SIRTURO® Appropriate Use

SIRTURO® Patient Access

Janssen Therapeutics, Division of Janssen Products, LP, is committed to appropriate and responsible access to SIRTURO®. SIRTURO® is available by prescription from healthcare professionals associated with qualified centers for the evaluation, diagnoses, and treatment of TB, including pulmonary MDR-TB. Qualified centers include public health departments, clinics that treat TB, and hospitals and institutions with a TB concentration.

If you have questions regarding access to SIRTURO®, please contact Cardinal Health/Metro Medical at 1-855-691-0963.

Patient Counseling

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Patients should be advised that the following serious side effects can occur with SIRTURO®: death, heart rhythm abnormalities, and/or hepatitis. In addition, patients should also be advised about other potential side effects: nausea, joint pain, headache, increased blood amylase, hemoptysis, chest pain, anorexia, rash and/or abdominal pain. Additional testing may be needed to monitor or reduce the likelihood of adverse effects.

Advise patients to take SIRTURO® in combination with other antimycobacterial drugs as prescribed. Emphasize compliance with the full course of therapy. Advise  patients that skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the treatment and (2) increase the likelihood that their mycobacterium may develop resistance and the disease will not be treatable by SIRTURO® or other antibacterial drugs in the future.

If a dose is missed during the first 2 weeks of treatment advise patients not to make up the missed dose but to continue the usual dosing schedule. From Week 3 onwards, if a 200-mg dose is missed, advise patients to take the missed dose as soon as possible, and then resume the 3 times a week regimen.

  • Patients should be informed to take SIRTURO® with food.
  • Patients should be advised to abstain from alcohol, hepatotoxic medications, or herbal products.
  • Patients should be advised to discuss with their physician the other medications they are taking and other medical conditions before starting treatment with SIRTURO®.
  • Advise patients or caregivers to monitor infants exposed to bedaquiline through breast milk for signs of bedaquiline-related adverse reactions, such as hepatotoxicity (yellowing of the eyes and changes in the color of the urine or stool)

Print out this helpful information on treating with SIRTURO® for your patients.

CDC TB Treatment Guidelines

The Centers for Disease Control and Prevention (CDC) has established guidelines for the treatment of TB, including drug-resistant pulmonary TB.

Prescribing physicians are responsible for not only prescribing an appropriate regimen but also for successful completion of therapy. Access the CDC Treatment Guidelines for TB here.