sirturo

Sirturo (bedaquiline) is an antibiotic that fights bacteria.

Sirturo is used together with other medications to treat tuberculosis that has been resistant to other antibacterial medications.

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options.

Sirturo may also be used for purposes not listed in this medication guide.

Important information

Sirturo can cause serious and sometimes fatal side effects. This medicine should be used only if you have no other treatment options. Use only the prescribed dose of Sirturo, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using this medicine.

Sirturo can affect your heart rhythm, especially if you also take certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sirturo, especially an antibiotic, anti-malaria medication, migraine headache medication, medicine for depression or mental illness, heart rhythm medicine, cancer medicine, or medicine to prevent or treat nausea and vomiting.

Before taking this medicine

You should not use Sirturo if you are allergic to bedaquiline.

To make sure Sirturo is safe for you, tell your doctor if you have:

• human immunodeficiency virus (HIV);

• liver disease;

• kidney disease;

• a personal or family history of long QT syndrome;

• a history of heart failure, or slow heartbeats caused by underactive thyroid;

• an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood); or

• if you have ever had an abnormal electrocardiogram or ECG (sometimes called an EKG).

FDA pregnancy category B. Sirturo is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether bedaquiline passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Sirturo.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Sirturo?

Take Sirturo exactly as prescribed by your doctor. Follow all directions on your prescription label. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

Take with food.

Take this medicine with a full glass of water. Swallow the tablet whole. Do not break.

Sirturo is usually taken every day for 2 weeks, and then only 3 times per week for the next 22 weeks.

Sirturo must be given in combination with at least 3 other tuberculosis medications and it should not be used alone. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice.

Follow your doctor"s dosing instructions very carefully.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

While using Sirturo, you may need frequent blood tests. Your heart function may also need to be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store this medicine in the original container at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose during the first 2 weeks of treatment: Skip the missed dose and do not take extra medicine to make up the missed dose.

If you miss a dose during week 3 or later: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking Sirturo.

Sirturo side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Sirturo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache and severe dizziness, fainting, fast or pounding heartbeats;

• chest pain;

• coughing up blood; or

• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Sirturo side effects may include:

• nausea;

• mild headache;

• skin rash; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Sirturo?

Many drugs can interact with Sirturo, and some should not be used at the same time. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Sirturo, especially:

• bosentan;

• droperidol;

• imatinib;

• isoniazid;

• methadone;

• St. John"s wort;

• another antibiotic--azithromycin, clarithromycin, erythromycin, moxifloxacin, pentamidine, telithromycin;

• an antidepressant--citalopram, escitalopram, nefazodone;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• anti-malaria medication--chloroquine, halofantrine;

• cancer medicine--arsenic trioxide, vandetanib;

• heart medication--amiodarone, disopyramide, dofetilide, flecainide, ibutilide, nicardipine, procainamide, quinidine, sotalol;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir;

• medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, mesoridazine, pimozide, thioridazine;

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

• tuberculosis medication--rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with Sirturo. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.