Cortisol Replacement Options for Adrenal Insufficiency

Cortisol Replacement for managing Adrenal Insufficiency

*DISCLAIMER- This information has been brought to you by the Adrenal Alternatives Foundation and is not to be used to provide medical care or advice.*

With all steroid replacement options, circadian rhythm dosing should be the standard protocol for adrenal insufficiency care.  Cortisol medications need to be administered not only at the right doses, but also at the right times according to the way the body would naturally produce cortisol with working adrenals. Cortisol is produced at the highest amount in the morning to induce the cortisol awakening response, then cortisol levels decrease in the evening time to induce sleep and allow for the secretion of melatonin.

Percentages of Cortisol Production

6:00am to noon 35%

Noon to 6:00pm 20%

6:00pm to Midnight 15%

Midnight to 6:00am 30%

(Source: Professor Hindmarsh. CAHISUS https://www.cahisus.co.uk/pdf/CIRCADIAN%20RHYTHM%20DOSING.pdf )

Cortisol Replacement Medications

Standard Oral Steroid Tablets

  • Hydrocortisone
  • Prednisone
  • Cortisone Acetate
  • Dexamethasone

Time Released Steroid Medications

Liquid Steroid Options

  • Prednisolone

Pediatric Options

Cortisol MDI– Multiple daily injections of cortisol (solucortef) into subcutaneous tissue.

Physicians calculate a baseline dose schedule based on circadian rhythm percentages, the patient’s cortisol clearance, activity level and health comorbidities.

Injection sites must cleaned with skin prep such as an alcohol wipe before insertion of needle into areas with subcutaneous tissue.

Injection sites must also be rotated to reduce irritation and infection risk

Supplies needed:

·Solu-Cortef 100mg vials

·Saline or Bacteriostatic Water

·Skin Prep such as alcohol swabs

·3ML Syringes to reconstitute Solu-Cortef ·Syringes or “insulin” needles for injections

Dosing:

1 to 1 ratio = 100mg of Solucortef per 1 ML of saline. 1 unit of this concentration creates a 1:1 ratio. 1 mg of cortisol is equal to 1 unit.  (1 unit- 1mg)

Actovials of a 2:1 ratio can also be used but are not the preferred treatment due to the increased dilution, which requires more volume to enter the subcutaneous tissue. Additionally, some patients have expressed increased irritation due to the formulation in the Actovials liquid. With this formulation 2units =2mg.

Cortisol Pumping Method

The Cortisol Pumping Method is the use of solu-cortef used in an infusion pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump.

This method bypasses the gastric passages and is able to deliver cortisol 24/7, which is a life-saving intervention for patients with absorption issues and hypermetabolizers of cortisol.

The cortisol pumping method is not a cure for adrenal insufficiency and is not a treatment that is right for everyone. If a patient well managed on steroid replacement pills, the pump method may not be necessary to achieve quality of life.

FDA approval is not necessary for cortisol pumping and is considered “off label use.” Infusion pumps have long been approved for the administration of medications.

According to the Department of Health and Human Services Centers for Medicare and Medicaid Services Medicare Coverage Issues Manual Section 60-14 A: “6. Other uses of external infusion pumps are covered if the contractor’s medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.”

In the USA, the Right to Try Act decreed that patients have legal rights to access life-saving treatments which are not yet FDA approved. 

The pump is not a replacement for acute adrenal crisis care. Adrenal patients should always carry an emergency injection and administer it immediately in the event of an adrenal crisis.

The decision of whether your insurance will cover a pump and supplies is dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal.

Adrenal Alternative’s Pumps for Purpose program helps adrenal patients receive Medtronic pumps and supplies through our Pumps for Purpose Program with CR3.

Pumps for Purpose Program Applications

(Both forms must be completed to be considered as a program recipient)

Cortisol Pumping Candidates

  • Patients who have failed to stabilize on traditional oral steroid tablet options.
  • Patients with absorption issues such as, but not limited to: Crohn’s disease or gastroparesis.
  • Patients who are hypermetabolizers of cortisol.

