healthcare professional
KOSELUGO® is indicated for the treatment of symptomatic, inoperable PN in paediatric patients with NF1 aged ≥ 3 years.1 Please refer to the KOSELUGO® SmPC for full prescribing information
KOSELUGO® is available in 25 mg and 10 mg capsules.1
Dosing is rounded to the nearest achievable 5 mg or 10 mg dose (up to a maximum single dose of 50 mg).1
Dosing is rounded to the nearest achievable 5 mg or 10 mg dose (up to a maximum single dose of 50 mg).1
KOSELUGO® should be taken orally twice daily (approximately every 12 hours).1
KOSELUGO® is administered orally and can be taken with or without food.1 Capsules should be swallowed whole with water and should not be chewed, dissolved or opened.1
KOSELUGO® should not be administered to patients who are unable or unwilling to swallow the capsule whole.1 Patients should be assessed for their ability to swallow a capsule before starting treatment.1
If a dose of KOSELUGO® is missed, it should only be taken if it is more than 6 hours until the next scheduled dose.1
If vomiting occurs after KOSELUGO® is administered, an additional dose should not be taken.1 The patient takes the next scheduled dose at the normal time.1
KOSELUGO® should not be administered to patients who are unable or unwilling to swallow the capsule whole.1 Patients should be assessed for their ability to swallow a capsule before starting treatment.1
If a dose of KOSELUGO® is missed, it should only be taken if it is more than 6 hours until the next scheduled dose.1
If vomiting occurs after KOSELUGO® is administered, an additional dose should not be taken.1 The patient takes the next scheduled dose at the normal time.1
Adapted from: KOSELUGO® SmPC 2024.1
BSA, body surface area.
BSA, body surface area.
Based on clinical trials, no dose adjustment is recommended in patients with mild, moderate, severe renal impairment or those with end-stage renal disease.1
No dose adjustment is required for patients with mild hepatic impairment.1 In patients with moderate hepatic impairment, the starting dose should be reduced to 20 mg/m2 BSA, twice daily.1 KOSELUGO® is contraindicated in patients with severe hepatic impairment.1
No specific adjustment to starting dose is recommended in paediatric Asian patients; however, these patients should be closely monitored for adverse events.1
The safety and efficacy of KOSELUGO® in children < 3 years of age has not been established. No data are available.
No dose adjustment is required for patients with mild hepatic impairment.1 In patients with moderate hepatic impairment, the starting dose should be reduced to 20 mg/m2 BSA, twice daily.1 KOSELUGO® is contraindicated in patients with severe hepatic impairment.1
No specific adjustment to starting dose is recommended in paediatric Asian patients; however, these patients should be closely monitored for adverse events.1
The safety and efficacy of KOSELUGO® in children < 3 years of age has not been established. No data are available.
Dose adjustments, interruptions or permanent discontinuations may be required based on individual safety and tolerability.1
If dose reductions are required, the daily dose may be split into two separate administrations of different strengths, or treatment may be given as a once-daily dose, according to the table below.1
If dose reductions are required, the daily dose may be split into two separate administrations of different strengths, or treatment may be given as a once-daily dose, according to the table below.1
Adapted from: KOSELUGO® SmPC 2024.1
*Permanently discontinue treatment in patients unable to tolerate KOSELUGO® after two dose reductions.1
BSA, body surface area.
*Permanently discontinue treatment in patients unable to tolerate KOSELUGO® after two dose reductions.1
BSA, body surface area.
If treatment-related adverse reactions occur, dose modifications can be made depending on the severity, using the Common Terminology Criteria for Adverse Events (CTCAE).1
Adapted from: KOSELUGO® SmPC 2024.1
CTCAE, Common Terminology Criteria for Adverse Events.
CTCAE, Common Terminology Criteria for Adverse Events.
BSA, body surface area; CTCAE, Common Terminology Criteria for Adverse Events.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Please report any adverse events via your national reporting system. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com or by calling 0800 783 0033.
Please report any adverse events via your national reporting system. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com or by calling 0800 783 0033.