Invokamet 150mg/500mg Tablets

Invokamet combines two antihyperglycemic agents with different mechanisms of action: canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a biguanide. Canagliflozin lowers the renal glucose threshold (RTG) and increases urinary glucose excretion by inhibiting SGLT2 in the renal proximal tubules. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Vaginal Yeast Infection: Itching, bad odor, or discharge.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge.
Bone Pain: Low blood sugar can occur, especially when this medication is used with other diabetes medications. Signs of low blood sugar may include dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Stomach Problems: If you experience stomach problems, such as upset stomach, vomiting, or diarrhea, after starting this medication, and they persist or worsen, contact your doctor right away, as this may be a sign of lactic acidosis, a serious condition.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well, seek medical help immediately, as this may be a sign of a rare but potentially deadly infection.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of toe and foot amputations, especially in people with a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. To minimize this risk, it is essential to take good care of your feet. Inform your doctor if you have any of these conditions, and contact them right away if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following possible side effects:

Passing urine more often
Gas
Stomach pain or heartburn
Diarrhea, upset stomach, or vomiting
Headache
Feeling tired or weak

If any of these side effects or others bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
+ Type 1 diabetes
Recent medical events, including:
+ A heart attack
+ A stroke
Any difficulties with eating or drinking, including situations where you may need to fast before a procedure or surgery
Upcoming or recent exams or tests that involve contrast agents (within the past 48 hours)
Pregnancy or potential pregnancy. Note: This medication should not be taken during the second or third trimester of pregnancy.
* Breastfeeding. You should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

Driving and Blood Sugar Levels

Do not operate a vehicle if your blood sugar levels are low, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Diet, Exercise, and Lifestyle

Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe management of your condition. Regularly check your blood sugar levels and have your blood work and other lab tests done as directed by your doctor. Discuss with your doctor the most suitable glucose tests for your needs.

Interactions and Lab Tests

This medication may affect certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Additionally, consult with your doctor before consuming alcohol.

Potential Side Effects

High cholesterol has been associated with this medication. If you have concerns, discuss them with your doctor. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience vomiting, diarrhea, or are unable to drink liquids, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.

Blood Sugar Control

Stressful events, such as fever, infection, injury, or surgery, can make it more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also impact blood sugar management.

Vitamin B-12 Levels and Ketoacidosis

Long-term treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, discuss this with your doctor. This medication can also cause ketoacidosis, a potentially life-threatening condition that requires hospitalization. People with diabetes, pancreas problems, or those who are sick, dehydrated, or have skipped meals are at higher risk of developing ketoacidosis. Check your ketone levels as directed by your doctor, and consult with your doctor if you have any questions or concerns.

Bone Health and Kidney Problems

This medication may increase the risk of bone fractures. Discuss this with your doctor. Kidney problems and severe urinary tract infections (UTIs) have been reported, and in some cases, may require hospitalization or dialysis.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may be at risk of pregnancy. If you wish to avoid pregnancy, use birth control while taking this medication. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.

• Iodinated contrast agents (for metformin, temporarily discontinue at time of or prior to procedure)
• Dofetilide (with canagliflozin, increases dofetilide exposure)

• Alcohol (with metformin, increases risk of lactic acidosis)
• Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide, zonisamide; with metformin, increases risk of lactic acidosis)
• Rifampin (with canagliflozin, decreases canagliflozin exposure, consider increasing canagliflozin dose)
• Diuretics (loop or thiazide; with canagliflozin, increased risk of volume depletion and hypotension)
• Digoxin (with canagliflozin, increases digoxin exposure)

• Cimetidine (with metformin, increases metformin Cmax and AUC)
• Other drugs that affect renal function or metformin disposition (e.g., NSAIDs, ACE inhibitors, ARBs, verapamil, furosemide, nifedipine)
• UGT enzyme inducers (e.g., phenytoin, phenobarbital, ritonavir; with canagliflozin, may decrease canagliflozin exposure)

• Not specifically detailed for minor interactions in combination products, but general caution with drugs affecting glucose levels.

• Unusual muscle pain
• Stomach discomfort
• Diarrhea
• Nausea/vomiting
• Weakness
• Dizziness
• Lightheadedness
• Unusual tiredness
• Difficulty breathing
• Slow or irregular heartbeat (signs of lactic acidosis)
• Increased urination
• Increased thirst
• Genital itching or discharge
• Painful urination
• Fever (signs of UTI/genital infection)
• Foot pain, tenderness, sores, ulcers, or infections (for amputation risk, though BBW removed for canagliflozin, still a class effect concern)

Canagliflozin is not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects in the developing fetus. Metformin is generally considered safe and often continued during pregnancy for gestational diabetes or pre-existing type 2 diabetes. However, due to the canagliflozin component, Invokamet should generally be avoided in the 2nd and 3rd trimesters. Discuss with a healthcare provider.

Metformin is excreted into human milk in small amounts and is generally considered compatible with breastfeeding. Canagliflozin is excreted into the milk of lactating rats, but it is unknown if it is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, Invokamet is not recommended during breastfeeding.

Safety and effectiveness have not been established in pediatric patients under 18 years of age. Not recommended for use in this population.

Elderly patients (≥65 years of age) are more likely to have decreased renal function and may be at increased risk for volume depletion, hypotension, and lactic acidosis. Renal function should be assessed more frequently. Initiate with lower doses and titrate carefully. The maximum recommended dose of canagliflozin is 100 mg daily for patients with eGFR 30 to < 60 mL/min/1.73 m².

• Invokamet is a fixed-dose combination, so dose adjustments must consider both components. If individual dose titration is needed beyond available strengths, separate components may be required.
• Always assess renal function (eGFR) before initiating and periodically during treatment, as both components have renal-dependent dosing and contraindications.
• Educate patients on the signs and symptoms of lactic acidosis (metformin's black box warning) and diabetic ketoacidosis (a rare but serious SGLT2 inhibitor class effect).
• Advise patients to temporarily discontinue Invokamet before any radiological procedure involving iodinated contrast agents or any surgical procedure requiring restricted food and fluid intake.
• Monitor for signs of volume depletion (e.g., dizziness, orthostatic hypotension), especially in elderly patients, those on diuretics, or those with impaired renal function.
• Counsel patients on proper hygiene to reduce the risk of genital mycotic infections and urinary tract infections, common side effects of SGLT2 inhibitors.

• Other SGLT2 inhibitors (e.g., Invokana, Farxiga, Jardiance)
• Other biguanides (e.g., Metformin monotherapy)
• DPP-4 inhibitors (e.g., Januvia, Tradjenta)
• GLP-1 receptor agonists (e.g., Ozempic, Trulicity)
• Sulfonylureas (e.g., Glipizide, Glyburide)
• Thiazolidinediones (e.g., Pioglitazone)
• Insulin

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.