Drug Interactions between FluMist Quadrivalent and Kisqali Femara Co-Pack

GENERALLY AVOID: The administration of live, attenuated virus or bacterial vaccines during immunosuppressant or intense antineoplastic therapy may be associated with a risk of disseminated infection due to enhanced replication of vaccine virus or bacteria in the presence of diminished immune competence. Patients may be immunosuppressed if they have recently received or are receiving 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. These patients may also have increased adverse reactions and decreased or suboptimal immunologic response to vaccines. Data concerning the use of live influenza virus vaccines in immunosuppressed patients are limited. In a study consisting of 57 HIV-infected subjects with a median CD4 cell count of 541 cells/mm3 and 54 HIV-negative adults aged 18 to 58 years, no serious adverse events were reported during the one-month follow-up period after administration of a live influenza virus vaccine (FluMist intranasal spray). Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on day 5 only and none of the HIV-negative vaccine recipients. No adverse effects on HIV viral load or CD4 counts were identified following vaccine administration. The effectiveness of live influenza virus vaccines in preventing influenza illness in HIV-infected individuals has not been evaluated.

MANAGEMENT: Administration of live influenza virus vaccines to immunocompromised persons should be based on careful consideration of potential benefits and risks. In general, live attenuated vaccines should preferably not be used in patients receiving immunosuppressive therapy or cancer chemotherapy. Vaccination should be deferred until after such therapy is discontinued and immune function has been restored, usually 4 to 12 weeks after stopping immunosuppressive therapy. A longer waiting period may be necessary following treatment with agents that have a prolonged elimination half-life (e.g., leflunomide, teriflunomide). Current local immunization guidelines should be consulted for recommendations. In patients who have recently been vaccinated, such therapy should not be initiated for at least 2 weeks (may be longer in some cases; refer to individual product labeling). However, the decision to vaccinate with a live influenza virus vaccine should be considered on an individual basis. Use of the inactivated form of the vaccine may be a safer alternative in some patients. Vaccines may generally be administered to patients receiving corticosteroids as replacement therapy (e.g., for Addison's disease).

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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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