Ibalizumab-uiyk

What is Ibalizumab-uiyk?

Ibalizumab-uiyk is a CD4 domain 2-directed humanized monoclonal antibody of immunoglobulin G (IgG) isotype 4 with a molecular weight of approximately 150 kDa. Ibalizumab-uiyk is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.

What are the uses of this medicine?

Ibalizumab-uiyk in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

How does this medicine work?

Ibalizumab-uiyk, a recombinant humanized monoclonal antibody, blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion.

Who Should Not Use this medicine?

Ibalizumab-uiyk is contraindicated in patients with a prior hypersensitivity reaction to Ibalizumab or any components of the product .

Is this medicine FDA approved?

It is approved by US FDA on March 6, 2018.

What are the brand names and dosage forms of this medicine?

• Brand name: TROGARZO; NDC codes: 62064-122-01, 62064-122-02
• Injection: 200 mg/1.33 mL (150 mg/mL) colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial.

How should this medicine be used?

• You will receive TROGARZO by your healthcare provider as an infusion given into your vein over 15 to 30 minutes. A healthcare provider will monitor you during the TROGARZO infusion and for a period of time after your infusion.
• You will receive TROGARZO every two weeks.
• It is important that you receive TROGARZO every two weeks as instructed by your healthcare provider. Do not change the schedule of your TROGARZO infusions or any of your antiretroviral medicines without talking to your healthcare provider first.
• Tell your healthcare provider right away if you stop receiving TROGARZO infusions or stop taking any other antiretroviral medicines.

What side effects can this medication cause?

• Allergic reactions: TROGARZO can cause allergic reactions, including serious reactions, during and after infusion.
• The most common side effects of TROGARZO include:

1. diarrhea
2. nausea
3. dizziness
4. rash

What to do in case of emergency/overdose?

• If TROGARZO is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Can this medicine be used in pregnancy?

Based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero. Immunoglobulin G (IgG) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus (see Clinical Considerations). There are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

Can this medicine be used in children?

The safety and effectiveness of TROGARZO in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and protect from light.
• Once diluted, the TROGARZO solution should be administered immediately

• Dailymed label info on Ibalizumab-uiyk
• FDA Ibalizumab-uiyk

Ibalizumab-uiyk Resources
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