For more information, please visit the following resources:

Download the Cortisol Care Options Handout

Adrenal Alternatives Foundation Free Resources Library

Adrenal Insufficiency 101 Guide Book

Cortisol Pump 101 Guide Book

Congenital Adrenal Hyperplasia: A Comprehensive Guide by Peter C. Hindmarsh

This information has been brought to you by the Adrenal Alternatives Foundation and is not to be used to provide medical care. Adrenal Alternatives is a nonprofit, patient advocacy organization dedicated to advocacy & access for all cortisol care.

If you’d like to support us, here are a few ways to get involved:

  • Sign up for our email list.
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Like, share and comment on our social media.

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  • Purchase, Share & Review our Books on Amazon:

Adrenal Insufficiency 101: A Patient’s Guide to Managing Adrenal Insufficiency

Cortisol Pumping Guidebook

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Text the word GIVE to 833-807-5813 Or donate at

http://www.paypal.com/paypalme/adrenalalternatives

You can also donate your old insulin pumps and supplies. (Broken pumps can still be used for research)

Adrenal Alternatives Foundation, Ein: 83-3629121.   501c3 Non-Profit Patient advocacy organization. All donations tax deductible.

Updates on the TwistJect Emergency Cortisol Injection Device

Adrenal Alternatives Foundation is a proud affiliate of SOLUtion medical, which is a company creating an auto-injecting device to deliver the lifesaving cortisol injection. This article contains the latest updates [2022] from  SOLUtion Medical about the Twistject device!

You can also listen to the podcast interview with SOLUtion’s founder, Julia Anthony, at the following link-  TwistJect Podcast Episode

SOLUtion Medical is developing a one-step injector for delivering adrenal crisis medication in a rescue situation. This incredible innovation will eliminate the need for cumbersome and confusing rescue kits, and replace those kits with a single, one-step device. This upcoming device automatically mixes medication without requiring shaking or visual monitoring. Initial data shows the product mixes hydrocortisone sodium succinate powder approximately 20X faster than the current standard of care in only one user step.

SOLUtion’s design teams, Neuma and IDE have been focused on the optimization and full integration, assembly, and prototyping of this device and recently finished the first complete prototype integration and demonstration successfully.

With their device prototype, SOLUtion has completed “hands-on” demonstrations with patients and advocacy groups to glean initial feedback from partners, patients, and caregivers. They are also planning to conduct a “human factor” study this year [2022] with The Children’s Hospital of Pennsylvania (CHOP). Having adrenal insufficiency herself, SOLUtion’s founder has maintained the focus of the product to be the usability and the human factors aspects of the device.  

On their drug formulation effort, they have optimized partners and supply chains and are working with two UK firms – Nova Labs (formulation) and Intertek (analytical) – to deliver the drug to the required specifications. These new formulation partners can offer potential cost/development savings.

SOLUtion was pleased with the promising analytical results of the optimized spray drying formulation and are moving forward with finalizing the formulation for manufacturability.

SOLUtion also completed a pricing and reimbursement strategy and payer stakeholder engagement and were very encouraged by the results, which included interviews with payer pharmacy benefit managers and medical directors. Based on this effort, they expect patients will have full access to the Twistject device across public and private payers, with no restrictions, no step through therapy (i.e. fail other methods first before changing), no prior authorization, and strong reimbursement rates.

Additionally, they are in the process of primary market research with patients and caregivers, to better understand their needs, the number of prescriptions per year, the number of crises per year, and other information relating to current adrenal crisis medication utilization. SOLUtion has had over 400 global survey respondents, which helped them better understand patient and caregiver needs, as well as aid them in payer discussions and negotiations.

SOLUtion Medical continues to expand external relationships and was selected to be part of the NASDAQ Milestone Maker Program, which has already led to several meetings with potential strategic partners for distribution worldwide.

