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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO. ( 5.1 ) Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies. ( 5.2 ) Embryo-Fetal Toxicity: Monitor infants exposed to TROGARZO in utero for signs and symptoms of immunosuppression. ( 5.3 , 8.1 ) 5.1 Hypersensitivity Including Infusion-Related and Anaphylactic Reactions Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO during post-approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO and initiate appropriate treatment. The use of TROGARZO is contraindicated in patients with known hypersensitivity with TROGARZO [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )]. 5.2 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. 5.3 Embryo-Fetal Toxicity Based on animal data, TROGARZO may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed to TROGARZO during pregnancy. Immune phenotyping of the peripheral blood and expert consultation are recommended to provide guidance regarding monitoring and management of exposed infants based on the degree of immunosuppression observed. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. [see Use In Specific Populations ( 8.1 )]
6 ADVERSE REACTIONS The following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 350 subjects have been exposed to TROGARZO in the ibalizumab clinical development program, including 45 subjects who received TROGARZO through expanded access programs. A total of 19 subjects received TROGARZO via IV push. The safety profile of TROGARZO administered via IV push (Trial TMB-302) was similar to that seen with IV infusion administration (Trial TMB-301) [see Clinical Pharmacology ( 12.3 )]. Trial TMB-301 The primary safety assessment of TROGARZO is based on 24 weeks of data from Trial TMB-301. TMB-301 was a single-arm trial of TROGARZO which enrolled 40 heavily treatment-experienced subjects with multidrug resistant HIV-1 on a failing HIV treatment regimen. Subjects received a single 2,000 mg IV loading dose of TROGARZO followed seven days later by the initiation of an optimized background regimen (OBR) including at least one agent to which the subject's virus was susceptible. Two weeks after the TROGARZO loading dose, 800 mg of TROGARZO was administered IV. The IV administration of TROGARZO 800 mg was continued every 2 weeks through Week 25. The most common adverse reactions (all Grades) reported in at least 5% of subjects were diarrhea, dizziness, nausea, and rash. Table 3 shows the frequency of adverse reactions occurring in 5% or more of subjects. Table 3. Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving TROGARZO and Optimized Background Regimen for 23 Weeks in Trial TMB-301 % Subjects N=40 Diarrhea 8% Dizziness 8% Nausea 5% Rash Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, and “rash papular” 5% Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed immune reconstitution inflammatory syndrome manifested as an exacerbation of progressive multifocal leukoencephalopathy. Laboratory Abnormalities Table 4 shows the frequency of laboratory abnormalities (≥ Grade 3) in Trial TMB-301. Table 4. Selected Laboratory Abnormalities (≥ Grade 3) in Trial TMB-301 % Subjects N=40 Bilirubin (≥ 2.6 x ULN) 5% Direct Bilirubin (> ULN) 3% Creatinine (> 1.8 x ULN or 1.5 x baseline) 10% Blood Glucose (> 250 mg/dL) 3% Lipase (> 3.0 x ULN) 5% Uric Acid (> 12 mg/dL) 3% Hemoglobin (< 8.5 g/dL) 3% Platelets (< 50,000/mm 3 ) 3% Leukocytes (< 1.5 x 10 9 cells/L) 5% Neutrophils (< 0.6 x 10 9 cells/L) 5% 6.2 Postmarketing Experience The following adverse reactions have been identified during post‐approval use of TROGARZO. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported [see Warnings and Precautions ( 5.1 )] . Skin and subcutaneous tissue disorders: pruritus