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.

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

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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.

FAQ: Cortisol Pumping Method

What is Cortisol Pumping?

The concept of Cortisol Pumping is the use of solu-cortef (inject-able version of cortisol when mixed with saline or bacteriostatic water) used in an insulin pump programmed to disperse cortisol according to the natural circadian rhythm by programming rates of delivery into the pump. This method bypasses the gastric passage and is able to deliver cortisol in a more natural way. With an infusion pump, an adrenal insufficient patient can receive a constant supply of cortisol and can lesson the instability experienced with oral steroid cortisol replacement. Side effects due to malabsorption can be decreased and patients have reported to have improved sleep, weight management and experience an overall improvement in their energy levels and sense of well-being. This method has also been shown to lessen the prevalence of adrenal crises and hospitalizations due to low cortisol.

Though this method is not a cure for adrenal disease, it is an option and a ray of hope for those who are struggling with quality of life.

According to a survey done by the Adrenal Alternatives Foundation[1] concluded that 94.2% of the 52 anonymous cortisol pumping patients reported that the cortisol pump had improved their quality of life.

Is Cortisol Pumping FDA approved?

Adrenal Alternatives Foundation is actively working to gain FDA approval for the cortisol pumping method, but that involves years of clinical trials, patient studies and funding. We will achieve this one day, but until then, we are educating patients that FDA approval is not necessary to safely and legally begin cortisol pumping under the care of a licensed physician. Use of the infusion pump for adrenal insufficiency is considered “off label.”

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 addition, according to the recently passed Right to Try Act, patients have legal rights to access to life-saving treatments which are not yet FDA approved.  The act states the following:

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561A (21 U.S.C. 360bbb–0) the following: ‘‘SEC. 561B. INVESTIGATION ‘‘SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS. ‘‘(a) DEFINITIONS.—For purposes of this section— ‘‘(1) the term ‘eligible patient’ means a patient— ‘‘(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations)); ‘‘(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who— ‘‘(i) is in good standing with the physician’s licensing organization or board; and ‘‘(ii) will not be compensated directly by the manufacturer for so certifying; and ‘‘(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent.”

According to the above legislation, adrenal patients meet the criteria for legal use of an infusion pump to administer glucocorticoid medication.

How do I get a pump?

The first step to cortisol pumping is establishing a care plan with a licensed medical professional. This can be a difficult challenge when trying to find a physician to manage your care with the pumping method, as most have never heard of it. This is why Adrenal Alternative Foundation has volunteers on our clinical advisory team willing to communicate with your healthcare team to help you establish a plan regarding your care on the cortisol pumping method.

It may take you many tries to find a physician willing to manage your care with the cortisol pumping method. Send your research, your health information, everything you can to the endocrinologist before your appointment so they are aware of your intentions beforehand. It may benefit you to write a letter to the endocrinologist prior to your appointment that explains your diagnosis, failed treatments and desire to be on the pump. They may or may not be receptive to your request and alerting them of your intentions beforehand may save you time, money and effort.

Will insurance cover pumps and supplies?

What your insurance will cover is completely dependent on your specific coverage plan and insurance company. If you are denied, you can always file an appeal. Visit this link to download the example appeal letter you can fill out with your information to appeal your insurance company’s denial.  

Adrenal Alternatives Foundation has also aligned with the organization CR3 to help adrenal patients acquire pumps in a safe and legal manner. Visit this link to apply for pump assistance.

It is also an option to cash purchase pumps and supplies specifically from companies such as Omnipod and Medtronic if you have a prescription from your overseeing physician.

Is cortisol pumping safe?

Adrenal insufficiency requires adequate cortisol replacement in the form of steroid medications. With the cortisol pumping method, patients can bypass the gastric pathway and absorb their life-sustaining medication better. This treatment is revolutionary for hypermetabolizers and for those with gastro-intestinal problems or malabsorption issues.

The pump truly puts adrenal patients in control of their cortisol distribution in a way that steroid pills cannot. In situations of physical or emotional stress where “updosing” is needed, the pump can immediately administer a bolus, which is extra cortisol administered through the pump canula at the amount you select. Instead of having to wait for pills to metabolize, the cortisol can be absorbed faster and can help prevent adrenal crisis.

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

Do I still need an emergency injection on the pumping method?

An adrenal crisis is defined as a life- threatening, medical emergency caused by insufficient levels of the hormone, cortisol. It will lead to death if left untreated and must be quickly addressed with the administration of an emergency cortisol injection. 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.

More information on cortisol pumping can be found on the cortisol pump advocacy tab on our website and also in the book A patient’s guide to managing adrenal insufficiency.


[1] CORTISOL PUMPING SURVEY

In-text: (adrenalalternatives.com, 2020) adrenalalternatives.com. (2020). Cortisol Pumping Survey. [online] Available at: https://docs.google.com/forms/d/1eWYZjIFP9HRJDosvdimJnOr8p54Rmpx_2A4Xz40f77A/edit#responses

THE ADRENAL ALTERNATIVES FOUNDATION IS REGISTERED WITH THE IRS AS A 501(C)3 NONPROFIT ORGANIZATION. WE ARE A PATIENT EMPOWERMENT ORGANIZATION THAT ENCOURAGES, EDUCATES AND ADVOCATES FOR SUFFERERS OF ALL ADRENAL DISEASES AND ARE GUIDING ADRENAL DISEASE SUFFERERS TO EVERY POSSIBLE RESOURCE TO MANAGE THEIR HEALTH.
EIN: 83-3629121.

We appreciate all contributions which allow us to further our mission, Education, Advocacy and Awareness for all adrenal disease.

Donate to Adrenal Alternatives Foundation

Can you donate blood with adrenal disease?

Donating blood is one of the most selfless acts a person can do, but when you have a life-threatening illness such as adrenal insufficiency, there are questions as to whether you are allowed to donate blood or not.

Can adrenal disease patients donate blood?

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The answer is complicated.

Some countries/territories allow blood donation from adrenal patients and others do not. It is ultimately dependent on the regional medical director’s decision of a particular organization.

According to the Pituitary Foundation, Addison’s disease is listed as a permanent deferral which means those with this diagnosis are permanently banned from donating blood.

The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee states that anyone diagnosed with any form of adrenal failure “Must not donate.” 
When we searched the American Red Cross website for adrenal disease information, we found no search results that pertained to whether adrenal patients could donate or not.
You can review the full eligibility requirements here.
To answer, the original question, Can you give blood with adrenal disease?
It depends on where you live and what organization is accepting blood donations.
If you are eligible to donate in your area, remember it is also a personal choice.  You should discuss it with your doctor to determine your risks and benefits of blood donation. 

 

 

 

 

 

Sources:

https://www.mskcc.org/about/get-involved/donating-blood/additional-donor-requirements/medical-conditions-affecting-donation

https://www.pituitary.org.uk/information/living-with-a-pituitary-condition/donating-blood/

https://www.redcrossblood.org/donate-blood/how-to-donate/eligibility-requirements/eligibility-criteria-alphabetical.html

https://www.transfusionguidelines.org/dsg/wb/guidelines/ad003-adrenal-failure