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KOSELUGO is a brand name for Selumetinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 02/2026 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 02/2026 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 03/2024 7 WARNINGS AND PRECAUTIONS 02/2026 7 WARNINGS AND PRECAUTIONS 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 03/2024 7 WARNINGS AND PRECAUTIONS 02/2026 7 WARNINGS AND PRECAUTIONS 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .......................................................................................... 2 Recommended Dose and Dosage Adjustment .....................................................
4 Administration ........................................................................................................ 5 Missed Dose ..........................................................................................................
8 5 OVERDOSAGE ................................................................................................................ 8
). Recommended dose reductions are given in Table 2. KOSELUGO® (selumetinib) Page 6 of 43 Table 2 - KOSELUGO Recommended Dose Reductions for Adverse Reactions a Permanently discontinue KOSELUGO in patients unable to tolerate KOSELUGO after two dose reductions Table 3 - Recommended KOSELUGO Dosage Modifications for Adverse Reactions CTCAE Grade a Recommended Dose Modification Grade 1 or 2 (tolerable) Continue treatment and monitor as clinically indicated Grade 2 (intolerable) or Grade 3 Interrupt treatment until toxicity is grade 0 or 1 and reduce by one dose level when resuming therapy (see Table 2) Grade 4 Interrupt treatment until toxicity is grade 0 or 1 and reduce by one dose level when resuming therapy (see Table 2).
Consider discontinuation. a Common Terminology Criteria for Adverse Events (CTCAE) Dose modification advice for left ventricular ejection fraction (LVEF) reduction In cases of asymptomatic LVEF reduction by ≥10% from baseline value and less than the institutional lower level of normal (LLN), KOSELUGO treatment should be interrupted until resolution.
Once resolved, reduce KOSELUGO by one dose level when resuming therapy (see Table 2). In patients who develop symptomatic LVEF reduction or a grade 3 or 4 LVEF reduction, KOSELUGO should be discontinued and a prompt cardiology referral should be carried out (see 7 WARNINGS AND PRECAUTIONS).
Dose modification advice for retinal toxicities KOSELUGO treatment should be interrupted in patients diagnosed with retinal pigment epithelial detachment (RPED) or central serous retinopathy (CSR) with reduced visual acuity until resolution; reduce KOSELUGO by one dose level when resuming therapy (see Table 2).
In patients diagnosed with RPED or CSR without reduced visual acuity, ophthalmic assessment should be conducted every 3 weeks until resolution. 90 m2 50 twice daily 35 35 25 25 KOSELUGO® (selumetinib) Page 7 of 43 vein occlusion (RVO), treatment with KOSELUGO should be permanently discontinued (see 7 WARNINGS AND PRECAUTIONS).
02/2026 7 WARNINGS AND PRECAUTIONS 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .......................................................................................... 2 Recommended Dose and Dosage Adjustment .....................................................
4 Administration ........................................................................................................ 5 Missed Dose ..........................................................................................................
8 5 OVERDOSAGE ................................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
KOSELUGO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose adjustments for co-administration with CYP3A4 and CYP2C19 inhibitors Concomitant use of strong or moderate CYP3A4 or CYP2C19 inhibitors is not recommended and alternative agents should be considered. If a strong or moderate CYP3A4 or CYP2C19 inhibitor must be co-administered, the recommended KOSELUGO dose reduction is as follows: If a patient is currently taking 25 mg/m2 twice daily, dose reduce to 20 mg/m2 twice daily.
If a patient is currently taking 20 mg/m2 twice daily, dose reduce to 15 mg/m2 twice daily (see Table 4 and
1 Special Populations ............................................................................................. 1 Pregnancy ....................................................................................................... 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
14 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ................................................................................ 2 Clinical Trial Adverse Reactions ..........................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 20 9 DRUG INTERACTIONS ..................................................................................................
2 Overview ............................................................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions ........................................................................................ 23 KOSELUGO® (selumetinib) Page 3 of 43 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 27 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 27 13 PHARMACEUTICAL INFORMATION ............................................................................
28 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ..................................................................................
29 Neurofibromatosis Type 1 with Inoperable Plexiform Neurofibromas ............................. 29 15 MICROBIOLOGY ............................................................................................................ 35 16 NON-CLINICAL TOXICOLOGY .....................................................................................
35 PATIENT MEDICATION INFORMATION .................................................................................. 37 KOSELUGO® (selumetinib) Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS KOSELUGO® (selumetinib) is indicated for: • The treatment of adult and pediatric patients aged 2 years and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
1 Pediatrics Safety and effectiveness have been established in pediatric patients 3 years of age and older with NF1 who have inoperable PN and information supporting this use is discussed throughout the Product Monograph. This indication was expanded to pediatric patients who are 2 years of age and older, because the safety, efficacy and pharmacokinetics of KOSELUGO in patients who are 2 years of age is expected to be similar to patients at 3 years of age and older.
2 Geriatrics Geriatrics (≥65 years of age): No data are available to Health […]