Bedaquiline (Oral)

Patients that are being treated for tuberculosis and are not responding well to the medications being used often experience good results with Bedaquiline when taken concurrently with at least three other TB drugs.

Overview

Bedaquiline is taken in tandem with at least three other drugs for the treatment of tuberculosis. It is imperative that this medication is taken exactly as prescribed and all directions given by the prescribing doctor are followed. Patients should never take more than the recommended dosage and never for a longer time period than that directed by their doctor. This medication can be effective in tuberculosis patients whose results with other TB drugs are not as significant as desired.

Many patients report relief as early as after two or three doses, but it is important that the entire 24-week protocol is followed when taking Bedaquiline. Alcohol should not be used at the same time as this drug, and the medication should always be taken with food. Patients with a history of heart disease, or whose immediate family members suffer from such conditions, should inform their doctor of their complete medical and family history prior to taking Bedaquiline.

This drug has been known to cause death is some of the patients using it and any heart irregularities should be reported to the prescribing doctor immediately. When the drug is administered for a significant period of time, the physician may require heart monitoring through such diagnostic tools as an EKG. Blood tests may also be used to determine any adverse effects that are occurring in the body. Any side effects that indicate problems with the liver, such as a tint of yellow to the skin or eyes that appear yellowed, should be reported immediately and emergency medical attention may be necessary.

Bedaquiline is not to be taken on its own, and due to the serious nature of some side effects should not be used in patients that are experiencing positive results with other medications. Your doctor should be notified if you experience any lightheadedness, feel dizzy, or faint. It is important to work closely with your doctor when taking Bedaquiline and their active participation during your use of Bedaquiline is necessary. Be sure to keep all follow-up appointments and keep your medical practitioner advised of all side effects, changes in your health, or other areas of concern.

Condition(s) Treated

  • Tuberculosis that is Resistant to Treatment by Other Drugs

Type of Medicine

  • Bacterial Infection Antibiotic

Side Effects

The use of Bedaquiline needs to be actively monitored as it can cause damage to the liver and other health problems. Patients that experience any of the side effects that are listed below are advised to notify their doctor immediately and may require emergency medical attention.

More Likely:

  • Abdominal tenderness or pain
  • Lower legs or feet that swell
  • Coughing or spitting up blood
  • Nausea and vomiting
  • Decreased appetite
  • Itching
  • Light-colored stools
  • A general feeling of weakness or feeling tired
  • Headache
  • Loss of appetite
  • Elevated fever
  • Skin rash
  • Dark-colored urine
  • Unusual weakness or feeling tired
  • Chest pain
  • Eyes that look yellow or a yellow appearance to the skin

Unknown Incidence:

  • A recurring irregular heartbeat
  • Lightheadedness, dizziness, or fainting

Additional side effects that are less serious in nature are also possible. The following three side effects typically dissipate on their own but if they worsen or remain longer than a few days medical attention should be sought. While taking this drug, many doctors may request that they are informed of all side effects regardless of how mild they may appear.

  • Joint pain
  • Difficulty with moving
  • Stiffness or muscle pain

Other side effects may occur which should be brought to the attention of the physician if they are worrisome, last longer than a few days or become worse with time. Any changes in the patient's overall health or in the effectiveness of Bedaquiline should be discussed with the doctor.

In addition to the side effects listed above, there are certain medical conditions that preclude patients from taking Bedaquiline without the advice and supervision of their doctor.

  • Heart failure
  • Heart rhythm problems (QT prolongation)
  • Heart rhythm problems (slow heart rate or long QT syndrome)
  • Hypomagnesemia (low magnesium in the blood)
  • Hypokalemia (low potassium in the blood)
  • Hypothyroidism (underactive thyroid)
  • Hypocalcemia (low calcium in the blood)
  • Liver disease

Patients that suffer from these conditions, as well as TB, should discuss the use of Bedaquiline prior to beginning their course of treatment. The physician may make changes to the dosage amount, the frequency with which the drug is taken, or in the length of time that Bedaquiline is administered.

Dosage

Bedaquiline is taken for a 24-week cycle at varying doses:

  • Every day for the first two-week period
  • From the 3rd week to the end of the course of treatment, the drug is taken three days per week with a 48-hour interval in between each dose. For example, the drug can be taken on Mondays, Wednesdays, and Fridays or on Tuesdays, Thursdays, and Saturdays.
  • During weeks 3 to 24, it is vitally important that the medication is taken at the same time on each of the three days that it is administered.

The doctor will provide a Medication Guide as well as further explanation of what Directly Observed Therapy (DOT) is and how it applies to the situation.

