Xospata Dosage/Direction for Use

Posology: Xospata is to be prescribed only by physicians who specialize in hematology and/or hemato-oncology.
The recommended starting dose of Xospata is 120 mg (three 40 mg tablets) once-daily.
Treatment should continue until the patient is no longer clinically benefiting from Xospata or until unacceptable toxicity occurs. Response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response.
In the absence of a response after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once-daily.
Xospata may be re-initiated in patients following hematopoietic stem cell transplantation (HSCT).
Assess blood chemistries, including creatine phosphokinase, prior to the initiation of treatment with Xospata, on day 15 of cycle 1 and monthly for the duration of therapy.
Perform electrocardiogram (ECG) prior to initiation of treatment with Xospata, on day 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and/or reduce the dose of Xospata in patients who have a QTcF >500 msec.
If differentiation syndrome is suspected, administer systemic corticosteroids and initiate hemodynamic monitoring until symptom resolution. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt Xospata until signs and symptoms are no longer severe. Treatment with Xospata can be resumed at the same dose when signs and symptoms improve to Grade 2 (moderate) or lower.
Interrupt Xospata for other Grade 3 (severe) or greater toxicity considered related to the drug.
Resume at a reduced dose when the toxicity resolves or improves to Grade 1 (mild).
Interrupt treatment with Xospata one week prior to administration of the conditioning regimen for HSCT. Treatment can be resumed 30 days after HSCT if engraftment was successful, the patient did not have grade ≥2 acute graft versus host disease and was in composite complete remission (CRc) (see PHARMACOLOGY: Pharmacodynamics under Actions).
The daily dose can be reduced from 120 mg to 80 mg or 200 mg to 120 mg.
Xospata should be administered at about the same time each day. If a dose is missed or not taken at the usual time, the dose should be administered as soon as possible on the same day, and patients should return to the normal schedule the following day. If vomiting occurs after dosing, patients should not take another dose but should return to the normal schedule the following day.
Elderly: No dose adjustment is required in patients ≥65 years of age (see PHARMACOLOGY: Pharmacokinetics under Actions).
Hepatic Impairment: No dose adjustment is required for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Xospata has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) (see PHARMACOLOGY: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild, moderate or severe renal impairment (see PHARMACOLOGY: Pharmacokinetics under Actions).
Paediatric population: There are no data to support the safety and efficacy of Xospata use in children. Therefore, Xospata is not recommended for use in children.
Method of administration: Xospata is for oral use.
The tablets can be taken with or without food. They should be swallowed whole with water and should not be broken or crushed.