This incredible company continues to build momentum and we are excited to support their ongoing efforts to make the Twistject device a reality!

To hear more about SOLUtion’s work, please join us for the Live Q & A event to be hosted on the Adrenal Alternatives Foundation facebook page on June 20, 2022 at 2:00pm EST.

This live event will feature SOLUtion’s founder, Julia Anthony, as she answers questions from the adrenal community regarding the upcoming Twistject Device.

You can also visit their website at: https://solutionmedllc.com/

This content was brought to you by, Adrenal Alternatives Foundation, a non profit, volunteer, patient empowerment organization providing advocacy and access for all cortisol care options. EIN: 83-3629121.

Ways to Get involved:

Sign up for our email list.

Listen to our Podcast on Spotify, iTunes & Anchor:

Read our publications:

Cortisol Pump 101 Guide Book

Adrenal Insufficiency 101 Book

Attend an online or in person event.

Schedule a consult with a team member for cortisol care support.

Purchase Adrenal Awareness Merch from our online store.

Donate:

Text the word GIVE to 833-807-5813 or donate at www.paypal.com/paypalme/adrenalalternatives

More information can be found on our website:

Dental Health with Adrenal Insufficiency

Dental Health with Adrenal Insufficiency

Dental care is a standard part of taking care of your body and should be practiced every single day with trips to the dentist for cleanings twice a year. Patients with adrenal diseases need to alert their dentist of their condition and always carry an emergency injection to your dental appointments just in case.

Patients will also need to updose their cortisol for dental procedures.  Additionally, stress and anxiety may require an adrenal insufficient patient to updose as well. If dental procedures or cleanings cause anxiety, you may need to updose before your appointment. If you know a visit to the dentist causes increased anxiety or will be painful, it is recommended you updose your cortisol. Talk to your doctor about suggestions on updosing. Remember, too little cortisol in one day is fatal, too much is not.

One of our foundation board members, Hannah Jessup is a licensed dental hygienist.  

Hannah Jessup has a degree in science and is also a licensed dental assistant and licensed dental hygienist. As a sufferer of chronic illness with rheumatoid arthritis, Hannah desires to help people realize that they can still achieve their dreams even if it takes longer than the average person.

She had to stall her schooling to get her RA under control and realized that everyone is at their own pace in life. Hannah’s passion for helping people fuels her desire to join this foundation. She educates the dental community on adrenal insufficiency and is an avid advocate.

Below is an interview with Hannah that answers some of the questions regarding dental care for adrenal patients.

Q- What is your name?

A- Hannah Jessup

Q- What is your affiliation with Adrenal Alternatives Foundation?

A- I am a board member.

Q- Tell us about your professional career?

A- I am a dental hygienist, meaning I take dental radiographs, help with educating people on their oral health, do oral cancer screenings, and do everything in my power to get your mouth in a clean and healthy state

Q- How has the pandemic impacted your industry?

A- It really hasn’t impacted the dental field much, we were already sterilizing everything that could be sterilized and disinfecting anything that couldn’t be placed in sterilization. The dental staff has had very little change due to the Corona-19 pandemic, our patients had to deal with minor changes, such as; wearing a mask in and out of the building, waiting in their vehicles and calling us to let us know that they were here (to keep people from crowding the lobby), and getting their temperatures checked before they entered the building. At this point, we have almost lifted all of our covid restrictions, as pertaining to our patients.

Q-  How often should adrenal patients go for teeth cleaning?

A- Most people should get a dental cleaning every six months, although we may recommend more frequent visits for certain patients. Those with; periodontal disease (a condition in which the patient is losing the bone in their mouth or lost bone support in the mouth), on certain medications that negatively affect their oral health condition, or those who can not physically or mentally take care of their dental hygiene at home will require more visits than the average patient to ensure their dental health is maintained.

Q- What is one piece of advice you wish you could tell each of your patients?

A- Just brush and floss the teeth, that you want to keep.

Q- How is the dental community’s awareness on adrenal disease?

