Ibalizumab

Information about Ibalizumab

Ibalizumab is a humanized monoclonal antibody to CD4, the cell surface receptor for the HIV-1 envelope glycoprotein (gp120), which is used to treat patients with multidrug resistant HIV-1 infection.

Liver safety of Ibalizumab

Ibalizumab therapy has not been associated with serum enzyme elevations or to instances of clinically apparent drug induced liver injury.

Mechanism of action of Ibalizumab

Ibalizumab (eye' ba liz' ue mab) is a recombinant humanized monoclonal antibody to CD4, the cell surface receptor for the HIV-1 envelope glycoprotein 120 (gp120). Ibalizumab does not block the binding of gp120 to CD4 but rather inhibits the conformation changes in the CD4/gp120 complex that allows binding to a second cellular receptor, chemokine-receptor-4 (CXCR4), thus inhibiting HIV replication. Clinical trials of ibalizumab in heavily treatment-experienced HIV-positive patients with multidrug resistance have shown that it decreased HIV RNA levels and resulted in full suppression in over half of patients.

FDA approval information for Ibalizumab

Ibalizumab was approved for use in the United States in 2018 for therapy (in combination with other antiretroviral agents) of patients with multidrug resistant HIV-1 infection.

Dosage and administration for Ibalizumab

Ibalizumab is available in solution in single dose vials of 200 mg/1.33 mL under the brand name Trogarzo. Ibalizumab is administered as an intravenous infusion. The recommended dose is an initial loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.

Side effects of Ibalizumab

Side effects are generally mild and include injection site reactions, diarrhea, dizziness, nausea and rash. Rare but potentially severe adverse events include hypersensitivity reactions and immune reconstitution syndrome.

Antiviral agents

Drugs for HIV Infection, in the Subclass Antiretroviral Agents

• Fusion Inhibitors (HIV)
  • Enfuvirtide, Maraviroc

• Integrase Inhibitors (HIV)
  • Dolutegravir, Elvitegravir, Raltegravir

• Monoclonal Antibodies
  • Ibalizumab

• Nonnucleoside Reverse Transcriptase Inhibitors (HIV)
  • Delavirdine, Efavirenz, Etravirine, Nevirapine, Rilpivirine

• Nucleoside Analogues (HIV)
  • Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Tenofovir, Zidovudine

• Protease Inhibitors (HIV)
  • Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir,Ritonavir, Saquinavir, Tipranavir

Drugs for Hepatitis B

• • Alpha Interferon, Adefovir, Emtricitabine, Entecavir, Lamivudine, Telbivudine, Tenofovir

Drugs for Hepatitis C

• Interferon Based Therapies
  • Alpha Interferon and Peginterferon, Ribavirin

HCV NS5A Inhibitors

• Daclatasvir, Elbasvir, Ledipasvir, Ombitasvir, Pibrentasvir, Velpatasvir

HCV NS5B (Polymerase) Inhibitors

• Dasabuvir, Sofosbuvir

HCV Protease Inhibitors

• Asunaprevir, Boceprevir, Glecaprevir, Grazoprevir, Paritaprevir, Simeprevir, Telaprevir, Voxilaprevir

Combination Therapies

• Epclusa, Harvoni, Mavyret, Technive, Viekira Pak, Vosevi, Zepatier

Drugs for Herpes Virus Infections (HSV, CMV, others)

• Acyclovir, Cidofovir, Famciclovir, Foscarnet, Ganciclovir, Valacyclovir, Valganciclovir

Drugs for Influenza

• Amantadine, Oseltamivir, Peramivir, Rimantadine, Zanamivir

• Dailymed label info on Ibalizumab
• FDA Ibalizumab