Treatment of HIV infection in combination with other agents.
Action
Lamivudine– After intracellular conversion to its active form (lamivudine-5-triphosphate), inhibits viral DNA synthesis by inhibiting the enzyme reverse transcriptase.
Raltegravir Inhibits HIV-1 integrase, which is required for viral replication.
Therapeutic Effect(s):
Slows the progression of HIV infection and decreases the occurrence of its sequelae.
Increases CD4 cell counts and decreases viral load.
Pharmacokinetics
Absorption: Lamivudine– Well absorbed after oral administration (86% in adults, 66% in infants and children); raltegravir– Unknown.
Distribution: Lamivudine– Distributes into the extravascular space. Some penetration into CSF; remainder of distribution unknown; raltegravir–
Metabolism and Excretion: Lamivudine– Mostly excreted unchanged in urine; <5% metabolized by the liver; raltegravir– Mostly metabolized by the uridine diphosphate glucuronosyltransferase (UGT) A1A enzyme system; 23% excreted in urine as parent drug and metabolite.
Administration with antacids, containing magnesium or aluminum ↓ absorption of raltegravir; separate administration of raltegravir and magnesium- or aluminum-containing antacids by ≥6 hr.
Route/Dosage
PO (Adults and Children ≥16 yr and children 6–16 yr weighing ≥ 30 kg): Lamivudine 150 mg/ raltegravir 300 mg twice daily.
Assess patient for change in severity of HIV symptoms and for symptoms of opportunistic infections during therapy.
Monitor for anxiety, depression (especially in patients with a history of psychiatric illness), suicidal ideation, and paranoia during therapy.
Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
Assess patient, especially pediatric patients, for signs of pancreatitis (nausea, vomiting, abdominal pain) periodically during therapy. May require discontinuation of therapy.
Monitor patient for signs and symptoms of peripheral neuropathy (tingling, burning, numbness, or pain in hands or feet); may be difficult to differentiate from peripheral neuropathy of severe HIV disease. May require discontinuation of therapy.
Upon discontinuation, monitor ALT and for signs and symptoms of hepatitis B for several mo. Discontinuation of lamivudine has caused exacerbations of hepatitis B.
Lab Test Considerations: Monitor viral load and CD4 levels before and periodically during therapy.
Monitor serum amylase, lipase, and triglycerides periodically during therapy. Elevated serum levels may indicate pancreatitis and require discontinuation.
Monitor liver function. May cause ↑ levels of AST, ALT, CPK, bilirubin, and alkaline phosphatase, which usually resolve after interruption of therapy. Lactic acidosis may occur with hepatic toxicity causing hepatic steatosis; may be fatal, especially in women.
PO Administer 1 tablet twice daily without regard to food, with other antiretroviral agents.
Patient/Family Teaching
Emphasize the importance of taking Dutrebis as directed, at evenly spaced times throughout day. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Instruct patient that Dutrebis should not be shared with others.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Inform patient that Dutrebis does not cure AIDS or prevent associated or opportunistic infections. Dutrebis does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and to avoid sharing needles or donating blood to prevent spreading the AIDS virus to others. Advise patient that the long-term effects of Dutrebis are unknown at this time.
Advise patient to notify health care professional if they develop any unusual symptoms, if any known symptom persists or worsen, or if signs and symptoms of rhabdomyolysis (unexplained muscle pain, tenderness, weakness), rash, or depression or suicidal thoughts occur.
Immune reconstitution syndrome may trigger opportunistic infections or autoimmune disorders (Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, or tuberculosis). Notify health care professional if symptoms occur.
Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
Rep: Instruct females using hormonal contraceptives to use an alternative nonhormonal method of contraception. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding. If pregnant patient is exposed to Dutrebis , register patient in Antiretroviral 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.
Evaluation/Desired Outcomes
Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
Decrease in viral load and improvement in CD4 cell counts.
lamivudine/raltegravir is a sample topic from the Davis's Drug Guide.
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