A- I feel that most dental practitioners are aware of adrenal conditions, I certainly wouldn’t say that we were experts in the subject, but we are trained on different adrenal related conditions, what to keep an eye out for with these patients, and how to respond if their conditions worsen while they are in our office.

Q-  In the event of an adrenal crisis in the dentist chair, how would you react?

A- I would first never leave my patient’s side while they were in crisis, and call out to my neighbor in the next room over or to a coworker in the hallway to grab one of the doctors, aka dentists, then I would prepare the patients hydrocortisone for injection (which we would have asked the patient to bring with them in case of such a emergency), after my coworker informed the dentist of the medical emergency, they would then go to the front desk and inform them to call 911, the dentist would have come to my room immediately after being informed, if the patient is able to inject themselves with the hydrocortisone then we will let them do it, if not the dentist will inject it for the patient, once the dentist arrives I would start monitoring their vitals while the coworker who I originally called out to for help, would be bringing in the oxygen tank to my room (after informing the front to call 911), I would be administering oxygen and recording vitals until paramedics arrived, and after the front office called 911, they would then call the patients emergency contact to inform them of what was happening.

Q- Is there a quote or mantra that helps or encourages you that you’d like to share?

A- Strive to be a better version of you

Q- What resources would you suggest to someone who wants to know more about good oral hygiene?

A- Crest and Colgate both have a lot of online educational resources, but your best oral hygiene educational resource is your dental hygienist, we are trained oral hygiene educators, so ask us anything.

Q- What is the number one thing you want the world to know about taking care of their teeth?

A- Just brush twice a day for two minutes each time and floss your teeth daily, if you do that you usually get to keep them, its really that easy!

This information has been brought to you by the Adrenal Alternatives Foundation and is not to be used to provide medical care or legal advice.

For more information  visit the links below:

Resources:

Downloadable Materials

Adrenal Insufficiency 101 Book

Cortisol Pumping Guide Book

Social media

Twitter: https://twitter.com/AdrenalAdvocate

Instagram: https://www.instagram.com/adrenalalternativesfoundation

Podcast: https://anchor.fm/adrenalalternatives

FB: https://www.facebook.com/hopeforadrenaldisease

Youtube: https://www.youtube.com/channel/UCxeZtgNgZpksinD2tV8_IlQ

Ways to Get involved:

Sign up for our email list.

Listen to our Podcast on Spotify, iTunes & Anchor https://anchor.fm/adrenalalternatives

Attend an online or in person event.

Schedule a consult with a team member for cortisol care support.

Purchase Adrenal Awareness Merch from our online store.

More information can be found on our website: https://adrenalalternatives.com/

Donate:

Text the word GIVE to 833-807-5813Or donate at www.paypal.com/paypalme/adrenalalternatives

Donate your old insulin pumps and supplies. (Broken pumps can still be used for research)

Adrenal Alternatives Foundation, Ein: 83-3629121.   501c3 Non-Profit Patient advocacy organization. All donations tax deductible.

Advocacy Update- Spring 2022

Advocacy Update- Spring 2022

The first months of 2022 kept our team busy! We are happy to share the progress we made for adrenal disease and disability advocacy at the start of 2022.

We hosted the first annual Disability Inclusion Celebration in beautiful Fort Myers, Florida on the Alliance for the Arts campus. This event was to commemorate the launch of the #AllAbilitiesIncluded campaign, a nationwide effort to promote equality, provide support and offer resources to people with all disabilities.

We came together with many other organization affiliates to release the official campaign video below:

The Disability Inclusion Event showcased community resources such as local charities, small businesses, health and wellness services, government programs and featured disabled artists, musicians, authors and crafters in Southwest Florida.

