mood effects (3.1%), dyspnea (2.7%), pneumonia (2.7%), and hypertension (2.0%). Approximately 24% of patients required at least 1 dose reduction for adverse reactions. The most frequent adverse reactions that led to dose reductions were edema (6%), peripheral neuropathy (4.7%), cognitive effects (4.1%), and mood effects (3.1%).
Tables 2 and 3 summarize common adverse reactions and laboratory abnormalities, respectively, in patients treated with LORBRENA in Study B7461001.
Table 2 Adverse Reactions Occurring in ≥10% of Patients in Study B7461001*
Additional clinically significant adverse reactions occurring at an incidence between 1% and 10% were hallucinations (7%).
Table 3 Worsening Laboratory Values Occurring in ≥20% of Patients in Study B7461001*
Abbreviations: NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; SOC=System organ class.
* Adverse reactions were graded using NCI CTCAE version 4.0. † Mood effects (including affective disorder, affect lability, aggression, agitation, anxiety, depressed mood, depression, euphoric mood, irritability, mania, mood altered, mood swings, personality change, stress, suicidal ideation). ‡ Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysesthesia, formication, gait disturbance, hypoesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral sensory neuropathy, sensory disturbance). § Cognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). ¶ Speech effects (including aphasia, dysarthria, slow speech, speech disorder) # Sleep effects (including abnormal dreams, insomnia, nightmare, sleep disorder, sleep talking, somnambulism) Þ Vision disorder (including blindness, diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters). SS Myalgia (including musculoskeletal pain, myalgia). À Edema (including edema, edema peripheral, eyelid edema, face edema, generalized edema, localized edema, periorbital edema, peripheral swelling, swelling). È Fatigue (including asthenia, fatigue). Ð Upper respiratory infection (including fungal upper respiratory infection, upper respiratory infection, viral upper respiratory infection). Ø Rash (including dermatitis acneiform, maculopapular rash, pruritic rash, rash).
Additional clinically significant adverse reactions occurring at an incidence between 1% and 10% were hallucinations (7%).
Table 3 Worsening Laboratory Values Occurring in ≥20% of Patients in Study B7461001*
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
N=number of patients who had at least one on-study assessment for the parameter of interest.
* Grades using NCI CTCAE version 4.0.
† N=292.
‡ N=293.
§ N=291.
¶ N=290.
# N=284.
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on LORBRENA
Effect of CYP3A Inducers
Concomitant use of LORBRENA wit |
