Version May 2024
HIV-1 infection, treatment: IV: Initial: 2 g as a single dose, followed by a maintenance dose of 800 mg every 14 days thereafter. Use as part of an appropriate combination regimen.
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); however, renal impairment is not expected to affect pharmacokinetics of ibalizumab.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
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. 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.
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.
Each 2 mL vial delivers approximately 1.33 mL containing 200 mg of ibalizumab.
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
Solution (Trogarzo Intravenous)
200MG/1.33ML (per mL): $1,335.34
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: For IV administration only. 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 IV push dose (loading dose) over ≥90 seconds. Observe patient for 1 hour after completion of administration. If no infusion-associated adverse reactions are observed, subsequent maintenance doses may be administered as IV push over ≥30 seconds and postinfusion observation time may be reduced to 15 minutes. Flush with 2 to 5 mL NS after IV push administration.
When administering by IV infusion, 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 and postinfusion observation time may be reduced to 15 minutes. Flush with 30 mL NS after completion of each infusion.
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.
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
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Contraception is not required to initiate or continue antiretroviral therapy.
The Health and Human Services (HHS) perinatal HIV guidelines note data are insufficient to recommend ibalizumab for patients with HIV who are not yet pregnant but are trying to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Optimization of the health of the person who will become pregnant is recommended. Selection of or changes to a specific antiretroviral regimen prior to pregnancy should be done as part of a shared decision-making process. 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 may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
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 do not recommend ibalizumab as initial therapy for pregnant patients with HIV who are antiretroviral naïve; data are insufficient to recommend ibalizumab for pregnant patients with HIV who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Consider switching if pregnancy occurs during therapy. Highly treatment experienced patients who become pregnant while taking ibalizumab may continue if other therapeutic alternatives are not available; frequent viral load monitoring is recommended. Data collected by the antiretroviral pregnancy registry are insufficient to make dosing recommendations.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of detection, and reduce the risk of perinatal transmission. Selection of or changes to a specific antiretroviral regimen during pregnancy should be done as part of a shared decision-making process. 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 should enroll all patients exposed to antiretroviral medications during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). Enrollment should be done as early in pregnancy as possible.
Health care providers caring for pregnant patients with HIV and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
It is not known if ibalizumab is present in breast milk.
Ibalizumab is a humanized monoclonal antibody. Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
Maintaining maximum viral suppression during pregnancy and postpartum decreases but does not eliminate the risk of HIV transmission via breast milk. In addition, multiclass-resistant virus has been detected in breastfeeding infants who acquire HIV 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 perinatal HIV guidelines do not recommend breastfeeding for patients with HIV when safer infant feeding options are available. Persons with HIV who maintain an undetectable viral load while taking antiretroviral therapy (ART) should evaluate infant feeding options (formula, banked donor milk, or breastfeeding) as part of a shared decision-making process (if breastfeeding is being considered, see guidelines for measures to reduce the risk of HIV transmission). When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available. If HIV infection is diagnosed after breastfeeding has been initiated, breastfeeding should be discontinued immediately. Breastfeeding is not recommended for persons with HIV who are not taking ART and/or who do not have sustained viral suppression.
Information is available for counseling and managing patients with HIV 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] 2023).
CD4 count, HIV RNA plasma levels, infusion-related reactions (observe for 1 hour after initial infusions; if no reaction occurs, may reduce postinfusion observation time to 15 minutes for subsequent infusions).
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)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
