EFMODY Modified-release hard capsule Ref.[50004] Active ingredients:

Posology

Treatment should be initiated by physicians experienced in the management of CAH.

As maintenance therapy the dose must be individualised according to the response of the individual patient. The lowest possible dose should be used.

Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dose adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, changes in electrolytes particularly hypokalaemia, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma). As the treatment has a modified-release profile, blood tests are used to monitor clinical response, 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.

Dose adjustments should be considered in case of concomitant use of potent CYP3A4 inducers or inhibitors (see section 4.5).

Treatment in CAH

Recommended replacement doses of hydrocortisone are 10-15 mg/m²/day 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 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.

The morning dose should be taken on an empty stomach at least 1 hour before a meal and the evening dose taken at bedtime at least 2 hours after the last meal of the day.

Changing from conventional oral glucocorticoid treatment to Efmody

When changing patients from conventional 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 Efmody an appropriate conversion factor should be used, and the patient monitored for response carefully.

Conversion to Efmody might elicit symptoms of adrenal insufficiency or overreplacement during dose optimisation.

A starting dose exceeding 40 mg per day of hydrocortisone is not recommended.

During serious trauma, intercurrent illness or periods of stress

In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment (see section 4.4).

In less severe situations when parenteral administration of hydrocortisone is not required, during periods of physical and/or mental stress, additional immediate release hydrocortisone at the same total daily dose as Efmody should be given in three divided doses; Efmody should be continued as well with the usual regimen (i.e. a doubled daily dose of hydrocortisone) to allow for easy return to the normal replacement dose of Efmody once additional hydrocortisone is no longer required.

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.

Special populations

Elderly

No clinical data on the safety and efficacy of Efmody are available in elderly patients over the age of 65 years.

Renal impairment

There is no need for dose adjustment in patients with mild to moderate renal impairment. In patients with severe renal impairment monitoring of the clinical response is recommended and adjustment of dose may be necessary (see section 4.4).

Hepatic impairment

There is no need for dose adjustment in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment monitoring of the clinical response is recommended and adjustment of dose may be necessary (see section 4.4).

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.

Adolescents

No clinical data on the safety and efficacy of Efmody are available in adolescents aged 12 to 18 years.

Method of administration

The capsules must be given orally.

Patients should be advised to swallow the capsules with water to wash the capsules down.

The capsules should not be chewed as chewing the capsule could affect the release profile.

Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone. In which case, symptomatic treatment should be instituted as necessary.

3 years.

Store in the original package.

Keep the bottle tightly closed in order to protect from moisture.

This medicinal product does not require any special temperature storage conditions.

The capsules are provided in high-density polyethylene bottles with child resistant, tamper-evident polypropylene screw cap with integrated desiccant.

Pack size: 1 bottle containing 50 modified-release hard capsules.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.