WARNING

Bedaquiline is a medication used to treat drug-resistant tuberculosis (TB). While it can be effective in fighting TB, like any medication, it carries potential risks. Some of the risks associated with taking Bedaquiline include:

• Heart-related issues: Bedaquiline may cause changes in the electrical activity of the heart, leading to a condition called QT prolongation. This can increase the risk of serious irregular heart rhythms, which may be life-threatening.
• Liver problems: Some people may experience liver-related side effects such as elevated liver enzymes or hepatitis while taking Bedaquiline.
• Nervous system effects: Bedaquiline may cause side effects such as headaches, dizziness, and confusion.
• Nausea and vomiting: Gastrointestinal side effects like nausea, vomiting, and diarrhea can occur with Bedaquiline use.
• Joint pain: Some individuals may experience joint pain or discomfort while taking Bedaquiline.
• Other side effects: Other less common side effects may include changes in blood sugar levels, rash, and low potassium levels.

It’s important for individuals taking Bedaquiline to be closely monitored by healthcare professionals for any signs of these side effects. Additionally, Bedaquiline should only be used under the supervision of a healthcare provider experienced in the treatment of TB and managing its potential side effects.

Why is this medication prescribed?

Bedaquiline is prescribed for the treatment of drug-resistant tuberculosis (TB), particularly when other medications have been ineffective or cannot be tolerated. TB that is resistant to multiple drugs is a serious and challenging condition to treat, and Bedaquiline can be a crucial part of the treatment regimen.

Bedaquiline is typically used in combination with other medications to form a comprehensive treatment plan for drug-resistant TB. This combination approach helps to increase the effectiveness of treatment and reduce the risk of developing further drug resistance.

How should this medicine be used?

Bedaquiline should be used exactly as prescribed by a healthcare professional. Here are some general guidelines on how Bedaquiline is typically used:

• Dosage: The dosage of Bedaquiline can vary based on factors such as the individual’s weight, the severity of the tuberculosis infection, and other medications being taken. Healthcare providers will determine the appropriate dosage for each patient.
• Administration: Bedaquiline is usually taken orally, in the form of tablets. It’s typically taken once daily with food to help improve absorption. The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
• Duration: The duration of treatment with Bedaquiline can vary depending on factors such as the extent of the tuberculosis infection and the overall treatment plan. Treatment with Bedaquiline is typically part of a comprehensive regimen that includes other medications, and it’s important to complete the full course of treatment as prescribed.
• Monitoring: While taking Bedaquiline, patients should be closely monitored by a healthcare professional for any potential side effects or complications. This may include regular check-ups, blood tests, and monitoring for signs of heart problems or other adverse reactions.
• Adherence: It’s crucial to take Bedaquiline exactly as prescribed, at the same time each day, and to not skip doses. Even if symptoms improve, it’s important to complete the full course of treatment to ensure the infection is fully eradicated and to prevent the development of drug resistance.
• Combination therapy: Bedaquiline is typically used in combination with other medications to treat drug-resistant tuberculosis. It’s important to take all prescribed medications as directed by a healthcare provider to maximize the effectiveness of treatment and reduce the risk of treatment failure or relapse.

Patients should discuss any questions or concerns about the use of Bedaquiline with their healthcare provider, and they should not hesitate to seek medical attention if they experience any unexpected side effects or complications while taking the medication.

Other uses for this medicine

Bedaquiline is primarily used for the treatment of drug-resistant tuberculosis (TB) and is not typically prescribed for other conditions. However, there may be some off-label uses or ongoing research into its potential applications for other diseases. Always follow your healthcare provider’s guidance regarding the appropriate use of Bedaquiline.

What special precautions should I follow?

Special precautions should be followed when using Bedaquiline. Here are some key points to consider:

• Heart health monitoring: Bedaquiline can potentially cause changes in heart rhythm, including a condition called QT prolongation, which may lead to serious irregular heartbeats. Before starting treatment, your healthcare provider may perform tests to assess your heart health, including an electrocardiogram (ECG). During treatment, regular monitoring of heart function may be necessary. Inform your doctor if you have a history of heart problems or if you are taking other medications known to affect heart rhythm.
• Liver function monitoring: Bedaquiline may affect liver function, leading to elevated liver enzymes or liver-related side effects. Your healthcare provider may monitor your liver function with blood tests before and during treatment. Inform your doctor if you have a history of liver disease or if you are taking other medications that may affect liver function.
• Drug interactions: Bedaquiline may interact with other medications, potentially affecting their effectiveness or increasing the risk of side effects. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking before starting Bedaquiline. Avoid starting any new medications without consulting your doctor while on Bedaquiline treatment.
• Pregnancy and breastfeeding: The safety of Bedaquiline during pregnancy and breastfeeding is not well established. Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. Your doctor will weigh the potential risks and benefits before prescribing Bedaquiline in such situations.
• Adherence to treatment: It’s crucial to take Bedaquiline exactly as prescribed by your healthcare provider. Do not skip doses or stop treatment prematurely, even if you start feeling better. Skipping doses or stopping treatment early can lead to treatment failure and the development of drug-resistant TB.
• Side effects: Be aware of potential side effects of Bedaquiline, including nausea, vomiting, headache, joint pain, and dizziness. Contact your healthcare provider if you experience any bothersome or concerning side effects during treatment.

