Thursday’s Daily Piece: Canagliflozin Loses Leg and Foot Amputation Boxed Warning

Well, a new bright day has dawned for canagliflozin. Canagliflozin has had a boxed warning for leg and foot amputations. FDA review of new data from three clinical trials resulted in the removal of the boxed warning for leg and foot amputations. Additionally, canagliflozin is now recognized for its heart and kidney related benefits. To learn more, please click on the link below.

https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and

INVOKANA® (canagliflozin) Significantly Reduced Major Cardiovascular Events  and Kidney Failure in Patients with Type 2 Diabetes and Chronic Kidney  Disease – Intelligence Pharma
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#canagliflozin #FDA

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August Blog: Insulin…Really??!!

Cindy, a 52-year-old female who has had type 2 diabetes for the past10 years, is preparing herself for an upcoming office visit with her primary care provider.  She feels both anxious and guilty for not better managing the day to day needs of having diabetes as well as she would like to do. Like so many others living with diabetes, life gets in the way.  Diabetes has become another “to-do” item on her daily list that makes her pull the sheets back up over her head each morning – fighting to get started.  Cindy wonders out loud, “am I alone?”  Lately, she has been afraid to check her glucose assuming in advance it will be “bad.” 

The day arrives for her office visit and she thinks, “okay, I can do this.” The visit begins and she waits in anticipation for the “finger stick” to get her hemoglobin A1c and glucose check.  The finger stick is not too bad this time.  As her primary care provider enters the room, she is friendly and shows genuine concern for Cindy.  Her provider shares her glucose is 300 mg/dL and hemoglobin A1c is 10%.  What??!! How could it be??!! She has taken her three oral diabetes medications (metformin, glipizide and sitagliptin) almost all of the time.  She begins to cry as a wave of guilt, exhaustion and shock overcome her.   Her provider reassures her and allows her time to let her tears fall. After a few minutes, they have a discussion of next steps.

Cindy is not alone. Many people are living the high demands of day to day life events while managing the daily realities of diabetes self-care.   Unfortunately, for persons with type 2 diabetes, for far too many years, insulin was used as a weapon of intimidation and a tool to threaten “compliance” to diabetes self-care.  Today, we have made much progress in the understanding of diabetes and know that insulin as a medication is part of the process for many persons with diabetes – especially those with insulin deficiency.  Those with type 2 diabetes requiring insulin medication have done absolutely nothing wrong, rather their body has lost the ability to make sufficient amounts of insulin to support insulin demands of the body.  Yes, more work is essential to remove the stigma of insulin therapy for persons with type 2 diabetes.  

As it turns out, Cindy’s provider ordered a c-peptide (a test that measures the body’s ability to produce insulin) to further assess CH’s ability to produce insulin.  Her c-peptide result was < 1 ng/mL indicating her body cannot produce sufficient insulin to match her body’s needs.   Also, her provider ordered a professional continuous glucose monitor so together they can see the trends in her glucose over a fourteen-day period to determine the most appropriate lifestyle changes and insulin regimen.

In the meanwhile, Cindy and her provider together develop a medication regimen which includes insulin and a couple of additional medications to match her body’s needs.  Before leaving, her provider schedules Cindy an appointment with the diabetes care and education specialist to provide ongoing support and education for her.  On the way out, Cindy meets her diabetes care and education specialist who greets her with a warm hello, words of encouragement, her business card, and asks her to call prior to her appointment if she gets overwhelmed with her diabetes.

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#insulin #diabetes #stop #shame

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Friday’s Daily Piece: Avoiding Hyperglycemic Emergency

A gentleman with type 2 diabetes recently shared his insulin mishap with me. He receives his long and rapid acting insulin through patient assistance program as he does not have health insurance. He ran out of his rapid acting insulin, and forgot to let his provider’s office know that he needed refill of this rapid acting insulin through patient assistance program which resulted in a hyperglycemic emergency and hospital visit. Upon discharge, he was determined to not let it happen again. His refills were ordered through patient assistance, and samples provided to get him through until the refill arrived. Lesson learned to always let his provider’s office know when he needs insulin refills through patient assistance as his body requires both the long and rapid acting insulin. He also recognizes need to allow a couple of weeks for the refill process through patient assistance.

