Generic Name: canagliflozin and metformin hydrochloride
Date of Approval: August 8, 2014
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Type 2 Diabetes
FDA Approves Invokamet
The U.S. Food and Drug Administration (FDA) has approved Invokamet, a fixed dose therapy combining a sodium glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin) and a biguanide (metformin hydrochloride) in a single tablet, for the treatment of adults with type 2 diabetes.
Invokamet Medication Guide
Read the Medication Guide that comes with your prescription before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information about Invokamet
Invokamet can cause serious side effects, including:
- Lactic Acidosis. One of the ingredients, metformin, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking this medicine and call your doctor right away if you have any of the following symptoms which could be signs of lactic acidosis:
- you feel very weak or tired
- you have unusual (not normal) muscle pain
- you have trouble breathing
- you have unusual sleepiness or sleep longer than usual
- you have stomach pains, nausea, or vomiting
- you feel dizzy or lightheaded
- you have a slow or irregular heartbeat
- have kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye. People whose kidneys are not working properly should not take Invokamet.
- have liver problems.
- have congestive heart failure that requires treatment with medicines.
- drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
- get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
- have surgery
- have a heart attack, severe infection, or stroke
- are 80 years of age or older and have not had your kidneys tested
Invokamet can have other serious side effects. See Invokamet side effects.
What is Invokamet?
- Invokamet contains two prescription medicines called canagliflozin (Invokana) and metformin hydrochloride (Glucophage). It can be used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes when treatment with either canagliflozin or metformin has not controlled your blood sugar.
- It is not for people with type 1 diabetes.
- It is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
- It is is not known if it is safe and effective in children under 18 years of age.
Who should not take Invokamet?
Do not take Invokamet if you:
- have severe kidney problems or are on dialysis.
- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
- are allergic to canagliflozin, metformin, or any of the ingredients in Invokamet. See the end of this Medication Guide for a list of active and inactive ingredients. Symptoms of allergic reaction may include:
- raised red patches on your skin (hives)
- swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Before taking Invokamet
Before you take this medicine, tell your doctor if you:
- have kidney problems.
- have liver problems.
- are on a low sodium (salt) diet. Your doctor may change your diet or your dose.
- have ever had an allergic reaction to Invokamet.
- are going to get an injection of dye or contrast agents for an x-ray procedure. You will need to stop taking this medicine for a short time. Talk to your doctor about when you should and when you should start retaking it again. See Important information about Invokamet.
- have heart problems, including congestive heart failure.
- drink alcohol very often, or drink a lot of alcohol in short term "binge" drinking.
- have other medical conditions.
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking Invokamet.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Invokamet may affect the way other medicines work and other medicines may affect how Invokamet works.
Especially tell your doctor if you take:
- diuretics (water pills)
- rifampin (used to treat or prevent tuberculosis)
- phenytoin or phenobarbital (used to control seizures)
- ritonavir (Norvir, Kaletra, Lopinavir)* (used to treat HIV infection)
- digoxin (Lanoxin)* (used to treat heart problems)
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take Invokamet?
- Take tablets by mouth two times each day with meals exactly as your doctor tells you to take it. Taking doses with meals may lower your chance of having an upset stomach.
- Your doctor will tell you how much to take and when to take it. Your doctor may change your dose if needed.
- Your doctor may tell you to take Invokamet along with other diabetes medicines. Low blood sugar can happen more often when this medicine is taken with certain other diabetes medicines. See Invokamet side effects.
- 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 at the same time. Talk to your doctor if you have questions about a missed dose.
- If you take too much, 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.
- Check your blood sugar as your doctor tells you to.
- Invokamet will cause your urine to test positive for glucose.
- Your doctor may do certain blood tests before you start, and during treatment as needed. Your doctor may change your dose 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 should I avoid?
- Avoid drinking alcohol very often, or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.
Invokamet side effects
Invokamet may cause serious side effects including:
- See Important information about Invokamet
- dehydration. This medicine can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you:
- have low blood pressure
- take medicines to lower your blood pressure, including diuretics (water pill)
- are on a low sodium (salt) diet
- have kidney problems
- are 65 years of age or older
- kidney problems
- a high amount of potassium in your blood
- low blood sugar (hypoglycemia). If you take this medicine with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take Invokamet. Signs and symptoms of low blood sugar may include:
- fast heartbeat
- shaking or feeling jittery
- vaginal yeast infection. Women who take this medicine 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 medicine 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
- serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking this medicine and call your doctor right away or go to the nearest hospital emergency room. See Who should not take Invokamet?. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- low vitamin B 12 (vitamin B 12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B 12 in your blood, especially if you have had low vitamin B 12 blood levels before. Your doctor may do blood tests to check your vitamin B 12 levels.
Other common side effects include:
- urinary tract infection
- changes in urination, including urgent need to urinate more often, in larger amounts, or at night
- nausea and vomiting
- upset stomach
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Invokamet. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-526-7736.
How should I store Invokamet?
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in the original container to protect from moisture. Do not put tablets in pill boxes or pill organizers.
- Keep all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for healthcare professionals.
What are the ingredients of Invokamet?
Active ingredients: canagliflozin and metformin hydrochloride
Inactive ingredients: The tablet core contains croscarmellose sodium, hypromellose, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. In addition, the tablet coating contains Macrogol/PEG, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide yellow (50 mg/1000 mg and 150 mg/500 mg tablets only), iron oxide red (50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg tablets only), and iron oxide black (150 mg/1000 mg tablets only).