Common use of Dose Modifications Clause in Contracts

Dose Modifications. There are no dose reductions for pembrolizumab. − Adverse events (both non-serious and serious) associated with pembrolizumab exposure may represent an immunologic etiology. These adverse events may occur shortly after the first dose or several months after the last dose of treatment. Pembrolizumab must be withheld for drug-related toxicities and severe or life-threatening AEs as per Table 9. • AE37 dose modifications − A reduction in the dose of AE37 may be required depending upon the local reaction to multiple doses (see Table 7). AE37 is given as split dose intradermal injections at two sites on the upper thigh 5 cm apart. If there is a large local reaction (>100 mm) such that the reaction at the two sites begins to merge, the subsequent dose of AE37 is reduced by one half (i.e., dose level – 1). See Table 7 and Table 8. − Vaccine-related toxicities requiring a ≥ 2 week delay in starting Cycle 2 or subsequent cycles will result in a dose level reduction for subsequent AE37 vaccinations. See Section 7.1.4, Table 7 and Table 8. Table 7. AE37 vaccine local reaction assessment Local skin reaction at vaccination sites Grade 1 Grade 2 Grade 3 Grade 4 Table 8. Dose levels for AE37 vaccine 1000 mcg 500 mcg 250 mcg 125 mcg Discontinue