Posology : מינונים

4.2    Posology and method of administration

Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant Mycobacterium tuberculosis.

SIRTURO should be used in combination with at least three medicinal products to which the patient’s isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible. Consideration should be given to WHO guidelines when selecting the appropriate combination regimen. Treatment with the other agents in the regimen should continue after completion of treatment with SIRTURO. Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their specific dosing recommendations.

It is recommended that SIRTURO is administered by directly observed therapy (DOT).

Posology

The recommended dosage is:
•     Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily
•     Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses).

Treatment duration
The total duration of treatment with SIRTURO is 24 weeks. Data on longer treatment duration is very limited. In patients with extensive drug resistance, where SIRTURO is considered necessary beyond 24 weeks to obtain a curative treatment, a longer duration of therapy may be considered only on a case by case basis and under close safety surveillance (see section 4.8).

Missed doses
Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy.

If a dose is missed during the first two weeks of treatment, patients should not make up the missed dose, but should continue the usual dosing schedule.

If a dose is missed from week three onwards, patients should take the missed dose of 200 mg as soon as possible and then resume the three times a week regimen.

Elderly population (≥ 65 years of age)
There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients.

Hepatic impairment
No dose adjustment is necessary for SIRTURO in patients with mild or moderate hepatic impairment (see section 5.2). SIRTURO should be used with caution in patients with moderate hepatic impairment (see section 5.2). SIRTURO has not been studied in patients with severe hepatic impairment and is not recommended in this population.

Renal impairment
No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease requiring haemodialysis or peritoneal dialysis, SIRTURO should be used with caution (see section 5.2).

Paediatric population
The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established.
No data are available.

Method of administration
SIRTURO should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold (see section 5.2). SIRTURO tablets should be swallowed whole with water.