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What is Pretomanid
Pretomanid is an oral nitroimidazooxazine antimycobacterial indicated for the treatment of adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant, or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) as part of a combination regimen with bedaquiline and linezolid.
Pretomanid is not indicated for the treatment of drug-sensitive tuberculosis, latent Mycobacterium tuberculosis infection, extra-pulmonary M. tuberculosis infection, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.
Safety and effectiveness have not been established for use in combination with drugs other than bedaquiline and linezolid. Approval is based on limited safety and efficacy data from a single open-label study.
Because it is used in the combination regimen with bedaquiline and linezolid, pretomanid is also contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated
Indications
- Mycobacterium tuberculosis
- tuberculosis infection
Side Effects
- abdominal pain
- acne vulgaris
- anemia
- arthralgia
- back pain
- blurred vision
- constipation
- cough
- diarrhea
- dizziness
- dysgeusia
- dyspepsia
- elevated hepatic enzymes
- gastritis
- headache
- hemoptysis
- hepatotoxicity
- hyperamylasemia
- hyperbilirubinemia
- hyperglycemia
- hyperkalemia
- hypertension
- hypoesthesia
- hypoglycemia
- hypokalemia
- hypomagnesemia
- hyponatremia
- hyporeflexia
- infection
- influenza
- insomnia
- lactic acidosis
- leukopenia
- maculopapular rash
- musculoskeletal pain
- myalgia
- nausea
- neutropenia
- optic neuritis
- pancreatitis
- pancytopenia
- paresthesias
- peripheral neuropathy
- peripheral neuropathy
- peripheral neuropathy
- pruritus
- QT prolongation
- rash
- seizures
- thrombocytopenia
- vesicular rash
- visual impairment
- vomiting
- weight loss
- xerosis
NOTE: Adverse reactions were reported in patients treated with the combination regimen of pretomanid, bedaquiline, and linezolid unless otherwise stated.
Monitoring Parameters
- LFTs
Contraindications
- breast-feeding
- hepatic disease
- infertility
- pregnancy
- reproductive risk
Interactions
No information is available regarding drug interactions associated with Pretomanid
