Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
In Phase 2 / 3 clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg. The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity.


Tabulated list of adverse reactions (Table 1)

The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin. Adverse reactions are classified according to System Organ Class and frequency.
Frequency categories are derived according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).

Table 1

System Organ Class         Common                     Uncommon                       Rare Infections and                              vulvovaginal mycotic infection, infestations                                urinary tract infection, fungal infection, Clostridioides (formerly
Clostridium) difficile colitis, oral candidiasis
Blood and lymphatic                         anaemia, thrombocytosis, system disorders                            eosinophilia, leucopenia, neutropenia
Immune system                                                                      anaphylactoid disorders                                                                          reaction Metabolism and                              decreased appetite nutrition disorders
Psychiatric disorders                       Insomnia
Nervous system            headache          dysgeusia, dizziness disorders
Vascular disorders                          flushing, phlebitis
Respiratory, thoracic                       Cough                                  bronchospasm and mediastinal disorders
Gastrointestinal          nausea,           constipation, abdominal pain, disorders                 diarrhoea,        dyspepsia, abdominal discomfort, vomiting
Skin and subcutaneous                       pruritus, urticaria, rash tissue disorders
Reproductive system                         vulvovaginal pruritus and breast disorders
General disorders and                       infusion-related reactions administration site conditions
Investigations                              blood lactate dehydrogenase increased, alanine aminotransferase increased,
aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl
System Organ Class          Common                    Uncommon                      Rare transferase increased,

Description of selected adverse reactions

Class adverse reactions
Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/
In addition, you may report suspected adverse reactions by sending an e-mail message to safety@tzamal-medical.co.il