Posology : מינונים

4.2    Posology and method of administration

Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.

Posology
The recommended dose of Welireg is 120 mg (three 40 mg tablets) administered orally once daily, with or without food. Tablets should be swallowed whole.

Treatment should continue until disease progression or unacceptable toxicity occurs.

Missed dose
If a dose of Welireg is missed, it can be taken as soon as possible on the same day. The regular daily dose should be resumed the next day. Extra tablets should not be taken to make up for the missed dose.

If vomiting occurs any time after taking Welireg, the dose should not be retaken. The next dose should be taken the next day.

Dose Modifications
Dosage modifications for Welireg for adverse reactions are summarised in Table 1 (see section 4.4).

Table 1: Recommended Dose Modifications
Adverse Reactions                 Severity*                            Dose Modification Anaemia                         Grade 3:              •        Withhold until resolved to ≤ Grade 2 (Hb ≥ 8 (see section 4.4)               Haemoglobin (Hgb               g/dL).
< 8g /dL)             •        Resume at a reduced dose (reduce by 40 mg) transfusion indicated          or discontinue depending on the severity and persistence of anaemia.
Grade 4: Life-             •   Withhold until resolved to ≤ Grade 2 (Hb ≥ 8 threatening or urgent          g/dL).
intervention               •   Resume at a reduced dose (reduce by 40 mg) indicated                      or permanently discontinue.
Hypoxia                         Grade 2: Decreased
(see section 4.4)               oxygen saturation               •   Consider withholding until resolved with exercise (e.g.             •   Resume at the same dose or at a reduced pulse oximeter <                    dose depending on the severity of 88%) intermittent                   hypoxia.
supplemental oxygen
Grade 3: Decreased         •   Withhold until resolved to ≤ Grade 2 oxygen saturation at       •   Resume at reduced dose (reduce by 40 mg) or rest (e.g. pulse               discontinue depending on the severity and oximeter <88% or               persistence of hypoxia.
PaO² <=55 mm Hg)
Grade 4: Life-             •   Permanently discontinue.
threatening
Other Adverse                   Grade 3                    • Withhold dosing until resolved to ≤ Grade 2.
Reactions                                                  • Consider resuming at a reduced dose (reduce (see section 4.8)                                            by 40 mg).
• Permanently discontinue upon recurrence of
Grade 3.
Grade 4                    • Permanently discontinue.
*Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 
Special Populations

Elderly (≥ 65 years old)
No dose adjustment is recommended for elderly patients. There are limited data available on the use of Welireg in patients aged 65 years and over (see sections 5.1 and 5.2).

Renal impairment
No dose adjustment of Welireg is recommended in patients with mild or moderate renal impairment (eGFR ≥ 30 mL/minute/1.73 m2). Welireg has not been studied in patients with severe renal impairment (see section 5.2).

Hepatic impairment
No dose adjustment of Welireg is recommended in patients with mild hepatic impairment. Welireg has not been studied in patients with moderate or severe hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of Welireg in children less than 18 years of age has not yet been established.
No data are available.

Method of administration
Welireg is for oral use.
It should be swallowed whole and may be taken with or without food.