Invokana is a new kind of drug that works differently than traditional medications used to treat patients with type 2 diabetes. Invokana is marketed as a simple, once-daily pill that can even help patients lose weight. But after only a few months on the market, patients started reporting serious, potentially life-threatening side effects. Learn more about this new-generation drug and how it lands some patients in the hospital.
What is Invokana and what is it used for?
Invokana is a prescription medication used to lower blood sugar in adults with type 2 diabetes in addition to diet and exercise. Invokana is not indicated for use in patients with type 1 diabetes.
Nearly 30 million Americans have type 2 diabetes, according to a 2012 statistic by the American Diabetes Association. Invokana is the number-one prescribed drug in its class, with more than 8 million prescriptions to date, according to the FDA.
How does Invokana work?
The main ingredient in Invokana, canagliflozin, belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. The drug works by blocking the reabsorption of glucose (blood sugar) in the kidney.
Mechanism of Action (MOA)
Canagliflozin inhibits, or blocks, a certain type of protein in the body called sodium-glucose co-transporter 2 (SGLT2) from doing its job.
SGLT2 is a transport protein largely involved in the re-absorption of glucose by the kidney. It is responsible for at least 90 percent of glucose reabsorption in the kidney, with SGLT1 responsible for the remaining 10 percent.
Canagliflozin blocks the SGLT2 protein from working, which blocks the kidneys from reabsorbing glucose back into the blood stream. The excess glucose is then removed from the body through the urine.
It is estimated up to 119 grams of blood glucose can be eliminated each day using Invokana.
When was Invokana approved by the FDA?
Invokana has only been on the market for three years. The Food and Drug Administration approved the first-of-its-kind drug on March 29, 2013.
Who makes Invokana?
Invokana is marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, under license with Japanese pharmaceutical company Mitsubishi Tanabe Pharma Corporation.
Janssen Pharmaceuticals was founded in 1953 by Paul Janssen and was purchased by Johnson & Johnson in 1961.
How do you take Invokana?
Invokana is a once-daily oral medication. Invokana should be taken before the first meal of the day, according to the drug’s label.
Invokana is available in two strengths, 100 mg and 300 mg. The recommended starting dose is 100 mg; doctors may recommend increasing the dose to 300 mg in patients who tolerate Invokana well and still need additional glycemic control.
Invokana 100 mg tablets are yellow in color; Invokana 300 mg tablets are white in color.
Invokamet is a combination of Invokana’s main ingredient canagliflozin and metformin, a diabetes medication used in the U.S. since 1995. Metformin is the first-line medication for the treatment of type 2 diabetes.
Invokamet is used along with diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing metformin or canagliflozin, or in patients who are already treated with both canagliflozin and metformin.
Invokamet is an oral tablet available in four strengths:
- 50 mg/500 mg tablets (mg canagliflozin/mg metformin)
- 50 mg/1000 mg tablets
- 150 mg/500 mg tablets
- 150 mg/1000 mg tablets
How much does Invokana cost?
Invokana is a relatively expensive drug, especially compared to more traditional type 2 diabetes medications like metformin. It is also being dropped by some insurance plans in 2016.
Without insurance but using an online discount card, the price of Invokana is about $14 per pill, or about $420 for 30 pills, according to Drugs.com.
The price for Invokana usually does not vary between the 100 mg and 300 mg doses.
- Janssen Pharmaceuticals offers a $0 per-month co-pay savings card for privately insured patients.
- Janssen Pharmaceutical offers patient assistant programs for those who are insured under federal programs and those who have no insurance.
Is there a generic version of Invokana available?
No. There is no generic equivalent currently available for Invokana. The first patent for Invokana is not set to expire until July 2024, so a generic version of Invokana may not be available for another eight years.
Are there similar drugs to Invokana on the market?
Invokana was the first in a new class of drugs to be approved by the FDA. Since its approval, two other SGLT2 inhibitors have been approved and are currently on the market in the U.S. Like Invokana, both are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Marketed under the brand name Farxiga, dapagliflozin is manufactured by Astrazeneca. It was approved for use in the U.S. on Jan. 8, 2014.
