Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The side effects caused by cytarabine depend on the dose, the method of administration and the duration of treatment. The most significant side effect caused by ARA-cell® is bone marrow suppression. The most common are gastro-intestinal undesirable effects.

In this section frequencies of undesirable effects are defined as follows: 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 (frequency cannot be estimated from the available data).


Neoplasms benign, malignant and unspecified (incl cysts and polyps) uncommon:       Lentigo
Blood and lymphatic system disorders:
Common: Changes in blood count (leucopenia, thrombocytopenia, anaemia, megaloblastosis) are dose-dependent, with leucopenia usually reaching its lowest values on days 12 to 24. Reduced reticulocytes, morphologic alterations of the bone marrow. High-dose treatment is associated with considerable myelotoxicity. Haemorrhages.
The severity of these reactions is dose and schedule dependent.
Uncommon: Immunosuppression, sepsis.

Immune system disorders:
Very common:     Cytarabine syndrome: characterised by fever, myalgia, bone pain, uncommonly chest pain, maculopapular rash, conjunctivitis and malaise.
These symptoms usually occur 6-12 hours after application. Corticosteroids have proven to be effective in the prophylaxis of this syndrome.
Uncommon: Immediate type allergic reactions (urticaria, anaphylaxis).

Nervous system disorders:
Central nervous system disorders are predominantly observed during high-dose therapy.
Toxic reactions of the central nervous system are rare in total doses less than 36 g cytarabine/m2 body surface area. Disposition factors are advanced age, hepatic and renal insufficiency, previous CNS-treatment (radiation, intrathecal administration of cytostatic drugs) and alcohol abuse. Central nervous system disorders are mostly reversible.
Common: Cerebral/cerebellar dysfunction (nystagmus, dysarthria, ataxia, confusional states), headaches, impaired thought, somnolence, lethargy, coma, seizures and anorexia.
Uncommon: peripheral neuropathy
Rare:         Dizziness, neuritis.
Not known: Reports on individual cases of peripheral nerve damages after high-dose cytarabine as well as cases of delayed progressive ascending paralysis.

Eye disorders:
Common: Conjunctivitis (may occur with rash), keratitis, photophobia, burning eyes, severe tearing and impaired vision; haemorrhagic conjunctivitis, ulcerative keratitis.
The complaints can be prevented or alleviated by frequent lavage of the eyes or prophylactic application of corticoidal eye drops.

Cardiac disorders:
Uncommon: Acute pericarditis
Very rare: Myocardial damage, transient cardiac arrhythmias, Arrhythmia.
Not known: sinus bradycardia

Respiratory, thoracic and mediastinal disorders
Uncommon: Pulmonary oedema due to an increase in the permeability of the alveolar capillaries, difficulty breathing, diffuse interstitial nia, Pneumonia, sore throat.

Gastrointestinal disorders
Common: Mucositis, mucosal ulceration (oral, anal), especially during high-dose treatment; severe diarrhoea with subsequent potassium and protein loss.
Nausea and vomiting (especially after rapid intravenous injection), abdominal pain, diarrhoea, dysphagia, oral/anal inflammation or ulceration.
Uncommon: Intestinal necrosis, necrotising colitis. High-dose treatment uncommonly causes intestinal necrosis with ileus and peritonitis, Oesophageal ulceration, oesophagitis, pneumatosis cystoides intestinalis.

Hepatobiliary disorders:
Common: Increase in enzymes denoting cholestasis and hyperbilirubinaemia, Jaundice Not known: Individual reports regarding the occurrence of hepatic vein thrombosis (Budd-Chiari syndrome).
Liver abscesses may occur.
In isolated cases, pancreatitis have been reported to occur with high-dose cytarabine therapy, Hepatic dysfunction.

Skin and subcutaneous tissue disorders:
Common: Maculopapular exanthema, erythroderma, erythema, alopecia, bullous dermatitis, urticaria, vasculitis.
Uncommon: cellulitis at injection site
Following the administration of high doses of cytarabine, up to 75% of patients develop generalised erythema including blistering and desquamation.
Uncommon: Burning pain in the palms and soles, Skin ulceration, pruritus.
Very rare: Neutrophilic eccrine hidradenitis.
Not known: Freckling, rash, Palmar-plantar erythrodysaesthesia syndrome Musculoskeletal and connective tissue disorders:
Uncommon: Myalgia and/or arthralgia in the neck region and in the legs.
Very rare: The occurrence of rhabdomyolysis has been described.

Renal and urinary disorders:
Common: hyperuricaemia, renal impairment, urinary retention.
Uncommon: Increase in plasma creatinine

General disorders and administration site conditions:
Common: Tissue damage at the site of injection, thrombophlebitis, fever and sore throat.
Not known: Following the administration of high-dose cytarabine, isolated cases of inadequate vasopressin incretion syndrome were observed.


Reporting suspected adverse reactions after authorization 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