Active ingredient: bedaquiline
Inactive ingredients: colloidal anhydrous silica, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, cornstarch, microcrystalline cellulose, polysorbate 20, purified water (removed during processing)
Before you take Sirturo, tell your healthcare provider if you:
- have had an abnormal heart rhythm (ECG) or other heart problems.
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anyone in your family has or has had a heart problem called “congenital long QT syndrome”.
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have liver or kidney problems or any other medical conditions, including HIV infection.
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are pregnant or plan to become pregnant. It is not known if Sirturo will harm your unborn baby.
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are breastfeeding or plan to breastfeed. It is not known if Sirturo passes into breast milk. You and your healthcare provider should decide if you will take Sirturo or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
The recommended dosage of Sirturo is:
Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily with food
Weeks 3-24: 200 mg (2 tablets of 100 mg) 3 times per week with food (with at least 48 hours between doses) for a total dose of 600 mg per week.
Store Sirturo at 77°F (25°C).
Keep Sirturo in the original container, and keep Sirturo out of light.
WARNINGS:
An increased risk of death was seen in the Sirturo treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial. Only use Sirturo when an effective treatment regimen cannot otherwise be provided.
QT prolongation can occur with Sirturo. Use with drugs that prolong the QT interval may cause additive QT prolongation.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- rifampin (Rifadin)
- rifapentine (Priftin)
- rifabutin (Mycobutin)
- lopinavir and ritonavir (Kaletra)
- medicines that prolong the QT interval such as ketoconazole (Nizoral)
This is not a complete list of Sirturo drug interactions. Ask your healthcare provider or pharmacist for more information.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sirturo there are no specific foods that you must exclude from your diet when receiving Sirturo.
Avoid alcohol while receiving Sirturo.
Sirturo can cause serious side effects.
- In one clinical trial, more deaths were seen in people who were treated with Sirturo compared to people who did not receive Sirturo.
- Heart rhythm problems can happen with Sirturo. See “FDA Warning”.
- Talk with your healthcare provider about whether Sirturo is right for you.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Sirturo passes into breast milk. You and your healthcare provider should decide if you will take Sirturo or breastfeed.
Sirturo must always be taken with other medicines to treat TB. Your healthcare provider will decide which other medicines you should take with Sirturo.
- Take Sirturo with food. Swallow the tablets whole with water.
- Take Sirturo exactly as your healthcare provider tells you to take it. Take Sirturo for a total of 24 weeks.
Week 1 and Week 2: Take 400 mg (4 tablets) 1 time each day.
Week 3 to Week 24:
- Take 200 mg (2 tablets) a day 3 times a week.
- For example, you may take Sirturo on Monday, Wednesday and Friday every week.
- Do not take more than 600 mg (6 tablets) Sirturo during a 7 day period.
- You may need to take your other TB medicines for longer than 24 weeks. Check with your healthcare provider.
- Do not skip Sirturo doses. If you skip doses, or do not complete the total 24 weeks of Sirturo your treatment may not work as well and your TB may be harder to treat.
- If you take more Sirturo than you should, talk to a healthcare provider right away.
- If you miss your Sirturo dose during Week 1 or Week 2: Do not take a double dose to make up for the missed dose. Take the next dose as usual.
- If you miss your Sirturo dose during Week 3 to Week 24: Take the missed dose as soon as possible and resume the three times a week schedule.
- Do not take more than 600 mg (6 tablets) in total during a 7 day period. You should take 2 tablets per day, three time a week.
If you miss a dose and you are not sure what to do, talk to your healthcare provider.
Do not stop taking Sirturo without first talking to your healthcare provider.
Sirturo is a prescription medication used to treat multi-drug resistant tuberculosis (TB) in people with limited treatment options.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Sirturo may cause serious side effects, including:
- See “Drug Precautions”
- 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 colored bowel movements, dark colored urine, yellowing of your skin or the white of your eyes.
Side effects of Sirturo include nausea, joint pain, headache, an abnormal lab test associated with damage to the pancreas, coughing up blood, chest pain, loss of appetite, and/or rash.
These are not all the possible side effects of Sirturo.
For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Sirturo will harm your unborn baby.
If you take too much Sirturo, call your healthcare provider or seek emergency medical attention right away.
Sirturo (generic: bedaquiline) is a prescription medication used to treat multi-drug resistant tuberculosis (TB) in people with limited treatment options.
Sirturo belongs to a group of drugs called antibiotics. It works by blocking the bacteria’s energy source and killing it.
This medication comes in tablet form. Sirturo is taken once daily with food for the first 2 weeks of therapy, and 3 times a week thereafter.
Common side effects of Sirturo include nausea, joint pain and headache.