Always discuss any questions or concerns about Bedaquiline with your healthcare provider. They can provide personalized guidance based on your medical history and specific circumstances.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Bedaquiline. However, taking Bedaquiline with food may help improve its absorption and reduce the risk of gastrointestinal side effects.

What should I do if I forget a dose?

If you forget to take a dose of Bedaquiline, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are unsure about what to do, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Bedaquiline, like any medication, can cause side effects. Common side effects may include:

• Nausea and vomiting: Gastrointestinal symptoms such as nausea and vomiting are relatively common side effects of Bedaquiline.
• Headache: Some individuals may experience headaches while taking Bedaquiline.
• Joint pain: Joint pain or discomfort may occur as a side effect of Bedaquiline.
• Dizziness: Feeling dizzy or lightheaded can occur in some people taking Bedaquiline.
• Fatigue: Feeling tired or fatigued is another possible side effect.
• Changes in liver function: Bedaquiline may lead to elevated liver enzymes or other liver-related side effects in some individuals.

Less common but potentially serious side effects of Bedaquiline include:

• Heart-related issues: Bedaquiline may cause changes in heart rhythm, including a condition called QT prolongation, which can lead to irregular heart rhythms and potentially serious heart problems.
• Liver problems: In rare cases, Bedaquiline may cause severe liver damage or hepatitis.
• Nervous system effects: Some individuals may experience neurological side effects such as confusion or changes in mental status.
• Hypokalemia: Bedaquiline may lower potassium levels in the blood, which can lead to weakness, muscle cramps, and abnormal heart rhythms.
• Allergic reactions: Although rare, allergic reactions to Bedaquiline can occur, leading to symptoms such as rash, itching, swelling, or difficulty breathing.

It’s important to report any side effects experienced while taking Bedaquiline to your healthcare provider. They can assess the severity of the side effects and determine whether any adjustments to your treatment plan are necessary.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Bedaquiline tablets at room temperature away from moisture and heat. Keep the medication in its original container, tightly closed, and out of reach of children and pets.
• Disposal: Dispose of any unused or expired Bedaquiline tablets properly according to local regulations or guidelines. Do not flush them down the toilet or pour them into a drain unless instructed to do so. Instead, consult with your pharmacist or local waste disposal facility for guidance on safe disposal methods.

In case of emergency/overdose

• Emergency: In case of a medical emergency or suspected overdose, call your local emergency services or poison control center immediately. Provide them with as much information as possible, including the amount of Bedaquiline ingested, the time of ingestion, and any symptoms experienced.
• Overdose symptoms: Symptoms of a Bedaquiline overdose may include severe nausea and vomiting, dizziness, irregular heartbeats, and other signs of toxicity. Prompt medical attention is crucial in the event of an overdose.

What other information should I know?

• Follow-up appointments: Attend all follow-up appointments with your healthcare provider as scheduled. Regular monitoring and evaluation are essential to ensure the effectiveness of treatment and to monitor for any potential side effects or complications.
• Drug interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting Bedaquiline. Some medications may interact with Bedaquiline, affecting its effectiveness or increasing the risk of side effects.
• Comprehensive treatment plan: Bedaquiline is typically used as part of a comprehensive treatment regimen for drug-resistant tuberculosis (TB). Follow your healthcare provider’s instructions carefully and take all prescribed medications as directed to maximize the effectiveness of treatment and reduce the risk of treatment failure or relapse.
• Symptom monitoring: Pay attention to any new or worsening symptoms while taking Bedaquiline and report them to your healthcare provider promptly. This includes symptoms such as chest pain, shortness of breath, severe headache, abdominal pain, or any other unusual or concerning symptoms.
• Pregnancy and breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before starting Bedaquiline. The safety of Bedaquiline during pregnancy and breastfeeding is not well established, and your doctor can provide guidance based on your individual circumstances.

By following these guidelines and communicating openly with your healthcare provider, you can ensure the safe and effective use of Bedaquiline as part of your treatment for drug-resistant tuberculosis.