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SIRTURO- bedaquiline fumarate tablet


  1. Patient Information
  2. Before You Take Sirturo, Tell Your Healthcare Provider About All Your Medical Conditions Including, If You:
  3. How Should I Take Sirturo?
  4. Week 1 And Week 2:
  5. Week 3 To Week 24:
  6. If You Miss Your Sirturo Dose During Week 1 Or Week 2:
  7. If You Miss Your Sirturo Dose During Week 3 To Week 24:
  8. What Should I Avoid While Taking Sirturo?
  9. What Are The Possible Side Effects Of Sirturo?sirturo May Cause Serious Side Effects, Including:
  10. General Information About The Safe And Effective Use Of Sirturo:
  11. What Are The Ingredients In Sirturo?active Ingredient:
  12. Inactive Ingredients:

Patient Information 

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 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.

Administration Instructions

Inform patients to take SIRTURO with food.

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)[
SIRTURO is a diarylquinoline antibiotic prescription medicine used in people 12 years of age and older with multi-drug resistant tuberculosis (MDR-TB) of the lungs when other effective treatment options are not possible.
It is not known if SIRTURO is safe and effective in:

  • people who have a tuberculosis (TB) infection, but do not show symptoms of TB (also known as latent TB).
  • people who have TB that is not resistant to antibiotics.
  • people who have types of TB other than TB of the lungs.
  • people who have an infection caused by a bacteria other than TB.
  • people who are being treated for Human Immunodeficiency Virus (HIV) who also have MDR-TB.
  • children under 12 years of age or weighing less than 66 pounds (30 kg).

Before You Take Sirturo, Tell Your Healthcare Provider About All Your Medical Conditions Including, If You: 

  • take any other medicines for your heart.
  • have had an abnormal heart rhythm (ECG) or other heart problems.
  • have a family history of a heart problem called "congenital long QT syndrome" or heart failure.
  • have decreased thyroid gland function (hypothyroidism).
  • have liver or kidney problems.
  • have HIV infection.
  • are pregnant or plan to become pregnant. It is not known if SIRTURO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SIRTURO passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking SIRTURO.
    • If you and your healthcare provider decide for you to breastfeed while taking SIRTURO,tell your healthcare provider right away if your baby has:
  • yellowing of their eyes.
  • darker than usual urine color.
  • lighter than usual stool color or stool that is pale or light brown.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
You shouldnottake certain liver medicines or herbal supplements while taking SIRTURO.

How Should I Take Sirturo? 

  • Take SIRTURO exactly as your healthcare provider tells you to take it.
  • You will take SIRTURO for a total of 24 weeks. You may need to take your other TB medicines for longer than 24 weeks. If you are not sure, you should talk with your healthcare provider.
  • SIRTURO must always be taken with other medicines to treat TB. Your healthcare provider will decide which other medicines you should take with SIRTURO.
  • It is important that you complete the full course of treatment with SIRTURO and not skip doses. Skipping doses may decrease the effectiveness of the treatment and increase the chances that your TB will not be treatable by SIRTURO or other medicines.
  • Take SIRTURO with food. Swallow the tablets whole with water.

Week 1 And Week 2: 


Take 400 mg (4 tablets)1 time each day.

Week 3 To Week 24: 

  • Take 200 mg (2 tablets) a day3 times a week.
  • Take SIRTURO doses at least 48 hours apart. For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 to week 24.
  • Do not skip SIRTURO doses.If you skip doses, or do not complete the total 24 weeks of SIRTURO, your treatment may not work as well, and your TB may be harder to treat.
  • If you take more SIRTURO than you should, talk to a healthcare provider right away.

If You Miss Your Sirturo Dose During Week 1 Or Week 2: 

  • Do nottake a double dose to make up for the missed dose. Take the next dose as usual.

If You Miss Your Sirturo Dose During Week 3 To Week 24: 

  • Take the missed dose as soon as possible and continue taking SIRTURO on the 3 times a week schedule.
  • If you miss a dose and you are not sure what to do, talk to your healthcare provider.
  • Do notstop taking SIRTURO without first talking to your healthcare provider.

What Should I Avoid While Taking Sirturo? 

  • You should not drink alcohol while taking SIRTURO.

What Are The Possible Side Effects Of Sirturo?sirturo May Cause Serious Side Effects, Including: 

    • Store SIRTURO at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep SIRTURO in the original container, and keep SIRTURO out of light.
    Keep SIRTURO and all medicines out of reach of children.

General Information About The Safe And Effective Use Of Sirturo: 


This Medication Guide summarizes the most important information about SIRTURO. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about SIRTURO that is written for health professionals.

What Are The Ingredients In Sirturo?active Ingredient: 

bedaquiline

Inactive Ingredients: 

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing)
Product of India
Finished Product Manufactured by: Recipharm Pharmaservices Pvt. Ltd., Bangalore, India
Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP Titusville, NJ 08560
Janssen Products, LP 2012



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