5.2.4 Drug dosage and frequency

The dosages of all drugs included in both variations of the 9-month all-oral regimen are outlined in the Annex. Most drugs, except for bedaquiline, are administered once a day, 7 days per week. In the 9-month regimen, bedaquiline is initially administered daily, with a higher loading dose for the first 2 weeks, followed by a lower maintenance dose on 3 days a week (with at least 48 hours between doses) thereafter. If one dose of bedaquiline is missed in the 2-week loading phase, the missed dose does not have to be made up and the patient can continue on the daily dosing schedule. If a dose of bedaquiline is missed in the maintenance phase but is remembered within that 48-hour dosing period, the dose should be administered as soon as possible, and the following dose adjusted to be taken 48 hours later, with resumption of the usual thrice-weekly dosing schedule thereafter. For example, if bedaquiline is dosed every Monday, Wednesday and Friday, then if the Wednesday dose is missed it can still be taken on Thursday, and then the following dose should be taken on Saturday, with a return to the usual dosing schedule on Monday. If bedaquiline is interrupted for more than 2 weeks (but <8 weeks) during the maintenance phase of dosing, the drug should be reloaded at the higher daily dose for 7 days before resuming the thrice-weekly dosing schedule. If bedaquiline is interrupted for less than 2 consecutive weeks during the maintenance phase, no reloading is required. If bedaquiline is interrupted for more than 8 consecutive weeks, then the patient and treatment plan should be reassessed because the patient will no longer be eligible to continue or restart the 9-month all-oral regimen.

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