Dosing modifications for adverse reactions1
- Monitor patients for rash throughout the treatment course
- Rash (drug eruption) may be visually indistinguishable from disease progression
- Consider skin biopsy to help make a differential diagnosis
Treatment with POTELIGEO may continue
Consider treating rash, including drug eruption, with topical corticosteroids.
Moderate or severe
Administer at least 2 weeks of topical corticosteroids.
If rash improves to ≤Grade 1, POTELIGEO may be resumed.
Permanently discontinue for life-threatening rash or for any SJS or TEN
For suspected SJS or TEN, stop POTELIGEO; do not resume treatment unless SJS or TEN have been excluded and the cutaneous reaction has been resolved to ≤Grade 1.a
- *Grades are based on CTCAE v.50.
- aLess than 1% of all POTELIGEO-treated patients in clinical trials experienced grade 4 skin adverse reactions; SJS occurred in <1% of patients.1
- SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis
Common signs of infusion reactions
chills | nausea | fever | tachycardia | rigors | headache | vomiting
Moderate or severe
Temporarily interrupt the infusion of POTELIGEO and treat symptoms
- Slow infusion rate by at least 50% when restarting the infusion after symptoms resolve
- If reaction recurs and is not manageable, discontinue infusion
- Prior to subsequent infusions, administer diphenhydramine and acetaminophen
Permanently discontinue POTELIGEO
Use in special populations
No clinically significant changes in the pharmacokinetics of POTELIGEO were observed based on age, renal impairment, or mild/moderate hepatic impairment. As a result, no corresponding dose modifications are required.
- In MAVORIC, 51% of patients treated with POTELIGEO were 65 years of age or older (range: 25 to 101)
- No overall differences in effectiveness were observed between patients 65 or older and younger patients
- Patients 65 or older had a greater number of grade 3 or higher adverse reactions than patients under 65, but the difference was not statistically significant
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- POTELIGEO [package insert]. Kyowa Kirin Inc., Princeton, NJ USA.