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Sirturo is a brand name for Bedaquiline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SIRTURO is indicated for use as part of an appropriate combination regimen in adult and paediatric patients (2 years to less than 18 years of age and weighing at least 7 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of TB due to M. tuberculosis resistant to at least rifampicin and isoniazid. Consideration should be given to WHO guidelines when selecting the appropriate combination regimen.
Only use SIRTURO in combination with other medicinal products to which the patient’s isolate has been shown to be susceptible in vitro or is likely to be susceptible. Refer to the Summary of Product 3 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 Adult Patients The recommended dosage for SIRTURO in adult (18 years and older) patients is shown in Table 1.
Table 1:
Recommended Dosage of SIRTURO in Adult Patients Population Dosing Recommendation Weeks 1 to 2 Weeks 3 to 24 Adults (18 years and older) 400 mg orally once daily 200 mg orally three times per week a a At least 48 hours between doses The total duration of treatment with SIRTURO is 24 weeks.
SIRTURO should be taken with food. Paediatric Patients The recommended dosage for SIRTURO in paediatric patients (2 years to less than 18 years of age) is based on body weight and shown in Table 2.
Table 2:
Recommended Dosage of SIRTURO in Paediatric Patients (2 years to less than 18 years of age) Body Weight Dosage Recommendation Weeks 1 to 2 Weeks 3 to 24 Greater than or equal to 7 kg to less than 10 kg 80 mg orally once daily 40 mg orally three times per week a Greater than or equal to 10 kg to less than 15 kg 120 mg orally once daily 60 mg orally three times per week a Greater than or equal to 15 kg to less than 20 kg 160 mg orally once daily 80 mg orally three times per week a Greater than or equal to 20 kg to less than 30 kg 200 mg orally once daily 100 mg orally three times per week a Greater than or equal to 30 kg 400 mg orally once daily 200 mg orally three times per week a a At least 48 hours between doses The total duration of treatment with SIRTURO is 24 weeks.
SIRTURO should be taken with food. 4 Treatment duration The total duration of treatment with SIRTURO is 24 weeks. 1). Missed doses Patients should be advised to take SIRTURO exactly as prescribed and to complete the full course of therapy.
Summary of the safety profile Adverse reactions for SIRTURO were identified from Phase IIb clinical trial data (both controlled and uncontrolled, C208 and C209) in 335 adult patients who received SIRTURO for 8 weeks or 24 weeks. No new adverse reactions were identified in the Phase III active-controlled trial including 354 patients 9 who received SIRTURO for 40 weeks or 28 weeks.
In these studies, patients received SIRTURO in combination with other antimycobacterial drugs. 0% of patients) reported during treatment with SIRTURO in the open-label Phase III trial were QT prolongation (61% in the SIRTURO group vs 56% in the control group), nausea (54% vs 63%), vomiting (54% vs 62%), arthralgia (45% vs 33%), transaminases increased (30% vs 29%), dizziness (18% vs 21%) and headache (17% vs 18%).
Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their respective adverse reactions. Tabulated list of adverse reactions Adverse reactions to SIRTURO based on reported safety data from Phase II and Phase III trials in adult patients treated with SIRTURO are presented in the Table below.
Adverse reactions are listed by system organ class (SOC) and frequency. Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1 000 to <1/100). System Organ Class (SOC) Frequency Categorya ARs Nervous system disorders Very Common Headache, dizziness Gastrointestinal disorders Very Common Nausea, vomiting Common Diarrhoea Hepatobiliary disorders Very Common Transaminases increasedb,c Musculoskeletal and connective tissue disorders Very Common Arthralgia Common Myalgia Investigations Very Common Electrocardiogram QT prolongedd a Frequencies derived from Phase III trial STREAM Stage 2 40-week, all-oral treatment of SIRTURO, levofloxacin, clofazimine, ethambutol, and pyrazinamide, supplemented by high-dose isoniazid and prothionamide in the first 16 weeks (intensive phase).
, central nervous system, bone) infections due to mycobacterial species other than M. tuberculosis latent infection with M. tuberculosis There are no clinical data on the use of SIRTURO as part of combination regimens used to treat drug-susceptible M.
tuberculosis. Resistance to bedaquiline Bedaquiline should only be used in an appropriate combination regimen for treatment of pulmonary TB due to M. 2). QT prolongation SIRTURO may prolong the QT interval. An electrocardiogram should be obtained before initiation of treatment with SIRTURO and at least monthly after starting treatment to monitor the QTc interval.
Serum potassium, calcium, and magnesium should be obtained at baseline and corrected if abnormal. 8). 5). Treatment with SIRTURO may be considered after a favourable benefit-risk assessment and with ECG monitoring. SIRTURO treatment must be discontinued if the patient develops: Clinically significant ventricular arrhythmia A QTcF interval of >500 ms (confirmed by repeat electrocardiogram).
