duce chromosomal damage in the human spermatozoa, males undergoing cytarabine treatment and their partner should be advised to use a reliable contraceptive method.
4.7 Effects on ability to drive and use machines
No documented effect on ability to drive or operate machinery.
Nevertheless, patients receiving chemotherapy may have an impaired ability to drive or operate machinery and should be warned of the possibility and advised to avoid such tasks if so affected.
4.8 Undesirable effects
The following adverse events have been reported in association with cytarabine therapy. Frequencies are defined using the following convention:
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), very rare (<1/10,000), not known (cannot be estimated from the available data)
Undesirable effects from cytarabine are dose-dependent. Most common are gastrointestinal undesirable effects. Cytarabine is toxic to the bone marrow, and causes haematological undesirable effects.
Infections and infestations
Uncommon: Sepsis (immunosuppression)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Uncommon: Lentigo
Blood and lymphatic system disorders:
Common: Anaemia, megaloblastosis, leukopenia, thrombocytopenia
Not known: Reticulocytopenia
These appear to be more evident after high doses and continuous infusions; the severity depends on the dose of the drug and schedule of administration.
Gastrointestinal disorders
Common: Dysphagia, abdominal pain, nausea, vomiting, diarrhoea, oral/anal inflammation or ulceration
Uncommon: Oesophagitis, oesophageal ulceration, pneumatosis cystoides intestinalis, necrotising colitis, peritonitis
Not known: Gastrointestinal haemorrhage, pancreatitis
Nausea and vomiting occur and are generally more frequent following rapid IV administration than with continuous IV infusion of the drug.
Skin and subcutaneous tissue disorders
Common: Reversible undesirable effects to the skin, such as erythema, bullous dermatitis, urticaria, vasculitis, alopecia
Uncommon: skin ulceration, pruritus, burning pain of palms and soles
Very rare: Neutrophilic eccrine hidradenitis
Not known: Rash, freckling, skin bleeding
Renal and urinary disorders
Common: Renal impairment, urinary retention
Not known: Renal dysfunction
General disorders and administration site conditions
Common: Fever, thrombophlebitis at the site of injection
Uncommon: Cellulitis at the injection site
Not known: Chest pain, irritation or sepsis at the injection site, mucosal bleeding
Cardiac disorders
Uncommon: Pericarditis
Very rare: Arrhythmia
Not Known: Sinus bradycardia
Hepatobiliary disorders
Common: Reversible effects on the liver with increased enzyme levels
Not known: Hepatic dysfunction and jaundice
Metabolism and nutrition disorders
Common: Anorexia, hyperuricemia
One case of anaphylaxis that resulted in cardiopulmonary arrest and necessitated resuscitation has been reported (see section 4.4 Special warnings and precautions for use).
Nervous system disorders
Common: At high doses cerebellar or cerebral influence with deterioration of the level of consciousness, dysarthria, nystagmus
Uncommon: Headache, peripheral neuropathy, paraplegia at intrathecal administration
Not known: Dizziness, neuritis or neural toxicity and pain, n |
