Names and pronunciation
(lam-i-voo′deen) Epivir, Epivir HBV, Heptovir
Source page 750
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Individual generic drug information
Extracted information for lamiVUDine 3TC only.
(lam-i-voo′deen) Epivir, Epivir HBV, Heptovir
Source page 750
Func. class.: Antiretroviral
Source page 750
Chem. class.: Nucleoside reverse transcriptase inhibitor (NRTI)
Source page 750
Do not confuse: lamiVUDine/lamoTRIgine
Source page 750
ACTION: Inhibits replication of HIV virus by incorporating into cellular DNA by viral reverse transcriptase, thereby terminating cellular DNA chain
Source page 750
USES: HIV-1–related infection in com- bination with at least 2 other antiretrovi- rals; chronic hepatitis B (Epivir HBV)
Source page 750
Unlabeled uses: HIV-1 nonoccupational postexposure prophylaxis, prevention of perinatal HIV transmission
Source page 750
Extracted information for lamiVUDine 3TC only.
CONTRAINDICATIONS: Hyper- sensitivity Precautions: Pregnancy, breastfeeding, children, geriatric patients, granulocyte count <1000/mm3 or HB <9.5 g/dL, renal disease, pancreatitis, peripheral neuropathy
Source page 750
Black Box Warning: Hepatitis B exacer- bation Black Box Warning: Hepatitis B exacer- bation: fatigue, anorexia, pruritus, jaun- dice during and for several months af- ter discontinuation; AST, ALT, bilirubin; amylase, lipase, triglycerides periodi- cally during treatment • Children for pancreatitis: abdominal pain, nausea, vomiting, neuropathy; dis continuing may be required; monitor amylase, lipase; use cautiously in children • Lactic acidosis, severe hepatomeg- aly with steatosis: obtain baseline LFTs; if elevated, discontinue treatment; dis continue even if LFTs are normal if lactic acidosis, severe hepatomegaly develops; may be fatal, especially in women • Pregnancy/breastfeeding: Epivir is a drug that is used in pregnancy to treat HIV; enroll patient in the Antiretroviral Pregnancy Registry at 800-258-4263; do not breastfeed. Obtain pregnancy test prior to starting therapy
Source pages 750, 752
SIDE EFFECTS CNS: Fever, headache, malaise, dizziness, insomnia, depression, fatigue, chills, sei zures, peripheral neuropathy, paresthesias EENT: Taste change, hearing loss, photophobia GI: Nausea, vomiting, diarrhea, anorexia, cramps, dyspepsia, hepatomegaly with steatosis; pancreatitis (more common in children) HEMA: Neutropenia, anemia, thrombocy topenia INTEG: Rash MS: Myalgia, arthralgia, pain RESP: Cough SYST: Lactic acidosis, anaphylaxis, Stevens-Johnson syndrome, immune reconstitution syndrome L
Source page 751
INTERACTIONS Decrease: both products—zalcitabine; avoid concurrent use Increase: pancreatitis—other products that cause pancreatitis Increase: lamotrigine level—sulfamethox- azole-trimethoprim • Do not use with emtricitabine, duplication Decrease: lamiVUDine effect—interferons Drug/Lab Test Increase: ALT, bilirubin Decrease: HB, neutrophil, platelet count
Source page 751
Extracted information for lamiVUDine 3TC only.
