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Invokana (canagliflozin) is an oral diabetes medicine that helps control blood sugar levels. Canagliflozin works by helping the kidneys get rid of glucose from your bloodstream.
Invokana is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Invokana is used to reduce the risk of cardiovascular events (including heart attack, stroke or death) in adults with type 2 diabetes and established cardiovascular disease.
Invokana is also used to reduce the risk of end stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease.
Invokana is not for treating type 1 diabetes.
You should not use Invokana if you have severe kidney disease or if you are on dialysis.
Invokana may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.
Invokana can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
You should not use Invokana if you are allergic to canagliflozin, or if you have:
severe kidney disease (or if you are on dialysis).
Invokana may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
heart problems;
a diabetic foot ulcer or amputation;
circulation problems or nerve problems in your legs or feet;
kidney disease;
liver disease;
bladder infections or other urination problems;
a pancreas disorder;
diabetic ketoacidosis; or
if you are on a low salt diet.
Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
You should not use canagliflozin during the second or third trimester of pregnancy.
You should not breast-feed while using this medicine.
Invokana is not approved for use by anyone younger than 18 years old.
Invokana is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Invokana is usually taken once per day, before the first meal of the day.
You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Drink plenty of liquids while you are taking Invokana.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Invokana is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using canagliflozin.
Store at room temperature away from moisture and heat.
about side effects. You may report side effects to FDA at 1-800-FDA-1088.Usual Adult Dose for Diabetes Type 2:
Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control but only in patients who have tolerated lower dose and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day
Comments:
-Do not initiate in patients with an eGFR less than 45 mL/min/1.73 m2 as this drug will not be effective.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.
Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Get emergency medical help if you have signs of an allergic reaction to Invokana: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
little or no urination;
pain or burning when you urinate;
new pain, tenderness, sores, ulcers, or infections in your legs or feet;
high potassium - nausea, irregular heartbeats, weakness, loss of movement;
ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out).
You may be more likely to have a broken bone while using Invokana. Talk with your doctor about how to avoid the risk of fractures.
Side effects may be more likely to occur in older adults.
Common Invokana side effects may include:
genital infections; or
urinating more than usual.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your other medicines, especially:
insulin or other oral diabetes medicines;
a diuretic or "water pill";
digoxin, digitalis;
rifampin;
ritonavir; or
seizure medication - phenobarbital, phenytoin.
This list is not complete. Other drugs may interact with canagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Invokana only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Invokana (www.drugs.com/invokana.html).
Note: This document contains side effect information about canagliflozin. Some of the dosage forms listed on this page may not apply to the brand name Invokana.
Common side effects of Invokana include: vulvovaginal candidiasis, vaginal infection, vulvitis, vulvovaginitis, and mean glomerular filtration rate decreased. Other side effects include: balanitis, balanoposthitis, increased urine output, nocturia, polyuria, urinary urgency, and pollakiuria. See below for a comprehensive list of adverse effects.
Applies to canagliflozin: oral tablet
Oral route (Tablet)
In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, canagliflozin has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg.Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving canagliflozin for infections or ulcers of the lower limbs, and discontinue if these occur.
Along with its needed effects, canagliflozin (the active ingredient contained in Invokana) 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 while taking canagliflozin:
More common
Less common
Incidence not known
Some side effects of canagliflozin 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
Rare
Applies to canagliflozin: oral tablet
The most commonly reported adverse reactions have included female genital mycotic infections, urinary tract infection, and increased urinary frequency.
In the CANVAS trial, amputations per 1000 patients per year in patients receiving canagliflozin (the active ingredient contained in Invokana) (100 mg or 300 mg per day) were 5.8 compared to 2.8 amputations per 1000 patients per year in the placebo group. In the CANVAS-R trials, these numbers were 7.5 and 4.2, respectively. The total number of amputations among canagliflozin-treated patients (n=5790) was 221 compared with 69 in the placebo group (n=4344). Amputations of the toe and midfoot were the most frequent; however, amputations involving the leg, below and above the knee, also occurred.
On September 10, 2015, the US Food and Drug Administration issued a drug safety communication regarding new information on bone fracture risk and decreased bone mineral density with use of canagliflozin. Based on updated data, fractures have occurred as early as 12 weeks after starting therapy with trauma that is usually minor, such as falling from standing height. Additionally, a 2-year study (n=714) has shown a greater loss of bone mineral density at the hip and lower spine in canagliflozin treated patients compared with placebo.
