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THE FIRST LONG‑ACTING ANTIRETROVIRAL AGAINST HIV‑11

TROGARZO® is a medicine that’s used in combination with other antiretroviral medicines to treat HIV‑1 infection in adults who:

HAVE BEEN ON DIFFERENT HIV‑1 TREATMENT REGIMENS IN THE PAST

HAVE HIV‑1 THAT IS RESISTANT TO MULTIPLE ANTIRETROVIRAL MEDICINES

ARE CURRENTLY ON AN HIV‑1 TREATMENT REGIMEN THAT IS FAILING

TROGARZO® IV Push Dosing & Administration1,2

TROGARZO® is not a daily pill. It is a long‑acting agent given once every two weeks to help make an undetectable viral load possible. Once you’ve received your first loading dose, all subsequent doses can be given in 30 seconds every two weeks.1,2

Given once every 2 weeks1

Appointments arranged by your personal THERA Patient Care Coordinator

Given by a healthcare provider at home, your healthcare provider’s office, or a hospital/IV center nearby.

All patients must be observed for 1 hour after completion of TROGARZO® loading dose. If no administration‑associated adverse reactions are observed, the post‑administration observation time for subsequent maintenance doses can be reduced to 15 minutes.

TROGARZO® can also be administered as an IV infusion. Administration time for IV infusion differs from that of IV push. Consult the TROGARZO® Prescribing Information for complete posology. Discuss the administration options of TROGARZO® with your healthcare provider to identify which may be right for you.

Survey: What do patients think?

87%

VERY SATISFIED with TROGARZO®

90%

VERY POSITIVE experience with TROGARZO® administration

80%

reported that having a 2‑week touchpoint with an HCP helped them adhere to their other HIV medications.

All patient survey data was collected prior to the FDA approval of TROGARZO® IV Push administration.

† Applies to 15/30 respondents. Information for the remaining 15 respondents was not available.

IS TROGARZO® RIGHT FOR YOU?

Are you getting the most from your HIV‑1 treatment?

If you have had to change your HIV medications in the past, and your viral load is still detectable while you are taking your current HIV medication, these questions can help you and your healthcare provider decide if TROGARZO® could be right for you.

1

Are you having any challenges adhering to your current HIV treatment?

2

Do you feel more time with a healthcare provider would be helpful for you to stick with your HIV therapy?

3

Would you be open to including something other than a daily pill in your treatment regimen if given the choice?

4

Do you worry about side effects from HIV medications, or interactions with other pills?

Discuss your answers with your doctor to better understand if TROGARZO® could be right for you.

Frequently asked questions

Treatment options

What antiretroviral (ARV) options are effective when HIV‑1 treatment fails?

To combat HIV‑1 when treatments fail, a regimen should be modified as soon as possible to minimize further resistance.5

The most effective HIV‑1 treatment regimen is one that combines 3 active antiretroviral medicines. An active antiretroviral medicine could be a new type you haven’t tried before.5

If you have been on treatments that have failed, you deserve to know about all of your treatment options, including TROGARZO® – the first long‑acting antiretroviral against HIV‑1.

Together, you and your healthcare provider can decide if TROGARZO® should be part of your treatment regimen to help keep your viral load in check.

TROGARZO® information

Who is TROGARZO® for?

TROGARZO® is a medicine that’s used in combination with other antiretroviral medicines to treat HIV‑1 infection in adults who:

  • have been on different HIV‑1 treatments in the past, and
  • have HIV‑1 that is resistant to multiple antiretroviral medicines, and
  • are currently on an HIV‑1 treatment regimen that is failing

If this describes you, TROGARZO® can make undetectable possible and may lower your pill count.

What are the side effects of TROGARZO®?

TROGARZO® is generally well tolerated, with a low incidence of adverse reactions. The most common side effects of TROGARZO® were diarrhea, dizziness, nausea, and rash. Most adverse reactions reported were mild to moderate in severity.

How does TROGARZO® work?

TROGARZO® is not a daily pill. It is a long‑acting agent given once every two weeks to help make an undetectable viral load possible.

TROGARZO® binds to the T‑cell’s surface to block HIV‑1 from entering. This protects your immune cells from the virus. This can reduce your viral load.

Can TROGARZO® reduce my viral load?

In a clinical study, TROGARZO® was proven to have a significant and long‑lasting impact on the amount of HIV‑1 in the body, reducing the viral load.

83% experienced a decrease in their viral load of at least 66% one week after receiving their loading dose of TROGARZO®.

Among heavily treatment‑experienced patients who received TROGARZO® within the original clinical trials:

  • 50% achieved and maintained viral suppression (<200 copies/mL), and
  • 43% achieved and maintained an undetectable viral load (<50 copies/mL)

through 25 weeks of treatment.

Does TROGARZO® interact with other drugs?

TROGARZO® does not interact with other drugs, so you can take it with other medications you may be taking. Be sure to discuss other medications you may be taking with your healthcare provider before taking TROGARZO®.

Administration

Where can my TROGARZO® be administered?

Depending on your insurance coverage, your THERA Patient Care Coordinator will arrange for your treatment to be given at a location of your choosing – at home, your healthcare provider’s office, or a hospital/IV center nearby. If you decide over time that another location would be more convenient for you, simply let them know.

What can I expect during TROGARZO® administration?

Before

  • Ask your THERA Patient Care Coordinator if you should bring any documents (like insurance information) to your appointment.

During

  • Someone will monitor you during treatment.
  • Take the opportunity to discuss HIV‑related topics with the care provider.

After

  • You’ll also be monitored afterwards for a short period of time to ensure that your body tolerates your treatment well.

What are the benefits of a 2‑week touchpoint?

The TROGARZO® administration schedule means that throughout your TROGARZO® journey, you get care and support. You can take this opportunity to ask questions about your health or treatment.

Important Safety Information

The most common side effects of TROGARZO® include diarrhea, dizziness, nausea, and rash. These are not all the possible side effects of TROGARZO®. For complete important safety information, please click here.

Important Safety Information

TROGARZO® (ibalizumab‑uiyk) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus‑1 (HIV‑1) infection in adults who:

  • have received 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

It is not known if TROGARZO® is safe and effective in children.

Before you receive TROGARZO® (ibalizumab‑uiyk), tell your healthcare provider about all of your medical conditions, including if you are:

  • Pregnant or plan to become pregnant. It is not known if TROGARZO® may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with TROGARZO®.
  • Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
  • Breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV‑1 because of the risk of passing HIV‑1 to your baby. Do not breastfeed if you are receiving TROGARZO® as it is not known if TROGARZO® passes into breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment with TROGARZO®.

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements.

TROGARZO® can cause serious side effects, including:

  • Allergic reactions. TROGARZO® can cause allergic reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction: trouble breathing, swelling in your throat, wheezing, chest pain, chest tightness, cough, hot flush, nausea or vomiting.
  • Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV‑1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after receiving TROGARZO®.
  • The most common side effects of TROGARZO® include diarrhea, dizziness, nausea, and rash. These are not all the possible side effects of TROGARZO®.

For more information or medical advice about side effects, ask your healthcare provider. You may report side effects to the FDA at 1‑800‑FDA-1088 or the THERA patient support® Program at 1‑833‑238-4372.

Please see Important Safety Information throughout or access the full Prescribing Information for TROGARZO® online at www.trogarzo.com.