The following booths were represented:

  • Bridging The Gap Foundation
  • Bumble Bee- Youth in Government Program
  • Cape Coral Quilters Guild
  • Cypress Pharmacy
  • Designed2bFit Wellness Coaching
  • Elite DNA Therapy Services
  • Fish with a Hero
  • Hope Healing Happy Co.
  • Lee County Library System
  • Lee Health
  • Meditative Movements
  • Vibe Yoga
  • We Rock the Spectrum Kid’s Gym
  • YMCA of Southwest Florida

Adrenal Alternative’s founder opened the ceremony with a moving speech entitled, “No Longer Caterpillars.”

“The caterpillar and a person diagnosed with adrenal insufficiency both undergo a process that changes their lives permanently, only to emerge to into a new, different life.

We are no longer caterpillars, we are butterflies.”

-Winslow E. Dixon 2022

Click this link to read the full speech or watch the video recording from the live event below.

During the event, guests were invited to bring a blanket or camping chair to enjoy entertainment on the outdoor amphitheater stage with world renowned concert violinist, Kendall Grady and local talent, Doug Mewhorter with additional performances of a crystal bowl meditation session by sound healer, Jenny Hong of Lotus Blossom Clinic and dance routines by the Studio 8 dance team. Participants were also welcomed to attend a Qigong session led by JaySun of Heart of Synergy.

The kids enjoyed a bounce house and slide and playing fun games sponsored by Special Olympics of Florida. They also were able to create their own craft project with A.R Workshop Fort Myers.

We also awarded raffle prizes every hour with donations from Nutranize, Lotus Blossom Clinic, TruSalon and Hope Healing Happy Co.

The day was an incredible reminder that when a community comes together, positive changes can be made, and you can truly BE the GOOD you want to see in the world.

As soon as our event was over, the very next day we started our advocacy work for Rare Disease Week on Capital Hill.

We met with U.S. Congressman Byron Donalds and discussed our All Ability Inclusion advocacy campaign and also discussed the importance of his vote to support the passing of the STAT ACT.

The STAT Act seeks to enact targeted, impactful, and attainable policy reforms at the Food and Drug Administration (FDA) to accelerate development of therapies across the spectrum of rare diseases and disorders and facilitate patient access to such therapies.

How does the STAT Act impact adrenal disease patients?

Adrenal insufficiency is a condition that renders a person cortisol deficient. In a normal person, during situations of emotional or physical stress their body releases more cortisol. The excitement from a happy event, the sadness from a death of a loved one or the strain from exercising are examples of things that would cause the body to release more cortisol.

In an adrenal insufficient person, this does not happen. They must artificially manage their cortisol with pills. Their personal cortisol needs may differ from day to day. No two days are the same and it is a struggle to regulate proper cortisol levels.

Unlike diabetic patients who can check blood glucose levels, adrenal disease patients have no meter to check their cortisol levels. They must be constantly vigilant of their own personal signs and symptoms of low cortisol and require an emergency injection if their levels drop too low.

Without adequate levels of cortisol, the body will go into an adrenal crisis, which will result in death if left untreated. Even when patients survive an adrenal crisis, they can be impacted by lowered quality of life as well. Therefore, it is imperative that the cortisol levels in the body are adequately replaced.

The standard treatment for adrenal insufficiency patients is daily cortisol replacement medication- steroids.  Medications such as prednisone, dexamethasone or hydrocortisone are prescribed to replace the deficits of steroid hormone in the body. The most commonly prescribed steroid for adrenal insufficiency is hydrocortisone (HC) pills. This medication has a blood serum half-life of 90 minutes and must be taken multiple times a day.

A large number of adrenal patients struggle with quality of life on the standard protocol. Oral HC must be processed through the stomach and the liver before reaching the blood stream.  This can cause a constant rise and fall of cortisol levels, which can result in subpar function and lowered quality of life.

Cortisol replacement advancements such as: time released steroid medications, compounded hydrocortisone and alternative delivery methods such as cortisol MDI (multiple daily injections) and the cortisol pump are not easily accessible. These treatments are legally prescribed, off label options which have documented research as being successful advancements, but due to not yet being FDA approved, most alternative options are not covered by insurance. 

