XTANDI™ FILM-COATED TABLETS 40MG [SIN17368P]

Product Info

XTANDI™ FILM-COATED TABLETS 40MG

[SIN17368P]

Indication

4.1 Therapeutic indications

Xtandi is indicated:

• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

Dosing

4.2 Posology and method of administration

Posology
The recommended dose is 160 mg enzalutamide (four 40 mg capsules, four 40 mg film-coated tablets, or two 80 mg film-coated tablets) as a single oral daily dose.

Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients with CRPC or mHSPC who are not surgically castrated.

Patients with high-risk BCR nmHSPC may be treated with Xtandi with or without a LHRH analogue. For patients who receive Xtandi with or without a LHRH analogue, treatment can be suspended if PSA is undetectable (< 0.2 ng/mL) after 36 weeks of therapy. Treatment should be reinitiated when PSA has increased to ≥ 2.0 ng/mL for patients who had prior radical prostatectomy or ≥ 5.0 ng/mL for patients who had prior primary radiation therapy. If PSA is detectable (≥ 0.2 ng/mL) after 36 weeks of therapy, treatment should continue (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Xtandi can be taken with or without food and should be taken at approximately the same time every day. If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.

If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.

Concomitant use with strong CYP2C8 inhibitors
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily. If co-administration of the strong CYP2C8 inhibitor is discontinued, the enzalutamide dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly
No dose adjustment is necessary for older people (see section 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is necessary for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C, respectively). An increased drug half-life has however been observed in patients with severe hepatic impairment (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment is necessary for patients with mild or moderate renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Caution is advised in patients with severe renal impairment or end-stage renal disease (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
There is no relevant use of enzalutamide in the paediatric population in the indication of treatment of adult men with CRPC, mHSPC, or high-risk BCR nmHSPC.

Swallowing difficulties/history of dysphagia population
Enzalutamide is also available as tablets (40 mg and 80 mg) for patients who have difficulties swallowing large capsules or for patients with a history of dysphagia.

Method of administration
Xtandi is for oral use.
The capsules should be swallowed whole with a sufficient amount of water. Do not chew, dissolve or open.
The film-coated tablets should be swallowed whole with a sufficient amount of water. Do not cut, crush or chew the tablets before swallowing.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Women who are or may become pregnant (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).