Rotateq

/ MSD

FOR ORAL USE ONLY. NOT FOR INJECTION.
The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

The prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3 and G4.

A demonstrated history of hypersensitivity to any component of the vaccine. Infants who develop symptoms suggestive of hypersensitivity after receiving one dose should not receive further doses.

Prior to administration, the current health status and previous vaccination history of the infant, including whether there has been a reaction to a previous dose of RotaTeq or other rotavirus vaccine should be verified. Use should be delayed in case of febrile illness except when withholding the vaccine entails a greater risk. May not result in complete protection in all recipients. Post-exposure prophylaxis: No clinical data are available. Immunocompromised populations: No safety or efficacy data are available. Infants with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system. Infants on immunosuppressive therapy (including high-dose systemic corticosteroids). May be administered to infants who are being treated with topical corticosteroids or inhaled steroids. Infants with primary and acquired immunodeficiency states. See literature. Infants who have received a blood transfusion or blood products, including immunoglobulins within 42 days. History of GI disorders. See literature. Infants with immunodeficient close contacts such as: Malignancies or who are otherwise immunocompromised or receiving immunosuppressive therapy.
See prescribing information for full details.

To be reported by the caregiver: GI disorders: Intussusception; Hematochezia; Skin and subcutaneous tissue disorders: Urticaria; Infections and infestations; Kawasaki disease.

Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.