SIRTURO® Appropriate Use

INDICATIONS AND USAGE

SIRTURO® is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided.

This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Limitations of Use

Do not use SIRTURO® for the treatment of:

  • Latent infection due to Mycobacterium tuberculosis
  • Drug-sensitive tuberculosis
  • Extra-pulmonary tuberculosis
  • Infections caused by non-tuberculous mycobacteria

The safety and efficacy of SIRTURO® in the treatment of HIV-infected patients with MDR-TB have not been established as clinical data are limited.

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).

Serious Adverse Reactions

Advise patients that the following serious side effects can occur with SIRTURO®: death, heart rhythm abnormalities, and/or hepatitis. In addition, advise patients 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.

Compliance with Treatment

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 dose is missed, advise patients to take the missed dose as soon as possible, and then resume the 3 times a week regimen. Ensure that the total dose of SIRTURO® during a 7-day period does not exceed the recommended weekly dose (with at least 24 hours between each intake).

Administration Instructions

Advise patients to take SIRTURO® with food.

Advise patients who have difficulty swallowing tablets that SIRTURO® 20 mg tablet can be administered by the following methods:

  • Dispersed in water and the mixture administered immediately. To aid with administration, the dispersed mixture in water can be further mixed with a beverage (e.g., water, milk products, apple juice, orange juice, cranberry juice or carbonated beverage) or soft food (e.g., yogurt, apple sauce, mashed banana or porridge) and then administered immediately,
  • Crushed and mixed with soft food and the mixture administered immediately,
  • Administered through a nasogastric tube

Use with Alcohol and other Medications

Advise patients to abstain from alcohol, hepatotoxic medications or herbal products. Advise patients to discuss with their physician the other medications they are taking and other medical conditions before starting treatment with SIRTURO®.

Lactation

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.