Tuesday’s Daily Piece: InPen Joins Medtronic Family

Many of you may be familiar with the smart insulin pen, InPen, which has all sorts of cool features. InPen, the genius of Companion Medical, has now joined the Medtronic line of amazing technology tools for persons with diabetes as Medtronic recently acquired Companion Medical. So what happens when the InPen joins the Medtronic Family….please click below to learn more ….

https://diatribe.org/diabetes-devices-expand-medtronic-will-improve-inpen-technology-and-availability-and-ascensia

Medtronic Launches New Activa Patient Programmer For DBS Therapy ...
3 Reasons why you should care about InPen, the Smart Insulin Pen ...
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#technology #inpen #medtronic #family

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Thursday’s Daily Piece: Think Beyond Glucose Lowering Benefits when Considering Diabetes Medications

Traditionally, we have thought of only glucose lowering benefit when considering diabetes medications. Times have changed! We know that diabetes does not exist alone rather it is typically seen with other chronic conditions such as hypertension (high blood pressure) and dyslipidemia (too much bad cholesterol and/or not enough of the good cholesterol). Longterm complications such as cardiovascular events (heart related events such as heart attack or stroke) or chronic kidney disease (kidneys no longer work like they should) can occur although these are preventable. So we need to consider positive benefits that diabetes medications can have on protecting the heart and kidneys not just the benefit in lowering the glucose to a healthy range. Two drug classes in particular, sodium glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide -1 (GLP-1) agonist, provide protective benefits for heart and kidneys. Also, there are savings programs and patient assistance programs that can assist in affording these medications. I will share more details in the August blog from RPDW on these benefits.

Vitamin E found to prevent muscle damage after heart attack
Kidneys: Facts, Function & Diseases | Live Science
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#diabetes #medications #kidneys #heart #benefits

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Tuesday’s Daily Piece: Resources for Insulin Patient Assistance

Persons with diabetes struggling to afford their insulin has been heavy on my heart recently. I have the privilege to work with many older adults with diabetes on insulin therapy which has created a passion for connecting these adults with resources to assist with affording insulin. I see time and time again older adults with Medicare Part D or Advantage Plan who simply can not afford their insulin. I also work with persons with diabetes who have lost their jobs and insurance coverage due to COVID so I also assist in connecting them with resources for the access to insulin.

What do I mean when I use the term, patient assistance, as relates to insulin? Receiving the medication from the pharmaceutical company at no cost to the patient. Typically, the medication is mailed to the provider’s office or person with diabetes’ home. I have found NovoCare (NovoNordisk – i.e. Novolog, Levemir, Tresiba, Fiasp), Lilly Cares (Lilly- i.e. Basaglar, Humalog) and Sanofi Patient Connection (Sanofi – i.e. Toujeo, Apidra) to provide excellent support for persons with diabetes who qualify (income requirements for persons covered through Medicare Part D or Medicare Advantage). Typically, persons who have lost their job and health insurance are able to get patient assistance through these programs. Also, each program varies in whether they require proof of income documentation to be submitted.

Below is the link to the website for NovoCare, Lilly Cares and Sanofi Patient Connection. If you are unsure of whether you qualify, please click on link below, and call phone to learn whether you qualify.

https://www.novocare.com/

https://www.lillycares.com/

http://www.sanofipatientconnection.com/

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#diabetes #insulin #affordability #resources

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July Blog: U-500 Insulin: What Makes It Unique?

Contributors: Ashley Butts and Saywon Flah, PharmD students at Philadelphia College of Osteopathic Medicine Georgia School of Pharmacy

CR, a 62-year-old male with a 20-year history of type 2 diabetes, is frustrated that he is taking over 200 total units of insulin daily and four injections each day.  He feels like the insulin is not being absorbed or working while enduring his frustration of feeling like a pen cushion.  His best friend, David, recently told him about a concentrated insulin, Humulin R U-500, which he started utilizing a few weeks ago. David says he injects with less frequency and less volume with each injection. CG has an upcoming appointment with his medical provider and he made a note to inquire about it.  In the meanwhile, he does a Google search to learn more about it.  

The NDEP's “4 Steps to Manage Your Diabetes For Life” brochure ...

