PEMAZYRE dosing and administration — 5 of 5

Specific dose modifications for PEMAZYRE (2/2)

Dose modifications may be needed in cases of hyperphosphataemia and serous retinal detachment1

Dose modifications for serous retinal detachment1

Asymptomatic

Continue PEMAZYRE at current dose

Monitoring should be performed as per the Warnings and Precautions (Section 4.4 of SmPC)

Moderate decrease in visual acuity

(Best corrected visual acuity 20/40 or better or ≤3 lines decreased vision from baseline); limiting instrumental activities of daily living

Withhold until resolution

If improved on subsequent examination, PEMAZYRE should be resumed at the next lower dose level

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Marked decrease in visual acuity

(Best corrected visual acuity worse than 20/40 or >3 lines decreased vision from baseline up to 20/200); limiting activities of daily living

Withhold until resolution

If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Visual acuity worse than 20/200 in affected eye

Limiting activities of daily living

Withhold until resolution

If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Continue PEMAZYRE at current dose

Monitoring should be performed as per the Warnings and Precautions (Section 4.4 of SmPC)

Withhold until resolution

If improved on subsequent examination, PEMAZYRE should be resumed at the next lower dose level

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Withhold until resolution

If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Withhold until resolution

If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower

If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered

Adapted from reference 1.
For further information, please refer to the PEMAZYRE Summary of Product Characteristics.1