Ibalizumab (Trogarzo) is the first humanized monoclonal antibody of its kind that is used in the treatment of HIV-1 infection. It blocks the entry of HIV-1 into CD4 cells. Because of its cellular receptors selectivity, it does not possess any immune-suppressant properties.

Ibalizumab Uses:

• HIV-1 infection:

  • It is indicated in combination with other antiretrovirals drugs for the treatment of HIV-1 infection in adult patients:
    • who have a multidrug-resistant HIV-1 infection
    • heavily treatment-experienced, and
    • who have failed their current antiretroviral regimen

Ibalizumab (Trogarzo) Dose in Adults:

Ibalizumab (Trogarzo) Dose in the treatment of HIV-1 infection:

• 2,000 mg intravenously over half an hour as a single dose, followed by a maintenance dose of 800 mg IV infusion every 14 days thereafter

Missed dose:

• Incase, the maintenance dose is missed for 3 days or more beyond the scheduled time, a repeat loading dose of 2000 mg should be given followed by a continuation of the maintenance dose every 14 days thereafter.

Ibalizumab (Trogarzo) use in children:

The safety and efficacy of the drug in children have not been established.

Pregnancy Risk Category: Not assigned

• Monoclonal antibodies are capable of crossing the placental barriers and can be exposed to fetal tissue.
• There is not enough data on the pregnancy effects of ibalizumab.
• To limit fetal exposure during pregnancy and to reduce the chance of vertical transmission to the infant, ART should be used.
• After delivery, the ART can be modified but it is maintained postpartum.
• Females who are exposed to the drug in early pregnancy should be enrolled in the Antiretroviral Pregnancy Registry (1-800-258-4263 or APRegistry.com).

Ibalizumab use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• It can enter breastmilk, as with most endogenous human immunoglobulins.
• Breastfeeding HIV-infected mothers is not recommended because of the risk of transmitting the virus to infants through breast milk.

Dose in Kidney Disease:

The manufacturer has not provided any adjustement in the dose in patients with kidney disease (the drug has not been studied in patients with kidney disease).

Dose in Liver disease:

The manufacturer has not provided any adjustement in the dose in patients with liver disease (the drug has not been studied in patients with liver disease).

Less Common Side Effects of Ibalizumab (Trogarzo):

• Central Nervous System:

  • Dizziness

• Dermatologic:

  • Skin Rash

• Endocrine & Metabolic:

  • Increased Serum Glucose
  • Increased Uric Acid

• Gastrointestinal:

  • Diarrhea
  • Increased Serum Lipase
  • Nausea

• Hematologic & Oncologic:

  • Decreased Neutrophils
  • Leukopenia
  • Decreased Hemoglobin
  • Decreased Platelet Count

• Hepatic:

  • Increased Serum Bilirubin
  • Increased Direct Serum Bilirubin

• Renal:

  • Increased Serum Creatinine

Contraindications to Ibalizumab (Trogarzo):

• The manufacturer has not provided any indications that it is contraindicated to be used.

Warnings and precautions

• Inflammatory syndrome of immune reconstitution

  • After the recovery of cellular immunity to indolent infection, an overt inflammatory response might occur.
  • The immune reconstitution syndrome (IRIS), is a paradoxical response in the initial phase to HIV treatment for indolent diseases like tuberculosis.
  • It is important to treat infective conditions before HIV treatment can be initiated. Concomitant short-term medication with glucocorticoids may also be necessary.

• Infusion-associated reactions

  • Hypersensitivity reactions to infusions may occur.
  • Patients should be monitored for at most one hour following their first infusion, and for at least 15 minutes after each subsequent infusion if hypersensitivity reactions occur.
  • If the patient is able to tolerate the drug, the infusion time can be reduced up to 15 minutes.

• Use it in the right way:

  • Antiretroviral therapy-naive people should not receive it.

Monitoring parameters:

• CD4 count,
• HIV RNA plasma levels,
• infusion-related hypersensitivity reactions

How to administer Ibalizumab?

• It is intended for intravenous use only.
• It should be infused as a slow intravenous infusion.
• IV bolus administration or IV push should be avoided.
• The initial infusion should be administered as a loading dose of over half an hour.
• The patient should be observed for one hour or more after the completion of the infusion.
• If the patient does not develop any hypersensitivity reaction, administer the subsequent infusion over 15 minutes, and monitor the patient for 15 minutes after the infusion.
• Following each infusion, flush the IV line with 30 ml of NS.

Mechanism of action of Ibalizumab (Trogarzo):

• Ibalizumab, a monoclonal recombinant humanized antibody, is used to prevent the HIV-1 virus from infecting CD4 T-lymphocytes. It blocks HIV-1 by binding domain 2 CD4 cell receptors.
• This causes conformational changes, which block HIV co-receptors from interacting with gp120.
• It is active against CXCR4 as well as CCR5 HIV-1 isolates. It selectively binds only to domain 2 CD4 cells.
• This blocks HIV entry without depleting CD4 count or causing immunosuppression.

The half-life elimination of the drug is 3.1 to 3.3 days.

International Brands of Ibalizumab:

• Trogarzo

Ibalizumab Brands Names in Pakistan:

No Brands Available in Pakistan.