What is Sirturo?
Sirturo, an antibacterial, is used in combination with other medications for the treatment of pulmonary tuberculosis, which has become resistant to other antibacterial drugs.
Sirturo can be used by adults and children who are at least five years old and weigh at least 15 kilograms (33 pounds). Sirturo may cause serious, and even fatal, side effects. It should only be used if there are no other options.
Warnings
Sirturo may cause serious side effects, including death. Use this medicine only if there are no other options. Only use the prescribed dosage of this medication and adhere to all instructions from your doctor.
Sirturo may cause serious side effects on your heart. If you experience rapid or irregular heartbeats, sudden nausea, or feel like you may pass out, tell your doctor.
Before you take this drug
Tell your doctor about any of the following to ensure that Sirturo will be safe for you:
- Heart problems or heart rhythm disorders;
- Underactive thyroid
- Long-QT syndrome
- Human immunodeficiency virus (HIV);
- Liver or kidney disease
- Electrolyte imbalances (such as low levels of potassium, calcium, or magnesium in the blood) can be a sign.
If you're pregnant, follow your doctor's advice about Sirturo. Tuberculosis can harm both the mother and her baby. Tell your doctor, if you're breastfeeding, if you notice a decreased appetite, nausea or stomach pain, dark urine or clay-coloured stools, or yellowing skin or eyes.
How to take Sirturo?
Sirturo should be taken exactly as prescribed by a doctor. Read all the instructions and directions that come with your prescription. Sometimes your doctor will change the dose. Sirturo can be administered in a clinic or doctor's office. Sirturo can be taken daily for two weeks and then three times per week for 22 weeks (with a minimum 48-hour interval between doses). Please follow your doctor's instructions for dosage. After the first two weeks of treatment, you may need to take fewer tablets per dose.
Sirturo is best taken with food. Take 100 milligrammes (mg) of the tablet with water. Do not chew, crush, or break the tablet. Swallow it whole. If needed, the 20-mg tablets can be broken along their split line. You can dissolve a 20-mg tablet in water and mix it with soft drinks or food if you are unable to swallow the whole tablet. Follow all instructions for mixing the 20-mg tablet. If you don't understand the instructions, ask your pharmacist or doctor.
The dose of bedaquiline is based on the weight of children and/or adolescents. If your child loses or gains weight, the dosage of bedaquiline may be adjusted. Sirturo should be taken for the entire prescribed time period, even if symptoms improve quickly. By skipping doses, you can increase the risk of developing an infection resistant to medications.
Sirturo should be taken in conjunction with other anti-tuberculosis drugs and not alone. All medications should be taken as prescribed. Read all instructions and medication guides. You should not stop taking medication or change the dose without consulting your doctor. You may require frequent blood tests. You may need an ECG or electrocardiograph (also called an EKG) to check your heart function. Sirturo should be stored in its original container at room temperature, away from moisture, heat, and light. Sirturo should not be used after the expiration date printed on the label.
Details on dosage
Adult dose of Sirturo -- Resistant:
Weeks 1 and 2: 400 mg orally, once daily
Weeks 3–24: Take 200 mg three times per week orally, with a minimum of 48 hours in between each dose.
Duration of treatment: 24 weeks
Comments:
Alcohol should be avoided while undergoing treatment.
The treatment should be administered through direct observation therapy (DOT).
This drug's approval was based on the sputum conversion time during clinical trials. Continued approval could be based on verification and clinical benefits in confirmatory studies.
This drug should only be used for infections that cannot be treated effectively with other treatments.
The treatment should include at least three other drugs that the MDR-TB isolate in vitro has shown to be sensitive to, or at least four other drugs the isolate may be susceptible to if the in-vitro test results are not available.
Use: As part of a combination therapy for the treatment of MDR-TB pulmonary disease caused by Mycobacterium tuberculosis
The usual paediatric dose of Sirturo to treat tuberculosis is:
Twelve years old and older
Over 30 kg:
Weeks 1 and 2: 400 mg orally, once daily
Weeks 3 to 24: Orally, 200 mg three times per week with a minimum of 48 hours in between each dose.
Duration of treatment: 24 weeks
Comments:
Alcohol should be avoided while undergoing treatment.
Treatment should be administered by DOT in conjunction with other antimycobacterial drugs.
This drug's approval was based on the sputum conversion time during clinical trials. Continued approval could be based on verification and clinical benefits in confirmatory studies.
This drug should only be used for infections that cannot be treated effectively with other treatments.
Treatment must be combined with at least three other drugs that the MDR-TB in vitro isolate has shown to be sensitive to, or at least four other drugs the isolate may be susceptible to if the in vitro test results are not available.
Use: As part of combination therapy for the treatment of M-TB pulmonary infection.
What happens if I miss the dose?
If you miss a dosage during the first two weeks of treatment, skip the missed dose. Use your next dose as usual. If you miss a dosage during week 3 or after, take it as soon as possible and continue to take the medicine according to the 3-times-per-week schedule. Use only one dose at a time. If you're not sure how to proceed if you missed a dose, call your doctor.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
Avoid alcohol. Alcohol can cause liver damage. Avoid taking herbal supplements.
Side effects of Sirturo
If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of your lips, face, tongue or throat, please seek emergency medical attention.
If you experience:
- Heartbeats that are fluttering, a feeling of shortness in the chest, or dizziness, as if you were about to pass out;
- Chest pain;
- If you cough up blood or vomit, which looks like coffee grounds,
- Liver disorders: loss of appetite (upper right), stomach pain, tiredness, dark urine, and clay-coloured stools. Jaundice: yellowing of the skin or eye.
Sirturo may cause a variety of side effects.
- Coughing up blood
- Chest pain;
- Nausea, stomach pain;
- Headache;
- Joint pain;
- Abnormal liver function tests
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Interaction with other drug
It is sometimes not safe to take certain medications together. Some drugs may affect the blood levels of drugs that you are taking, which can increase side effects and make them less effective. Sirturo may cause serious heart problems if combined with other medications for infection, high blood pressure, asthma, depression, mental illness, or HIV/AIDS.
Bedaquiline can interact with many drugs. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.
