Invokamet 150mg/1000mg Tablets

Invokamet combines two antihyperglycemic agents with different mechanisms of action: Canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Metformin, a biguanide. Canagliflozin lowers blood glucose by inhibiting SGLT2 in the renal proximal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin primarily 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 Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Bone Pain: Notify your doctor if you experience bone pain.
Low Blood Sugar: This medication may increase the risk of low blood sugar, especially when used with other diabetes medications. Signs of low blood sugar 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: While it's common to experience stomach upset, vomiting, or diarrhea when starting this medication, if you notice these symptoms later during treatment, contact your doctor immediately, as they may be a sign of a serious condition called lactic acidosis.
Rare but Serious Infection: A rare but potentially life-threatening infection has been reported with medications like this one. Seek medical help right away if you experience tenderness, redness, or swelling in the genital area, along with a fever or feeling unwell.
Increased Risk of Lower Limb Amputations: This medication may increase the risk of lower limb amputations, particularly toe and foot amputations. Discuss foot care with your doctor, and notify them if you have a history of amputation, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. Contact your doctor immediately if you experience new pain or tenderness, sores or ulcers, or infections in your legs or feet.

Other Possible Side Effects

Most people taking this medication do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. 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 you experienced.
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 be required 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 the safety of taking this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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 need to stop this medication before certain surgeries, and they will advise you on when to resume taking it after the procedure.

Driving and Blood Sugar Levels

Do not drive if your blood sugar levels are low, as this can increase the risk of accidents. To minimize the risk of dizziness or fainting, get up slowly from sitting or lying down, and be cautious when climbing stairs.

Diet, Exercise, and Lab Tests

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. Regularly check your blood work and other lab tests as instructed by your doctor, and monitor your blood sugar levels as advised.

Interactions and Precautions

This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking it. Discuss with your doctor before consuming alcohol. Be aware that this medication may cause high cholesterol, and consult your doctor if you have any concerns.

Dehydration and Heat

In hot weather or during physical activity, drink plenty of fluids to avoid dehydration. If you are unable to drink liquids or experience persistent stomach upset, vomiting, or diarrhea, contact your doctor to prevent dehydration, which can lead to low blood pressure or worsen kidney problems.

Blood Sugar Control

Stress, 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 control.

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. Additionally, this medication can cause ketoacidosis, a potentially life-threatening condition that requires hospital treatment. This risk is higher in people with diabetes, pancreas problems, or those who are sick, dehydrated, or have skipped meals. Check your ketone levels as instructed by your doctor.

Bone Health and Kidney Problems

This medication may increase the risk of broken bones. Discuss this with your doctor. Kidney problems and severe urinary tract infections (UTIs) have been reported, and in some cases, hospital treatment or dialysis may be necessary.

Age-Related Precautions

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Birth Control

Women of childbearing age who have not been ovulating may be at risk of pregnancy while taking this medication. If you want to avoid pregnancy, use birth control. If you become pregnant or are planning to become pregnant, inform your doctor immediately, as this medication may harm the unborn baby.

• Iodinated contrast agents (for Metformin, temporarily discontinue)
• Severe renal impairment (eGFR <30 mL/min/1.73m²)
• Metabolic acidosis, including diabetic ketoacidosis

• Diuretics (loop or thiazide): Increased risk of volume depletion and hypotension with canagliflozin.
• UGT enzyme inducers (e.g., rifampin, phenytoin, phenobarbital, ritonavir): May decrease canagliflozin exposure and efficacy.
• Digoxin: Canagliflozin may increase digoxin exposure.
• Alcohol: Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide): May increase risk of lactic acidosis with metformin.

• Insulin and insulin secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia when co-administered with Invokamet; dose reduction of insulin/sulfonylurea may be required.
• Cimetidine: May increase metformin plasma concentrations.
• Other drugs eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin): May interact with metformin via competition for renal tubular transport systems.

• Not specifically listed as minor for this combination, but general caution with drugs affecting glucose levels.

• Unusual muscle pain
• Stomach discomfort
• Diarrhea
• Nausea
• Vomiting
• Weakness
• Dizziness
• Lightheadedness
• Increased thirst
• Increased urination
• Genital itching or discharge
• Painful urination
• Fever
• Swelling in legs or feet
• Unusual fatigue
• Shortness of breath

Invokamet is not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus. Limited data on use in pregnant women are insufficient to determine drug-associated risks for major birth defects or miscarriage. Metformin is generally considered safer than canagliflozin during pregnancy if medication is needed for glycemic control.

Canagliflozin is present in breast milk in animal studies, and there is a potential for serious adverse reactions in a breastfed infant (e.g., renal dysfunction, hypoglycemia). Metformin is excreted into human milk in small amounts, and adverse effects in breastfed infants are not expected. Due to the canagliflozin component, breastfeeding is not recommended while taking Invokamet.

Safety and effectiveness of Invokamet have not been established in pediatric patients. Not recommended for use in patients younger than 18 years of age.

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 (due to metformin). Renal function should be assessed more frequently. Canagliflozin dose may need to be limited to 100mg daily if eGFR is 45 to <60 mL/min/1.73m². Exercise caution with dose titration.

• Always take Invokamet with the first meal of the day to minimize gastrointestinal side effects of metformin.
• Ensure adequate hydration, especially during illness, hot weather, or strenuous exercise, to reduce the risk of volume depletion and acute kidney injury.
• Educate patients on the signs and symptoms of lactic acidosis (for metformin) and diabetic ketoacidosis (for canagliflozin), emphasizing the need for immediate medical attention if these occur.
• Temporarily discontinue Invokamet before any radiological procedure involving iodinated contrast agents or any surgical procedure requiring restricted food and fluid intake.
• Monitor for genital mycotic infections and urinary tract infections, which are common side effects of SGLT2 inhibitors.
• Consider periodic monitoring of Vitamin B12 levels in patients on long-term metformin therapy, especially if anemia or neuropathy develops.

• Other SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin, ertugliflozin)
• Other biguanides (Metformin monotherapy)
• DPP-4 inhibitors (e.g., sitagliptin, saxagliptin, linagliptin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide)
• Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
• Insulin

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.