Patients must remember to continue taking Bedaquiline for the entire 24-week course of treatment in order to fully address tuberculosis. Even if they are feeling better it is imperative that the entire cycle is followed to ensure effective treatment.

Patients whose condition has proven to be resistant to a number of TB drugs will take 400mg during the first two-week period at the same time every day and with food.

During weeks 3 through 24, the dosage is 200mg on each of the three days that the patient is taking the drug, (observing 48 hours between doses).

Any children that have been prescribed Bedaquiline should follow the directions provided by their doctor or pediatrician.

Bedaquiline should always be taken with food.

If a dose is missed during the first two weeks of treatment when one dose is taken each day, it is advised that the patient skip the missed dose and continue with the next dosage as directed. In weeks 3 to 24, it is advised that the missed dose be taken as soon as possible, and the next dose taken as normal. Never administer a double dosage of Bedaquiline, and if there is confusion about how to best handle a missed dose, it is always best to contact the prescribing physician.

Major Drug Interactions

The following drugs have been shown to have a negative interaction with Bedaquiline and should not be used concurrently:

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

Depending on the overall medical situation, the use of the following drugs may be modified or altered by the prescribing physician for patients that need to take both drugs:

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

Warnings

Do not use alcohol during the administration of Bedaquiline.

Notify the prescribing doctor of all other medications that are currently being taken including any over the counter drugs or vitamin or mineral supplements, or herbal remedies.

Alert the doctor if the patient experiences any signs of heartbeat irregularities, including an increase in heart rate, excessive pounding, or a heartbeat that is uneven or irregular. Patients who have had, or whose family members have QT prolongation or other similar heart conditions should discuss their comprehensive medical and family history prior to beginning the course of treatment.

Aches and pains, especially in the upper region of the abdominal area should be reported to the doctor as soon as possible, this includes any type of tenderness in the area as well as pain. It is also advised that any vomiting and nausea, dark urine, pale stools, decreases in appetite, vomiting, or a yellow tint to the skin or eyes be immediately reported. These symptoms can be caused by damage to the liver and can be serious in nature.

Inform the prescribing doctor of any medical conditions that you may have in addition to TB and alert them to any medications that you may be taking to treat such ailments. This drug should be taken as directed and the active involvement of a medical professional is necessary during the entire course of treatment.

Due to the serious nature of some possible side effects, keep your doctor informed of any changes to your overall health, any side effects while taking the drug, and any changes in its effectiveness.

Storage

All medications should be stored in its original packaging whenever possible. The drug should be kept from direct sunlight or other bright light, moisture, and excessive heat and cold. Bedaquiline should never be frozen.

Consult with your pharmacist or doctor about the appropriate way to discard unused or outdated drugs.

Keep this and all medications out of the reach of children.

Summary

Patients that are suffering from tuberculosis and are not experiencing the desired results of multiple medications have found relief when using Bedaquiline in tandem with at least three other TB drugs.

The drug is administered for a 24-week period with one dose taken during the first two weeks. Two doses are then taken three days a week from week 3 through to week 24, with 48 hours between each dose. It is important that the drug is taken at the same time on each of the specified days. The medication should be taken with food and alcohol should be avoided by all patients who are on Bedaquiline.

Doctors may require heart monitoring of patients taking this drug, and any heart irregularities such as arrhythmia, accelerated heartbeats, excessive pounding in the chest, and chest pain. Blood tests may also be utilized to follow the effects that the drug is having on the patient's overall system and to determine if any changes in dosage or to the length of time that the drug should be taken are required.

It may take a short period of time for the body to adjust to Bedaquiline and during the first few days of treatment, many of the side effects that occur will dissipate on their own. Patients should alert their physician to any side effects and also report how the medication is working and its effectiveness. If significant positive results are experienced after two to four doses it is imperative that the entire course of treatment be administered for the most effective outcome.

This drug is taken with at least three other TB medications and is not useful on its own. Due to the potential danger of Bedaquiline, it is not recommended for patients that are achieving positive results from other medications.

Do not ever take a double dose of Bedaquiline or in an amount that is greater than the prescribed dosage. Missed dosages during the initial two weeks should be skipped, while any missed doses in the ensuing weeks should be taken as soon as possible. If there is confusion about how to address a missed dose, consult with a physician or pharmacist.

Patients that do not experience significant improvement with other TB drugs may find relief by adding Bedaquiline to their treatment as advised by their doctor. This drug requires the active participation of the doctor and patient, and all major side effects should be reported and monitored. Discuss the appropriateness of Bedaquiline with your doctor if you suffer from TB and your current medications are not yielding the desired results.

Resources
Last Reviewed:
December 24, 2017
Last Updated:
April 04, 2018
Content Source: