Pharmaceutical

 Therapeutic indications

Therapeutic Use

Neurological diseases:

• Acute exacerbations in patients suffering from multiple sclerosis.

• West syndrome (Infantile myoclonic encephalopathy with hypsarrhythmia).

Rheumatic diseases:

Short-term therapy in conditions for which

• glucocorticoids are normally indicated;

• in patients showing poor gastrointestinal tolerance of oral glucocorticoids;

• where glucocorticoids in normal doses have not elicited an adequate response.

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Skin diseases:

Long-term treatment of skin disorders responsive to glucocorticoids - e.g. pemphigus, severe chronic 

eczema, erythrodermal or pustular forms of psoriasis.

Diseases of the gastrointestinal tract

• Ulcerative colitis;

• regional enteritis.

Oncology

As adjuvant therapy to improve the tolerability of chemotherapy.

Diagnostic use for the investigation of adrenocortical insufficiency:

A 5-hour test can be performed using TRICOSACITIDE when the 30-minute test with TRICOSACITIDE i.m./i.v. 

gives inconclusive results, or if the aim is to determine the functional reserve of the adrenal cortex (see 

TRICOSACITIDE i.m./i.v. data sheet).

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 Dose and method of administration:

Dosage

Therapeutic use:

Treatment is initiated with daily doses of TRICOSACITIDE and continued with intermittent doses after about 

3 days.

Adults:

The initial dose is 1 mg daily administered intramuscularly; in acute cases and in oncological indications,

treatment can be started with 1 mg every 12 hours. Once the acute manifestations have subsided, the usual 

dosage is 1 mg every 2 to 3 days; in patients who respond well, the dosage may be reduced to as little as 

0.5 mg every 2 to 3 days or 1 mg weekly.

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Special populations:

Renal impairment:

No studies have been performed in patients with renal impairment.

​

Hepatic impairment: 

No studies have been performed in patients with hepatic impairment.

Paediatric patients: 

Due to the presence of benzylalcohol, TRICOSACITIDE is contraindicated in premature babies and in 

neonates (less than 1 month) (see also section 4.3 Contraindications and section 4.4 Special Warnings 

and precautions.).

month to less than 2 years: Initially 0.25 mg daily administered intramuscularly; the maintenance dose is 

0.25 mg every 2 to 8 days.

to less than 5 years: Initially 0.25 to 0.5 mg daily administered intramuscularly; the maintenance dose is 

0.25 to 0.5 mg every 2 to 8 days.

5 to less than 12 years: Initially 0.25 to 1 mg daily administered intramuscularly; the maintenance dose is 

0.25 to 1 mg every 2 to 8 days.

Elderly patients:

There is no such information available which would necessitate dosage modification in elderly (65 years of 

age and above).

Fertility, Pregnancy and Lactation

Fertility

There is no data available

Use in Pregnancy

There is a limited amount of data on the use of TRICOSACITIDE in pregnant patients. Data from animal studies

are insufficient with respect to reproductive toxicity/teratogenicity. Synacthen should be used during 

pregnancy only if the expected benefit outweighs the potential risk to the foetus.

Use in Labour/Delivery

There is no special recommendation.

Breastfeeding

It is unknown whether this drug is excreted in human milk. Because many drugs are

excreted in human milk, caution should be exercised when Synacthen is administered to 

a breastfeeding woman

 Effects on ability to drive and use machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side 

effects such as dizziness.

 Undesirable effects

Adverse drug reactions may be related to tetracosactide, to the presence of benzylalcohol or to the 

stimulation of glucocorticoids and mineralocorticoid secretion during the use of TRICOSACITIDE.

Adverse Drug Reactions Related to Tetracosactide

The following adverse reactions have been derived from post-marketing experience via spontaneous cases 

reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain 

size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. 

Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system 

organ class, ADRs are presented in order of decreasing seriousness.