Prescription Drug Information: KOSELUGO
KOSELUGO- selumetinib capsule
AstraZeneca Pharmaceuticals LP
1 INDICATIONS AND USAGE
KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage of KOSELUGO is 25 mg/m2 orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity.
KOSELUGO can be taken with or without food [see Clinical Pharmacology (12.3)]. The recommended dose of KOSELUGO based on body surface area (BSA) is shown in Table 1.
| |
Body Surface Area * | Recommended Dosage |
0.55 – 0.69 m2 | 20 mg in the morning and 10 mg in the evening |
0.70 – 0.89 m2 | 20 mg twice daily |
0.90 – 1.09 m2 | 25 mg twice daily |
1.10 – 1.29 m2 | 30 mg twice daily |
1.30 – 1.49 m2 | 35 mg twice daily |
1.50 – 1.69 m2 | 40 mg twice daily |
1.70 – 1.89 m2 | 45 mg twice daily |
≥ 1.90 m2 | 50 mg twice daily |
Swallow KOSELUGO capsules whole with water. Do not chew, dissolve or open capsule.
Do not administer to patients who are unable to swallow a whole capsule.
Do not take a missed dose of KOSELUGO unless it is more than 6 hours until the next scheduled dose.
If vomiting occurs after KOSELUGO administration, do not take an additional dose, but continue with the next scheduled dose.
2.2 Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 2.
| ||||
Body Surface Area | First Dose Reduction (mg/dose) | Second Dose Reduction * (mg/dose) | ||
Morning | Evening | Morning | Evening | |
0.55 – 0.69 m2 | 10 | 10 | 10 mg once daily | |
0.70 – 0.89 m2 | 20 | 10 | 10 | 10 |
0.90 – 1.09 m2 | 25 | 10 | 10 | 10 |
1.10 – 1.29 m2 | 25 | 20 | 20 | 10 |
1.30 – 1.49 m2 | 25 | 25 | 25 | 10 |
1.50 – 1.69 m2 | 30 | 30 | 25 | 20 |
1.70 – 1.89 m2 | 35 | 30 | 25 | 20 |
≥ 1.90 m2 | 35 | 35 | 25 | 25 |
Dosage modifications for adverse reactions are in Table 3.
Severity of Adverse Reaction | Recommended Dosage Modifications for KOSELUGO |
---|---|
Cardiomyopathy [see Warnings and Precautions (5.1)] | |
| Withhold until resolution. Resume at reduced dose. |
| Permanently discontinue. |
Ocular Toxicity [see Warnings and Precautions (5.2)] | |
| Withhold until resolution. Resume at reduced dose. |
| Permanently discontinue. |
Gastrointestinal Toxicity [see Warnings and Precautions (5.3)] | |
| Withhold until improved to Grade 0 or 1. Resume at same dose. Permanently discontinue if no improvement within 3 days. |
| Permanently discontinue. |
| Permanently discontinue. |
Skin Toxicity [see Warnings and Precautions (5.4)] | |
| Withhold until improvement. Resume at reduced dose. |
Increased Creatine Phosphokinase (CPK) [see Warnings and Precautions (5.5)] | |
| Withhold until improved to Grade 0 or 1. Resume at reduced dose. Permanently discontinue if no improvement within 3 weeks. |
| Permanently discontinue. |
Other Adverse Reactions [see Adverse Reactions (6.1)] | |
| Withhold KOSELUGO until improved to Grade 0 or 1. Resume at reduced dose. |
| Withhold KOSELUGO until improved to Grade 0 or 1. Resume at reduced dose. Consider discontinuation. |
* Per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
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