Common (1% to 10%): Lower limb amputations
Uncommon (0.1% to 1%): Bone fracture, upper extremity fracture
Frequency not reported: Loss of bone mineral density at hip and lower spine
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Very common (10% or more): Female genital mycotic infections including vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal (up to 11.4%), recurrent male genital mycotic infections (22%)
Common (1% to 10%): Urinary tract infection, increased urination, male genital mycotic infections including balanitis, balanoposthitis, balanitis candida, and fungal genital infection
Uncommon (0.1% to 1%): Phimosis
Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene
Common (1% to 10%): Adverse reactions related to reduced intravascular volume (postural hypotension, orthostatic hypotension, hypotension, dehydration, and syncope)
Very common (10% or more): Hypoglycemia when combined with insulin or an insulin secretagogue (up to 49%), hyperkalemia (up to 27%)
Common (1% to 10%): Increased serum magnesium, increased serum phosphate, increased low-density lipoprotein (LDL-C)
Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis
Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.
Common (1% to 10%): Constipation, thirst, nausea, abdominal pain, pancreatitis
Common (1% to 10%): Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema
Frequency not reported: Serious hypersensitivity reaction
Postmarketing reports: Anaphylaxis
In a pooled analysis among patients with moderate renal impairment, the incidence of renal related adverse reactions such as increased serum creatinine, decreased eGFR, renal impairment, or acute renal failure, was 8.9% and 9.3% in patients receiving canagliflozin (the active ingredient contained in Invokana) 100 mg or 300 mg, compared with 3.7% in those receiving comparator drug or placebo.
From March 2013 to October 2015, the US FDA received 101 confirmable case reports of acute kidney injury (AKI) with use of canagliflozin (n=73) or dapagliflozin (n=28). Hospitalization was necessary for evaluation and management in 96 cases; admission to the intensive care unit occurred in 22 cases, and death occurred in 4 patients, of which 2 were cardiac-related. Dialysis was necessary in 15 patients, 3 of whom had a history of chronic kidney disease or previous AKI. In 58 cases, time to onset of AKI was within 1 month or less of initiating therapy. In 78 cases in which drug discontinuation was reported, 56 reported subsequent improvement; 3 patients recovered with sequelae, 11 patients did not recover (including the 4 deaths mentioned earlier). Median age was 57 years (range 28 to 78 years; based on 84 cases reporting age). Concomitant ACE inhibitor therapy was reported in 51 cases, diuretic use in 26 cases, and NSAID use in 6 cases. Almost half the patients reported a change in renal function at time of diagnosis (median elevation of serum creatinine from baseline 1.6 mg/dL [based on 32 cases reporting serum creatinine] and median decrease in eGFR 46 mL/min/1.73m2 [based on 13 cases reporting eGFR]).
Frequency not reported: Increases in serum creatinine, decreases in eGFR, renal impairment, acute renal failure
Postmarketing reports: Acute kidney injury
Uncommon (0.1% to 1%): Renal cell carcinoma
In the CANVAS trial (mean duration of follow-up of 5.7 years), the incidence of renal cell carcinoma was 0.29% (8/2716) in patients receiving this drug (placebo: 0.15% [2/1331]) excluding patients with less than 6 months of follow-up, less than 90 days of treatment, or a history of renal cell carcinoma.
Uncommon (0.1% to 1%): Photosensitivity reactions, rash, urticaria
Final results from 2 clinical trials, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and the CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) have shown leg and foot amputations occurred almost twice as often in canagliflozin (the active ingredient contained in Invokana) treated patients compared with placebo treated patients. Amputations of the toe and middle of the foot were most common, however some amputations involved the leg, below and above the knee. Some patients had more than 1 amputation; some involved both limbs.
The risk of amputation calculated from the CANVAS trial showed 5.9 per 1000 patients per year for canagliflozin treated patients compared to 2.8 per 1000 patients per year for placebo patients. The CANVAS-R trial showed 7.5 per 1000 patients per year compared to 4.2 per 1000 patients per year for canagliflozin treated patients and placebo patients, respectively.
Common (1% to 10%): Fatigue, asthenia, falls
Uncommon (0.1% to 1%): Leg and foot amputations
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Invokana (www.drugs.com/invokana.html).
August 9, 2016
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