Instructions for Use:

• Bedaquiline has to be taken along with food so that its effectiveness and absorption both increase. Doing so will make the drug freely available to the body and prevent it from harming the stomach as well.
• The tablet has to be swallowed in its whole form, rather than being chewed or crushed, as the drug’s activity could be hampered by it.
• Take the tablet once daily for two weeks and then three times a week. Extend the dosage as advised for maximum effect.
• Do not stop taking Bedaquiline abruptly. Abrupt discontinuation of the medication without advice from your doctor can lead to aggravation of your disease or drug resistance.

Missed Dose:

If a dose is missed, take the dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Never double doses to make up for a skipped dose.

Bedaquiline prevents an enzyme known as ATP synthase from working. This is one of the critical components of the energy metabolism of TB-causing bacteria, Mycobacterium tuberculosis. The medication prevents the energy metabolism of the bacteria, making the bacteria useless, and it becomes harder for them to reproduce. This reduces the infection and allows the body’s immune system to fight the bacteria. It needs to be recalled that Bedaquiline does not lethally attack the bacteria as single entities but forms a regimen that is whole during the process of treating MDR-TB.

Common Side Effects

• Nausea: Nausea is one of the more common side effects of Bedaquiline. It will be felt in the initial few weeks of treatment but decreases as the body adapts to the drug.
• Joint Pain: Mild or moderate joint pain can be endured in most patients on Bedaquiline. This can disturb some.
• Headaches: The other common side effect to endure with patients is headaches, mostly on drug initiation.

Serious Side Effects

• Cardiac Adversities: Bedaquiline has been associated with an increased risk for QT interval prolongation, with ensuing arrhythmias. Treatment patients are typically monitored very closely by employing serial electrocardiogram (ECG) screening.
• Abnormalities of the Liver: Pre-therapy and in-course of therapy liver function tests are advised because some abnormalities of the liver have been seen in a minority of patients taking Bedaquiline, including jaundice (yellow eyes or skin), dark urine, or upper abdominal pain.
• Allergic Reaction: While rare, a patient may have an allergic reaction to Bedaquiline. Rash, swelling, or difficulty in breathing are indications of such a reaction, and it will need to be treated medically at once.

• Cardiac Monitoring: As Bedaquiline is likely to alter the heart rhythm, physicians recommend that the heart must be monitored more closely, particularly in patients having a history of heart disease or those who are likely to develop heart disease.
• Liver Function: Patients with a history of liver disease or those who are currently suffering from liver diseases should be monitored closely when treated with Bedaquiline.
• Pregnancy and Breastfeeding: Bedaquiline use in pregnancy and lactation is not well established. If pregnant, planning to become pregnant, or breastfeeding, make sure to talk to your doctor before starting treatment.
• Pre-existing Illnesses: Patients with a history of prior heart disease, liver disease, or alcoholism must take Bedaquiline cautiously and under close medical supervision. Your doctor must be informed of such a condition before proceeding with the drug.

• Antifungal Medications: If you take some antifungal medications like ketoconazole, Bedaquiline reacts with them. The antifungal may increase the concentration of Bedaquiline in your body, hence its effect. Therefore, the dose needs to be regulated by your doctor.
• Antiretroviral Medication: Bedaquiline will interact with antiretroviral drugs like efavirenz and ritonavir. The interaction will alter the efficacy of the HIV drug as well as Bedaquiline. Ensure you notify your doctor if you have already begun using antiretroviral drugs.
• Certain Antibiotics: Rifampin and certain antibiotics may be able to reduce the level of Bedaquiline in your body. Rifampin can also affect the activity of Bedaquiline, and hence these drugs need to be controlled and regulated properly.

• The adult patient of MDR-TB receives a dose of 400 mg once daily for the first two weeks. The dose is increased to 200 mg three times a week thereafter.
• Dose adjustment in liver disease patients needs to be performed and the regimen may be adjusted based on the response of the patient.
• The patient has to adhere to the dosage regimen as prescribed by the physician to make the treatment as effective as it can be.

