When other treatments are ineffective, bedaquiline should only be used to treat patients with multi-drug resistant tuberculosis (MDR-TB; a serious infection that affects the lungs and other parts of the body and cannot be treated with at least two of the medications that are typically used to treat the condition). In a research trial, bedaquiline users experienced higher fatalities than those who did not take the drug. Bedaquiline may be prescribed to you by your doctor if previous therapies are ineffective for MDR-TB since it is a life-threatening condition.

Your heart rhythm may be seriously or fatally altered by bedaquiline. Before starting treatment and numerous times during it, you will need to have an electrocardiogram (ECG), a test that gauges the electrical activity of the heart, to determine how this medicine affects your heart rhythm. Tell your doctor if you currently have or have ever had a slow or irregular heartbeat, an underactive thyroid gland, low levels of calcium, magnesium, or potassium in your blood, heart failure, or a recent heart attack. Also mention if you or anyone in your family has prolonged QT syndrome, a rare heart condition that can cause irregular heartbeat, fainting, or sudden death. Inform your physician and pharmacist if you are taking any of the following medicines: erythromycin (E.E.S, E-Mycin, Erythrocin), ciprofloxacin (Cipro), clarithromycin (Biaxin), clofazimine (Lamprene), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and azithromycin (Zithro (Ketek). Call your doctor right away if your heartbeat becomes fast or irregular or if you experience dizziness.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start taking bedaquiline and at each time your prescription is renewed. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

You should discuss the dangers of taking bedaquiline with your doctor.

Multi-drug resistant tuberculosis (MDR-TB), a serious infection that affects the lungs and other parts of the body and cannot be treated with other drugs that are typically used to treat the condition, is treated in adults and children 5 years of age and older who weigh at least 33 lbs (15 kg) with bedaquiline and at least three other drugs. Treatment for TB that primarily affects different body areas shouldn’t involve bedaquiline. A group of drugs known as anti-mycobacterials includes bedaquiline. The MDR-TB-causing bacteria are eliminated as a result of it.

Bedaquiline is available as a tablet to be swallowed whole with water. It is typically taken once daily with food for two weeks, followed by three times per week for 22 weeks. Allow at least 48 hours between doses if you take bedaquiline three times per week. Every week, take bedaquiline on the same days and at the same time of day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the bedaquiline directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Swallow the tablets whole with plenty of water.

The 20 mg tablet may be broken in half on the score mark if you or your kid is unable to swallow it whole.

You or your child can dissolve the 20 mg tablets in 1 teaspoon (5 mL) of water in a drinking cup if you or your child is unable to take the tablets whole or in half (no more than 5 tablets). You can drink this mixture right away, or you can add at least 1 teaspoon (5 mL) of more water, milk product, apple juice, orange juice, cranberry juice, or a fizzy beverage to make it simpler to consume. You can also add a soft food if you want. After that, instantly swallow the entire combination.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking bedaquiline,

• If you have any allergies, including to bedaquiline, other medicines, or any of the substances in bedaquiline tablets, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: (Equetro, Tegretol, Teril, among others) carbamazepine; a number of drugs used to treat HIV infection, such as efavirenz (Sustiva, in Atripla), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra, in Viekira Pak); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); ne (Priftin). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Be important to inform your doctor about all of the medications you are taking, even those not on this list, as many other drugs may also interact with bedaquiline.
• Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
• Inform your doctor if you have HIV, liver, or kidney illness, or if you ever did.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking bedaquiline. If your baby has yellow eyes or skin, or if the colour of their urine or stool changes, let your doctor know if you’re nursing.
• While taking bedaquiline, refrain from consuming alcohol. You are more likely to suffer severe bedaquiline side effects if you consume alcohol.

If you want to consume grapefruit or grapefruit juice while taking this medication, see your doctor.

Skip the missed dosage and carry on with your regular dosing plan if you forget to take a dose during the first two weeks of your therapy. To make up for a missing dose, do not take a second one.

Take the missed dose with food as soon as you remember it and carry on with your three times-per-week dosing plan if you have missed a dose since week 3 of your therapy. Ensure that at least 24 hours pass between taking the missed medication and the following dose that is scheduled. Avoid taking more than your weekly dose in a 7-day span or taking two doses to make up for a missed one.

Side effects from bedaquiline are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Joints hurt
• Headache
• Rash

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

• Extreme fatigue
• Reduced appetite
• Nausea
• Eyes or skin that have a yellow tint
• Urine with a dark colour
• Bowel movements that are pale in colour
• Stomach ache in the top right corner
• Fever
• Spitting blood
• Chest ache

Other negative effects of bedaquiline could exist. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from light, excessive heat, and moisture at room temperature (not in the bathroom). To keep the pills dry, keep the desiccant (drying agent) packet in the container of medicine.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to bedaquiline, your doctor will request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.