Epilepsy Information

ACTH (Adrenocorticotropic Hormone)


Commercial names and formulations:
Acthar Gel

Years on the market:
In the US since 1952

How to store it?
Acthar Gel (repository corticotropin injection) should be refrigerated between 2°-8°C
(36°-46°F). 

What does the body do to the medication?

Can I take it with food?
ACTH is not taken by mouth, so taking it with food is not a concern.

How long does it take to get to the blood after I take it?
Immediately if given intravenously (by vein).  If given intramuscularly (by muscle, which is most common using the repository form), it takes 8 to 16 hours to absorb in adults which have been studied. 

How long does it take to start having a steady effect?
Usually during the first one to two week of treatment.

Can this medication be started at a high dose or it has to be started gradually?
The medication can be started at a high dose.  Some practitioners prefer to start with a lower dose, since it is not clear that the high dose is more effective.

How long does it stay in the body?
The half-life is 15 minutes

How is it eliminated?
Removed from the blood by many different organs in the body.

What does the medication do to the body?

Type of epilepsy that helps:
Most commonly used for infantile spasms.  Rarely used for other epilepsies as well such as Lennox-Gastaut Syndrome, Landau-Kleffner syndrome, and others

FDA approved for:
ACTH is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Common side effects:
Skin: acne, rash, hirsutism (extra hair).  These side effects usually disappear after treatment
Bones: osteoporosis (weakening of the bone).  This is usually not a complication, because ACTH is given for a short period of time
Blood: worsening of diabetes, electrolyte (blood salt) imbalances
Liver: none
Kidneys: Small risk of kidney stones
Stomach and intestines: constipation, diarrhea, vomiting, increased or decreased appetite, weight gain, GI bleeding, gastric ulcer
• Heart: cardiac hypertrophy (enlargement)- this finding is very common but usually resolves once the treatment is stopped, high blood pressure
Brain: Shrinkage of the brain size (this also usually reverses after treatment is discontinued), rarely brain bleeding
Mood: irritability, behavioral and mood changes
Others: Cushing’s syndrome, nasal congestion, increased risk of infection, cataracts in the eye

Serious side effects:
ACTH can have severe side effects. The decision to prescribe this medication is never taken lightly. Side effects include high blood pressure, infections, brain and gastrointestinal bleeding, serious allergic reactions which may interfere with breathing.  Close monitoring for side effects is always required during ACTH treatment.

What happens if I get too much of it (intoxication)?
An isolated large dose is not expected to have serious side effects.  An overdose reaction has never been reported.

What happens if I stop it suddenly (withdrawal)?
Sudden withdrawal may lead to serious medical issues such as adrenal insufficiency (failure of the adrenal glands which can result in very low blood pressure and other complications) or worsening seizure control.  It is usually necessary to slowly taper the medicine.

Who should not take this medication?
Patients with certain medical conditions such as osteoporosis (bone thinning), a rare skin condition called scleroderma, bad fungal infections throughout the body, herpes simplex viral infection of the eye, recent surgery, peptic ulcers at present or in the past, serious heart or blood pressure problems, or allergies to pork-derived products.

What is the average dose and how many times a day should be given?
There is no  agreement on the correct dose of ACTH.  If there is a good response, after 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 1-2-week period.  If there is no response, the dose may be increased.  ACTH is given twice a day

Does the body get used to the medication?
ACTH is used for the shortest amount of time possible.  The risk of serious side effects increases with longer treatment duration.

Medications to be careful with:

No significant medical interactions are known

Blood work required?

CBC and CPM?
Yes

How often?
Weekly

Are medication levels in blood useful?
No

Normal range
N/A

Women’s health

Affects contraceptives?
Unknown.  Typically not used in women of childbearing age

Affect fertility?
Unknown

Are safe in pregnancy?
ACTH use is not safe in pregnancy.  The risks of ACTH therapy have to be weighed against the risk of injury to the fetus.

Category
Pregnancy Class C

Can breastfeed?
Unknown. 

Affect bones (osteoporosis)?
See above

Men’s health

Affects sexual performance?
Unknown

Affects fertility?
Unknown

Use other than epilepsy:
ACTH is indicated for the treatment of exacerbations of multiple sclerosis in adults and is also used rarely for other inflammatory conditions

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