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Drugs List

  • ACTHAR 400unit/5ml gel for injection
  • corticotropin 400unit/5ml gel for injection
  • Therapeutic Indications

    Unlicensed Uses

    Corticotropin injection is indicated for diagnostic testing of adrenocortical function.

    Corticosteroid therapy is considered the treatment of choice in conditions responsive to corticosteroids. Corticotropin may be used as an alternative to corticosteroids in the following conditions:

    Endocrine Disorders:
    Nonsuppurative thyroiditis; Hypercalcaemia associated with cancer
    Nervous System Disorders:
    Acute exacerbations of multiple sclerosis
    Rheumatic Disorders:
    Adjunctive therapy for short-term administration in acute exacerbations of:
    Psoriatic arthritis; rheumatoid arthritis ( including juvenile rheumatoid arthritis); ankylosing spondylitis; acute and subacute bursitis; acute non-specific tenosynovitis; acute gouty arthritis; post-traumatic arthritis; synovitis of osteoarthritis; epicondylitis
    Collagen Diseases:
    During an exacerbation or as maintenance therapy in selected cases of:
    Systemic lupus erythematosus; Systemic dermatomyositis (polymyositis); Acute rheumatic carditis
    Dermatologic Diseases:
    Pemphigus; Bullous dermatitis herpetiformis; Severe erythema multiforme (Stevens-Johnson Syndrome); Exfoliative dermatitis; Severe psoriasis; Severe seborrhoeic dermatitis; Mycosis fungoides
    Allergic States:
    Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
    Seasonal or perennial allergic rhinitis; Bronchial asthma; Contact dermatitis; Atopic dermatitis; Serum sickness
    Ophthalmic Diseases:
    Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
    Allergic conjunctivitis; Keratitis; Herpes zoster ophthalmicus; iritis and iridocyclitis; Diffuse posterior uveitis and choroiditis; Optic neuritis; Sympathetic ophthalmia; Chorioretinitis; Anterior segment inflammation; Allergic corneal marginal ulcers
    Respiratory Diseases:
    Symptomatic sarcoidosis; Loeffler's syndrome uncontrollable by other means; Berylliosis; Fulminating or disseminated pulmonary tuberculosis (with anti-TB chemotherapy); Aspiration pneumonitis
    Haematologic Disorders:
    Autoimmune haemolytic anaemia; Secondary thrombocytopaenia in adults; Erythroblastopenia; Congenital hypoplastic anaemia
    Neoplastic Diseases:
    Palliative management of:
    Leukaemias and lymphomas in adults; Acute leukaemia in children
    Oedematous State:
    To induce diuresis or remission of proteinuria in nephrotic syndrome without uraemia of the idiopathic type or that due to lupus erythmatosus
    Gastrointestinal Diseases:
    During the critical period of: Ulcerative colitis; Regional enteritis
    Miscellaneous:
    Tuberculous meningitis with subarachnoid block or impending block (with appropriate anti-TB chemotherapy); Trichinosis with neurologic or myocardial involvement

    Dosage

    Standard tests for verification of adrenal responsiveness to corticotropin using the route(s) of administration proposed for treatment should be performed prior to initiation of treatment. A rise in urinary and plasma corticosteroid values provides evidence of a stimulatory effect.

    Dosage should be individualised according to the disease being treated and the general medical condition of the patient. Frequency of administration and dose should be determined according to disease severity, plasma and urine corticosteroid levels and initial response of the patient.

    Any changes to dosage schedules should be made gradually and only after the full effects of the drug have become apparent.

    Adults

    The usual dosage is 40 to 80 units given by intramuscular or subcutaneous injection every 24-72 hours.

    Treatment of acute exacerbations of multiple sclerosis:

    80 to 120 units may be administered daily by intramuscular injection for a period of 2 to 3 weeks.

    Treatment of acute gouty arthritis:

    Treatment should be limited to a few days as there is a risk of rebound attacks when corticotropin is discontinued. Conventional concomitant therapy should be given during treatment and for several days after.

    Children

    No dosage recommendations available.

    Prolonged use in children will inhibit skeletal growth. If the use of corticotropin is necessary in children, it should be given intermittently and the child should be carefully monitored.

    Patients with Renal Impairment

    Corticotropin should be used with caution in patients with renal impairment as it may exacerbate the condition.

    Patients with Hepatic Impairment

    Corticotropin produces an enhanced effect in patients with hepatic impairment, therefore caution is advised in these patients.

    Additional Dosage Information

    Chronic administration of doses greater than 40units daily may be associated with uncontrollable adverse effects.

    If reduction in dosage is indicated, it should be done gradually by either reducing the amount of each injection, administering injections at longer intervals or by a combination of both, with careful monitoring of the patient and the disease throughout.

    Precautions and Warnings

    Corticotropin injection is not licensed in the UK. Both the patient and professional should be aware that this is an unlicensed product.

    Treatment should not be initiated until adrenal responsiveness has been verified using the chosen route of administration for treatment (see 'Dosage' section).

