Pretomanid Dosage

Medically reviewed by Drugs.com. Last updated on Nov 30, 2023.

Applies to the following strengths: 200 mg

Usual Adult Dose for:

Tuberculosis - Resistant

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Tuberculosis - Resistant

Pretomanid: 200 mg orally once a day for 26 weeks
Bedaquiline: 400 mg orally once a day for 2 weeks followed by 200 mg orally 3 times a week (at least 48 hours between doses) for 24 weeks (for a total of 26 weeks)
Linezolid: Starting at 1200 mg/day orally for 26 weeks (with dose adjustment to 600 mg/day and further reduction to 300 mg/day or dose interruption as needed for known linezolid side effects of myelosuppression, peripheral neuropathy, and optic neuropathy)

Discontinuation of Dosing:

If this drug or bedaquiline are discontinued, the entire combination regimen should also be discontinued.
If linezolid is permanently discontinued during the initial 4 consecutive weeks of therapy, bedaquiline and this drug should also be discontinued; if linezolid is discontinued after the initial 4 weeks of consecutive therapy, administration of bedaquiline and this drug should continue.

Comments:

If the combination regimen is interrupted by a healthcare provider for safety reasons, missed doses can be made up at the end of therapy; doses of linezolid alone (missed due to linezolid side effects) should not be made up.
Dosing of the combination regimen can be extended beyond 26 weeks, if needed.

Use: As part of a combination regimen with bedaquiline and linezolid, for the treatment of patients with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
Combination regimen: Contraindications to bedaquiline and/or linezolid

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Before starting the combination regimen: Assess for signs/symptoms of liver disease (e.g., fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly); obtain laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin)
Before starting the combination regimen: Obtain CBC; obtain serum potassium, calcium, and magnesium and correct if abnormal; obtain ECG before staring therapy.
Only use this drug in combination with bedaquiline and linezolid as part of the recommended dosing regimen.
Administer the combination regimen by directly observed therapy (DOT) with food.
Swallow the tablets whole with water.
Emphasize to patients the need for compliance with the full course of therapy.

Storage requirements:

Store below 30C (86F).
Dispense only in original container; keep container tightly closed.

General:

Approval of indication based on limited clinical safety and efficacy data.
This drug is indicated for use in a limited and specific patient population.
Limitations of Use: This drug is not indicated in patients with drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M tuberculosis, OR MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.
Limitations of Use: Safety and efficacy of this drug have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.

Monitoring:

Cardiovascular: ECG (before starting therapy, and at least 2, 12, and 24 weeks after starting therapy; frequently if risk for QT prolongation; if syncope occurs)
Hematologic: CBC in patients using linezolid (at least at baseline, at 2 weeks, and then monthly)
Hepatic: For signs/symptoms of liver disease (at least at baseline, at 2 weeks, and then monthly during therapy and as needed); laboratory tests for ALT, AST, alkaline phosphatase, and bilirubin (at least at baseline, at 2 weeks, and then monthly during therapy and as needed); for viral hepatitides (if proof of new/worsening liver dysfunction)
Metabolic: Serum potassium, calcium, and magnesium (at baseline; if QT prolongation detected)
Ocular: Visual function in all patients

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide) for this drug and bedaquiline.
The combination regimen (pretomanid, bedaquiline, and linezolid) is for patients with XDR-TB or treatment-intolerant or nonresponsive MDR-TB; it must be administered by directly observed therapy.
Promptly inform physician if changes in vision occur during linezolid therapy; obtain prompt ophthalmological evaluation if symptoms of visual impairment occur.
Linezolid dosing may be modified or interrupted during therapy to manage the known linezolid side effects of myelosuppression, peripheral neuropathy, and optic neuropathy.
This drug must be taken as part of a combination regimen with bedaquiline and linezolid; compliance with the full course of therapy must be emphasized. Avoid missing doses (unless directed by physician) and complete the entire course of therapy.
Abstain from alcohol, hepatotoxic agents, and herbal products.