PRETAMYL Tablet Ref.[115272] Active ingredients: Pretomanid

Posology

Important Administration Instructions

PRETAMYL must be used only in combination with bedaquiline and linezolid as part of the recommended dosing regimen.

Emphasize the need for compliance with the full course of therapy to patients. Administer the combination regimen of PRETAMYL, bedaquiline, and linezolid by directly observed therapy (DOT).

Recommended Dosage

PRETAMYL must be administered in combination with bedaquiline and linezolid. The recommended dosage and duration for bedaquiline and linezolid when used in the combination regimen with PRETAMYL are as follows:

• PRETAMYL 200 mg orally (1 tablet of 200 mg), once daily, for 26 weeks. Swallow PRETAMYL whole with water.
• Bedaquiline 400 mg orally once daily for 2 weeks followed by 200 mg 3 times per week, with at least 48 hours between doses, for 24 weeks for a total of 26 weeks.
• Linezolid starting at 1,200 mg orally per day for 26 weeks, with dose adjustments to 600 mg daily and further reduction to 300 mg daily or interruption of dosing as necessary for known linezolid adverse reactions of myelosuppression, peripheral neuropathy, and reversible optic neuropathy (see section 4.4).
• Take the combination regimen of PRETAMYL, bedaquiline, and linezolid with food (see section 5.1).
• If the combination regimen of PRETAMYL, bedaquiline, and linezolid is interrupted by a healthcare provider for safety reasons, missed doses can be made up at the end of the treatment; doses of linezolid alone missed due to linezolid adverse reactions should not be made up.
• Dosing of the combination regimen of PRETAMYL, bedaquiline, and linezolid can be extended beyond 26 weeks, if necessary (see 5.3 CLINICAL STUDIES).

Assessments Prior to Initiating the Combination Regimen of PRETAMYL, Bedaquiline, and Linezolid

Assess for symptoms and signs of liver disease (such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, and hepatomegaly). Obtain laboratory tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and bilirubin). See section 4.4.

Obtain complete blood count (see section 4.4). Obtain serum potassium, calcium, and magnesium and correct if abnormal (see section 4.4). Obtain an ECG before initiation of treatment (see section 4.4).

Discontinuation of Dosing

If either bedaquiline or PRETAMYL are discontinued, the entire combination regimen should also be discontinued.

If linezolid is permanently discontinued during the initial four consecutive weeks of treatment, bedaquiline and PRETAMYL should also be discontinued. If linezolid is discontinued after the initial four weeks of consecutive treatment, continue administering bedaquiline and PRETAMYL.

Method of administration

For oral use.

There is no experience with the treatment of acute overdose with pretomanid. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QT interval) in case of deliberate or accidental overdose.

48 months.

Store at or below 30ºC.

Dispense only in original container and keep container tightly closed.

PRETAMYL is packaged in either white, round, high-density polyethylene bottles with white polypropylene child-resistant closure or child-resistant blister packages comprised of a polyvinylchloride film with foil and paper backing.

Pack sizes:

Bottles of 30 tablets and 28 tablets.

Unit dose blister pack of 28 (2 strips of 14 tablets).

No special precautions are required.