Trogarzo

Generic name: Ibalizumab-uiyk
Dosage form: injectable injection
Drug class: Miscellaneous antivirals

Usage of Trogarzo

Trogarzo ((ibalizumab-uiyk) is an antiviral medicine that is used in combination with other antiviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:

have received several anti-HIV-1 regimens in the past, and

have HIV-1 virus that is resistant to many antiretroviral medicines, and

who are failing their current antiretroviral therapy.

Trogarzo ((ibalizumab-uiyk) is a recombinant humanized monoclonal antibody that works by binding to domain 2 of CD4 and blocking HIV-1 from infecting CD4+ T cells and preventing the viral transmission that occurs via cell-cell fusion.

HIV-1 is a virus that attacks the body’s immune system. If HIV is not treated, people typically progress through three phases (acute HIV infection, chronic HIV infection, and Acquired Immune Deficiency Syndrome [AIDS]). Untreated, people with AIDS usually only survive about 3 years.

Trogarzo was FDA approved on March 6, 2018.

Trogarzo side effects

Get emergency medical help if you have signs of an allergic reaction to Trogarzo which may include hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Trogarzo affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Trogarzo side effects that affect 5% or more of people include:

nausea

diarrhea

dizziness

rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Trogarzo

Before you receive Trogarzo, tell your doctor about all your medical conditions or allergies.

Trogarzo affects your immune system. Tell your doctor if you have signs of a new infection such as fever, night sweats, swollen glands, cough, diarrhea, or weight loss.

Tell your doctor if you are pregnant or become pregnant while taking Trogarzo or any other medications used to treat HIV. Continue taking your medications throughout pregnancy. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

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How to use Trogarzo

Usual Adult Dose for HIV Infection

Loading dose: 2000 mg IV infusion (diluted: over at least 30 minutes) or IV push (undiluted: over at least 90 seconds)

Maintenance dose: 800 mg IV every 2 weeks IV infusion (diluted: over at least 15 minutes) or IV push (undiluted: over at least 30 seconds).

Warnings

Trogarzo may cause hypersensitivity reactions including infusion-related reactions and anaphylactic reactions. You should not use Trogarzo if you are allergic to ibalizumab. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction, such as:

trouble breathing

cough

swelling in your throat

hot flush

wheezing

nausea

chest pain

vomiting

chest tightness.

Immune Reconstitution Inflammatory Syndrome (IRIS) is a state of hyperinflammatory response that has been reported in patients treated with combination antiretroviral therapies.

Trogarzo may cause irreversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed during pregnancy. Your healthcare provider will monitor exposed infants for signs and symptoms of immunosuppression. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

It is not known if Trogarzo is safe and effective in children.

What other drugs will affect Trogarzo

Other drugs may interact with ibalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.