The STAT act supports methods that allow the FDA to accelerate and approve such therapies, therefore increasing treatment options for patients suffering from adrenal diseases that result in cortisol deficiency. 

The passing of the STAT Act will not only broaden treatment accessibility for adrenal disease patients but also benefit many other rare conditions in need of better treatment options!

This is a step in the right direction for legislative advocacy, because all humans deserve the chance to experience quality of life, and this will open doors for many conditions.

You can find more information on how YOU can help support the STAT Act at this link.

But our work was not done yet! As a part of our #AllAbilitiesIncluded campaign, we have proudly aligned with the Literary Equality Initiative to promote equality and accurate representation for the disabled in literature.

We will be donating copies of our publications below to help raise awareness on adrenal diseases and cortisol care options.

Adrenal Insufficiency 101 Book

Cortisol Pumping Guide Book

We are proudly supporting Disability Book Week!

What is it?

A nationwide project to promote disability inclusion in literature and support disabled authors.

When is it?

The last week in April, annually.

By supporting disability equality in literature we can educate the world on the truth of living life with chronic illnesses and other conditions and empower disabled authors to achieve their goals.

To join the movement, please upload a social media photo with the hashtags-#AllAbilitiesIncluded  & #LiteraryEquality

Where to find disability books?

The website- Disabilitybookweek.org has a gallery of books featuring disabled characters and a directory of disabled authors.

How can your library get involved?

Ask your local library to celebrate Disability Book Week with one or all of the following suggestions:

  • Feature a display of books with disabled characters and/or books written by disabled authors.
  • Host a book reading with a disabled author.
  • Social media posts with disability books and/or books by disabled authors.

We are working hard to continue our mission of adrenal awareness and disability advocacy and can’t wait to share more updates on what we are doing.

Sign up for our member email list to get the latest updates at this link.

We appreciate all social media shares and financial contributions which allow us to further our mission, improving access and awareness to all cortisol care options.

To donate safely and securely text the word GIVE to 833-807-5813 or donate through PayPal 

Adrenal Alternatives Foundation is registered with the IRS as a 501(c)3 nonprofit organization. All donations are tax deductible.  EIN: 83-3629121.

All Abilities Campaign- Literary Equality Project

Literary Equality Project is proudly supported by Adrenal Alternatives Foundation as an active part of the All Abilities Included campaign. Disability Book week is a nonprofit project and social movement to promote equality and accurate representation for the disabled in literature.

We invite you to Support Disability Book Week!

What is it?

A nationwide project to promote disability inclusion in literature and  support disabled authors.

When is it?

The last week in April, annually.

How can your library get involved?

Ask your local library to celebrate Disability Book Week!

  1. Feature a display of books with disabled characters and/or books written by disabled authors.
  2. Host a book reading with a disabled author.
  3. Social media posts with disability books and/or books by disabled authors.

Where can I find disability books?

The website- Disabilitybookweek.org has a gallery of books featuring disabled characters and a directory of disabled authors.

How do I schedule author readings?

Many disabled authors are happy to schedule live book readings via zoom for public engagements nationwide.  We can also connect libraries with authors in their area for in person readings of their books. For booking requests, send an email to:  disabilitybookweek@gmail.com

How can I support literary equality?

To join the movement, please upload a social media photo with the hashtags-#AllAbilitiesIncluded  & #LiteraryEquality

Literary Equality Project is proudly supported by Adrenal Alternatives Foundation as an active part of the All Abilities Included campaign. Disability Book week is a nonprofit project to promote equality and accurate representation for the disabled in literature.

We appreciate all contributions which allow us to further our mission of disability advocacy and improving access and awareness to all cortisol care options.

To donate safely and securely text the word GIVE to 833-807-5813 or use the link below.

Donate to Adrenal Alternatives Foundation

Sign up for our member email list to get the latest updates.

Adrenal Alternatives Foundation is registered with the IRS as a 501(c)3 nonprofit organization.

EIN: 83-3629121.