For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the indication and dose received and also when given in combination with other therapeutic agents.
The following convention has been utilised for the classification of frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Tab: Tabulated list of adverse reactions: (see table.)
Click on icon to see table/diagram/image
Inj: Blood and Lymphatic System Disorders: Very common: bone marrow depression leading to leucopenia, thrombocytopenia and anaemia. Rare: haemolytic anaemia.
Immune System Disorders: Rare: allergic reactions (see Skin and Subcutaneous Tissue Disorders as follows).
Allergic reactions to ALKERAN such as urticaria, oedema, skin rashes and anaphylactic shock have been reported uncommonly following initial or subsequent dosing, particularly after intravenous administration. Cardiac arrest has also been reported rarely in association with such events.
Respiratory, Thoracic and Mediastinal Disorders: Rare: interstitial pneumonitis and pulmonary fibrosis (including fatal reports).
Gastrointestinal Disorders: Very common: nausea, vomiting and diarrhoea; stomatitis at high dose. Rare: stomatitis at conventional dose.
The incidence of diarrhoea, vomiting and stomatitis becomes the dose-limiting toxicity in patients given high intravenous doses of ALKERAN in association with autologous bone marrow transplantation. Cyclophosphamide pre-treatment appears to reduce the severity of gastrointestinal damage induced by high-dose ALKERAN and the literature should be consulted for details.
Hepatobiliary Disorders: Rare: hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice; veno-occlusive disease following high dose treatment.
Skin and Subcutaneous Tissue Disorders: Very common: alopecia at high dose. Common: alopecia at conventional dose. Rare: maculopapular rashes and pruritus (see Immune System Disorders as previously mentioned).
Musculoskeletal and Connective Tissue Disorders: Injection, following isolated limb perfusion: Very common: muscle atrophy, muscle fibrosis, myalgia blood creatine phosphokinase increased. Common: compartment syndrome. Not known: muscle necrosis, rhabdomyolysis.
Renal and Urinary Disorders: Common: temporary significant elevation of the blood urea has been seen in the early stages of ALKERAN therapy in myeloma patients with renal damage.
General Disorders and Administration Site Conditions: Very common: subjective and transient sensation of warmth and/or tingling.