Bedaquiline Instructions, Indications, Usage and Dosage

Indications: Bedaquiline is used with at least three other drugs to treat multidrug-resistant tuberculosis (MDR-TB; a serious infection that affects the lungs and other parts of the body and cannot be treated with other drugs usually used to treat TB) in adults and children 5 years and older who weigh at least 33 pounds (15 kilograms) and whose lungs have been affected. Bedaquiline should not be used to treat tuberculosis that primarily affects other parts of the body. Bedaquiline belongs to a class of drugs called antimycobacterial drugs. It works by killing the bacteria that cause multidrug-resistant tuberculosis.

Dosage: Bedaquiline is available as oral tablets. Bedaquiline should only be used in combination with at least three other drugs to which the patient's MDR-TB strain is susceptible in vitro. If in vitro test results are not available, treatment with bedaquiline may be initiated in combination with at least four other drugs to which the patient's MDR-TB bacteria may be sensitive. The recommended doses of bedaquiline are as follows: Weeks 1-2: 400 mg (4 100 mg tablets) once daily with food. Weeks 3-24: Take 200 mg (2 100 mg tablets) 3 times per week with food (leave at least 48 hours between doses), for a total weekly dose of 600 mg. Tablets should be swallowed whole with water.

SIDE EFFECTS: Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Bedaquiline may cause serious side effects. Contact your doctor right away if you have: fast or pounding heartbeat, fluttering chest, shortness of breathand sudden dizziness (like you might pass out); chest pain; coughing up blood or vomit that looks like coffee grounds; or liver problems—loss of appetite, stomach pain (top right), tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of bedaquiline may include: coughing up blood; chest pain; nausea, stomach pain; headache; joint pain; or abnormal liver function tests. This is not a complete list of side effects, and other side effects may occur.

Precautions: Bedaquiline may cause serious and sometimes fatal side effects. Bedaquiline should be used only if you have no other treatment options. Use only the prescribed dose of this medication and follow all patient instructions for safe use.

Bedaquiline can cause serious side effects to your heart. Tell your doctor if your heartbeat is fast or irregular and you suddenly feel dizzy, like you might pass out.

Interactions: Sometimes it is not safe to use certain drugs together. Some medicines can affect the blood levels of other medicines you take, which may increase side effects or make the medicine less effective.

Bedaquiline can cause serious heart problems. Your risk may be higher if you also use certain other medicines to treat infections, asthma, heart disease, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect bedaquiline. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Storage: Store this medication in its original container at room temperature, away from moisture, heat, and light.