Pretomanid Dosage

Medically reviewed by Drugs.com. Last updated on Dec 2, 2024.

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 OR 200 mg orally once a day for 8 weeks followed by 100 mg orally once a day for 18 weeks

• Total duration: 26 weeks

Linezolid:

• Preferred regimen: 600 mg orally once a day for 26 weeks
• If myelosuppression, peripheral neuropathy, or optic neuropathy occurs: Reduce dosage to 300 mg orally once a day or interrupt linezolid dosing.
• Alternative regimen: 1200 mg orally once a day 26 weeks
• If myelosuppression, peripheral neuropathy, and optic neuropathy occurs: Reduce dosage to 600 mg orally once a day, further reduce dosage to 300 mg orally once a day, or interrupt linezolid.

Discontinuation of Dosing:

• If this drug or bedaquiline are discontinued: Discontinue the entire combination regimen.
• If linezolid is permanently discontinued during the initial 4 consecutive weeks of therapy: Discontinue bedaquiline and this drug.
• If linezolid is discontinued after the initial 4 weeks of consecutive therapy: Continue administration of bedaquiline and this drug.

Comments:

• This drug must be administered in combination with bedaquiline and linezolid.
• 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 tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone, and a second line injectable antibacterial agent OR patients with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Liver dysfunction: Data not available

If hepatotoxicity develops during therapy (aminotransferase elevations with total bilirubin elevation greater than 2 times the upper limit of normal [2 x ULN], aminotransferase elevations greater than 8 x ULN, or aminotransferase elevations greater than 5 x ULN that persist beyond 2 weeks): Interrupt treatment with the entire regimen.

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) and obtain laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin).
• Obtain CBC; obtain serum potassium, calcium, and magnesium and correct if abnormal.
• Obtain an ECG before starting treatment.
• Administer this drug only in combination with bedaquiline and linezolid as part of the recommended dosage regimen.
• Administer the combination regimen by directly observed therapy.
• Administer with food.
• Swallow the tablet whole with water; for patients with swallowing difficulties:
• Either crush and suspend the tablet in 1 teaspoon (about 5 mL) of room temperature water in a drinking cup OR soak the tablet for 4 to 5 minutes in 1 teaspoon of room temperature water in a drinking cup and then crush any remaining solid.
• Mix the contents in the cup well (stir vigorously), then immediately administer the cup contents orally.
• To ensure no tablet residual is left in the cup, rinse with an additional teaspoon of water, then immediately administer the cup contents orally.
• Do not store the mixture for later use.
• Emphasize to patients the need for compliance with the full course of therapy.
• If a health care provider interrupts the combination regimen for safety reasons, missed doses can be made up at the end of therapy.
• Doses of linezolid alone (missed due to linezolid adverse reactions) should not be made up.

Storage requirements:

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

General:

• Approval of the indication is 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 TB, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M tuberculosis, TB resistant to isoniazid and rifampin who are responsive to standard therapy and not treatment-intolerant, or TB with known resistance to any component of the combination.
• 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)
• General: Alkaline phosphatase (at least at baseline, at 2 weeks, and then monthly during therapy and as needed); serum potassium, calcium, and magnesium (at baseline)
• Hematologic: CBC in patients receiving linezolid as part of the combination regimen (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); ALT, AST, and bilirubin (at least at baseline, at 2 weeks, and then monthly during therapy and as needed)
• Ocular: Visual function in all patients receiving the entire combination regimen

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide) for this drug and bedaquiline.
• You must receive the combination regimen by directly observed therapy.
• Promptly inform your physician if changes in vision occur during linezolid therapy; obtain prompt ophthalmological evaluation if symptoms of visual impairment occur.
• You must take this drug 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 a physician) and complete the entire course of therapy.
• Abstain from alcohol, hepatotoxic medications, and herbal products.

See also:

Further information

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