Pronunciation:

bed-AK-wi-leen

Brand Names:

• Sirturo

Dosage Forms:

• Tablet

Warnings:

An increased risk of death was seen bedaquiline treatment group compared to the placebo treatment group in one placebo-controlled trial in adults. Only use bedaquiline in patients 12 years or age and older when an effective treatment regimen cannot otherwise be provided. QT prolongation can occur with bedaquiline. Use of other QT prolonging drugs may cause additive QT prolongation. Monitor ECG. Discontinue bedaquiline if significant ventricular arrhythmia or if a QTc interval of greater than 500 milliseconds develops .

Classifications:

Therapeutic—

Anti-Infective Agent

Uses of This Medicine:

Bedaquiline is used to treat multidrug resistant tuberculosis (MDR-TB) in the lungs. It is used in patients who have already been treated with other medicines that did not work well. Bedaquiline prevents the growth of tuberculosis in the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of bedaquiline in children 5 years of age and older and weighing at least 15 kilograms (kg). Safety and efficacy have not been established in children younger than 5 years of age or weighing less than 15 kg.

Older adults—

Appropriate studies on the relationship of age to the effects of bedaquiline have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Boceprevir
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Citalopram
• Clarithromycin
• Clofazimine
• Clothiapine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Erythromycin
• Escitalopram
• Fedratinib
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Fosamprenavir
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Gatifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mavacamten
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nilotinib
• Nirmatrelvir
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pitolisant
• Ponesimod
• Primidone
• Quetiapine
• Quinidine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Telaprevir
• Telithromycin
• Tetrabenazine
• Tipranavir
• Trazodone
• Triclabendazole
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart failure, history of or
• Heart rhythm problems (eg, slow heart rate, long QT syndrome), history of or
• Hypocalcemia (low calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypothyroidism (underactive thyroid), history of—Use with caution. May cause side effects to become worse.

• HIV infection—Safety and efficacy have not been established to treat MDR-TB in patients with this condition.

• Infections caused by non-tuberculous mycobacteria or
• Other types of tuberculosis (eg, latent, extrapulmonary, or drug-sensitive TB)—Should not be use to treat patients with these conditions.

• Kidney disease, severe (eg, patients receiving dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Bedaquiline is given by directly observed therapy (DOT). It must always be taken with at least 3 other medicines for TB. Carefully follow your doctor's instructions.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

It is best to take this medicine with food.

Swallow the 100-mg tablet whole with water. Do not crush, break, or chew it. Take this medicine with food.

If you can swallow the 20-mg tablet whole:

• Swallow the tablet whole with water.
• You may also split it in half at the score line (middle of the tablet) and swallow each half-tablets (10 mg each) with water.

If you cannot swallow the 20-mg tablet whole:

• Mix a maximum of 5 tablets into 1 teaspoon (5 milliliters) of water in a drinking cup.
  • Swallow the mixture right away.
  • To help with taking the mixture, you may add at least 1 more teaspoon (5 mL) of beverage (eg, water, milk products, carbonated beverage, or apple, orange, or cranberry juice) or soft food (eg, yogurt, applesauce, mashed banana, or porridge) and mix, then swallow it right away.
  • Make sure no medicine is left in the drinking cup, rinse with beverage or soft food and swallow it right away.
  • If you need more than 5 tablets to get your total dose, repeat these steps until you reach the desired dose.
• Crush the tablets and mix with soft food (eg, yogurt, applesauce, mashed banana, or porridge), then swallow the mixture right away. Make sure no medicine is left in the container, add more soft food and swallow it right away.

The 20-mg tablet may also be given through a feeding tube by your doctor or nurse. :

This medicine is taken for a total of 24 weeks. On the first 2 weeks, you will take the medicine every day. On the 3rd to 24th week, you have to take it at the same time on the same 3 days (eg, Monday, Wednesday, and Friday) at least 48 hours apart each week.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of multi-drug resistant tuberculosis:
    • Adults and children 5 years of age and older weighing at least 30 kilograms (kg)—
      • Week 1-2: 400 milligrams (mg) (4 tablets of 100 mg or 20 tablets of 20 mg) once a day.
      • Week 3-24: 200 mg (2 tablets of 100 mg or 10 tablets of 20 mg) 3 times per week (with at least 48 hours between doses), for a total of 600 mg per week.
    • Children 5 years of age and older weighing 15 to less than 30 kg—
      • Week 1-2: 200 mg (2 tablets of 100 mg or 10 tablets of 20 mg) once a day.
      • Week 3-24: 100 mg (1 tablet of 100 mg or 5 tablets of 20 mg) 3 times per week (with at least 48 hours between doses), for a total of 300 mg per week.
    • Children younger than 5 years of age or weighing less than 15 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose during the first 2 weeks, skip the missed dose and continue to use your medicine as usual. If you missed a dose during weeks 3 to 24, take the missed dose as soon as possible and then go back to your normal dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original container.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects. Your doctor may also need to check your heart.

If your symptoms do not improve or if they get worse, call your doctor.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest pain

coughing or spitting up blood

dark-colored urine

decreased appetite

fever

general feeling of tiredness or weakness

headache

itching or skin rash

light-colored stools

loss of appetite

nausea and vomiting

stomach pain or tenderness

swelling of the feet or lower legs

unusual tiredness or weakness

yellow eyes or skin

Incidence not known

Dizziness or fainting

fast or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

muscle pain or stiffness

pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.