Empagliflozin is manufactured by Boehringer Ingelheim and marketed under the brand name Jardiance. The drug was approved by the FDA on Aug. 1, 2014.
What are the potential side effects of Invokana?
As Invokana works to lower blood sugar in patients with type 2 diabetes, it can also cause other, unwanted side effects. Below is a list of both common and less common side effects associated with Invokana.
Common side effects
- Hypoglycemia (low blood sugar)
- Changes in urination including urgent need to urinate more often, in larger amounts or at night
- Urinary tract infection (UTI)
- Vaginal yeast infections
- Yeast infections of the penis
Less common side effects:
- Hypotension (low blood pressure)
- Extreme loss of body water
- Feeling faint or weak
- Hyperkalemia (high potassium in blood)
- Hypermagnesemia (high magnesium in blood)
- Blood pressure drop upon standing
- Dry mouth
- Excessive thirst
- Genital itching
- Increases in cholesterol
- High levels of hemoglobin
- Incomplete or infrequent bowel movements
- Low energy
- Kidney problems, including Kidney disease and bacterial infection of the kidney and renal pelvis
- Bone fractures
- Serious allergic reactions
- Diabetic ketoacidosis
- Hives or rash
- Sun-sensitive skin
- Stomach cramps
- Decreased calcification or density of bone
- Sepsis caused by bacteria
The positive side effects of Invokana?
Invokana may cause weight loss in people who take the drug – a potentially positive side effect, as weight management is an important part of diabetes treatment.
Invokana works by blocking the re-absorption of sugar by the kidneys. That excess sugar is removed from the body through urination, along with the sugar’s calories. Up to 119 grams of sugar can be eliminated each day, meaning nearly 500 calories can be removed from the body just by using the bathroom.
What is diabetic ketoacidosis?
Diabetic ketoacidosis is a serious complication of diabetes. It is usually associated with type 1 diabetes, but an increasing number of people with type 2 diabetes have been diagnosed with the serious condition after using Invokana.
Diabetic ketoacidosis occurs when there isn’t enough insulin in the body. Insulin plays a major role in helping sugar (glucose) enter your body’s cells, which fuels your muscles and other tissues. Without insulin, the body starts to break down fat as fuel instead of sugar, causing a buildup of acids (ketones) in the bloodstream. If untreated, this can develop into diabetic ketoacidosis.
Diabetic ketoacidosis is a serious, life-threatening condition that could lead to death if not treated.
Symptoms of Diabetic Ketoacidosis
Symptoms of diabetic ketoacidosis can develop quickly, sometimes within 24 hours. Symptoms may include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Breath that smells fruity
Diabetic Ketoacidosis and Blood Sugar Levels
Diabetic ketoacidosis is usually characterized by high blood sugar levels (hyperglycemia), but patients taking Invokana who developed diabetic ketoacidosis did not have high blood sugar levels – this led to misdiagnoses or prolonged diagnoses in some patients. Diabetic ketoacidosis without hyperglycemia is called euglycemic diabetic ketoacidosis.
Has the FDA issued any warnings about Invokana?
Yes. The FDA has issued several warnings in the few short years Invokana has been on the market. Most of these warnings include alerts about possible adverse side effects.
May 2014 – Drug Interactions Updated
The FDA issued a safety communication in May 2014 updating possible drug interactions between Invokana and urine glucose tests. The communication explained that monitoring glucose control using urine glucose tests is not recommended in patients taking SGLT2 inhibitors like Invokana because the drugs increase urinary glucose excretion and may lead to positive urine glucose tests. Patients should use alternative methods to monitor glycemic control, the communication stated.
March 2015 – Increased Risk for Genital Infections
A March 2015 communication warned of the increased risk of genital infections, including yeast infections in both men and women, after using Invokana.
