Trogarzo

• It is used to treat HIV infection.
• This medicine is used with other drugs. Talk with your doctor.

• If you have an allergy to Trogarzo (ibalizumab-uiyk) or any part of Trogarzo (ibalizumab-uiyk).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed while you take Trogarzo (ibalizumab-uiyk).

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Trogarzo (ibalizumab-uiyk) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Trogarzo (ibalizumab-uiyk). This includes your doctors, nurses, pharmacists, and dentists.
• If you stop taking Trogarzo (ibalizumab-uiyk) or any of your other drugs used to treat HIV, talk with your doctor right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Trogarzo (ibalizumab-uiyk) while you are pregnant.

Use Trogarzo (ibalizumab-uiyk) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• It is important that you do not miss or skip a dose of Trogarzo (ibalizumab-uiyk) during treatment.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

Recommended Dosage

Trogarzo is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk.

Trogarzo is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of 0.9% Sodium Chloride Injection, USP. Patients should receive a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.

Dose modifications of Trogarzo are not required when administered with any other antiretroviral or any other treatments.

Preparation

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard vial if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter.

See Table 1 for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.

 Trogarzo solution for infusion should be prepared by a trained medical professional using aseptic technique as follows:

• Remove the flip-off cap from the single-dose vial and wipe with an alcohol swab.
• Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of 0.9% Sodium Chloride Injection, USP. Other intravenous diluents must not be used to prepare the Trogarzo solution for infusion.
• Once diluted, the Trogarzo solution should be administered immediately.
• If not administered immediately, store the diluted Trogarzo solution at room temperature (20°C to 25°C, 68°F to 77°F) for up to 4 hours, or refrigerated (2°C to 8°C, 36°F to 46°F) for up to 24 hours. If refrigerated, allow the diluted Trogarzo solution to stand at room temperature (20°C to 25°C, 68°F to 77°F) for at least 30 minutes but no more than 4 hours prior to administration.
• Discard partially used vials or empty vials of Trogarzo and any unused portion of the diluted Trogarzo solution.

Administration

Diluted Trogarzo solution should be administered by a trained medical professional.

Administer Trogarzo as an IV infusion in the cephalic vein of the patient’s right or left arm. If this vein is not accessible, an appropriate vein located elsewhere can be used. Do not administer Trogarzo as an intravenous push or bolus.

The duration of the first infusion (loading dose) should be no less than 30 minutes. If no infusion-associated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.

After the infusion is complete, flush with 30 mL of 0.9% Sodium Chloride Injection, USP.

All patients must be observed for 1 hour after completion of Trogarzo administration for at least the first infusion. If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.

If a maintenance dose (800 mg) of Trogarzo is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible. Resume maintenance dosing (800 mg) every 14 days thereafter.

Immune Reconstitution Inflammatory Syndrome

Immune reconstitution inflammatory syndrome has been reported in one patient treated with Trogarzo in combination with other antiretrovirals. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment.

Ibalizumab is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Ibalizumab is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Ibalizumab is not a cure for HIV or AIDS.

Ibalizumab is usually given after other treatments have failed.

Ibalizumab may also be used for purposes not listed in this medication guide.

Ibalizumab 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.

You should not use ibalizumab if you are allergic to it.

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

Tell your doctor if you are pregnant, and use your medications properly to control your infection. 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 breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.BasicDescription Back to TopTrogarzo Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ibalizumab 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 side effects may include:

• nausea, diarrhea;
• dizziness; or
• 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.