Bedaquiline is a prescription medication. It would be advisable to obtain it from a doctor who will examine your condition and prescribe the right regimen. Due to the nature of the drug and some of the side effects, it would be advisable to obtain it under the guidance of a health care provider knowledgeable in the treatment of drug-resistant tuberculosis.

1. What is Bedaquiline?

Answer: Bedaquiline is an antibiotic medication used to treat multidrug-resistant tuberculosis (MDR-TB) in adults and adolescents.

2. How does Bedaquiline work?

Answer: Bedaquiline works by inhibiting the ATP synthase enzyme in Mycobacterium tuberculosis, disrupting the bacteria’s energy production and ultimately leading to its death.

3. What is the recommended dosage of Bedaquiline?

Answer: The standard dosage for Bedaquiline is 400 mg taken once daily for the first two weeks, followed by 200 mg taken three times a week for a total duration that varies depending on the treatment regimen.

4. Can Bedaquiline be used alone?

Answer: No, Bedaquiline should be used in combination with other antitubercular medications to prevent the development of resistance.

5. What are the common side effects of Bedaquiline?

Answer: Common side effects include nausea, fatigue, headache, and joint pain. It can also cause changes in heart rhythm in some patients.

6. How is Bedaquiline administered?

Answer: Bedaquiline is taken orally in tablet form, and it should be taken with food to enhance absorption.

7. Is Bedaquiline safe during pregnancy?

Answer: The safety of Bedaquiline in pregnancy has not been established; pregnant individuals should discuss their options with a healthcare provider.

8. Can Bedaquiline be used in children?

Answer: Bedaquiline is currently approved for use in adolescents aged 12 years and older; its safety in younger children has not been established.

9. Are there any contraindications for using Bedaquiline?

Answer: Bedaquiline should not be used in patients who have a known hypersensitivity to the drug or its components.

10. Does Bedaquiline interact with other medications?

Answer: Yes, Bedaquiline can interact with certain medications, particularly those that affect liver enzymes, so patients should inform their healthcare provider of all medications they are taking.

11. How long is the treatment with Bedaquiline?

Answer: Treatment duration with Bedaquiline typically lasts 24 weeks, but the overall duration of tuberculosis treatment may be longer, depending on the regimen.

12. What should I do if I miss a dose of Bedaquiline?

Answer: If a dose is missed, take it as soon as remembered unless it’s almost time for the next dose. Do not double up on doses.

13. How does Bedaquiline compare to other TB medications?

Answer: Bedaquiline offers an effective option for treating MDR-TB and is often used when other drugs are ineffective or not tolerated.

14. Are there specific tests required during Bedaquiline treatment?

Answer: Yes, regular monitoring of liver function tests and electrocardiograms (ECGs) may be required to assess for potential side effects.

15. Can I drink alcohol while taking Bedaquiline?

Answer: It is advisable to limit alcohol intake while taking Bedaquiline, as it may increase the risk of liver damage and enhance side effects.

16. What should I do if I experience severe side effects?

Answer: If severe side effects occur, such as chest pain or severe allergic reactions, seek immediate medical attention and inform your healthcare provider.

17. Is Bedaquiline effective against all types of tuberculosis?

Answer: Bedaquiline is specifically indicated for multidrug-resistant tuberculosis and is not approved for treating drug-susceptible TB.

18. How should Bedaquiline be stored?

Answer: Bedaquiline should be stored at room temperature in a tightly closed container, away from moisture and direct sunlight.

19. Is Bedaquiline available worldwide?

Answer: Bedaquiline is available in many countries, but its availability may vary; check with local health authorities or pharmacies.

20. Can I become resistant to Bedaquiline?

Answer: Yes, there is a risk of developing resistance if Bedaquiline is not taken as prescribed or used alone without appropriate combination therapy.