Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
Selumetinib hyd-sulfate eqv Selumetinib
ASTRAZENECA SINGAPORE PTE LTD
L01EE04
CAPSULE
Selumetinib hyd-sulfate eqv Selumetinib 25mg
ORAL
Prescription Only
Patheon Pharmaceuticals Inc.
ACTIVE
2021-07-09
1 KOSELUGO ® (SELUMETINIB) 1. NAME OF THE MEDICINAL PRODUCT KOSELUGO (selumetinib) 10 mg, hard capsules KOSELUGO (selumetinib) 25 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg hard capsule contains 10 mg of selumetinib (as hydrogen sulfate). Each 25 mg hard capsule contains 25 mg of selumetinib (as hydrogen sulfate). For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. KOSELUGO 10 mg hard capsule White to off-white, opaque, size 4 hard capsule, banded and marked with “SEL 10” in black ink. KOSELUGO 25 mg hard capsule Blue, opaque, size 4 hard capsule, banded and marked with “SEL 25” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KOSELUGO is indicated for the treatment of paediatric patients aged 3 years and above with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with NF1-related tumours. POSOLOGY The recommended dose of KOSELUGO is 25 mg/m 2 of body surface area (BSA), taken orally twice daily (approximately every 12 hours). Dosing is individualised based on BSA (mg/m 2 ) and rounded to the nearest achievable 5 mg or 10 mg dose (up to a maximum single dose of 50 mg). Different strengths of KOSELUGO capsules can be combined to attain the desired dose (Table 1). TABLE 1 KOSELUGO RECOMMENDED DOSAGE BASED ON BODY SURFACE AREA 2 BODY SURFACE AREA (BSA) A RECOMMENDED DOSAGE 0.55 – 0.69 m 2 20 mg in the morning and 10 mg in the evening 0.70 – 0.89 m 2 20 mg twice daily 0.90 – 1.09 m 2 25 mg twice daily 1.10 – 1.29 m 2 30 mg twice daily 1.30 – 1.49 m 2 35 mg twice daily 1.50 – 1.69 m 2 40 mg twice daily 1.70 – 1.89 m 2 45 mg twice daily ≥1.90 m 2 50 mg twice daily a The recommended dosage for patients with a BSA less than 0.55 m 2 has not been established. Treatment with KOSELUGO should continue as long as clinical benefit is o Lesen Sie das vollständige Dokument