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THERATECHNOLOGIES ANNOUNCES THAT
TROGARZOTM (IBALIZUMAB-UIYK) INJECTION IS NOW AVAILABLE IN THE U.S.
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Montreal, Canada - April 30, 2018 - Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that its novel antiretroviral TrogarzoTM is now commercially available in the United States. TrogarzoTM is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 failing their current antiretroviral regimen.
"Given the clinical significance of TrogarzoTM for patients with multidrug resistant HIV-1, our goal was to ensure that it would be available as quickly as possible. Patients that have already been prescribed TrogarzoTM may now be able to receive treatment," said Luc Tanguay, President and CEO, Theratechnologies Inc.
"We are also quite pleased that some payers have already updated their reimbursement policy to include Trogarzo™. While it will take a few more months before access is optimized, the initial feedback from payers is definitely going in the right direction," added Mr. Tanguay.
Trogarzo™ was approved by the U.S. Food and Drug Administration on March 6, 2018.
About TrogarzoTM (ibalizumab-uiyk) injection
TROGARZO is a CD4-directed post-attachment HIV-1 inhibitor.
Trogarzo™, 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.
Important Safety Information
Before you receive Trogarzo™, tell your healthcare provider if you:
- are pregnant or plan to become pregnant. It is not known if Trogarzo™ may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Trogarzo™ passes into breast milk.
Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements.
Trogarzo™ can cause serious side effects, including:
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 health care provider right away if you start having new symptoms after starting your HIV-1 medicine.
The most common side effects of Trogarzo™ include: diarrhea, dizziness, nausea and rash.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo™. For more information, ask your healthcare provider or pharmacist.
Full prescribing information available at www.trogarzo.com
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