniazid, used to treat tuberculosis.
- phenothiazines, a group of medicines used to treat mental problems, including schizophrenia.
- thiazide (water pills); used to treat high blood pressure.
- thyroid medicines such as levothyroxine.
- birth control pills and other products containing estrogens.
- a group of medicines known as Calcium channel blockers such as nifedipine used to treat heart problems, amlodipine, felodipine, veramapil, diltiazem.
- medicine used to treat epilepsy (seizures) such as phenytoin.
- nicotinic acid, used to prevent and treat niacin deficiency.
- bronchodilators (known as beta-2-agonists) medicines that make breathing easier, used to treat asthma like salbutamol or formoterol.
- Alcohol.
How to take INVOKAMET XR:
- take INVOKAMET XR exactly as your healthcare professional tells you. Check with your healthcare professional if you are not sure.
- swallow the tablets whole. Do not split, break, crush or chew the tablets.
your healthcare professional may prescribe INVOKAMET XR together with another
medicine to help control your blood sugar.
Usual adult dose:
Your healthcare professional will decide on the strength of INVOKAMET XR that is right for you
- take two tablets once a day with a morning meal to lower your chance of having an upset stomach.
- swallow each tablet whole, one immediately after the other.
Overdose:
| If you think you have taken too much INVOKAMET XR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you forget to take a dose of INVOKAMET XR, take it as soon as you remember.
However, if it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using INVOKAMET XR?
These are not all the possible side effects you may feel when taking INVOKAMET XR. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
Changes in urination:
- urinating more often or in larger amounts.
- an urgent need to urinate.
- a need to urinate at night.
- Constipation, excess gas, abdominal discomfort.
- Nausea, vomiting, diarrhea, indigestion, loss of appetite.
- Changes in taste or a metallic taste.
- Feeling thirsty.
- Rash, hives.
- Headache.
- Fatigue.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| VERY COMMON | ||||
| Vaginal yeast infection: vaginal odor, white or yellowish vaginal discharge, and/or itching | ✓ | |||
| COMMON | ||||
| Balanitis (yeast infection of the penis): rash or redness of the penis or foreskin | ✓ | |||
| Urinary tract infection: burning sensation when urinating, cloudy or bloody urine, strong odor | ✓ | |||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| Skin Ulcer (a break or sore on the skin with tissue breakdown) predominantly of the lower legs: It may start off red then get swollen and tender. Next, blisters can form with loss of skin layers. It can lead to an open round crater with a bad smell. Ulcers take a long time or may not heal. | ✓ | ||||
| UNCOMMON | |||||
| Peripheral Ischemia (blocked or narrow blood vessels): Leg pain with walking that gets better with rest. Poor circulation, bluish, cold skin, and poor nail and hair growth. It can lead to Skin Ulcers and Lower Leg or Toe Amputation. | ✓ | ||||
| Low blood pressure: fainting, dizziness or light-headedness with standing | ✓ | ||||
| Dehydration (not having enough water in your body): dry or sticky mouth, headache, dizziness or urinating less often than normal | ✓ | ||||
| Kidney problems: any change in the amount, frequency or colour (pale or dark) of urine | ✓ | ||||
| RARE | |||||
| Acute kidney infection: painful, urgent or frequent urination, lower back (flank) pain, fever or chills, cloudy or foul smelling urine, blood in your urine | ✓ | ||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Urosepsis (severe infection that spreads from urinary tract throughout body): fever or low body temperature, rapid breathing, chills, rapid heartbeat, pain with urination, difficulty urinating, frequent urination | ✓ | |||
| Diabetic ketoacidosis (when your body produces high levels of blood acids called ketones): difficulty breathing, feeling very thirsty, vomiting, stomach pain, nausea, loss of appetite, confusion, and unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth or a different odour to urine or sweat | ✓ | |||
| Severe hypoglycemis (severe low blood sugar): disorientation, loss of consciousness, seizure | ✓ | |||
| Lactic acidosis (a build up of lactic acid in your body): feeling cold or uncomfortable, severe nausea with or without vomiting, stomach pain, unexplained weight loss, rapid breathing | ✓ | |||
| Angioedema and severe allergic reactions: rash, hives, swelling of the face, eyes, lips or throat, difficulty swallowing or breathing, wheezing, fever, stomach cramps, chest discomfort or tightness, unconsciousness | ✓ | |||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| Fournier’s gangrene (necrotizing fasciitis of the perineum): pain or tenderness, redness of the skin, or swelling in the genital or perineal area, with or without fever, or feeling very weak, tired, or uncomfortable | ✓ | ||||
| VERY RARE | |||||
| Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||||
| Pancreatitis (inflammation of the pancreas): severe stomach pain that lasts and gets worse when you lie down, nausea, vomiting | ✓ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store INVOKAMET XR in the original container.
- Store at room temperature (15-30°C).
- Do not use INVOKAMET XR after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
- Keep out of reach and sight of children.
If you want more information about INVOKAMET XR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; www.janssen.com/canada or call 1-800-567-3331 or 1-800-387-8781.
Last Revised: February 27, 2023
All trademarks used under license.