1 What is Invokamet?

Brand: Invokamet

Generic: Canagliflozin and metformin

Invokamet is used to treat type 2 diabetes. It is used together with a proper diet and exercise to help control blood sugar levels.

Canagliflozin works in the kidney to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. It does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

2 What to Know Before Using

Before using Invokamet, you must know all about the risks and complications associated with it.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:
Appropriate studies have not been performed on the relationship of age to the effects of canagliflozin and metformin combination in the pediatric population. Safety and efficacy have not been established.

3. Geriatric Population:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of canagliflozin and metformin combination in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving canagliflozin and metformin combination.

4. Pregnancy:
Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

5. Breastfeeding:
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

6. Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Acetrizoic Acid
  • Diatrizoate
  • Ethiodized Oil
  • Iobenzamic Acid
  • Iobitridol Iocarmic Acid Iocetamic Acid Iodamide Iodipamide Iodixanol Iodohippuric Acid Iodopyracet Iodoxamic Acid Ioglicic Acid Ioglycamic Acid Iohexol Iomeprol Iopamidol Iopanoic Acid Iopentol Iophendylate Iopromide Iopronic Acid Ioseric Acid Iosimide Iotasul Iothalamate Iotrolan Iotroxic Acid Ioversol Ioxaglate Ioxitalamic Acid Ipodate
  • Metrizamide Metrizoic Acid
  • Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetazolamide
  • Balofloxacin Besifloxacin Bupropion
  • Ciprofloxacin
  • Dabrafenib Dichlorphenamide Digoxin Dofetilide Dolutegravir
  • Enoxacin Eslicarbazepine Acetate
  • Fleroxacin Flumequine Fosphenytoin
  • Gatifloxacin Gemifloxacin
  • Lanreotide Levofloxacin Lomefloxacin
  • Moxifloxacin
  • Nadifloxacin Norfloxacin
  • Octreotide Ofloxacin
  • Pasireotide Pazufloxacin Pefloxacin Phenobarbital Phenytoin Prulifloxacin
  • Rifampin Ritonavir Rufloxacin
  • Sparfloxacin
  • Tosufloxacin
  • Vandetanib
  • Zonisamide

7. Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

8. Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal gland problem (underactive)
  • Alcohol abuse, history of
  • Congestive heart failure
  • Dehydration, severe
  • Pancreatic insulin deficiency, history of
  • Pituitary gland problem (underactive)
  • Poorly nourished condition
  • Sepsis (severe infection)
  • Weakened physical condition—Use with caution. May cause side effects to become worse.
  • Anemia (low red blood cells)
  • Dehydration
  • Genital yeast (fungus) infection (eg, balanitis, balanoposthitis, vulvovaginitis), history of
  • Hypercholesteremia (high levels of cholesterol)
  • Hyperkalemia (high potassium in the blood)
  • Hypotension (low blood pressure)
  • Hypovolemia (low blood volume)
  • Kidney disease
  • Urinary tract infection, history of
  • Vitamin B12 deficiency—Use with caution. May make these conditions worse.
  • Diabetic ketoacidosis (high ketones and acid in the blood)
  • Kidney disease, severe
  • Liver disease
  • Metabolic acidosis (acid in the blood)
  • Patients receiving dialysis
  • Type I diabetes—Should not be used in patients with these conditions.
  • Fever
  • Infection
  • Surgery
  • Trauma—Use with caution. These conditions may cause problems with blood sugar control.

3 Proper Usage

To use Invokamet properly, you must follow all instructions given by your doctor.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should be taken with meals to help reduce unwanted stomach effects that may occur during the first few weeks.
Tell your doctor if you are on a low-salt or sodium diet.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

  • For type 2 diabetes:
  • For patients on metformin therapy:
    • Adults—Canagliflozin 50 milligrams (mg) two times a day plus the total daily dose of metformin already being taken, divided into two doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than metformin 2000 mg and canagliflozin 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For patients on canagliflozin therapy:
    • Adults—Metformin 500 milligrams (mg) two times a day plus the total daily dose of canagliflozin already being taken, divided into two doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than metformin 2000 mg and canagliflozin 300 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For patients previously treated with canagliflozin and metformin:
    • Adults—The dose is the same as the dose you are already taking. Your doctor may adjust your dose as needed. However, the dose is usually not more than metformin 2000 mg and canagliflozin 300 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep the tablets in its original container to protect them from moisture. Do not put the tablets in pill boxes or pill organizers.

4 Precautions to Take

Before using Invokamet, there are some precautions you must take.

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your doctor about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your doctor.
  • Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Lactic Acidosis:
Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. The symptoms of lactic acidosis include: abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.

Potassium levels:
This medicine may cause high levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand up slowly if you feel dizzy.

If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.

Do not drink a lot of alcohol while you are using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.

Bone Fractures:
This medicine may increase the risk of bone fractures. Ask your doctor about ways to keep your bones strong to help prevent fractures.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

Surgery and medical tests:
Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to stop taking this medicine before you have major surgery or diagnostic tests, especially tests with contrast dye.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Invokamet.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Abdominal or Stomach discomfort
  • Bladder pain
  • Bloody or Cloudy urine
  • Decreased appetite
  • Diarrhea
  • Difficult, Burning, or Painful urination
  • Fast, Shallow breathing
  • Frequent urge to urinate
  • Frequent urination
  • General feeling of discomfort
  • Increased urge to urinate during the night
  • Increased volume of pale, dilute urine
  • Itching of the vagina or genitals
  • Itching, Stinging, or Redness of the vaginal area
  • Lower back or side pain
  • Muscle pain or cramping
  • Nausea
  • Shortness of breath
  • Sleepiness
  • Thick, White vaginal discharge with mild or no odor
  • Unusual tiredness or weakness
  • Waking to urinate at night

Less common

Incidence not known

  • Anxiety
  • Blurred vision
  • Chills
  • Cold sweats
  • Coma
  • Confusion
  • Cool, Pale skin
  • Depression
  • Difficulty swallowing
  • Dizziness
  • Dizziness, Faintness, or Lightheadedness when getting up suddenly from a lying or sitting position
  • Fast heartbeat
  • Fever
  • Headache
  • Hives
  • Increased hunger
  • Irregular heartbeat
  • Nightmares
  • Numbness or Tingling in the hands, feet, or lips
  • Pain in the skin around the penis
  • Reddening of the skin, especially around the ears
  • Redness, Itching, or Swelling of the penis
  • Seizures
  • Shakiness
  • Slurred speech
  • Stomach pain
  • Sweating
  • Swelling of the eyes, face, or inside of the nose
  • Vomiting
  • Weakness or Heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Difficulty having a bowel movement (stool)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.