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According to the European Medicines Agency, brand name Sirturo originating from Europe is manufactured at the following site(s):Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Information about Sirturo (Bedaquiline)
Sirturo, with the active ingredient bedaquiline, is a medication used for the treatment of multidrug-resistant tuberculosis (MDR-TB). It works by inhibiting the Mycobacterium tuberculosis ATP synthase, an enzyme crucial for the energy production of the bacteria. By disrupting energy production, bedaquiline kills the bacteria and helps treat infections that are resistant to other tuberculosis drugs. Sirturo is typically used in combination with other anti-TB drugs and is a part of a comprehensive treatment regimen.
Product Highlights
- It is specifically approved for the treatment of MDR-TB, a form of tuberculosis resistant to at least two of the first-line TB drugs, isoniazid and rifampicin.
- Sirturo may also be used in cases of XDR-TB, a more severe form of drug-resistant TB.
Key Ingredient
Key Benefits
- Sirturo is particularly useful for treating multidrug-resistant and extensively drug-resistant TB, which are challenging to treat with standard TB drugs.
- The drug acts specifically on Mycobacterium tuberculosis, reducing the risk of harming healthy cells and tissues.
- When used in combination with other TB drugs, it enhances the effectiveness of the treatment, especially in cases where other drugs have failed.
- Sirturo helps improve the prognosis for individuals with MDR-TB, providing an additional treatment option for patients who have limited choices.
Direction of Use
- Sirturo is taken by mouth in the form of tablets.
- The usual initial dose is 400 mg once daily for the first two weeks, then 200 mg three times a week for the rest of the treatment period. The specific regimen should be followed as prescribed by a healthcare provider.
- Sirturo can be taken with or without food.
- The treatment duration varies depending on the individual patient's condition but usually lasts for at least 6 months as part of a comprehensive regimen.
Safety Concerns
- Sirturo may cause QT interval prolongation, which can lead to serious heart rhythm abnormalities. Ongoing monitoring of heart function is necessary throughout the treatment.
- Bedaquiline can affect liver function. Liver function tests should be conducted before and during treatment to monitor for any abnormalities.
- Sirturo can interact with other medications, especially those that affect the liver enzymes involved in its metabolism. It is crucial to notify the healthcare provider about all medications being used.
- Common side effects include nausea, joint pain, headache, and liver enzyme changes. Serious side effects, although rare, may include heart problems, liver damage, and changes in vision.
- Incomplete treatment or misuse of bedaquiline can contribute to the development of resistance, making the drug less effective in the future.
Avoid Sirturo (Bedaquiline) If:
- Individuals who are allergic to bedaquiline or any other components of the medication should not use Sirturo.
- Sirturo should be avoided in patients with severe liver impairment or active liver disease.
- People with a history of QT interval prolongation or other heart conditions that increase the risk of arrhythmias should avoid Sirturo unless closely monitored by a healthcare provider.
- Sirturo should be used with caution during pregnancy and breastfeeding. A healthcare provider should carefully assess the potential risks and benefits.
- Drugs that strongly affect the cytochrome P450 enzyme system (especially CYP3A4 inhibitors and inducers) should be avoided while on Sirturo, as they can interfere with the metabolism of bedaquiline and increase the risk of side effects.