HIV-1 infection, treatment: IV: Initial: 2 g as a single dose, followed by a maintenance dose of 800 mg every 14 days thereafter.
Missed dose: If a maintenance dose (800 mg) is missed by ≥3 days beyond the originally scheduled dosing day, a loading dose (2 g) should be given as soon as possible. Resume maintenance dosing every 14 days thereafter.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Trogarzo: Ibalizumab-uiyk 150 mg/mL (1.33 mL) [contains polysorbate 80]
No
Each 2 mL vial delivers approximately 1.33 mL containing 200 mg of ibalizumab.
IV: For IV administration only. Administer loading dose by IV infusion; maintenance dose may be administered by IV infusion or IV push (undiluted). Administer in the cephalic vein, or if not accessible, an appropriate vein elsewhere may be used. When administering IV push, allow vials to reach room temperature (~5 minutes) and then administer immediately.
Administer initial infusion (loading dose) over ≥30 minutes. Observe patient for 1 hour after completion of initial infusion. If no infusion-associated adverse reactions are observed, subsequent maintenance doses may be administered as an IV infusion over ≥15 minutes or IV push over 30 seconds and postinfusion observation time may be reduced to 15 minutes. Flush with 30 mL NS after completion of each infusion or 2 to 5 mL of NS after IV push administration.
HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other antiretrovirals in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions reported with combination therapy.
1% to 10%:
Dermatologic: Skin rash (5%)
Endocrine & metabolic: Increased serum glucose (>250 mg/dL: 3%), increased uric acid (>12 mg/dL: 3%)
Gastrointestinal: Diarrhea (8%), increased serum lipase (>3 x ULN: 5%), nausea (5%)
Hematologic & oncologic: Decreased hemoglobin (<8.5 g/dL: 3%), decreased neutrophils (<0.6 x 109 cells/L: 5%), decreased platelet count (<50,000/mm3: 3%), leukopenia (<1.5 x 109 cells/L: 5%)
Hepatic: Increased direct serum bilirubin (> ULN: 3%), increased serum bilirubin (≥2.6 x ULN: 5%)
Nervous system: Dizziness (8%)
Renal: Increased serum creatinine (>1.8 x ULN or 1.5 x baseline: 10%)
<1%: Immunologic: Antibody development, immune reconstitution syndrome
Postmarketing:
Dermatologic: Pruritus
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Miscellaneous: Infusion related reaction
Hypersensitivity to ibalizumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity and infusion-related reactions: Hypersensitivity and infusion-related reactions, including anaphylaxis, have occurred; symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. Observe patients for 1 hour after completion of infusion for at least the first infusion; if no infusion-related reactions are observed after the first infusion, may reduce postinfusion observation time to 15 minutes for subsequent infusions. Discontinue immediately for severe hypersensitivity/anaphylaxis and initiate appropriate treatment.
• Immune reconstitution inflammatory syndrome: Patients may develop immune reconstitution inflammatory syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment; further evaluation and treatment may be required.
Disease-related concerns:
• Appropriate use: Use is not recommended in antiretroviral therapy-naïve patients.
Dosage form specific issues:
• Polysorbate 80: Contains polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
The Health and Human Services (HHS) perinatal HIV guidelines note data are insufficient to recommend ibalizumab for patients with HIV infection who are not yet pregnant but are trying to conceive.
Viral suppression sustained below the limits of detection with antiretroviral therapy (ART) and modification of therapy (if needed) is recommended in all patients with HIV infection who are planning a pregnancy. Optimization of the health of the person who will become pregnant and a discussion of the potential risks and benefits of ART during pregnancy is also recommended prior to conception. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV infection may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2021).
Ibalizumab is a humanized monoclonal antibody (IgG4). Monoclonal antibodies are known to cross the placenta and fetal exposure to ibalizumab may be expected. Based on data from animal reproduction studies, newborns exposed to ibalizumab in utero may develop reversible CD4+ T-cell and B-cell lymphocytopenia. Evaluate infants for immunosuppression; immune phenotyping of the peripheral blood and expert consultation are recommended based on degree of immunosuppression. The safety of administering live vaccines is not known. Data collected by the antiretroviral pregnancy registry are insufficient to evaluate human teratogenic risk.
The Health and Human Services (HHS) perinatal HIV guidelines note data are insufficient to recommend ibalizumab for pregnant patients with HIV infection who are antiretroviral naive, who have had antiretroviral therapy (ART) therapy in the past but are restarting, who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen), or who become pregnant while taking ibalizumab. Available pharmacokinetic data are insufficient to make dosing recommendations.
ART is recommended for all pregnant people with HIV infection to maximize their health, maintain the viral load below the limit of detection, and reduce the risk of perinatal transmission. Therapy should be individualized following a discussion of the potential risks and benefits of treatment during pregnancy. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitoring of patients who are pregnant is more frequent than in patients who are not pregnant. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Health care providers are encouraged to enroll patients who are pregnant exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or www.APRegistry.com).
Health care providers caring for pregnant patients with HIV infection and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2021).
It is not known if ibalizumab is present in breast milk; however, endogenous human immunoglobulins are present.
Maternal or infant antiretroviral therapy does not completely eliminate the risk of postnatal HIV transmission. In addition, multiclass-resistant virus has been detected in breastfeeding infants despite maternal therapy. In the United States, where formula is usually accessible, affordable, safe, and sustainable, and the risk of infant mortality due to diarrhea and respiratory infections is low, the Health and Human Services (HHS) perinatal HIV guidelines do not recommend breastfeeding for patients with HIV infection when safer infant feeding options are available.
Information is available for counseling and managing patients with HIV infection who are considering breastfeeding (1-888-448-8765). In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2021).
CD4 count, HIV RNA plasma levels, infusion-related reactions
Ibalizumab, a recombinant humanized monoclonal antibody, is a post-attachment inhibitor. It blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4+ cell receptors leading to a conformational change that blocks the interaction of gp120 and HIV co-receptors; it is active against CCR5 and CXCR4 isolates. The selective binding to domain 2 of the CD4+ cells allows ibalizumab to block HIV entry without causing immunosuppression or depleting CD4+ cell counts (Iacob 2017).
Distribution: Vd: 4.8 L
Half-life elimination: 3.1 to 3.3 days (Jacobson 2009)
Solution (Trogarzo Intravenous)
200MG/1.33ML (per mL): $1,291.58
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