XOLREMDI Hard capsule Ref.[116582] Active ingredients: Mavorixafor

Treatment should only be initiated by specialist physicians with experience in the diagnosis or management of immune deficiencies.

Posology

The recommended dose is:

• Weight more than 50 kg: 400 mg (four 100 mg capsules) orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food.
• Weight less than or equal to 50 kg: 300 mg (three 100 mg capsules) orally once daily on an empty stomach after an overnight fast, and at least 30 minutes before food.

Missed dose

If a dose is missed, the next dose should be taken as scheduled. The patient should not take a double dose to make up for a missed dose.

Dose modifications

Concomitant use of Xolremdi with strong or moderate CYP3A4 inhibitors When used concomitantly with a strong CYP3A4 inhibitor, daily dose should be reduced to 200 mg.

Concomitant use of Xolremdi with strong or moderate CYP3A4 inhibitors

When used concomitantly with a strong CYP3A4 inhibitor, daily dose should be reduced to 200 mg. When used concomitantly with a moderate CYP3A4 inhibitor, Xolremdi adverse reactions that may be associated with an increase in mavorixafor exposure should be monitored more frequently (see section 4.5), and the Xolremdi daily dose should be reduced by steps of 100 mg, as clinically necessary, but not to a dose less than 200 mg.

Concomitant use of Xolremdi with P-gp inhibitors

When used concomitantly with a P-gp inhibitor, Xolremdi adverse reactions that may be associated with an increase in mavorixafor exposure should be monitored more frequently (see section 4.5), and the Xolremdi daily dose should be reduced by steps of 100 mg, as clinically necessary, but not to a dose less than 200 mg.

Special populations

Risk of QTc prolongation

In patients with risk factors for QTc prolongation and/or when used concomitantly with medicinal product with a known potential to prolong the QTc interval, QTc assessment and monitoring is required (see section 4.4). If dose reduction is required, the daily dose should be reduced by steps of 100 mg, but not to a dose less than 200 mg. Discontinuation of Xolremdi may be required (see section 4.4).

Elderly

There are limited data on patients aged 65 years and older.

Renal impairment

The safety and efficacy of Xolremdi have not been established in patients with severe renal impairment (creatinine clearance 15 to less than 30 mL/min) or end-stage renal disease (creatinine clearance less than 15 mL/min). It is not recommended to administer Xolremdi to patients with severe renal impairment or end-stage renal disease. No dose adjustment is recommended in patients with creatinine clearance ≥30 mL/min, including in patients with mild to moderate renal impairment.

Hepatic impairment

The safety and efficacy of Xolremdi have not been established in patients with moderate to severe hepatic impairment (ChildPugh score ≥7). Xolremdi is not recommended for use in patients with moderate to severe hepatic impairment. No dose adjustment is recommended in patients with mild hepatic impairment.

Paediatric population

The safety and efficacy of Xolremdi in children from 2 to 11 years of age have not yet been established. No data are available.

Xolremdi should not be used in children <2 years of age because exposure to mavorixafor may cause developmental defects (see section 5.3).

Method of administration

Xolremdi is for oral use.

The capsule should be taken on an empty stomach after an overnight fast, and at least 30 minutes before food (see section 5.2).

The capsules should be swallowed whole and should not be opened, broken or chewed to ensure product efficacy and stability.

There is no specific antidote or therapeutic intervention to enhance elimination of mavorixafor. In the event of overdose, it is recommended to stop treatment, and symptomatic supportive treatment be initiated as clinically indicated.

2 years.

After first opening the bottle: 45 days.

Store in a refrigerator (2°C–8°C).

Keep the bottle tightly closed in order to protect from moisture.

High density polyethylene round white bottle with 38 mm child-resistant screw cap with label. Each bottle contains one desiccant positioned between the rayon coil and cap.

Pack sizes of 60, 90 or 120 hard capsules.

Not all pack sizes may be marketed.

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