According to the release, 0.7 percent of females stopped using Invokana because of genital infections during clinical studies, while 0.5 percent of males stopped using Invokana for the same reason.
September 2015 – Increased Risk for Bone Fractures
In September 2015, the FDA issued a warning about the increased risk for bone fractures in patients taking Invokana. The increased risk could occur as early as four months after starting treatment, the communication said.
A pool of nine clinical trials showed that after less than two years of treatment with Invokana, 1.5 percent of patients taking Invokana 100 mg and 2.1 percent of patients taking Invokana 300 mg had experienced falls.
The same pool showed the incidence rates of bone fractures after less than two years of treatment were 1.4 and 1.5 per 100-patient-years for Invokana 100 mg users and Invokana 300 mg users, respectively. Fractures were seen as early as four months after treatment began and were more likely to be low-trauma affecting the upper extremities.
September 2015 – Use in Specific Populations Updated
At the same time the FDA warned about an increased risk for bone fractures in patients using Invokana, the agency updated a section of the drug’s label. The Use in Special Populations highlights the risk of taking Invokana in patients with renal (kidney) impairment. The section warns that people with severe renal impairment should not take Invokana, and those with moderate renal impairment had a higher occurrence of adverse reactions.
May 2015/December 2015 – Risk of Diabetic Ketoacidosis
In May 2015, the FDA first warned about the risk of diabetic ketoacidosis in patients taking Invokana or other SGLT2 inhibitors. The agency issued an updated warning in December 2015.
The warnings resulted in new labels for all SGLT2 inhibitors, but the FDA stopped short of requiring a “black box” warning, the agency’s strongest warning before a recall.
The FDA issued the first warning after reviewing about 20 adverse event reports related to diabetic ketoacidosis and the new-generation diabetes drugs. When the agency issued an updated warning roughly seven months later, that number had jumped to over 70 reports.
In the warning, the agency said it investigated 73 cases of ketoacidosis in patients with either Type I or Type II diabetes being treated with SGLT2 inhibitors; of those 73 cases, 48 were related to Invokana.
All of the patients required hospitalization or treatment in emergency rooms. In many cases, doctors did not diagnose patients with ketoacidosis right away because blood sugar levels were lower than what is normally expected.
If not treated, ketoacidosis can lead to kidney failure and death. On average, patients reported these side effects about 43 days after starting Invokana or other SGLT2 inhibitor drugs.
December 2015 – Risk of Severe UTIs
Along with the December 2015 update about diabetic ketoacidosis, the FDA warned about the risk of developing severe urinary tract infections (UTIs). These infections were serious enough to land some patients in intensive care units due to kidney failure.
Between March 2013 and October 2014, the FDA said it investigated 19 cases of life-threatening blood and kidney infections in patients taking SGLT2 inhibitors. Each of the infections had started as urinary tract infections. Of the 19 cases, four people were admitted into intensive care units and two required dialysis to treat kidney failure.
On average, patients reported these side effects about 45 days after starting Invokana or other SGLT2 inhibitor drugs.
March 2016 – Hypersensitivity Warning
In March 2016, the FDA warned about hypersensitivity warnings in some patients taking Invokana. These reactions included angioedema, a reaction similar to hives but the swelling is under the skin, and anaphylaxis, a severe, potentially life-threatening allergic reaction.
Has Invokana been recalled?
No. Neither the FDA nor the drug’s manufacturer has issued a recall of Invokana.
Are there lawsuits against the makers of Invokana?
Attorneys are accepting cases involving patients who took Invokana or Invokamet and developed diabetic ketoacidosis, renal failure and urinary tract infections. If you or a loved one were harmed after taking the drug, you need to exercise your right to make a claim for compensation.
The Hood National Law Group is currently investigating possible kidney failure injury from the drug Invokana. Our attorneys and lawyers hold companies like Janssen responsible for the harm they have been inflicting on consumers for decades. Call us today a 1-800-214-1010 for a free case evaluation, or use the form on the right-hand side of the screen.