Bedaquiline

Name: Bedaquiline

Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in human breast milk Pharmacology

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Pharmacology

Mechanism of Action

Diarylquinoline; inhibits mycobacterial adenosine 5'-triphosphate (ATP) synthase, an enzyme essential for the generation of energy in Mycobacterium tuberculosis

Absorption

Bioavailability: Increased 2-fold when taken with standard meal compared with fasted conditions

Peak Plasma Concentration: 5 hr

Distribution

Protein Bound: >99.9%

Vd: 164 L

Metabolism

Metabolized primarily by CYP3A4 to form N-monodesmethyl metabolite (M2) which is 4- to 6-times less active

Elimination

Half-life: 5.5 months (mean terminal half-life of bedaquiline and the M2 metabolite)

Renal clearance: <0.001%

Excretion: Mainly in feces

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Bedaquiline Side Effects

Get emergency medical help if you have signs of an allergic reaction: 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
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, loss of appetite;
  • 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.

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.

Uses For bedaquiline

Bedaquiline is used to treat multidrug resistant tuberculosis (MDR-TB) in the lungs. It is used in patients who have already been treated with other medicines that did not work well. Bedaquiline prevents the growth of tuberculosis in the body.

bedaquiline is available only with your doctor's prescription.

bedaquiline Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain or tenderness
  • chest pain
  • coughing or spitting up blood
  • dark-colored urine
  • decreased appetite
  • fever
  • general feeling of tiredness or weakness
  • headache
  • itching
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • skin rash
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin
Incidence not known
  • Fainting
  • irregular heartbeat recurrent

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty with moving
  • muscle pain or stiffness
  • pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Bedaquiline

  • It is used to treat TB (tuberculosis).

How is this medicine (Bedaquiline) best taken?

Use bedaquiline as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Be sure you know how to take this medicine. Talk with your doctor if you have questions.
  • Take with food.
  • Swallow whole with a drink of water.
  • To gain the most benefit, do not miss doses.
  • Keep taking bedaquiline as you have been told by your doctor or other health care provider, even if you feel well.
  • This medicine is taken with other drugs. Be sure you know about the warnings, benefits, and risks of these other drugs. Talk with the doctor if you have questions or concerns about any of the drugs.

What do I do if I miss a dose?

Weeks 1 and 2:

  • Skip the missed dose and go back to your normal time.

Week 3 or more:

  • Take a missed dose as soon as you think about it and go back to your normal time.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

All weeks:

  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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