What is Bedaquiline?
It is an antibiotic that is combined with other medicines to treat tuberculosis of the lungs, which is intolerant to other antibacterial medicines. Bedaquiline can be used by adults and young children who are at least 5 years old and weigh a minimum of 33 lbs (15 kg). Bedaquiline could cause severe and even fatal adverse consequences. Bedaquiline should only be employed if you have no alternatives to treatment. Bedaquiline is also used for reasons not mentioned in this guideline.
Side effects of Bedaquiline
See a doctor immediately. If you are experiencing symptoms that indicate an allergic reaction, such as difficulty breathing, hives, and swelling of your lips, face, and tongue,
Bedaquiline could cause severe adverse effects. Consult with your physician immediately in the event of:
- Heartbeats that are fast or rapid rise in your chest. the feeling of breathing becoming short and suddenly feeling dizzy (like you're about to pass out).
- Chest pain.
- Vomiting blood, or vomit that appears to be coffee grounds.
- Issues with the liver: loss of appetite, stomach discomfort (upper right side), fatigue, dark urine, stools that are clay-colored, jaundice (yellowing of the eyes or skin).
Common adverse effects of bedaquiline could include:
- The coughing up of blood.
- Chest pain.
- Nausea, stomach pain.
- Headache.
- Joint pain.
- Abnormal tests of liver function.
This is not an exhaustive list of probable adverse effects; more may occur. Consult your doctor for medical advice on any side effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.
Warnings
Bedaquiline may cause severe and even fatal adverse consequences. Bedaquiline should only be used if there are no alternatives to treatment. Only use the dosage prescribed for this medication and adhere to all instructions given to patients to use it safely. Bedaquiline could cause a severe heart attack. Inform your doctor when you experience rapid or irregular heartbeats, as well as sudden dizziness that makes you feel like you could faint.
Before you take this drug.
Inform your doctor if you were ever diagnosed with:
- Heart problem or a rhythm disorder.
- A thyroid that is underactive.
- Long QT syndrome (in the case of you or family members).
- Human immunodeficiency virus (HIV).
- Kidney disease, liver failure.
- An unbalanced electrolyte (such as low levels of potassium, calcium, and magnesium in the blood).
Follow the instructions of your doctor on how to use this medicine when you are pregnant. Having tuberculosis during pregnancy could be harmful to both the mother and the baby. If you are nursing, inform the doctor if you notice a decrease in appetite, nausea, sleepiness, stomach swelling or pain, dark urine, stools that are clay-colored, or yellowing of your eyes or skin of the infant who is nursing.
How to take Bedaquiline?
Follow the instructions on the label of your prescription and read the medication guide or instructions sheets. Your doctor might alter the dosage. Follow the medication precisely as directed. Bedaquiline can be obtained in the office of a doctor or in another clinical setting. The dose is typically taken once a day for two weeks, and then it is only taken three times every week (at a minimum of 48 hours between dosages) for the following 22 weeks. Follow your doctor's instructions for dosing extremely carefully. You might have to take smaller doses of tablets within the first two months of therapy. Always take bedaquiline along with your food.
Consume the 100-milligram (mg) tablet by drinking water. Suck the tablet completely and make sure you don't crush, chew, or break it. The tablet that contains 20 mg could be broken along the split line, if necessary. If you're unable to take a tablet of 20 mg whole, then you can mix the tablets in water before mixing them in soft drinks. Be sure to read and follow the instructions for mixing the 20 mg tablet in order to help you swallow it. Talk to your pharmacist or doctor if you don't understand these directions. Doses are determined by weight gain in teenagers and children. The dose of your child's medication could alter if your child loses or gains weight.
Use this medicine even if symptoms rapidly improve. Inadequate doses can make your disease more resistant to treatment. Bedaquiline should not be taken with any other tuberculosis medicine. Take all medicines as directed. Do not alter the dose or stop taking medication without consulting your doctor. There is a chance that you will require medical tests to determine the heart's function. Place the medicine in the original container at room temperature, away from heat, moisture, and light. Do not take bedaquiline until the expiration date on the label has passed.
Details on dosage
Usual Adult Dose for Tuberculosis—Resistant:
In weeks 1 and 2, 400 mg are taken orally at least once per day.
Weeks 3–24: 200 mg taken orally three times per week, with a minimum of 72 hours between each dose.
Time of treatment The duration of therapy is 24 weeks.
Comments: Alcohol should be avoided in the course of treatment.
The treatment should be administered through direct observation (DOT).
This medication was approved due to the time it took for sputum cultures to be converted during clinical trials. The continued approval could be contingent on confirmation and the clinical benefits of clinical studies.
The use of this medication is recommended to be restricted to infections for which effective treatment strategies are not available.
The treatment should be administered in conjunction with at least three other drugs to which the in-vitro multidrug-resistant tuberculosis (MDR-TB) isolate is shown to be susceptible, or at least four other drugs to which the MDR-TB isolate is likely to be susceptible if in-vitro findings are not available.
Use: A component of combination therapy to treat MDR-TB in the lungs, which is caused by Mycobacterium tuberculosis.
Usual Pediatric Dose for Tuberculosis—Resistant:
12-year-olds and over:
30 kg or more:
Weeks 1 and 2: 400 mg oralally, twice per day
Weeks 3 through 24 3 to 24: 200 mg, orally 3 times per week, and at a minimum of 72 hours in between dosages.
Therapy duration: 24 weeks
Comments: It is recommended to avoid alcohol during treatment.
Treatment should be administered via DOT and in conjunction with other antimycobacterial agents.
The drug was approved due to the time it took for sputum cultures to be converted during clinical trials. The continued approval may depend on confirmation and the clinical benefits of the confirmation studies.
The use of this medication should be limited to cases of infection when effective treatment methods aren't available.
The treatment should be administered in conjunction with at least three other medications to which the in vitro MDR-TB isolate has been proven to be susceptible, or with at least four other medications to which the MDR-TB isolate could be found to be susceptible if in-vitro findings are not available.
Use: A component of combination therapy for the treatment of MDR-TB in the lungs due to M. tuberculosis.
What happens if i miss a dose?
If you don't take your dose in the initial 2 weeks of treatment, skip the dose you missed and take your subsequent dose at your regular time. If you do not take a dose during week 3 or after, take the dose as quickly as you are able and continue taking the medication on the three times per week schedule. Do not take two doses at once. Contact your doctor for guidance. If you're not certain what to do, don't take your medication as scheduled.
What happens if I overdose?
Get medical attention in an emergency or contact the Poison Help line toll-free at 1-800-222-1222.
What should be avoided?
Consuming alcohol can increase your risk of sustaining liver damage. Beware of taking herbal supplements.
Interaction with other drugs
It is sometimes not safe to take certain medications simultaneously. Certain medications can alter the blood levels and the other drugs that you take, which can create side effects or render the medication less effective. Bedaquiline may cause serious heart conditions. The risk is higher if you take certain other drugs to treat asthma, infections, heart issues, high blood pressure, depression, mental illness, malaria, cancer, or HIV. Bedaquiline can be affected by a variety of drugs. Prescription and over-the-counter drugs, vitamins, and herbal supplements are all included. The interactions between these products are not mentioned here. Inform your physician about any other medications you are taking
