Bydureon BCise and Valacyclovir Hydrochloride

• Generic Name: exenatide
• Dosage Forms: injection, suspension, extended release
• Other Brand Names: Bydureon BCise, Bydureon Pen, Bydureon Tray, Bydureon, Byetta Prefilled Pen

This medication guide provides information about the Bydureon brand of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.

Bydureon BCise is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is a long-acting form of exenatide.

Bydureon is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Bydureon is not for treating type 1 diabetes.

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

• Generic Name: valacyclovir
• Dosage Forms: n.a.
• Other Brand Names: Valtrex

Treatment of initial episodes of genital herpes in immunocompetent or HIV-infected adults and adolescents.

Episodic treatment of recurrent episodes of genital herpes in immunocompetent or HIV-infected adults and adolescents.

Chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent or HIV-infected adults and adolescents. When used for suppressive therapy in immunocompetent individuals, the risk of heterosexual transmission of genital herpes to susceptible partners is reduced; efficacy for reducing transmission not established in those with multiple partners or in non-heterosexual couples.

CDC and others recommend oral acyclovir, oral famciclovir, or oral valacyclovir as drug of choice for treatment of initial episodes of genital herpes and for episodic treatment or chronic suppressive therapy of recurrent genital herpes.

Treatment of herpes labialis (perioral herpes, cold sores, fever blisters) in adults and adolescents.

Safety and efficacy not established in immunocompromised patients.

Treatment of recurrent mucocutaneous HSV infections in HIV-infected adults.

Chronic suppressive or maintenance therapy (secondary prophylaxis) against recurrence of HSV infections in HIV-infected individuals who have frequent or severe recurrences.

Treatment of acute, localized herpes zoster (shingles, zoster) in adults and adolescents.

Treatment of localized dermatomal herpes zoster in HIV-infected adults or adolescents. If cutaneous lesions are extensive or there is clinical evidence of visceral involvement, IV acyclovir should be used for initial treatment.

Safety and efficacy not established in immunocompromised patients.

Safety and efficacy not established for treatment of disseminated herpes zoster.

Prevention of CMV disease in kidney transplant recipients at high risk (CMV-seropositive donor).

Not recommended for prevention of CMV disease in hematopoietic stem cell transplant (HSCT) recipients because the drug is presumed to be less effective than ganciclovir.

Not recommended for primary prevention of CMV disease in HIV-infected individuals because of an unexplained trend toward increased mortality in clinical studies.