Names and pronunciation
(eye-ba-liz′ue-mab) Trogarzo
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Drug reference
(eye-ba-liz′ue-mab) Trogarzo
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Func. class.: HIV antiviral
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Chem. class.: HIV-1 entry inhibitor/ fusion inhibitor
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ACTION: Blocks HIV-1 from infecting CD4, T cells by binding to CD4 and inter- fering with the steps required for the entry of HIV-1 virus into host cells, pre- venting viral transmission
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USES: Human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with mul- tidrug-resistant HIV-1 infection failing their current antiretroviral regimen
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CONTRAINDICATIONS: Hyper- sensitivity Precautions: Autoimmune disease, breastfeeding, Graves’ disease, Guillain- Barré disease, immune reconstitution syndrome, pregnancy, progressive mul- tifocal leukoencephalopathy, immune reconstitution syndrome
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SIDE EFFECTS CNS: Dizziness ENDO: Increased serum glucose and uric acid GI: Nausea, diarrhea INTEG: Rash MISC: Thrombocytopenia, dizziness, rash, hyperglycemia, neutropenia
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INTERACTIONS None known
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DOSAGE AND ROUTES • Adult: IV 2000 mg once, then 800 mg q2wk as part of combination therapy
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Available forms: Sol for infusion 200 mg/1.33 mL
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Administer: IV route • Visually inspect for particulate matter and discoloration before use Dilution • Select the appropriate number of vi- als necessary for either the loading dose (10 vials) or maintenance dose (4 vials) • Withdraw 1.33 mL from each vial and transfer into a 250-mL IV bag of 0.9% sodium chloride for injection. Do not use other diluents • Once diluted, solution should be given immediately • Storage: diluted solution may be stored at room temperature (20°C- 25°C or 68°F-77°F) for up to 4 hr or refrigerated (2°C-8°C or 36°F-46°F) for up to 24 hr. If refrigerated, allow to stand at room temperature for at least 30 min, but no more than 4 hr before use Intermittent IV infusion route: • Do not administer as an IV push or bolus • Administer in the cephalic vein of the patient’s arm or an appropriate vein lo- cated elsewhere • Infuse the loading dose (2000 mg) over no less than 30 min I • If there are no infusion-associated ad- verse reactions, the maintenance doses (800 mg) can be decreased to no less than 15 min • Flush with 30 mL of 0.9% NaCl for in- jection after the completion • Observe for 1 hr after completion for at least the first infusion. If there are no adverse reactions, observation time can be reduced to 15 min Missed doses • If a maintenance dose (800 mg) is missed by 3 days or longer, a loading dose (2000 mg) should be given as early as possible • Resume maintenance dosing (800 mg) q14days thereafter
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Assess: • HIV: monitor CD4+ T-cell count, plasma HIV RNA baseline and periodically • Immune reconstitution syndrome: Moni tor beginning treatment when used with combination antiretrovirals; an inflamma tory response to opportunistic infections may occur • Blood studies: blood glucose, CBC with differential, LFTs, pregnancy test- ing, serum bilirubin (total and direct), serum creatinine/BUN baseline and periodically • Pregnancy/breastfeeding: no ade quate human data available. Report cases of antiretroviral drug exposure to the An tiretroviral Pregnancy Registry, 1-800- 258-4263 or http://www.apregistry.com/. Avoid breastfeeding
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Evaluate: • Therapeutic response: increased CD4+ counts, plasma HIV-1 RNA levels, decreased viral load, slowing progres- sion of HIV-1 infection
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That lab work will be necessary at the start of treatment and periodically thereafter • Pregnancy/breastfeeding: to notify health care provider if pregnancy is planned or suspected; that pregnancy test will be required before starting treatment; to enroll in Antiretroviral Pregnancy Registry, which monitors fe tal outcomes of pregnant women ex posed to this product; not to breastfeed, HIV-1 can be passed to the baby in breast milk • To report nausea, diarrhea if severe • To read the patient information provided • Immune reconstitution syndrome: to inform health care provider immediately of any symptoms of infection • That product is given q2wk as recom- mended by the health care provider; not to change the dosing schedule or any antiretroviral medication without con- sulting the health care provider • To notify health care provider immedi- ately if patient stops taking this product or any other drug in his or her antiretro- viral regimen • That product is not a cure for HIV-1 but controls symptoms and that disease still can be passed to others; to use in combination with other antiretrovirals
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PHARMACOKINETICS Half-life 64 hr
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• Adult: IV 2000 mg once, then 800 mg q2wk as part of combination therapy
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