Drug Interaction Report

MONITOR: Vosoritide may cause transient decreases in blood pressure. Theoretically, coadministration with antihypertensives, organic nitrates, or agents with hypotensive properties may increase the potential for symptomatic hypotension. In clinical trials, 13% of patients treated with vosoritide experienced a transient decrease in blood pressure compared to 5% of patients on placebo. The median time to onset from injection was 31 (18 to 120) minutes with resolution within 31 (5 to 90) minutes. Two out of 60 (3%) vosoritide-treated patients each had one symptomatic episode of decreased blood pressure with vomiting and/or dizziness compared to 0 of 61 (0%) patients on placebo. Data on this interaction are lacking as patients with significant cardiac or vascular disease and patients on antihypertensive drugs were excluded from vosoritide clinical trials.

MANAGEMENT: Caution is advised during coadministration of vosoritide with blood pressure lowering agents or agents with hypotensive properties. To reduce the risk of low blood pressure and its associated signs and symptoms, patients should have adequate food intake before vosoritide administration and should drink approximately 240 to 300 mL of fluid within the hour prior to vosoritide administration. Patients should be advised to avoid rising abruptly from a sitting or recumbent position and to notify their doctor if they experience fatigue, nausea, dizziness, or lightheadedness. Patients should also avoid driving or operating hazardous machinery until they know how the medications affect them.

MONITOR: Vosoritide may cause transient decreases in blood pressure. In clinical trials, 13% of patients treated with vosoritide experienced a transient decrease in blood pressure compared to 5% of patients on placebo. The median time to onset from injection was 31 (18 to 120) minutes with resolution within 31 (5 to 90) minutes. Two out of 60 (3%) vosoritide-treated patients each had one symptomatic episode of decreased blood pressure with vomiting and/or dizziness compared to 0 of 61 (0%) patients on placebo.

MANAGEMENT: To reduce the risk of low blood pressure and its associated signs and symptoms, patients should have adequate food intake before vosoritide administration and should drink approximately 240 to 300 mL of fluid within the hour prior to vosoritide administration. Patients should be advised to avoid rising abruptly from a sitting or recumbent position and to notify their doctor if they experience fatigue, nausea, dizziness, or lightheadedness.