DOVPRELA Tablet Ref.[111585] Active ingredients: Pretomanid

Treatment with pretomanid should be initiated and monitored by a physician experienced in the management of TB due to drug-resistant M. tuberculosis.

Pretomanid should be administered by directly observed therapy (DOT) or in accordance with local practice.

Posology

The recommended dosage is 200 mg (one tablet) pretomanid once daily, for 26 weeks.

A longer duration of therapy may be considered in patients who have not responded adequately to treatment at 26 weeks on a case by case basis (see section 5.1).

Pretomanid should be administered only in combination with bedaquiline (400 mg once daily for 2 weeks followed by 200 mg 3 times per week [with at least 48 hours between doses] orally for a total of 26 weeks) and linezolid (600 mg daily orally for up to 26 weeks).

The product information for bedaquiline and linezolid should be consulted for additional information on the use of these medicinal products.

In addition, see section 4.4 for information on the dose modification of linezolid that was applied during the ZeNix clinical study and see section 5.1 for details of the study.

Discontinuation of the pretomanid-bedaquiline-linezolid treatment regimen (see also sections 4.4, 4.8 and 5.1)

• If either bedaquiline or pretomanid is discontinued for any reason, the entire combination regimen should be discontinued.
• If linezolid is permanently discontinued during the initial four consecutive weeks of treatment, the entire combination regimen should be discontinued.
• If linezolid is discontinued after the initial four weeks of consecutive treatment, the regimen may be continued with only bedaquiline and pretomanid.

Missed doses

Any missed doses of pretomanid and bedaquiline should be made up at the end of treatment. Doses of linezolid that are missed due to linezolid adverse reactions should not be made up at the end of treatment.

Refer to the product information of bedaquiline and linezolid for additional information on these medicinal products.

Treatment duration

The total duration of treatment with pretomanid in combination with bedaquiline and linezolid is 26 weeks. Data on longer treatment duration is limited. A longer duration of therapy may be considered in patients who have not responded adequately to treatment at 26 weeks on a case by case basis (see section 5.1).

Elderly population (≥65 years of age)

There is limited clinical data on the use of pretomanid in elderly patients. Hence, the safety and efficacy of pretomanid in elderly patients have not been established.

Hepatic impairment

The safety and efficacy of pretomanid in populations with hepatic impairment have not been established (see section 4.4).

Renal impairment

The safety and efficacy of pretomanid in populations with renal impairment have not been established. No data are available. Use in patients with renal impairment is not recommended.

Paediatric population

The safety and efficacy of pretomanid in children and adolescents have not yet been established. No data are available.

Method of administration

For oral use.

Pretomanid should be taken with food (see section 5.2).

Tablets should be swallowed with water.

There is no experience of acute overdose with pretomanid. General measures should be taken to support basic vital functions including monitoring of vital signs and ECG in case of deliberate or accidental overdose.

4 years.

This medicinal product does not require any special temperature storage conditions.

High-density polyethylene (HDPE) bottles with polypropylene screw cap with a pulp liner and an absorbent cotton or an ullage filler.

Pack size: 26 tablets.

PVC/PVdC-Aluminium foil blisters packs.

Pack sizes: 14, 14 × 1 (unit dose), 182, 182 × 1 (unit dose) tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.