DOSAGE AND ROUTES Initiation of therapy for HIV treatment For adults, initiation of treatment immedi- ately (or as soon as possible) after HIV diagnosis is recommended in all patients to reduce the risk of disease progression and to prevent the transmission of HIV, including perinatal transmission and transmission to sexual partners. Starting antiretroviral ther- apy early is particularly important for patients with AIDS-defining conditions, those with acute or recent HIV infection, and individuals who are pregnant; delaying therapy in these subpopulations has been associated with high risks of morbidity, mor- tality, and HIV transmission Antiretroviral drug-resistance testing • Genotypic drug-resistance testing is recommended prior to initiation of ther- apy and prior to changing therapy for treatment failure • Phenotypic resistance testing may be used in conjunction with the genotypic test for patients with known or suspected com- plex drug-resistance mutation patterns • HIV-1 proviral DNA resistance testing is available for use in patients with HIV RNA concentrations below the limits of detection or with low-level viremia (i.e., <1000 copies/mL), where genotypic testing is unlikely to be successful; how- ever, the clinical utility of this assay has not been fully determined • Pediatric guidelines are also available Therapy for HIV treatment • For pregnant and nonpregnant patients, lamivudine plus tenofovir alafenamide, tenofovir disoproxil fumarate, or abaca- vir (HLA-B*5701–negative patients only) are preferred 2-NRTI backbones • In nonpregnant patients unable to take abacavir or tenofovir, lamivudine may be given with dolutegravir (if pretreatment HIV RNA is <500,000 copies/mL and without HBV coinfection) or darunavir boosted with ritonavir (if without HBV coinfection) • Lamivudine is used as part of a 3-drug combination antiretroviral regimen with zidovudine and either nevirapine or raltegravir for the prevention of perinatal HIV transmission in neonates with pre- sumed HIV exposure or those at high risk for perinatal HIV transmission (i.e., mother has not received antepartum an- tiretroviral therapy) • Pediatric guidelines are also available Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: hepatitis B vi- rus, human immunodeficiency virus (HIV) HBV infection (Epivir-HBV) Adult PO: 100mg daily HIV infection (Epivir) Adult PO: 150mg twice daily or 300mg once daily Renal dose • Adult/adolescents: PO CCr 30-49 mL/ min: Epivir 150 mg/day; Epivir HBV 100 mg 1st dose, then 50 mg/day; CCr 15-29 mL/min: Epivir 150 mg 1st dose, then 100 mg/day; Epivir HBV 100 mg 1st dose, then 25 mg/day; CCr 5-14 mL/ min: Epivir 150 mg 1st dose, then 50 mg/day; Epivir HBV 35 mg 1st dose, then 15 mg/day; CCr <5 mL/min: Epivir 50 mg 1st dose, then 25 mg/day; Epivir HBV 35 mg 1st dose, then 10 mg/day
Source pages 750, 751
Available forms: (Epivir) oral sol 10 mg/mL; tabs 150, 300 mg; (Epivir HBV) oral sol 5 mg/mL; tabs 100 mg
Source page 751
Administer: • PO daily or bid, without regard to meals • Epivir and Epivir HBV are not inter changeable • Use with other antiretrovirals only; do not use triple antiretroviral with abaca vir or didanosine; resistance may occur • Store in cool environment; protect from light
Source page 751
Extracted information for lamiVUDine 3TC only.
Assess: • HIV: Test for HIV before starting treat- ment, blood counts q2wk; watch for neu- tropenia, thrombocytopenia, HB, CD4, viral load; if low, therapy may have to be discontinued and restarted after hemato- logic recovery; blood transfusions may be required; assess for lessening of symptoms; if HBV is present, a higher dose of Epivir HBV is needed • Monitor CBC, with differential, plate- lets, blood glucose, cholesterol/lipids, urinalysis, BUN, creatinine baseline and periodically during treatment
Source pages 751, 752
Evaluate: • Therapeutic response: decreasing symptoms of HIV, CD4, viral load
Source page 752
CLINICAL CONSIDERATIONS
Source page 751
Patient and caregiver information: • That GI complaints, insomnia resolve after 3-4 wk of treatment • That product is not a cure for HIV but will control symptoms; that compliance is necessary; to take as directed; to com- plete full course of treatment even if feeling better • To notify prescriber of sore throat, swol len lymph nodes, malaise, fever, peripheral neuropathy; other infections may occur • To report symptoms of pancreatitis, immune reconstitution syndrome imme diately • That patient is still infective, may pass HIV virus on to others • That follow-up visits must be continued since serious toxicity may occur; that blood counts must be done • That other products may be necessary to prevent other infections • That product may cause fainting or dizziness • Pregnancy/breastfeeding: to enroll in the Antiretroviral Pregnancy Registry at 800-258-4263; not to breastfeed, a preg nancy test will be required prior to begin ning therapy in those who can become pregnant
Source page 752
Extracted information for lamiVUDine 3TC only.
PHARMACOKINETICS Rapidly absorbed, distributed to extra- vascular space, excreted unchanged in urine, protein binding <36%, half-life 5-7 hr, child 2 hr, peak 3.2 hr
Source page 751
Filter the extracted dose blocks for this individual drug.
tality, and HIV transmission Antiretroviral drug-resistance testing
• Adult/adolescents: PO CCr 30-49 mL/ min: Epivir 150 mg/day; Epivir HBV 100 mg 1st dose, then 50 mg/day; CCr 15-29 mL/min: Epivir 150 mg 1st dose, then 100 mg/day; Epivir HBV 100 mg 1st dose, then 25 mg/day; CCr 5-14 mL/ min: Epivir 150 mg 1st dose, then 50 mg/day; Epivir HBV 35 mg 1st dose, then 15 mg/day; CCr <5 mL/min: Epivir 50 mg 1st dose, then 25 mg/day; Epivir HBV 35 mg 1st dose, then 10 mg/day
Candidate age grouping · source pages 750, 751