So what is Humulin R U-500?  Humulin R U-500 is 5 times more concentrated than the standard U-100 insulin. It is often selected for persons with diabetes who are insulin-resistant and require more than 200 units daily.  It is typically injected two to three times daily 30 minutes before a meal.

U-500 Insulin Errors - Consumer Med Safety

So, does this change require the individual to recalculate insulin dose when being switched from U-100 to U-500 as the math can get tricky? Well, it all depends.  U-500 pen (officially, the Kwikpen) requires no dosage changes.  However, the vial and syringe method can be trickier as U-500 and U-100 insulin syringes are available. Use of U-100 syringes with U-500 insulin vial requires dose conversion as every unit of U-500 insulin contains 5 units of insulin so divide the U-500 dose by 5 to obtain units to draw up on U-100 syringe. Fortunately, a U-500 syringe is available from BD which simplifies things as no dose conversion is required.

FDA Approves Humulin U500 KwikPen - Bringing Convenient Pen ...

How much insulin is in U-500 pen and vial?  The pen contains 1500 units of insulin. Each click of the pen delivers 5 units of insulin, and pen can deliver 5 – 300 units with each injection.  The 20 mL vial contains 10,000 units of insulin with each line indicating 5 units and allowing for 5 – 250 units with each injection.

What is the cost? Cost varies depending on insurance coverage. A good place to start is the drug formulary (list of preferred medications by tiers; higher the tier the more $$$) as this can give a ballpark of the cost. Also, checking for copay cards and additional resources to help offset the cost of the U-500 is possible by visiting https://www.lillycares.com/

Trulicity Cost Information | With or Without Insurance | Trulicity ...

Back to CR, after researching U-500 insulin, he decides to discuss this as an alternative to his current insulin regimen with his medical provider.  He is interested in the U-500 pen as he can carry it in this pocket and only inject a couple times of day for less expensive copay each month than his current insulin copay total.

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#diabetes #U-500 #treatment #insulin

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Saturday’s Daily Piece: Novel Option for Relieving Foot Pain from Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN) can cause major pain especially in feet. Several different oral medications are currently available for treatment of DPN. A new treatment option, Qutenza (capsaicin 8% patch), is now available. It is patch formulation of capsaicin that can only be administered by a healthcare professional as a single, 30 minute application on the feet using up to four patches. The single application can provide up to 3 months of pain relief.

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#diabetes #pain #treatment #patch

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Tuesday’s Daily Piece: InPen Approved for Kids and More Metformin Recalls

This week in diabetes, good news and not so good news to share. Let’s begin with the good news. InPen, a bluetooth enabled smart insulin pen has received expanded indication for kids age 7 years old and older. You may recall that InPen received FDA approved for use in adults back in 2019. It is a reusable pen that allows for tracking of insulin doses which can bring peace of mind for parents of kids with type 1 diabetes. It is available with a prescription at pharmacies. To help with cost, there is a copay card available through Companion Medical (simply click on link below).

https://www.companionmedical.com/get-inpen/

3 Reasons why you should care about InPen, the Smart Insulin Pen ...

Now, the not so good news. More metformin extended release recalls now from Lupin Pharmaceuticals and Granules Pharmaceuticals due to elevated levels of NMDA (which can increase risk of developing cancer). Please contact your pharmacy to find if out if your metformin ER has been recalled.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended

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#InPen #pediatrics #metformin #recall

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Tuesday’s Daily Piece: First Ready to Use (No Mixing!!!) Glucagon Autoinjector Now Available

The old school glucagon autoinjector was a challenge to use because it required mixing before use which is super stressful when one is experiencing severe hypoglycemia. Exciting news! The first ready to use (NO mixing) glucagon autoinjector, Gvoke HypoPen, is now available. No more mixing!!! To use this pen, one simply pulls off the red cap, and pushes the yellow end on the skin and holds for 5 seconds. It comes in a 2 pack box. It is indicated for persons with diabetes over 2 years of age for severe hypoglycemia. A $0 copay card is available for those with commercial insurance. Depending on your insurance, a prior authorization may be required which your medical provider will need to complete. Also the out pocket cost for the medication will vary depending on your insurance so if you are unsure of the cost contact your insurance company.

Xeris Pharmaceuticals Announces Gvoke HypoPen™ – the First ...
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#Gvoke HypoPen #ReadyToUse #Glucagon

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