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Johnson & Johnson's SGLT2 canagliflozin (Invokana) has just received FDA approval

18K views 25 replies 18 participants last post by  silvertiger 
#1 ·
SGLT2 Inhibitor Approvals and Updates

U.S. health regulators have approved a new diabetes drug from Johnson & Johnson, making it the first in its class to be approved in the United States.

The U.S. Food and Drug Administration approved the drug, Invokana, after data showed it was effective in lowering blood sugar in patients with Type 2 diabetes, the most common form of the disease.

The FDA has asked for five postmarketing studies for the drug including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, the agency said in a statement on its website. Invokana is expected to generate sales in 2016 of around $468 million, according to analysts' estimates.

Known chemically as canagliflozin, Invokana is a member of a new class of diabetes treatments called sodium-glucose co-transporter-2 (SGLT2) inhibitors that lower blood sugar by blocking reabsorbtion of glucose and increasing its excretion in urine.

Earlier this year, an advisory committee to the FDA discussed the benefits and risks of canagliflozin with a focus on any potential increased risk of heart attack or stroke.

A clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event compared with just one patient taking a placebo. After that, the imbalance was reversed. The drug also caused a slight increase in unhealthy LDL cholesterol.

In January, 2012, the FDA rejected a similar drug, dapagliflozin, made by Bristol-Myers Squibb Co and AstraZeneca Plc, citing concerns over a possible increased risk of cancer and liver injury. The drug was subsequently approved in Europe under the brand name Forxiga.
 
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#19 ·
Anyone here on invokana or canagliflozin? Do you know how much it costs? I am thinking of trying it, so have interest in any contraindications. Cheers.
FDA approves Invokana to treat type 2 diabetes
Hi, Auto!

Why don't you try increasing your metformin first before trying anything new? The maximum dose for metformin is 2000 mg/day, so you're only at 50% of the allowable dose. Try increasing gradually, add 500 mg for a few weeks, then another 500 mg. You know, your numbers aren't really that high. Try the simple route first.
 
#3 · (Edited)
Uhhhm ... "Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.

The FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

The most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection. Because Invokana is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension (a sudden fall in blood pressure when standing up). This may result in symptoms such as dizziness or fainting, and is most common in the first three months of therapy."

Ahhh, no, thanks. But if it turns out to be wonderful, and cost-effective, let us know ...

OH HOLY POOP: "
"Invokana will have a wholesale price of $8.77 per tablet, with one tablet taken daily. Johnson & Johnson said the price was competitive with that of some other diabetes drugs. "

Who wants to pay 270 a month, to get vagitch??? ACK!
 
#4 ·
Johnson & Johnson must make vagitch cream, no?

Winning!
 
#5 ·
I'll stick with my "if it ain't there, nothin to block" treatment and avoid the chance of goob itch if that's a possibility. (Didn't quite look right as one word)
 
#6 ·
Diabetes Update: FDA Approves a Highly Questionable New Diabetes Drug, Invokana

Say "No" to Brand New Diabetes Drugs!

If your doctor tries to put you on this drug, say no. Wait ten years, and search the literature then to see what scientists have found out about its real effects on patients before you try it.

If you can't control your blood sugar using standard therapies the safest approach is this:

1. Try the dietary strategy described on this page: How to Lower Your Blood Sugar

2. If that doesn't lower your blood sugar to a healthy level, ask your doctor about starting metformin ER. Make sure you end up with a clinically effective dose which for most people is at least 1500 mg a day. The ER form is kinder to the stomach.

3. If you don't respond to metformin, ask your doctor to prescribe long-acting insulin, which should lower your fasting blood sugar. Read up on how to set the dose so that it is most effective.

4. If that isn't enough, ask your doctor to prescribe fast acting insulin to cover the carbs in your meals. Read up to learn how to set the dose, as most family doctors don't have the resources to give Type 2s the proper training in using this kind of insulin. (Don't use mixtures of fast and slow insulin (70/30 mixes) as they almost always make it extremely hard to get good control of blood sugar.)

These are the safe, long-tested strategies that provides the best reward for the smallest amount of risk in people with Type 2 diabetes.
 
#7 ·
These are the safe, long-tested strategies that provides the best reward for the smallest amount of risk in people with Type 2 diabetes.
And with no side effects.

I refuse to take a medication for which the side effects could be life-threatening or make quality of life poor (i.e., constant itch!).

I think the point of developing this kind of drug is in the statement of how much the drug mnfs will be getting from sales - $480 million!!! in just 3 years. I'm really sceptical of "them" thinking of the best interests of their customers .
 
#11 ·
Unfortunately I can relate to Type 2 diabetics out there grasping at whatever hope may be given to them to control their blood sugars. Not saying that I would ever even consider taking this medication, but so many blindly follow what their doctor gives them or tells them.

I am one of those who does everything possible to control, but yet still seems to have the tight control just out of reach. I am on an insulin pump, I watch everything I eat (50 grams carbs or less per day), exercise, metformin, supplements....yet still cannot obtain good fbg's or sometimes even daytime numbers. Now mind you, I am a whole lot better than I was, but I really try to avoid increasing the need for insulin since it is extremely difficult to lose weight while taking insulin. However, I may just have to give in and readjust again because my morning numbers are creeping back up for whatever reason.

