TROGARZO Dosing Guide
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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 multi-drug resistant HIV-1 infection failing their current antiretroviral regimen. Dosing and Administration (ibalizumab-uiyk) Injection TROGARZO™ IMPORTANT SAFETY INFORMATION •P regnancy: No adequate human data are available to establish whether or not TROGARZO™ poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab-uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab-uiyk has the potential to be transmitted from the mother to the developing fetus. •L actation: No data are available regarding the presence of TROGARZO™ in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO™. • Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in 1 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. Use in Specific Populations Warnings and Precautions Adverse Reactions • The most common adverse reactions (reported in ≥5.0% of patients) were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: 1 subject had a severe rash and 1 subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy. Please see the enclosed full Prescribing Information for TROGARZO™. For more information, talk to your Theratechnologies Representative or call at 1-833-238-4372. To report suspected adverse reactions, contact THERA patient support™ (1-833-238-4372) or the FDA (1-800-FDA-1088 or fda.gov/medwatch). Reference: 1. TROGARZO™ Prescribing Information. Theratechnologies Inc. TROGARZO™ is a trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc. © 2018 Theratechnologies Inc. All rights reserved. 344-01-11/17 *If the patient does not experience any infusion-related adverse reactions. 2,000 mg 30 min infusion 1 hr observation 800 mg 15 min infusion* 15 min observation* Maintenance Doses Loading Dose Administration1 TROGARZO™ (ibalizumab-uiyk) Injection Dosing1 TROGARZO™ is administered by intravenous (IV) infusion as: • A single loading dose of 2,000 mg •M aintenance doses of 800 mg every 2 weeks If a scheduled maintenance dose is missed by 3 or more days, a loading dose should be administered as early as possible. Resume maintenance doses every 2 weeks thereafter. •T ROGARZO™ is used in combination with other antiretroviral(s). •D ose modifications of TROGARZO™ are not required when administered with any other antiretrovirals or concomitant treatments. •D rug-drug interactions are not expected, based on TROGARZO™’s mechanism of action and target-mediated drug disposition. 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 multi-drug resistant HIV-1 infection failing their current antiretroviral regimen. Dosing and Administration (ibalizumab-uiyk) Injection TROGARZO™ IMPORTANT SAFETY INFORMATION •P regnancy: No adequate human data are available to establish whether or not TROGARZO™ poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab-uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab-uiyk has the potential to be transmitted from the mother to the developing fetus. •L actation: No data are available regarding the presence of TROGARZO™ in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO™. • Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in 1 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. Use in Specific Populations Warnings and Precautions Adverse Reactions • The most common adverse reactions (reported in ≥5.0% of patients) were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: 1 subject had a severe rash and 1 subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy. Please see the enclosed full Prescribing Information for TROGARZO™. For more information, talk to your Theratechnologies Representative or call at 1-833-238-4372. To report suspected adverse reactions, contact THERA patient support™ (1-833-238-4372) or the FDA (1-800-FDA-1088 or fda.gov/medwatch). Reference: 1. TROGARZO™ Prescribing Information. Theratechnologies Inc. TROGARZO™ is a trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc. © 2018 Theratechnologies Inc. All rights reserved. 344-01-11/17 *If the patient does not experience any infusion-related adverse reactions. 2,000 mg 30 min infusion 1 hr observation 800 mg 15 min infusion* 15 min observation* Maintenance Doses Loading Dose Administration1 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 multi-drug resistant HIV-1 infection failing their current antiretroviral regimen. Dosing and Administration (ibalizumab-uiyk) Injection TROGARZO™ IMPORTANT SAFETY INFORMATION Warnings and Precautions Use in Specific Populations • Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in 1 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. •P regnancy: No adequate human data are available to establish whether or not TROGARZO™ poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab-uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab-uiyk has the potential to be transmitted from the mother to the developing fetus. •L actation: No data are available regarding the presence of TROGARZO™ in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO™. Adverse Reactions •T he most common adverse reactions (reported in ≥5.0% of patients) were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: 1 subject had a severe rash and 1 subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy. Please see the enclosed full Prescribing Information for TROGARZO™. For more information, talk to your Theratechnologies Representative or call at 1-833-238-4372. To report suspected adverse reactions, contact THERA patient support™ (1-833-238-4372) or the FDA (1-800-FDA-1088 or fda.gov/medwatch). Reference: 1. TROGARZO™ Prescribing Information. Theratechnologies Inc. TROGARZO™ is a trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc. © 2018 Theratechnologies Inc. All rights reserved. 344-01-11/17 *If the patient does not experience any infusion-related adverse reactions. 800 mg 15 min infusion* 15 min observation* Maintenance Doses 2,000 mg Loading Dose Administration1 30 min infusion 1 hr observation
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