Monitoring and Preventive Measures Sample Clauses

Monitoring and Preventive Measures. In early dose escalation of Study 0401, a relationship was observed between MIRV plasma exposure and likelihood of an ocular event and response. Exposure-response modeling suggested that a dose of 6.0 mg/kg AIBW provided adequate exposure for response while also maintaining overall exposure within a range that decreased the potential for ocular AEs. Due to the observation of ocular disorders consistent with reversible keratopathy/corneal epitheliopathy in patients treated with MIRV, ocular function will be carefully monitored. Ocular symptom assessments will be performed at baseline and at Day 1 of every cycle thereafter (Table 2). Complete ophthalmologic exams will be performed in all patients at baseline and every other cycle thereafter if there is a TEAE reported. Patients are advised to avoid using contact lenses while on MIRV. Baby shampoo and a soft cloth should be used to clean the eyes, and a warm compress at bedtime may be used to decrease any possible inflammation on the eyelid’s surface. Please refer to Section 5.4.2.1 and Section 5.4.2.2 for details on the prophylactic use of steroid eye drops and lubricating artificial tears. The use of UVA/UVB sunglasses is recommended in full daylight during the study. The use of temporary lower punctal plugs to increase lubrication of the eyes is optional if lubricating artificial tears and corticosteroid eye drops are not sufficient. If patients report signs or symptoms of ocular disorders, including, but not limited to, blurred vision or eye irritation, the management and dose modification guidelines outlined in Table 5 should be followed.
Sample 1
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Related to Monitoring and Preventive Measures

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