I will not take what I don't feel is a safe drug. Just listening or reading all the possible side effects makes me scratch my head as to why anyone would even consider taking that med. But, I understand desperation.
 
#18 ·
Unfortunately I can relate to Type 2 diabetics out there grasping at whatever hope may be given to them to control their blood sugars. Not saying that I would ever even consider taking this medication, but so many blindly follow what their doctor gives them or tells them.

I am one of those who does everything possible to control, but yet still seems to have the tight control just out of reach. I am on an insulin pump, I watch everything I eat (50 grams carbs or less per day), exercise, metformin, supplements....yet still cannot obtain good fbg's or sometimes even daytime numbers. Now mind you, I am a whole lot better than I was, but I really try to avoid increasing the need for insulin since it is extremely difficult to lose weight while taking insulin. However, I may just have to give in and readjust again because my morning numbers are creeping back up for whatever reason.

I will not take what I don't feel is a safe drug. Just listening or reading all the possible side effects makes me scratch my head as to why anyone would even consider taking that med. But, I understand desperation.


I also understand desperation. I have RA---rheumatoid arthritis, and have had an extremely severe case for many years. I've had both hips replaced, both kneew, both ankles fused, multiple hand surgeries, and spinal fusions. so we're not talking about " a little arthritis". I have found relief by taking a combination of Methotrexate and Enbrel. If one reads the side effects of either drug, they would be quite concerned. But, I was quite desperate. I started Enbrel when it first came out, about 10 years ago. Even though a new drug with lots of potential side effects, I was willing to try it because I was so desperate. I've had good luck with the drugs and no problems.

For those diabetics who have a severe case, and find no relief with other drugs, Invokana may be worth a try. However, if one if maintaining fair control with more conservative measures, well, wait and see....
 
#13 ·
Er - I'm not so sure about that. I'm thinking I'm in the right place because my blood glucose was >600 when I was diagnosed. I'm definitely diabetic! And the fact I can manage my diabetes is =because= I have gotten so much information and support here - and because it keeps me keepin' on, doing what I need to do ... and I'm always learning new things that inspire me as I continue on my journey ...
 
#14 ·
Hi I'm a 60 yo male diagnosed T2 in 1993 (20 years ago) went thru the gemut of meds #'s started creeping up the last 6 months morning #'s 145-170 Hbaic in the mid 7's freaking me out i'm on bydureon, amaryl and metformin as well as prandin before heavy meals. I have done quite a bit of research and asked my endo to start me on Invokana started 100 mg 3 days ago my morning #'s were between 131-141, 2 hour post meals around 130 not my #'s around 200 as of late. So meanwhile so good hope it lasts. Oh by the way I do have to urinate almost every hour during the 1st half of the day but as it wears off as I understand about 10 hrs after taking the urge to urinate calms down as well...so, so far so good
 
#20 ·
I am 71 years old and was also DX in 1993. My a1c started to climb about a year and a half ago and June of this year was 7.4. I had expected that the only way to get my bg down was either an increase in meds or insulin. After some research and finding this forum I have been able to bring my bg down dramatically and find that keeping my bg below 140 after eating and even lower is actually possible. I take Metformin and probably always will but am working on dropping the Glipizide. I believe that this WOE will work for many if not most people but you have to learn all of the reasons it works and follow it. We are led to believe that a lot of things advertised as " low carb " or " sugar free " are really not. One of the first things I had to learn was to read the label and to eat to your meter. To me this sure beats any new drug.
 
#15 ·
This is my 5th day on Invokana and surprisingly after almost a year of #'s creeping up i'm doing good just checked my #'s and WOW 104 about 2 hours after breakfast. I had problems keeping it below 180. I do have to urinate just about every 1 1/2 hours the first part of the day but the need calms down after lunch as I understand the half life of this drug is about 10 and a half hours...it works great for me ...so far...
 
#16 ·
Thank you all or your input about Invokana. I am off of it as it began to affect my mood. I have tried Metformin ER 500X2 and the nausea was so bad that I could barely function. I am not wanting to start insulin but it may be my only choice. I was controlled on 100mg. Januvia and 30 Actos but because the doctor wants me down to 15 Actos because of all the problems others have suffered from it, I may have no choice.
 
#22 ·
Well to all the naysayers on Invokana...I'm taking invokana for 5 months now with fantastic results..Ha1c down to 6.6 waking up below 120. I get these inner ear issues almost every year at this time and the only drug that helps is Prednisone I ook it once and it raised my glocuse to over 300 for a few weeks and I dread starting the prdnisone. Well, this time I just finished a 6 day course of Prednisone my glocuse levels didn't go up at all...INVOKANA has been a life saver for me with NO side effects...
 
#25 ·
You're already taking two drugs which stimulate the release of more insulin, unless you've stopped taking amaryl & prandin since your last post - so I'm thankful to hear that Invokana won't do that. Bydureon also stimulates the release of insulin, but at least it works in response to glucose in the bloodstream.

Have you been tested for c-peptide lately?
 
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