Adynovate recombinant and Cytomegalovirus Immune Globulin IV

• Generic Name: antihemophilic factor
• Dosage Forms: n.a.
• Other Brand Names: Advate, Adynovate, Afstyla, Eloctate with Fc Fusion Protein, Helixate FS, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Recombinate, Xyntha, Hemofil-M, Koate-DVI, Monoclate-P, Jivi, Obizur

Adynovate is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A. Recombinant this medicine works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant Adynovate is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Recombinant Adynovate is not for use in people with von Willebrand disease.

Recombinant Adynovate may also be used for purposes not listed in this medication guide.

• Generic Name: cytomegalovirus immune globulin
• Dosage Forms: n.a.
• Other Brand Names: CytoGam

CMV prophylaxis in kidney transplant recipients at risk for primary CMV infection and disease (i.e., CMV-seronegative recipients of a kidney from a CMV-seropositive donor). Generally used in conjunction with an antiviral (e.g., acyclovir, ganciclovir); has been used alone.

CMV prophylaxis in liver, lung, pancreas, or heart transplant recipients. Usually used in conjunction with an antiviral (e.g., ganciclovir, acyclovir).

Optimum regimens for CMV prophylaxis based on type of organ being transplanted and degree of risk for CMV infection or disease not identified, especially for those at greatest risk (e.g., CMV-seronegative recipients of organs from CMV-seropositive donors, patients receiving muromonab-CD3 [OKT3 monoclonal antibodies] or other immunosuppressive therapy).

Has been used in individuals undergoing allogeneic BMT in an attempt to prevent primary CMV infection in those who are CMV-seronegative prior to transplant or to prevent or attenuate secondary CMV disease (reactivation of CMV) in individuals who are CMV-seropositive prior to transplant.

Most effective regimen for CMV prophylaxis in allogeneic BMT patients at risk for CMV infection and disease not established; conflicting results regarding possible benefits of CMV-IGIV prophylaxis in this patient population.

Has been used in conjunction with ganciclovir for treatment of CMV pneumonitis in allogeneic BMT recipients or CMV pneumonitis in solid organ transplant recipients (e.g., liver transplant patients). Additional study needed to determine whether combined ganciclovir and CMV-IGIV therapy has any effect on long-term survival rate in allogeneic BMT patients who develop CMV pneumonitis.

Do not use alone for treatment of CMV pneumonia in BMT recipients.

Has been used in limited number of pregnant women with primary CMV infection in an attempt to treat or prevent congenital CMV infection.

Not currently recommended for prevention of maternal-fetal transmission of CMV; additional study needed to evaluate possible benefits and risks of antenatal CMV-IGIV.

Potential role, if any, for prevention or treatment of CMV infection or disease in HIV-infected individuals not evaluated to date. Recommendations from CDC, National Institutes of Health (NIH), and HIV Medicine Association of the Infectious Diseases Society of America (IDSA) regarding CMV prophylaxis and treatment in such individuals include information on antivirals, but do not address CMV-IGIV.