Pretomanid
Extensively Drug-Resistant Tuberculosis
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
YES
Known Teratogen
NO
Pharmaceutical Class
Antimycobacterial
Controlled Drug Substance
NO
Pretomanid
Summary
Pretomanid is used for treating multidrug-resistant tuberculosis (MDRTB) in adults. It is used in combination with other medications like bedaquiline and linezolid to treat pulmonary tuberculosis, which is caused by Mycobacterium tuberculosis resistant to other medications.
Pretomanid works by inhibiting the synthesis of cell wall lipids in the bacteria that cause tuberculosis. This leads to the death of the bacteria. It also generates reactive nitrogen species under anaerobic conditions, which further contributes to its antibacterial effects.
The usual dose for adults is 200 mg of Pretomanid taken orally once daily with food. The treatment typically lasts for 26 weeks. It's important to note that the safety and efficacy of Pretomanid in children have not been established, so it's not recommended for pediatric use.
Common side effects of Pretomanid include nausea, vomiting, headache, and fatigue. Some serious adverse effects can include liver toxicity (hepatotoxicity), QT prolongation (a heart rhythm condition), and peripheral neuropathy (nerve damage causing weakness, numbness, and pain).
Pretomanid carries a risk of hepatotoxicity and QT prolongation. It should not be taken by patients who are hypersensitive to its components. It also interacts with certain other medications, so patients should inform their doctor of all the medications they are taking. Alcohol should be avoided as it can exacerbate liver-related side effects.
Indications and Purpose
How does Pretomanid work?
Pretomanid works by inhibiting the synthesis of cell wall lipids in tuberculosis bacteria under aerobic conditions and generating reactive nitrogen species under anaerobic conditions, which helps kill the bacteria.
Is Pretomanid effective?
Pretomanid has been evaluated in clinical trials, such as the Nix-TB and ZeNix trials, showing effectiveness in treating multi-drug resistant tuberculosis when used in combination with bedaquiline and linezolid. The trials demonstrated high rates of favorable outcomes in patients.
What is Pretomanid?
Pretomanid is used to treat multi-drug resistant tuberculosis in adults, in combination with bedaquiline and linezolid. It works by killing the bacteria that cause tuberculosis, inhibiting cell wall synthesis, and generating reactive nitrogen species under anaerobic conditions.
Directions for Use
For how long do I take Pretomanid?
Pretomanid is typically used for 26 weeks. However, the duration may be extended on a case-by-case basis if the patient has not responded adequately to treatment.
How do I take Pretomanid?
Pretomanid should be taken once daily with food to enhance absorption. There are no specific food restrictions, but alcohol should be avoided due to the risk of liver-related side effects.
How should I store Pretomanid?
Store Pretomanid in its original container, tightly closed, at room temperature, away from excess heat and moisture. Keep it out of reach of children and do not store it in the bathroom.
What is the usual dose of Pretomanid?
The usual daily dose for adults is 200 mg, taken once daily with food for 26 weeks. The safety and efficacy of Pretomanid in children have not been established, so there is no recommended dose for children.
Warnings and Precautions
Can I take Pretomanid with other prescription drugs?
Significant drug interactions with Pretomanid include CYP3A4 inducers like rifampicin and efavirenz, which can reduce its effectiveness. It also interacts with linezolid and bedaquiline, which are part of the treatment regimen, requiring careful monitoring.
Can Pretomanid be taken safely while breastfeeding?
It is unknown whether Pretomanid is excreted in human milk. A decision should be made to either discontinue breastfeeding or the medication, considering the benefits of breastfeeding and the need for treatment.
Can Pretomanid be taken safely while pregnant?
There is limited data on the use of Pretomanid during pregnancy. It should only be used if the benefits outweigh the risks. Animal studies do not indicate direct harm, but human data is insufficient, so consult a doctor for personalized advice.
Is it safe to drink alcohol while taking Pretomanid?
Drinking alcohol while taking Pretomanid is not recommended as it increases the risk of serious side effects. Alcohol can exacerbate liver-related side effects, making it important to avoid alcohol during treatment.
Is Pretomanid safe for the elderly?
There is limited clinical data on the use of Pretomanid in elderly patients. The safety and efficacy have not been established, so elderly patients should use this medication under close medical supervision.
Who should avoid taking Pretomanid?
Important warnings for Pretomanid include the risk of hepatotoxicity, QT prolongation, and interactions with other medications. It is contraindicated in patients with hypersensitivity to its components. Patients should avoid alcohol and other hepatotoxic substances during treatment.