Managing Adverse Reactions 1

Manage certain adverse reactions with dose modifications

Dosage adjustment chart for EMRELIS
EMRELIS dosing modifications chart

Adverse reaction

Severity*

Grade 2 or 3

Dosage modification

Withhold EMRELIS until recovery to Grade ≤1

Resume EMRELIS at the next lower dose level

Severity*

Grade 4

Dosage modification

Permanently discontinue 
EMRELIS

Severity*

Grade 1

Dosage modification

Withhold EMRELIS and consider corticosteroids as soon as ILD/pneumonitis is suspected

Resume EMRELIS upon radiographic resolution

Severity*

Grade ≥2

Dosage modification

Permanently discontinue EMRELIS

Severity*

Grade 2

Dosage modification

 Withhold EMRELIS

 Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops)

 Resume EMRELIS at the same dose at the discretion of the healthcare provider

Severity*

Grade 3 or 4

Dosage modification

Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops)

Permanently discontinue EMRELIS

Severity*

Grade 1-3

Dosage modification

Interrupt EMRELIS infusion and administer supportive treatment

Resume infusion at a 50% rate reduction. Increase infusion rate as tolerated for subsequent doses

For patients who experience an IRR, administer premedications prior to all future doses (see table below)

Severity*

Grade 4

Dosage modification

Permanently discontinue EMRELIS

Administer supportive treatment

Severity*

Grade ≥2

Dosage modification

First occurrence

Withhold EMRELIS until recovery to Grade ≤1 

Resume EMRELIS at the same dose level

Subsequent occurrence

Withhold EMRELIS until recovery to Grade ≤1 

Resume EMRELIS at the next lower dose level

Severity*

Grade 3

Dosage modification

First occurrence

Withhold EMRELIS until recovery to Grade ≤1 

Resume EMRELIS at the same dose

Subsequent occurrence

Withhold EMRELIS until recovery to Grade ≤1 

Resume EMRELIS at the next lower dose level

Severity*

Grade 4

Permanently discontinue 
EMRELIS

*Adverse reactions were graded using NCI CTCAE version 4.03.

Recommended premedications for patients who experience infusion-related reactions for subsequent infusions1

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