    Corticotropin injection should be used at the lowest effective dose for the shortest period of time required to accomplish the therapeutic goal. It suppresses the symptoms without altering the progression of the disease.

    Pregnancy - see 'Pregnancy' section.

    Use with caution in patients with hypothyroidism or those with hepatic impairment as an enhanced effect will be seen in these patients.

    If corticotropin is required in patients where infection is present, appropriate antibiotic therapy be be administered. Caution is advised in patients with latent tuberculosis and close observation is recommended. If treatment is prolonged, chemoprophylaxis should be initiated.

    Corticotropin may increase the susceptibility to infections and their severity through suppression of the inflammatory response and immune function. The clinical presentation of infections may be atypical and serious infections may be masked and may reach an advanced stage before being recognised. New infections, including fungal and viral infections of the eye, may develop during treatment.

    Corticotropin injection should be used with caution in patients with diabetes melitis, renal impairment, diverticulitis and myasthenia gravis as these conditions may be exacerbated by administration of corticotropin.

    Precipitation of psychiatric disturbances is possible with corticotropin use and it should be used with caution in patients with a history of psychiatric disturbances as corticotropin may exacerbate existing symptoms. This may range from mood alteration to a psychotic state.

    Live vaccines should be avoided in patients receiving corticotropin. Other immunisations should be undertaken cautiously due to the possible hazards of neurological complications and the lack of antibody response.

    Corticotropin may depress the hypothalamic-pituitary-adrenal axis and therefore abrupt withdrawal may produce adrenocortical and pituitary unresponsiveness. Consequently, withdrawal or dose reduction should be done gradually. An increase in corticosteroid requirements associated with stress, infection, surgery or trauma may also precipitate acute adrenocortical insufficiency and the use of rapidly acting corticosteroids before, during and after unusually stressful situations is indicated in patients on prolonged therapy. Corticotropin should not be withdrawn suddenly in patients who have received prolonged therapy as this may lead to recurrent symptoms. Doses should be tapered and the injection interval increased to gradually withdraw the drug.

    Corticotropin should be avoided in patients where disease is accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction.

    Chronic administration of corticotropin may lead to irreversible adverse effects and also increases the risk of hypersensitivity reactions.

    Prolonged administration of corticotropin may cause subcapsular cataracts and glaucoma, with possible damage to the optic nerves.

    Sodium and water retention can occur with the use of corticotropin and dietary salt restriction may be required. Potassium loss can also occur which may require supplementation. An increase in calcium excretion may also be seen.

    Use with caution in children under 18 years as prolonged use has been shown to inhibit skeletal growth ( see 'Dosage - Children' ).

    Pregnancy and Lactation

    Pregnancy

    Manufacturer advises that corticotropin has been shown to have an embryocidal effect although there is no published information on adequate, well-controlled studies in pregnant women at the time of writing. Corticotropin should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the foetus.

    Studies reporting use in pregnancy have not demonstrated adverse foetal effects although corticosteroid use in pregnancy has been suspected of causing malformations. Since corticotropin stimulates the release of endogenous corticosteroids, this relationship should be considered when prescribing to women of child-bearing potential.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at https://www.toxbase.org/

    Lactation

    It is not known whether corticotropin is excreted in breast milk as there is no published experience concerning the use of corticotropin during breastfeeding at the time of writing. Manufacturer recommends that because of the potential risk of adverse reactions in the infant, a decision should be made to either discontinue breast-feeding or to discontinue corticotropin, considering the requirements of the mother.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Sodium retention
    Fluid retention
    Potassium loss
    Hypokalaemic alkalosis
    Increased calcium excretion
    Muscle weakness
    Myopathy
    Reduced muscle mass
    Osteoporosis
    Vertebral compression fractures
    Aseptic necrosis
    Vertebral and long bone fractures
    Peptic ulceration with perforation and haemorrhage
    Pancreatitis
    Abdominal distension
    Ulcerative oesophagitis
    Wound healing retarded
    Thinning of skin
    Petechiae
    Ecchymosis
    Facial erythema
    Increased sweating
    Suppression of reactions to skin tests
    Acne
    Hyperpigmentation of skin
    Hypertension
    Necrotising angiitis
    Congestive cardiac failure
    Convulsions
    Raised intracranial pressure
    Papilloedema
    Headache
    Vertigo
    Menstrual disturbances
    Cushingoid changes
    Suppression of growth in children and adolescents
    Secondary adrenocortical and pituitary unresponsiveness
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Precipitation of diabetes
    Hirsutism
    Posterior subcapsular cataracts
    Increased intra-ocular pressure
    Glaucoma
    Optic nerve damage
    Exophthalmos
    Negative nitrogen balance
    Allergic skin reactions
    Hypersensitivity reactions
    Abscess
    Anaphylaxis
    Increased susceptibility and severity of infections
    Opportunistic infections
    Suppression of clinical signs of infection

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111.

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet (https://www.toxbase.org/).

    Shelf Life and Storage

    Store at 2 - 8 degrees C

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