SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause disease. SIRTURO is used to treat tuberculosis (TB) when it has become resistant to other antibiotics. This is called multi-drug resistant TB. SIRTURO must always be taken together with other medicines for treating tuberculosis. It is used in adults and children (5 years and over, who weigh atleast 15 kg).
1. What SIRTURO is and what it is used for
2. What you need to know before you take SIRTURO
Do not take SIRTURO
- If you are hypersensitive (allergic) to bedaquiline or any of the other ingredients of SIRTURO (see above WHAT SIRTURO CONTAINS).
- You have a personal or family history of a heart problem called “congenital long QT syndrome”.
- You have a serious irregular heartbeat.
- You are using medicines that can cause a heart problem called “congenital long QT syndrome” and serious irregular heartbeat.
- You have severe liver problems.
Warnings and precautions
Tell your doctor, pharmacist or nurse before taking SIRTURO, if:
Take special care with SIRTURO:
- You have had an abnormal heart tracing (ECG) or heart failure.
- You have any other diseases, including HIV infection.
- You have kidney problems.
- You have a decreased thyroid gland function. This can be seen in a blood test.
Children and adolescents
Do not give SIRTURO to children (under 5 years of age) or weighing less than 15 kg. This is because it has not been studied in this age group.
Other medicines and SIRTURO
Always tell your healthcare professional if you are taking any other medicines. The following are examples of medicines patients with multi-drug resistant tuberculosis may take and which may potentially interact with SIRTURO:
- rifampicin, rifapentine, rifabutin to treat some infections like tuberculosis (antimycobacterial)
- ketoconazole, fluconazole to treat fungal infections (antifungals)
- efavirenz, etravirine, lopinavir/ritonavir to treat HIV infection (antiretroviral non-nucleoside reverse transcriptase inhibitors, antiretroviral protease inhibitors)
- clofazimine to treat some infections like leprosy (antimycobacterial)
- carbamazepine, phenytoin to treat epileptic fits (anticonvulsants)
- St. John’s wort (Hypericum perforatum) an herbal product to relieve anxiety
- ciprofloxacin, erythromycin, clarithromycin to treat bacterial infections (antibacterials) (This includes complementary or traditional medicines).
3. How to take SIRTURO
Do not share medicines prescribed for you with any other person. Always take SIRTURO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.
The usual dose for Adults (18 years and older) is shown in table 1:
Table 1: Recommended Dosage of SIRTURO in Adult Patients
| Dosage Recommendation | Weeks 1 and 2 | Weeks 3 to 24 |
|---|---|---|
| 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) orally once daily | 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally three times per week |
a After week 2, do not take a total dose of more than 600 mg SIRTURO in total during a 7-day period. a = At least 48 hours between doses. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 onwards. The total duration of treatment with SIRTURO is 24 weeks. SIRTURO should be taken with food. You may need to continue treatment beyond the 24 week course if you have extensive resistance to TB medicines in order to be cured. This may only be considered based on individual cases by your doctor. You may need to keep taking your other medicines for TB for longer than 24 weeks. Check with your doctor or pharmacist. Do not stop early because your TB infection could get worse or become resistant to SIRTURO and other medicines. If you have the impression that the effect of SIRTURO is too strong or too weak, tell your doctor or pharmacist.
4. Possible side effects
SIRTURO can have side effects. Not all side effects reported for SIRTURO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SIRTURO, please consult your healthcare provider for advice.
Serious heart rhythm changes (QT prolongation): Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.
Liver problems (hepatotoxicity): Call your healthcare provider right away if you have unexplained symptoms such as nausea or vomiting, stomach pain, fever, weakness, itching, unusual tiredness, loss of appetite, light coloured bowel movements, dark coloured urine, yellowing of your skin or the white of your eyes (jaundice).
Frequent side effects:
- headache
- joint pain
- feeling dizzy
- feeling sick (nausea) or being sick (vomiting).
- diarrhoea
- increased liver enzymes shown in blood tests
- aching muscles, tender or weak muscles, not caused by exercise
- abnormal ECG called “QT prolongation”
Additional side effects in children
- Increased liver enzymes (shown in blood tests).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/index/8 By reporting side effects, you can help provide more information on the safety of SIRTURO. Alternatively, you may report side effects experienced with SIRTURO directly to Janssen Pharmaceutica (see section ‘Holder of the Certificate of Registration’ for contact details or visit www.janssen.com).
5. How to store SIRTURO
• Store at or below 25 °C.
• Store SIRTURO in the original container in order to protect from light.
• Do not use SIRTURO after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month.
• Store all medicines out of reach of children.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).