What is Sirturo?

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• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

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.

Proper UseTOP

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.

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

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.

DosingTOP

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—
      • Week 1-2: 400 milligrams (mg) (4 tablets of 100 mg) once a day with food.
      • Week 3-24: 200 mg (2 tablets of 100 mg) three times per week (with at least 48 hours between doses), for a total of 600 mg per week.
    • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

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.

Use & StorageTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of bedaquiline in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Although 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.

PregnancyTOP

Breast FeedingTOP

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.

Drug InteractionsTOP

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.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• 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.

• Alfuzosin
• Amiodarone
• Amprenavir
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Boceprevir
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Citalopram
• Clarithromycin
• Clofazimine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Encorafenib
• Enzalutamide
• Erythromycin
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Fosamprenavir
• Foscarnet
• Fosphenytoin
• Gatifloxacin
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Methadone
• Metronidazole
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nilotinib
• Ofloxacin
• Ondansetron
• Osimertinib
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Phenytoin
• Pimavanserin
• Pitolisant
• Primidone
• Quetiapine
• Quinidine
• Ranolazine
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Sertraline
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Telaprevir
• Telithromycin
• Tetrabenazine
• Tipranavir
• Tizanidine
• Triptorelin
• Vandetanib
• Vemurafenib
• Vinflunine
• Voriconazole
• Zuclopenthixol

Other InteractionsTOP

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 ProblemsTOP

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.

• Heart rhythm problems (eg, QT prolongation) or
• Liver disease—Use with caution. May make these conditions worse.

PrecautionsTOP

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.

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 such as 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.