Sirturo : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:
Sirturo should only be used to treat people who have 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 drugs that are generally used to treat the condition) when other treatments cannot be used. In a clinical study, there were more deaths among people who took Sirturo than among people who did not take the drug. However, MDR-TB is a life-threatening disease, so you and your doctor may decide that you should be treated with Sirturo if other treatments cannot be used.

Sirturo can cause serious or life-threatening changes in heart rhythm. An electrocardiogram (ECG; a test that measures the electrical activity of the heart) will need to be done before your treatment and several times during your treatment to see how this medication affects your heart rhythm. Tell your doctor if you or someone in your family has long QT syndrome (a rare heart problem that can cause an irregular heartbeat, fainting, or sudden death) and if you have or have ever had a slow or irregular heartbeat, a underactive thyroid gland, low levels of calcium, magnesium, or potassium in the blood, heart failure, or a recent heart attack. Tell your doctor and pharmacist if you are taking any of the following medications: azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), clofazimine (Lamprene), erythromycin (EES, E-Mycin, Erythrocin), gemifloxacin (Factive) , levofloxacin (Levaquin), moxifloxacin (Avelox) and telithromycin (Ketek). If you develop a fast or irregular heartbeat, or if you pass out, call your doctor immediately.

Your doctor or pharmacist will provide you with the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with Sirturo and each time you get a refill. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of taking Sirturo.

Why is this medication prescribed?
Sirturo (Bedaquiline) is used together with at least three other medications to treat adults 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 usually used to treat the condition) that has affected the lungs. Sirturo should not be used to treat tuberculosis that mainly affects other parts of the body. Sirturo belongs to a class of medications called antimycobacterials. It works by killing the bacteria that cause MDR-TB.

How should this medicine be used?
Sirturo (Bedaquiline) comes as a tablet to take by mouth. It is usually taken with food once a day for 2 weeks and then three times a week for 22 weeks. When you are taking Sirturo three times a week, wait at least 48 hours between doses. Take Sirturo at the same time of day and the same days of the week every week. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take Sirturo exactly as directed. Do not take more or less or take it more often than prescribed by your doctor.

Swallow the tablets whole with plenty of water; don’t crush them.

Continue to take Sirturo until the prescription ends and do not skip doses, even if you feel better. If you stop taking Sirturo too soon or miss doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics. This will make your infection more difficult to treat in the future. To make it easier for you to take all of your medications as directed, you can participate in a directly observed therapy program. In this program, a healthcare worker will give you each dose of medicine and will watch as you swallow the medicine.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking Sirturo,

• Tell your doctor and pharmacist if you are allergic to Sirturo, any other medications, or any of the ingredients in Sirturo tablets. Consult your pharmacist or consult the Medication Guide for a list of ingredients.
• Tell your doctor and pharmacist what prescription and over-the-counter medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: carbamazepine (Equetro, Tegretol, Teril, others); certain medicines for human immunodeficiency virus (HIV) infection, including efavirenz (Sustiva, in Atripla), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); nefazodone; phenobarbital; phenytoin (Dilantin); rifabutin (mycobutin); rifampicin (Rifadin, Rimactane, in Rifamate, in Rifater); and rifapentine (Priftin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications can also interact with Sirturo, so be sure to tell your doctor about all the medications you are taking, even those that are not listed here.
• Tell your doctor what herbal products you are taking, especially St. John’s wort.
• Tell your doctor if you have or have ever had HIV, or liver or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Sirturo, call your doctor.
• Avoid drinking alcoholic beverages while you are taking Sirturo. Drinking alcohol increases the risk that you will experience serious side effects from Sirturo.

What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medication.

What should I do if I forget a dose?
If you miss a dose during the first 2 weeks of your treatment, skip the missed dose and continue your regular dosing schedule. If you miss a dose during the remaining weeks of your treatment, take the missed dose as soon as you remember. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Sirturo may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint pain
• headache
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• excessive tiredness
• loss of appetite
• nausea
• yellowing of the skin or eyes
• dark colored urine
• light colored bowel movements
• pain in the upper right area of the stomach
• fever
• coughing up blood
• chest pain

Sirturo may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit an online report to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?
Keep this medicine in its container, tightly closed and out of the reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medications out of the sight and reach of children, as many containers (such as those for taking pills weekly and those used for eye drops, creams, patches, and inhalers) are not resistant to children and children. young children can easily open them. To protect young children from poisoning, always close the safety caps and immediately put the medicine in a safe place, one that is up and away and out of your sight and reach. http://www.upandaway.org

Unnecessary medications must be disposed of in a special way to ensure that pets, children and others cannot consume them. However, you should not flush this medicine down the toilet. Instead, the best way to get rid of your medication is through a medication take-back program. Talk to your pharmacist or contact your local garbage / recycling department for information on return programs in your community. Consult the FDA’s Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or cannot wake up, call 911 immediately.

What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests to check your body’s response to Sirturo.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important that you keep a written list of all prescription and over-the-counter (non-prescription) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should carry this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names

• Sirturo

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.