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Bring the potential of ROZLYTREK® to life

ROZLYTREK is well tolerated and has a manageable and consistent safety profile in both adult and paediatric patients1

ROZLYTREK is well tolerated and has a manageable and consistent safety profile in both adult and paediatric patients1

ROZLYTREK safety was evaluated in 504 adults and paediatric patients across multiple biomarkers and tumour types as an integrated analysis of four clinical trials: ALKA-372-001. STARTRK-1, STARTRK-2 and STARTRK-NG1

ROZLYTREK safety summary

ROZLYTREK was well tolerated in clinical trials2

  • Most adverse events were of Grade 1 or 2
  • 27.0% of patients required dose interruption due to TRAEs
  • 24.6% of patients required dose reduction due to TRAEs
  • Permanent discontinuation of ROZLYTREK due to a TRAE occurred in 4.6% of patients
  • Treatment compliance is considered acceptable, with a median dose intensity as high as 96.5%3
     

The majority of adverse reactions were manageable2

ROZLYTREK adverse reactions

Adverse reactions were generally mild or moderate1,2

  • In 504 patients across 4 trials
Infections andinfestations Cardiac disorders Musculoskeletal andconnective tissuedisorders General disordersand administrationsite conditions Hepatobiliary disorders Renal and urinarydisorders Skin and subcutaneous tissue disorders Eye disorders Vascular disorders Respiratory, thoracic and mediastinaldisorders Gastrointestinaldisorders Blood and lymphaticsystem disorders Nervous systemdisorders Metabolism andnutritional disorders Lung infection1 very common 13.1 6.0* Vision blurred10 very common 11.9 0.4 Hypotension12 very common 16.5 2.4 Urinary tract infection very common 12.7 2.6 Congestive heart failure11 very common 3.0 2.2 Electrocardiogram QTc prolonged common 2.0 0.6 Myalgia very common 19.6 0.6 Fractures14 common 6.2 2.4 Arthralgia very common 19.0 0.6 Muscular weakness very common 12.3 1.2 Fatigue16 very common 45.0 5.0 Pyrexia very common 20.0 0.8 Oedema17 very common 37.3 1.4 Pain18 very common 24.4 1.6 AST increased very common 17.5 3.6 ALT increased very common 16.1 3.4 Blood creatinine increased very common 25.4 0.6 Urinary retention15 very common 10.9 0.6 Rash13 very common 11.5 1.4 Pleural effusion common 6.9 2.8 Dyspnoea very common 27.0 5.8* Cough very common 21.4 0.6 Nausea very common 32.1 0.8 Constipation very common 42.9 0.4 Diarrhoea very common 33.5 2.6 Dysphagia very common 10.1 0.4 Vomiting very common 23.2 1.2 Abdominal pain very common 11.1 0.6 very common Anaemia 28.2 9.7 very common Neutropenia2 11.3 4.4 Weight increased very common 26.4 7.3* Decreased appetite very common 11.9 0.2 common Hyperuricemia 9.1 1.8 common Dehydration 7.9 1.0 uncommon Tumour lysis syndrome 0.2 0.2* Dysgeusia very common 42.3 0.4 Dizziness3 very common 39.7 1.2 very common Dysaesthesia4 29.0 0.2 very common Cognitive disorders5 24.2 4.4 Headache very common 17.5 1.0* Peripheral sensory neuropathy6 very common 15.7 1.0 very common Ataxia7 15.7 0.8 very common Sleep disturbances8 13.5 0.4 common Mood disorders9 9.1 0.6 common Syncope 4.6 3.0 *Grades 3 to 5, inclusive of fatal adverse reactions (including 2 reactions of pneumonia, 2 reactions of dyspnoea, and 1 reaction of tumour lysis syndrome)1Lung infection (bronchitis, lower respiratory tract infection, lung infection, pneumonia, respiratory tract infection, upper respiratory tract infection)2Neutropenia (neutropenia, neutrophil count decreased)3Dizziness (dizziness, vertigo, dizziness postural)4Dysaesthesia (paresthesia, hyperesthesia, hypoesthesia, dysaesthesia)5Cognitive disorders (cognitive disorder, confusional state, disturbance in attention, memory impairment, amnesia, mental status changes, hallucination, delirium, ‘visual hallucination’ and mental disorder)6Periphery sensory neuropathy (neuralgia, neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy)7Ataxia (ataxia, balance disorder, gait disturbances)8Sleep disturbances (hypersomnia, insomnia, sleep disorder, somnolence)9Mood disorders (anxiety, affect lability, affective disorder, agitation, depressed mood, euphoric mood, mood altered, mood swings, irritability, depression, persistent depressive disorder, psychomotor retardation)10Vision blurred (diplopia, vision blurred, visual impairment)11Congestive heart failure (acute right ventricular failure, cardiac failure, cardiac failure congestive, chronic right ventricular failure, ejection fraction decreased, pulmonary oedema)12Hypotension (hypotension, orthostatic hypotension)13Rash (rash, rash maculopapular, rash pruritic, rash erythematous, rash papular)14Fractures (ankle fracture, femoral neck fracture, femur fracture, fibula fracture, foot fracture, fracture, humerus fracture, jaw fracture, lower limb fracture, pathological fracture, rib fracture, spinal compression fracture, spinal fracture, stress fracture, tibia fracture, wrist fracture)15Urinary retention (urinary retention, urinary incontinence, urinary hesitation, micturition disorder, micturition urgency)16Fatigue (fatigue, asthenia)17Oedema (face oedema, fluid retention, generalised oedema, localised oedema, oedema, oedema peripheral, peripheral swelling)18Pain (back pain, neck pain, musculoskeletal chest pain, musculoskeletal pain, pain in extremity) System Organ Class Adverse Reaction All Grades(%) ROZLYTREK (N=504) Frequencycategory(all grades) Grade ≥3(%)

Monitoring

Monitoring considerations with ROZLYTREK1

  • Patients receiving ROZLYTREK should be carefully monitored for clinical signs and symptoms of congestive heart failure, including shortness of breath or oedema
  • ROZLYTREK should be avoided in patients with congenital long QTc syndrome and in patients taking medications that are known to prolong QTc interval:
    • Baseline and periodic monitoring of electrocardiograms and electrolytes is recommended
  • Patients should be monitored for signs of cognitive changes

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for details on how to report adverse reactions.

Footnotes

ALT, alanine aminotransferase; AST, aspartate aminotransferase; QT, time from the start of the Q wave to the end of the T wave; QTc, the corrected QT interval; TRAE, treatment-related adverse event.

References

  1. ROZLYTREK Summary of Product Characteristics, 2020.
  2. Patel M, et al. Ann Oncol 2020;31(Suppl 3):232–233.
  3. European Medicines Agency CHMP assessment report for ROZLYTREK. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek (Accessed December 2020).