Drug Interactions between Cervarix and letrozole / ribociclib

MONITOR: Coadministration with ribociclib may increase the plasma concentrations and pharmacologic effects of drugs that are substrates of CYP450 3A4. The proposed mechanism is decreased clearance due to ribociclib-mediated inhibition of CYP450 3A4 metabolism. In healthy study subjects, administration of midazolam, a sensitive CYP450 3A4 substrate, with multiple 400 mg daily doses of ribociclib increased the midazolam peak plasma concentration (Cmax) and systemic exposure (AUC) by 2.1-fold and 3.8-fold, respectively, compared to midazolam administered alone. When given at a clinically relevant dose of 600 mg daily, ribociclib is predicted to increase midazolam Cmax and AUC by 2.4-fold and 5.2-fold, respectively.

MANAGEMENT: Caution is advised when ribociclib is used concomitantly with drugs that undergo metabolism by CYP450 3A4, particularly those with a narrow therapeutic range. Dosage adjustments as well as clinical and laboratory monitoring may be appropriate for some drugs whenever ribociclib is added to or withdrawn from therapy.

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MONITOR: The administration of inactivated, killed, or otherwise noninfectious vaccines to immunosuppressed patients is generally safe but may be associated with a diminished or suboptimal immunologic response due to antibody inhibition. Such patients may include those who have recently received or are receiving immunosuppressive agents, antilymphocyte globulins, alkylating agents, antimetabolites, radiation, some antirheumatic agents, high dosages of corticosteroids or adrenocorticotropic agents (e.g., greater than or equal to 2 mg/kg/day or 20 mg/day of prednisone or equivalent for 14 consecutive days or more), or long-term topical or inhaled corticosteroids.

MANAGEMENT: In general, the U.S. Department of Public Health Advisory Committee on Immunization Practices (ACIP) recommends that inactivated or killed vaccines be administered to non-HIV immunosuppressed patients according to the same guidelines as for healthy patients. However, higher dosages, more frequent boosters, and/or serological testing may be required in some cases. Local guidelines and prescribing information for individual vaccines should be consulted. For Haemophilus influenzae b vaccine, some experts recommend that it be administered at least 2 weeks before starting or 3 months after discontinuing chemotherapy when used in patients with Hodgkin's disease. For rabies vaccine, some authorities suggest that immunosuppressive agents should generally be avoided during postexposure therapy except when absolutely necessary for the treatment of other conditions. For SARS-CoV-2 (COVID-19) vaccines, vaccination should generally be completed at least 2 weeks before initiation or resumption of immunosuppressive therapies; however, decisions to delay or temporarily withhold immunosuppressive therapy to complete COVID-19 vaccination should consider the individual's risks relative to their underlying condition. Some authorities recommend administering the COVID-19 vaccine approximately 4 weeks prior to the next scheduled therapy for those on B-cell-depleting therapies on a continuing basis. Additional shots, boosters, and even revaccination may be appropriate depending on age, prior COVID-19 vaccine formulation(s) received, current or planned immunosuppressive therapy, and other factors in individuals with moderate to severe immune compromise due to medical conditions or immunosuppressive medications or treatments (e.g., solid organ transplant recipients on immunosuppressive therapy; patients on active treatment for solid tumor and hematologic malignancies). Vaccines may generally be administered to patients receiving corticosteroids as replacement therapy (e.g., for Addison's disease).

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