Alkeran Special Precautions

Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts. Therefore, immunisation with live organism vaccines is not recommended.
For the safe handling of Alkeran, see Cautions for Usage.
Monitoring: Since Alkeran is a potent myelosuppressive agent, it is essential that careful attention should be paid to the monitoring of blood counts to avoid the possibility of excessive myelosuppression and the risk of irreversible bone marrow aplasia.
Blood counts may continue to fall after treatment is stopped, so at the 1st sign of an abnormally large fall in leucocyte or platelet counts, treatment should be temporarily interrupted.
Alkeran should be used with caution in patients who have undergone recent radiotherapy or chemotherapy in view of increased bone marrow toxicity.
Renal Impairment: Alkeran clearance may be reduced in patients with renal impairment, who may also have uraemic bone marrow suppression. Dosage reduction may therefore be necessary (see Dosage & Administration), and these patients should be closely observed.
Carcinogenicity & Mutagenicity: Chromosome aberrations have been observed in patients being treated with Alkeran.
Alkeran, in common with other alkylating agents, may be leukaemogenic in man. There have been reports of acute leukaemia occurring after prolonged Alkeran treatment for diseases eg, amyloid, malignant melanoma, multiple myeloma, macroglobulinaemia, cold agglutinin syndrome and ovarian cancer.
A comparison of patients with ovarian cancer who received alkylating agents with those who did not showed that the use of alkylating agents, including Alkeran, significantly increased the incidence of acute leukaemia.
The leukaemogenic risk must be balanced against the potential therapeutic benefit when considering the use of Alkeran.
Use in pregnancy: The teratogenic potential of Alkeran has not been studied. In view of its mutagenic properties and structural similarity to known teratogenic compounds, it is possible that melphalan could cause congenital defects in the offspring of patients treated with Alkeran.
Alkeran causes suppression of ovarian function in premenopausal women resulting in amenorrhoea in a significant number of patients.
There is evidence from some animal studies that Alkeran can have an adverse effect on spermatogenesis. Therefore, it is possible that Alkeran may cause temporary or permanent sterility in male patients.
As with all cytotoxic chemotherapy, adequate contraceptive precautions should be practised when either partner is receiving Alkeran.
The use of melphalan should be avoided whenever possible during pregnancy, particularly during the 1st trimester. In any individual case, the potential hazard to the foetus must be balanced against the expected benefit to the mother.