General: Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs, including IMCIVREE^®.

Psychiatric: IMCIVREE^® may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour. Consider discontinuing IMCIVREE^® if patients experience suicidal thoughts or behaviours or if clinically significant or persistent depression symptoms occur.

Reproductive Health: Disturbance in sexual arousal may occur in patients treated with IMCIVREE^®. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Skin: Increased skin pigmentation occurred in majority of patients treated with IMCIVREE^®. IMCIVREE^® may cause darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE^® to monitor pre-existing and new skin pigmentary lesions. IMCIVREE^® should not be used in patients with a personal medical history or a family history of melanoma or pre-melanoma skin lesions.

Pregnancy
Breast-feeding
Renal impairment
Pediatrics
Geriatrics

For more information:
Consult the product monograph at www.rhythmtx.ca/product for adverse reactions, drug interactions and dosing. The product monograph is also available through our medical department. Call us at 1-833-789-6337.