Safety summary1

No systemic AEs were considered to be related to the use of the
NovoTTF-100L™ System

  • Mild-to-moderate skin irritation was the most common device-related side effect with NovoTTF-100L

Severe (Grade 3-4) AEs by body system seen in >1 patient

System organ class/
preferred term
NovoTTF-100L and pemetrexed + cisplatin/
 
carboplatin (N=80)
Number of patients
with ≥1 AE
32 (40%)
Blood and lymphatic
system disorders
18 (23%)
Anemia 9 (11%)
Leukopenia 3 (4%)
Neutropenia 7 (9%)
Thrombocytopenia 4 (5%)
Cardiac disorders 3 (4%)
Pericardial effusion 2 (3%)
Gastrointestinal disorders 3 (4%)
Vomiting 2 (3%)
System organ class/
preferred term
NovoTTF-100L and pemetrexed + cisplatin/
 
carboplatin (N=80)
General disorders and administration site conditions 6 (8%)
Fatigue 3 (4%)
Infections and infestations 2 (3%)
Investigations 2 (3%)
Respiratory, thoracic, and mediastinal disorders 4 (5%)
Dyspnea 2 (3%)
Skin and subcutaneous tissue disorders 4 (5%)
Medical device site reaction (rash beneath transducer arrays) 4 (5%)

The only AE attributed to the use of NovoTTF-100L is the known skin irritation seen in 71% of patients in this study (66% mild to moderate and 5% severe).
In the case of chemotherapy discontinuation due to toxicity, TTFields therapy may continue.

  • Note: In glioblastoma, mild-to-moderate skin irritation, the most common device-related side effect with Optune®, was easily manageable, reversible, and did not result in treatment discontinuation2

Proper skin care is essential for patients using NovoTTF-100L

  • Proactive management is key to helping patients avoid skin irritation and infection
  • Discuss with your patients how to properly care for their skin while using NovoTTF-100L

Download the skin care guidelines for your patients

Download

AEs, adverse events; GBM, glioblastoma; TTFields, Tumor Treating Fields.

References: 1. NovoTTF-100L Instructions For Use for Unresectable Malignant Pleural Mesothelioma. Novocure 2019. 2. Optune Instructions For Use for GBM. Novocure 2019.

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Indications For Use
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The NovoTTF-100L System is indicated for the treatment of adult patients with unresect…