Safety profile demonstrated in 355 patients across 4 trials 1
- Safety was evaluated in 355 patients, including 17 pediatric
patients (<18 years of age) 1,4
- 48% of patients were treated with ROZLYTREK for 6 months or longer and 24% of patients were treated for 1 year or longer
- Serious adverse reactions occurred in
39% of patients
- The most frequent serious adverse reactions (≥2%) were pneumonia (3.9%), dyspnea (3.7%), pleural effusion (3.4%), sepsis (2.5%), pulmonary embolism (2.3%), respiratory failure (2%), and pyrexia (2%)
- Fatal events
included dyspnea (0.6%), pneumonia (0.6%), sepsis (0.6%), completed
suicide (0.3%), large intestine perforation (0.3%), and tumor lysis
- 1 patient developed Grade 4 myocarditis after 1 dose of ROZLYTREK, which resolved after discontinuation of ROZLYTREK and administration of high-dose corticosteroids
- Dose reductions due to adverse reactions occurred in 29% of patients
discontinuation of ROZLYTREK for adverse reactions occurred in 9% of
- The most frequent adverse reactions that led to permanent discontinuation of ROZLYTREK were pneumonia, cardio-respiratory arrest, dyspnea, and fatigue
Most common adverse reactions (≥10%) in patients treated with ROZLYTREK in studies ALKA, STARTRK-1, STARTRK-2, and STARTRK-NG
aGrades 3-5, inclusive of fatal adverse reactions,
including 2 events of pneumonia and 2 events of dyspnea.
bIncludes fatigue, asthenia.
face edema, fluid retention, generalized edema, localized edema,
edema, edema peripheral, peripheral swelling.
dIncludes abdominal pain upper, abdominal pain, lower
abdominal discomfort, abdominal tenderness.
dizziness, vertigo, dizziness postural.
paresthesia, hyperesthesia, hypoesthesia, dysesthesia, oral
hypoaesthesia, palmar-plantar erythrodysaesthesia, oral paresthesia,
gIncludes amnesia, aphasia,
cognitive disorder, confusional state, delirium, disturbance in
attention, hallucinations, visual hallucination, memory impairment,
mental disorder, mental status changes.
neuralgia, neuropathy peripheral, peripheral motor neuropathy,
peripheral sensory neuropathy.
balance disorder, gait disturbances.
hypersomnia, insomnia, sleep disorder, somnolence.
kIncludes anxiety, affect lability, affective disorder,
agitation, depressed mood, euphoric mood, mood altered, mood swings,
irritability, depression, persistent depressive disorder, psychomotor
lIncludes musculoskeletal pain,
musculoskeletal chest pain, myalgia, neck pain.
mIncludes blindness, cataract, cortical cataract, corneal
erosion, diplopia, eye disorder, photophobia, photopsia, retinal
hemorrhage, vision blurred, visual impairment, vitreous adhesions,
vitreous detachment, vitreous floaters.
lower respiratory tract infection, lung infection, pneumonia,
respiratory tract infection.
pIncludes rash, rash
maculopapular, rash pruritic, rash erythematous, rash papular.
Laboratory abnormalities 1
Laboratory abnormalities (≥20%) worsening from baseline in patients receiving ROZLYTREK in ALKA, STARTRK-1, STARTRK-2, and STARTRK-NG
qDenominator for each laboratory parameter is based on the
number of patients with a baseline and post-treatment laboratory value
available, which ranged from 111 to 346 patients.
rBased on NCI-CTCAE v5.0.
evaluable. Grade 1 and 2 could not be determined per NCI-CTCAE v5.0,
as fasting glucose values were not collected.
aminotransferase; AST=aspartate aminotransferase; NCI-CTCAE=National
Cancer Institute Common Terminology Criteria for Adverse Events.
Ongoing monitoring considerations with ROZLYTREK 1
This list reflects a subset of monitoring considerations. For additional important considerations, please see the full Prescribing Information.