Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Haematological toxicity
Treatment with Onureg can be associated with neutropenia, thrombocytopenia and febrile neutropenia (see section 4.8 for frequencies). Interruption, reduction or discontinuation of Onureg may be necessary to manage haematological toxicities. Patients should be advised to promptly report febrile episodes. Patients with low platelet counts should be advised to report early signs or symptoms of bleeding. Supportive care such as antibiotics and/or antipyretics for management of infection/fever and GCSF for neutropenia should be provided based on individual patient characteristics, treatment response and according to the current clinical guidelines (see section 4.2 Table 1).

Gastrointestinal toxicity
Gastrointestinal toxicities were the most frequent adverse reactions in patients treated with Onureg (see section 4.8). Patients should be administered prophylactic anti-emetic therapy for the first 2 cycles of Onureg treatment (see section 4.2). Diarrhoea should be treated promptly at the onset of symptoms.
Interruption, reduction or discontinuation of Onureg may be necessary to manage gastrointestinal toxicities (see section 4.2).

Women of childbearing potential/Contraception in males and females
Women of childbearing potential have to use effective contraception during and up to 6 months after treatment. Men have to use effective contraception during and up to 3 months after treatment (see section 4.6).

Lactose intolerance
Onureg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Effects on Driving

4.7   Effects on ability to drive and use machines

Onureg has minor influence on the ability to drive and use machines. Fatigue has been reported with the use of Onureg. Therefore, caution is recommended when driving or operating machines.