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Efmody is a brand name for Hydrocortisone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Efmody is indicated in adolescents aged 12 years and over and adults for the: • Treatment of adrenal insufficiency (AI) • Treatment of congenital adrenal hyperplasia (CAH)
Verbatim from this product's EMA label. Tap a section to expand.
Posology Treatment should be initiated by physicians experienced in the management of AI and/or CAH. As maintenance therapy the dose must be individualised according to the response of the individual patient. The lowest possible dose should be used.
g. 3 surgery, infection, trauma). As the treatment has a modified-release profile when blood tests are used to monitor clinical response in CAH; assessment of the evening dose should be done with a morning blood test and assessment of the morning dose should be done with an early afternoon blood test.
During excessive physical and/or mental stress it may be necessary to increase the dose of Efmody, and/or add additional immediate release hydrocortisone especially in the afternoon or evening. 5). Treatment in AI and CAH Recommended replacement doses of hydrocortisone are 10-15 mg/m2/day (CAH) and 8-10 mg/m2/day (other forms of AI) in adolescents aged 12 years and over who have not completed growth, and 15-25 mg/day in adolescents who have completed growth and adult patients with AI or CAH.
In patients with some remaining endogenous cortisol production a lower dose may be sufficient. At initiation the total daily dose should be split into two doses with two thirds to three quarters of the dose given in the evening at bedtime and the rest given in the morning.
Patients should then be titrated based on their individual response. 2). Changing from conventional oral glucocorticoid treatment to hydrocortisone modified-release hard capsules When changing patients from other oral hydrocortisone replacement therapy to Efmody, the identical total daily dose should be given, but the dose should be given in two doses with two thirds to three quarters of the dose given in the evening at bedtime and the rest given in the morning.
When changing patients from other glucocorticoids to hydrocortisone modified-release hard capsules an appropriate conversion factor should be used, and the patient monitored for response carefully. Conversion to hydrocortisone modified-release hard capsules might elicit symptoms of adrenal insufficiency or overreplacement during dose optimisation.
A starting dose exceeding 40 mg per day of hydrocortisone is not recommended. 4). e. a doubled total daily dose of hydrocortisone is given). Efmody should be continued with the usual regimen to allow for easy return to the normal replacement dose of hydrocortisone once additional hydrocortisone is no longer required.
Summary of the safety profile The adverse drug reactions reported to Efmody in the clinical trial programmes for AI and CAH, and from post-marketing surveillance of CAH are discussed in this section. 8 In the clinical trial programmes of AI and CAH, 284 adverse reactions were reported from 203 Efmody-treated patients.
3% of patients. 9%) were reported commonly. 8%). 2). 2%) were reported in the long-term extension study DIUR-006 for patients that were receiving a mineralocorticoid. 9% of clinical trial participants without causal attribution. Acute adrenal insufficiency has been reported in CAH patients as a post-marketing ADR for Efmody.
Tabulated list of adverse reactions The adverse reactions reported for Efmody in the pooled population (n= 203) in the clinical trial programme for CAH and AI, and from post-marketing surveillance, are tabulated below. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1 000), very rare (< 1/10 000), or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 4). Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids especially when a patient has a history of allergies to medicinal products.
4) - it is unclear if these relate to hydrocortisone therapy using current replacement regimens. Historical cohorts of adults treated from childhood for AI and CAH have been found to have raised cardiovascular risk factors and a higher risk of cerebrovascular disease than the general population - it is unclear if these relate to hydrocortisone therapy using current replacement regimens.
10 Paediatric population Limited paediatric patients were included in the clinical development programme for Efmody. Hydrocortisone has been used for more than 60 years in paediatrics with a safety profile similar to that in adults.
Adrenal crisis Acute adrenal insufficiency may develop in patients with known adrenal insufficiency or CAH who are on inadequate daily doses or in situations with increased cortisol need. Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention.
Sudden discontinuation of therapy with hydrocortisone risks triggering an adrenal crisis and death. 9%) solution for infusion, should be administered according to current treatment guidelines. 5 Pre-operatively, during serious trauma or during intercurrent illness Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.
Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.
Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis. In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency.
2). Patients with AI or CAH are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early. Immunisation Treatment schedules of corticosteroids for people with AI or CAH do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In case of long-term increases in hydrocortisone daily dose due to prolonged periods of stress or illness, the additional hydrocortisone should be carefully weaned off. Missed doses If a dose of Efmody is missed, it is recommended that it be taken as soon as possible.
4 Special populations Elderly Limited clinical data on the safety and efficacy of Efmody are available in elderly patients (over the age of 65 years) with AI or with CAH. There are no data available in patients over the age of 75 years.
Renal impairment There is no need for dose adjustment in patients with mild to moderate renal impairment. 4). Hepatic impairment There is no need for dose adjustment in patients with mild to moderate hepatic impairment. 4). Paediatric population No clinical data on the safety and efficacy of Efmody are available in children aged below 12 years.
Other hydrocortisone containing medicinal products are available for children below 12 years of age. Limited clinical data on the safety and efficacy of Efmody are available in adolescents aged 12 to 18 years. In the clinical development programme 2 patients ≤ 18 years of age have been treated with Efmody for CAH.
Their response was comparable to that of patients > 18 years of age. Method of administration Oral use. Patients should be advised to swallow the modified-release hard capsules with water to wash the capsules down. The capsules should not be chewed as chewing the capsule could affect the release profile.
Growth retardation has been seen in children treated with hydrocortisone for CAH and can be caused by both the disorder and hydrocortisone. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Adverse reactions to corticosteroid replacement therapy Most adverse reactions to corticosteroids are dose and duration of exposure related. Adverse reactions are therefore less likely when using corticosteroids as replacement therapy.
High (supra-physiological) doses of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing´s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Patients should be warned of the signs of diabetes and the need to seek medical advice if they occur. All glucocorticoids increase calcium excretion and reduce the bone-remodelling rate. 8). 8). Symptoms typically emerge within a few days or weeks of starting the treatment.
5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Patients should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently. 8). e. chronic diarrhoea, due to the risk of impaired cortisol exposure.
There are no data in patients with confirmed slow gastric emptying or decreased motility disease/disorder. The clinical response should be monitored in patients with these conditions. Growth retardation Corticosteroids may cause growth retardation in childhood and adolescence; this may be irreversible.
Treatment should be limited to the minimum dose required to achieve desired clinical response and when reduction in dose is possible, the reduction should be gradual. Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement.
Children require frequent assessment to assess growth, blood pressure, and general well-being. Accelerated sexual maturation Adolescents with CAH may show accelerated sexual maturation. Patients should be closely monitored; and if signs of early puberty or accelerated sexual maturation are present, an increase in dose should be considered.
Careful and regular monitoring of adolescent patients with dose adjustment according to the response of the individual patient is recommended. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist […]