Bedaquiline

What is Bedaquiline?

• Bedaquiline (Sirturo) is a diarylquinoline antimycobacterial drug used in combination with other antituberculosis agents used in the treatment of multidrug resistant tuberculosis.

Bedaquiline

What are the uses of this medicine?

• Sirturo is a diarylquinoline antibiotic prescription medicine used in people 5 years of age and older with multi-drug resistant tuberculosis (MDR-TB) of the lungs when other effective treatment options are not possible.

Limitations of Use: It is not known if Sirturo is safe and effective in:

• people who have a tuberculosis (TB) infection, but do not show symptoms of TB (also known as latent TB).
• people who have TB that is not resistant to antibiotics.
• people who have types of TB other than TB of the lungs.
• people who have an infection caused by bacteria other than TB.
• people who are being treated for Human Immunodeficiency Virus (HIV) who also have MDR-TB.
• children under 5 years of age or weighing less than 33 pounds (15 kg).

How does this medicine work?

• Bedaquiline (bed ak' wi leen) is relatively newly approved antimycobacterial agent that has been shown to have activity against multidrug resistant mycobacterium tuberculosis both in vitro and in vivo.
• Sirturo is a diarylquinoline antimycobacterial drug that inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, by binding to subunit c of the enzyme that is essential for the generation of energy in M. tuberculosis.

Who Should Not Use this medicine ?

Limitations of Use:

• It is not known if Sirturo is safe and effective in:
• people who have a tuberculosis (TB) infection, but do not show symptoms of TB (also known as latent TB).
• people who have TB that is not resistant to antibiotics.
• people who have types of TB other than TB of the lungs.
• people who have an infection caused by bacteria other than TB.
• people who are being treated for Human Immunodeficiency Virus (HIV) who also have MDR-TB.
• children under 5 years of age or weighing less than 33 pounds (15 kg).

What drug interactions can this medicine cause?

• Avoid use of strong and moderate CYP3A4 inducers with Sirturo.
• Avoid use for more than 14 consecutive days of systemic strong CYP3A4 inhibitors with Sirturo unless the benefit outweighs the risk. Monitor for Sirturo-related adverse reactions.

Is this medicine FDA approved?

• Bedaquiline was approved for use in pulmonary, multidrug resistant tuberculosis in combination with other antituberculosis agents in the United States in 2012 and was the first drug approved for therapy of tuberculosis is over 40 years.
• It is not approved for use in latent or drug sensitive tuberculosis or in atypical mycobacterial infections.
• In addition, bedaquiline has not been proven to be effective for extra-pulmonary tuberculosis.

How should this medicine be used?

Prior to administration, obtain ECG, liver enzymes and electrolytes. Obtain susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible.

Recommended dosage:

• Only use Sirturo in combination with at least 3 other drugs to which the patient's MDR-TB isolate has been shown to be susceptible in vitro.
• If in vitro testing results are unavailable, may initiate Sirturo in combination with at least 4 other drugs to which patient's MDR-TB isolate is likely to be susceptible.

Recommended dosage in adult patients:

• 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) once daily for 2 weeks followed by 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) 3 times per week (with at least 48 hours between doses) for 22 weeks.

• Recommended dosage in pediatric patients (5 years and older and weighing at least 15 kg) is based on body weight as shown below:

15 kg to less than 30 kg:

• Week 1 and Week 2:200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally once daily
• Week 3 to Week 24:100 mg (1 of the 100 mg tablets OR 5 of the 20 mg tablets) orally three times per week

Greater than or equal to 30 kg:

• Week 1 and Week 2:400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) orally once daily
• Week 3 to Week 24:200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally three times per week

Administration:

• Take Sirturo exactly as your healthcare provider tells you to take it.
• You will take Sirturo for a total of 24 weeks. You may need to take your other TB medicines for longer than 24 weeks. If you are not sure, you should talk with your healthcare provider.
• Sirturo must always be taken with other medicines to treat TB. Your healthcare provider will decide which other medicines you should take with Sirturo.
• It is important that you complete the full course of treatment with Sirturo and not skip doses. Skipping doses may decrease the effectiveness of the treatment and increase the chances that your TB will not be treatable by Sirturo or other medicines.

Week 1 and Week 2:

• Take your prescribed dose 1 time each day.

Week 3 to Week 24:

• Take your prescribed dose 3 times a week.
• Take Sirturo doses at least 48 hours apart. For example, you may take Sirturo on Monday, Wednesday and Friday every week from week 3 to week 24.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg, functionally scored
• Tablets: 100 mg

This medicine is available in fallowing brand namesː

• Sirturo

What side effects can this medication cause?

The most common side effects of this medicine include: In adults:

• nausea
• joint pain
• headache
• coughing up blood
• chest pain

In children 12 years to less than 18 years of age:

• joint pain
• nausea
• stomach pain

In children 5 years to less than 12 years of age:

• increased level of liver enzymes in the blood.

What special precautions should I follow?

• You should not drink alcohol while taking Sirturo.
• QT prolongation can occur with Sirturo. Monitor ECGs and discontinue Sirturo if significant ventricular arrhythmia or QTcF interval > 500 ms develops.
• Hepatotoxicity may occur with use of Sirturo. Monitor liver-related laboratory tests. Discontinue Sirturo if evidence of liver injury occurs.

What to do in case of emergency/overdose?

Treatment of overdosage:

• Take measures to support basic vital functions including monitoring of vital signs and ECG (QT interval) in case of deliberate or accidental overdose.
• It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.
• Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.

Can this medicine be used in pregnancy?

• Available data from published literature of Sirturo use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Sirturo have been established in pediatric patients 5 years and older weighing at least 15 kg.
• The safety, effectiveness and dosage of Sirturo in pediatric patients less than 5 years of age and/or weighing less than 15 kg have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: bedaquiline fumarate
• Sirturo 20 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose 2910 5 mPa s, polysorbate 20, purified water (removed during processing), silicified microcrystalline cellulose and sodium stearyl fumarate.
• Sirturo 100 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing)

Product of India

Who manufactures and distributes this medicine?

Manufactured by: Recipharm Pharmaservices Pvt. Ltd., Bangalore, India Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP Titusville, NJ

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

• Store Sirturo at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Sirturo in the original container.
• Protect Sirturo from light.
• The Sirturo 20 mg container contains a desiccant packet to keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.

The following are list of antituberculosis medications that are discussed individually:

• Bedaquiline
• Capreomycin
• Cycloserine
• Ethambutol
• Ethionamide
• Isoniazid
• Pyrazinamide
• Rifabutin
• Rifampin
• Rifapentine
• Streptomycin

• Dailymed label info on Bedaquiline
• FDA Bedaquiline

Bedaquiline Resources
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