If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation. 8). Patients should be monitored throughout the treatment course, since the increases in liver enzymes were slow to appear and increased gradually during the 24 weeks.
Monitor symptoms and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed. If AST or ALT exceeds 5 times the upper limit of normal then the regimen should be reviewed and SIRTURO and/or any hepatotoxic background medicinal product should be discontinued.
Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve. 2). This may be associated with an increased risk of QT prolongation or hepatotoxicity. Interactions with other medicinal products CYP3A4 inducers Bedaquiline is metabolised by CYP3A4.
1.
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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 as soon as possible and then resume the three times a week regimen.
The total dose of SIRTURO during a 7-day period should not exceed the recommended weekly dose (with at least 24 hours between each intake). 2). 2). 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. 2). Paediatric population The safety and efficacy of SIRTURO in children less than 2 years of age or weighing less than 7 kg have not yet been established.
No data are available. SIRTURO may be included in the treatment regimen for children greater than or equal to 2 years of age and weighing at least 7 kg with confirmed or probable pulmonary TB due to M. 1). 2). There is one method of administration of SIRTURO 100 mg tablet and four different options for administration of SIRTURO 20 mg tablet.
Each administration method requires SIRTURO to be taken with food. SIRTURO 100 mg tablets SIRTURO 100 mg tablets should be swallowed whole with water and taken with food. SIRTURO 20 mg tablets Administration of 20 mg Tablets to Patients Who Can Swallow Intact Tablets: SIRTURO 20 mg tablet should be swallowed whole, or in two equal halves divided along the functional score line, with water and taken with food.
5 Administration of 20 mg Tablets to Patients Who Cannot Swallow Intact Tablets: Dispersed in Water and Administered with Beverage or Soft Food For patients who have difficulty swallowing intact tablets, SIRTURO 20 mg tablet can be dispersed in water before being administered with food.
, yoghurt, apple sauce, mashed banana or porridge) as follows: Disperse tablets in water (maximum of 5 tablets in 5 mL of water) in a drinking cup. Mix the contents of the cup well until the tablets are completely dispersed and then orally administer the contents of the cup immediately with food.
To aid with oral administration, the dispersed mixture in water can be further mixed with at least 5 mL of beverage or 1 teaspoonful of soft food and then orally administer the […]
b Terms represented by ‘transaminases increased’ included AST increased, ALT increased, hepatic enzyme increased, hepatic function abnormal, hypertransaminasaemia, and transaminases increased (see section below). 9% in the SIRTURO group and 1% in placebo control).
8% in placebo control). Description of selected adverse reactions QT prolongation Clinical trials of SIRTURO in adult TB patients collectively show a mild (<10 ms) QTcF increase throughout treatment attributable to M2, the major bedaquiline metabolite.
5). 5 ms for placebo). 2 ms in the placebo group. 4). In the Phase IIb, open-label study (C209), where patients with no treatment options received other QT-prolonging medicinal products used to treat pulmonary TB including clofazimine, concurrent use with SIRTURO resulted in additive QT prolongation.
In patients taking SIRTURO with no other QT-prolonging drugs, there were no patients with QTcF interval durations above 480 ms, and in 10 patients who were taking at least two other QT-prolonging drugs, there was one patient with a QTcF interval duration above 500 ms.
In the controlled Phase III study, in which the 40-week SIRTURO and active control treatment groups included both clofazimine and a fluoroquinolone, the mean QTcF gradually increased from baseline over the first 10 to 14 weeks, when a plateau was reached and additive QT prolongation was observed.
9 ms for the non-SIRTURO-containing control. Throughout treatment, mean QTcF increase was less than 10 ms higher in the SIRTURO-containing group compared to the control. Upon treatment completion mean QTcF decreased steadily. 5). 8%]) in the placebo treatment group.
In the SIRTURO treatment group, the majority of these increases occurred throughout the 24 weeks of treatment and were reversible. 3%) in the placebo treatment group. 2%) patients in the 40-week active control group. Paediatric population The safety assessment of bedaquiline is based on the Week 120 analyses for patients 12 years to less than 18 years of age and 5 years to less than 12 years of age, and the Week 24 analysis for patients 2 years to less than 5 years of age, from 45 paediatric patients greater than or equal to 2 years of age with confirmed or probable pulmonary TB due to M.
tuberculosis resistant to at least rifampicin in an ongoing, single-arm, open-label, multi-cohort trial (see […]
Co-administration of SIRTURO with moderate or strong CYP3A4 inducers decreases bedaquiline plasma concentrations and may reduce the therapeutic effect of SIRTURO. 5). Lactose intolerance and lactase deficiency SIRTURO 100 mg tablets SIRTURO 100 mg tablet contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take SIRTURO 100 mg tablet. 7