Assess for change in severity of HIV symptoms and for symptoms of opportunistic infections during therapy.
Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
Monitor bone mineral density in patients who have a history of pathologic bone fracture or are at risk for osteoporosis or bone loss. Calcium and vitamin D supplementation may be beneficial for all patients.
Monitor for signs or symptoms of severe skin or hypersensitivity reactions (severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia). Discontinue Complera immediately if signs develop.
Lab Test Considerations: Monitor viral load and CD4 cell count regularly during therapy.
Assess for hepatitis B virus (HBV). Complera is not approved for administration in patients with HIV and HBV.
Monitor liver function tests before and periodically during therapy, especially in patients with underlying liver disease or marked ↑ transaminase. May cause ↑ serum creatinine, AST, ALT, total bilirubin, total cholesterol, LDL, and triglycerides. May cause lactic acidosis and severe hepatomegaly with steatosis. These events are more likely to occur if patients are female, obese, or receiving nucleoside analogue medications for extended periods of time. Monitor patient for signs (increased serum lactate levels, elevated liver enzymes, liver enlargement on palpation). Therapy should be suspended if clinical or laboratory signs occur.
Calculate creatinine clearance (CCr), urine glucose, and urine protein prior to therapy. CCr should be >70 mL/min before starting therapy. Monitor CCr, urine glucose, and urine protein in all patients periodically during therapy and serum phosphorous in patients at risk for renal impairment. Assess patients with persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness for proximal renal tubulopathy; evaluate renal function promptly.
Emphasize the importance of taking Complera as directed, at the same time each day. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses with a meal if remembered <12 hr from the time it is usually taken, then return to regular schedule. If more than 12 hr from time dose is usually taken, omit dose and resume dosing schedule; do not double doses. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
Advise patient to take antacids 2 hr before or 4 hr after and H2-antagonists 12 hr before or 4 hr after Complera.
Instruct patient that Complera should not be shared with others.
Inform patient that Complera does not cure AIDS or prevent associated or opportunistic infections. Rilpivirine does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the AIDS virus to others. Advise patient that the long-term effects of Complera are unknown at this time.
Advise patient to notify health care professional immediately if symptoms of lactic acidosis (nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) occur.
Inform patients and families of risk of suicidal thoughts and behavior and advise that behavioral changes, emergency or worsening signs and symptoms of depression, unusual changes in mood, or emergence of suicidal thoughts, behavior, or thoughts of self-harm should be reported to health care professional immediately.
Immune reconstitution syndrome may trigger opportunistic infections or autoimmune disorders. Notify health care professional if symptoms occur.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
Rep: Advise patients to notify health care professional if pregnancy is planned or suspected. Advise patient to avoid breast feeding during Complera therapy. Encourage women who become pregnant during Complera therapy to enroll in Antiviral Pregnancy Registry by calling 1-800-258-4263.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.
Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
Decrease in viral load and increase in CD4 cell counts.
emtricitabine/rilpivirine/tenofovir disoproxil fumarate is a sample topic from the Davis's Drug Guide.
Davis’s Drug Guide for Nurses App + Web from F.A. Davis and Unbound Medicine covers 5000+ trade name and generic drugs. Includes App for iPhone, iPad, and Android smartphone + tablet. Handbook covers dosage, side effects, interactions, uses. Davis Drug Guide PDF. Complete Product Information.