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QARZIBA®'s efficacy and safety profiles
Safety profile

Safety profile

Before prescribing please consult the Prescribing Information or Summary of Product Characteristics for further safety information.

QARZIBA® offers flexible administration with a manageable safety profile.1-7

The safety of QARZIBA® has been evaluated in 628 patients with high-risk and relapsed/refractory neuroblastoma, who received it as a continuous infusion (212) or as repeated daily infusions (416). It was combined with isotretinoin in most patients and with IL-2 in 307 patients.1

Most common AEs (all grades):1

88%

Pyrexia

77%

Pain

Note: these AEs occurred despite analgesic treatment.

Other frequent AEs:1

74.1%

Hypersensitivity

40%

Capillary leak syndrome

49.6%

Thrombocytopenia

57%

Vomiting

72.3%

Anaemia

42.2%

Hypotension

51%

Diarrhoea

52%

Neutropenia

Neuropathic pain is a known and expected on-target side effect of treatment with QARZIBA®, caused by high levels of GD2 expressed on the surface of nerve cells. It usually occurs at the beginning of the treatment and premedication with analgesics prior to each infusion is required.1,3

Reports of immunotherapy-related neuropathic pain associated with QARZIBA® decrease with subsequent treatment cycles.1,3,5-7

jamie-mum-path@2x

Grade 3 and 4 immunotherapy-related pain by cycle

Severe infusion-related reactions, including cytokine release syndrome, anaphylactic and hypersensitivity reactions, may occur despite the use of premedication with antihistamines.1

Patients are likely to be immunocompromised as a result of prior therapies and are often at risk of developing systemic infection. Patients should therefore have no evidence of systemic infection and any infection should be under control before starting therapy.1

Contraindications: Hypersensitivity to the active substance or to any of the excipients, and acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD).1

Regulatory monitoring of liver function and electrolytes is recommended due to the possibility of laboratory abnormalities.1

Other pages in this section

Efficacy data

jamie-house-path@2x

GL-DNB-2200039 | December 2022

Abbreviations

AE=adverse event; IL-2=interleukin 2.

References

  1. QARZIBA® (dinutuximab beta). Summary of product characteristics. Accessed: November 2022.
  2. Ladenstein R et al. Cancers 2020; 12 (2): 309.
  3. Sait S and Modak SI. Expert Rev Anticancer Ther 2017; 17 (10): 889–904.
  4. Keyel ME and Reynolds CP. Biologics 2019; 13: 1–12.
  5. Ladenstein R et al. Lancet Oncol 2018; 19: 1617–1629.
  6. Ladenstein R et al. Lancet Oncol 2018; 19: 1617–1629. (Supplementary appendix).
  7. Mueller I et al. MAbs 2018; 10 (1): 55–61.

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