Invokamet XR

Invokamet XR is a prescription medication used to treat type 2 diabetes.

It is a single product containing 2 different medications: canagliflozin and metformin.

Canagliflozin belongs to a group of drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. SGLT2 inhibitors work by allowing the kidneys to get rid of more sugar by dumping it in the urine. Metformin belongs to a group of drugs called biguanides. Biguanides work by helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes and decreasing the amount of sugar your intestines absorb. Together, these medications work to lower blood sugars. 

This medication comes in tablet form and is taken once daily in the morning with a meal.

Swallow the tablet whole; do not split, crush, dissolve, or chew.

Common side effects of Invokamet XR include diarrhea, bloating, frequent urination, and thirst. Invokamet XR may also cause urinary tract infections and female genital yeast infections.

Invokamet XR can also cause low blood sugar, which can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Invokamet XR affects you.

Invokamet XR is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Serious side effects have been reported with Invokamet XR. See the “Drug Precautions” section.

Common side effects of Invokamet XR include the following:

• Frequent urination
• Genital fungal infections (yeast infections)
• Urinary tract infections (UTI)
• Diarrhea
• Nausea
• Stomach discomfort
• Gas
• Bloating
• Thirst

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take/use:

• Alcohol
• Pimozide
• Diuretics such as
  • Acetazolamide (Diamox)
  • Amiloride (Midamor)
  • Bumetanide (Bumex)
  • Chlorothiazide (Diuril)
  • Chlorthalidone (Thalitone)
  • Ethacrynic acid (Edecrin)
  • Furosemide (Lasix)
  • Hydrochlorothiazide (Microzide, HCTZ)
  • Metolazone (Zaroxolyn)
  • Spironolactone (Aldactone)
  • Torsemide (Demadex)
  • Triamterene (Dyrenium, Dyazide, Maxzide)
• Angiotensin-converting enzyme (ACE) blockers such as
  • Benazepril (Lotensin, Lotensin HCT)
  • Captopril (Capoten, Capozide)
  • Enalapril (Vasotec, Vaseretic)
  • Fosinopril (Monopril, Monopril HCT)
  • Lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • Moexipril (Univasc, Uniretic)
  • Quinapril (Accupril, Accuretic, Quinaretic)
  • Ramipril (Altace)
  • Trandolapril (Mavik, Tarka)
• Angiotensin receptor II blockers such as
  • Azilsartan (Edarbi)
  • Candesartan (Atacand)
  • Irbesartan (Avapro)
  • Losartan (Cozaar)
  • Olmesartan (Benicar)
  • Telmisartan (Micardis, Twynsta)
  • Valsartan (Diovan)
• Beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• Calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), diltiazem (Cardizem)
• Vasodilators such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), clonidine (Catapres), hydralazine (Bidil, Hydra-Zide), minoxidil

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Invokamet XR including the following:

• Lactic acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis:
  • Feeling very weak, tired, or uncomfortable
  • Unusual muscle pain
  • Trouble breathing
  • Unusual or unexpected stomach discomfort
  • Feeling cold
  • Feeling dizzy or lightheaded
  • Suddenly developing a slow or irregular heartbeat
• Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugar:
  • Feeling shaky
  • Feeling nervous
  • Sweating
  • Feeling cold or clammy
  • Confusion
  • Fast or irregular heart rate
• Serious urinary tract infections. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting.
• Kidney problems.Talk to your doctor right away if you:
  • reduce the amount of food or liquid you drink for example, if you are sick or cannot eat or
  • you start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long.
• Vaginal yeast infection. Women who take this medication may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis or balanoposthitis). Men who take this medication may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
  • redness, itching, or swelling of the penis
  • rash of the penis
  • foul smelling discharge from the penis
  • pain in the skin around the penis
• High levels of potassium in your blood (hyperkalemia). Tell your healthcare provider right away if you have some or all of the following symptoms of having high levels of potassium in your blood:
  • Muscle weakness
  • Irregular heart rhythm
  • Nausea
  • Suddenly collapsing
• Low levels of Vitamin B12. 
• Bone fractures. Patients taking Invokamet are at an increased risk of bone fractures. In addition, this medication may decrease bone mineral density.
• Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking this medication and call your doctor right away or go to the nearest hospital emergency room.

Do not take Invokamet XR if you:

• are allergic to Invokamet XR or to any of its ingredients 
• have kidney damage
• have acute or chronic metabolic acidosis
• are undergoing radiologic exams where contrast dye is used

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Invokamet XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Alcohol in combination with metformin may increase the risk of developing lactic acidosis. Avoid excessive alcohol use while taking Invokamet XR. Contact your doctor or pharmacist if you have any questions regarding alcohol use and Invokamet XR. 

Before taking Invokamet XR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Invokamet or to any of its ingredients
• have kidney problems
• have a history of urinary tract infections or problems with urination.
• are on a low sodium (salt) diet.
• are going to get an injection of dye or contrast agents for an x-ray procedure.
• have heart problems, including heart failure.
• are going to have surgery.
• are eating less due to illness, surgery, or a change in your diet.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• are a premenopausal woman who does not have periods regularly or at all and who are not planning to become pregnant. 
• have liver problems
• drink alcohol frequently 
• are dehydrated
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

There are no well-controlled studies that have been done in pregnant women. This medication may cause harm to your unborn baby. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Metformin has been detected in human breast milk, but canagliflozin is not known if it crosses into human breast milk. Because of the possibility for adverse reactions in nursing infants from Invokamet XR, a choice should be made whether to stop nursing or to stop the use of this medication. This medication is not recommended when breastfeeding. The importance of the drug to the mother should be considered.

• Take Invokamet XR exactly as prescribed.
• Invokamet comes in a tablet form and is taken once daily in the morning.
• Take this medication with food to reduce the risk of stomach upset. 
• Swallow the tablet whole; do not split, crush, dissolve, or chew.
• You may sometimes pass a soft mass in your stools (bowel movement) that looks like Invokamet XR tablets. It is normal to see this in your stool.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Invokamet at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended maximum dose of metformin is 2,000 mg a day and 300 mg of canagliflozin a day. 

If you take too much Invokamet XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Invokamet XR at room temperature. 
• Keep this and all medicines out of reach of children. 
• Store in the original container to protect from moisture. Do not put this medication in pill boxes or pill organizers.

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure.
• The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
• Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
• If lactic acidosis is suspected, Invokamet should be discontinued and the patient hospitalized immediately