There are no data from the use of rasburicase in pregnant women. Results from animal studies could not be interpreted due to the presence of endogenous urate oxidase in standard animal models. Because teratogenic effects of rasburicase cannot be ruled out, rasburicase should only be used during pregnancy if strictly necessary.
Rasburicase is not recommended in women of childbearing potential not using contraception.
It is unknown whether rasburicase is excreted in human milk. As a protein the dose for the infant is expected to be very low. During treatment with rasburicase, the advantage of breastfeeding should be weighted against the potential risk for the infant.
There are no data regarding the effect of rasburicase on fertility.
No studies on the effects on the ability to drive and use machines have been performed.
Rasburicase is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea.
In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by rasburicase. The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Adverse reactions possibly attributable to rasburicase and reported in the clinical trials, are listed below, by system organ class and by frequency. Frequencies are defined using the following MedDRA convention as: 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).
Tabulated list of adverse reactions:
| MedDRA Organ system classes | Very common | Common | Uncommon | Rare | Not known |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Haemolysis, Haemolytic anaemia, Methaemoglobinaemia | ||||
| Immune system disorders | Allergy/ allergic reactions (rashes and urticaria) | Severe hypersensitivity reactions | Anaphylaxis | Anaphylactic shock* | |
| Nervous system disorders | Headache+ | Convulsion** | Muscle contraction involuntary** | ||
| Vascular disorders | Hypotension | ||||
| Respiratory, thoracic and mediastinal disorders | Bronchospasm | Rhinitis | |||
| Gastrointestinal disorders | Diarrhoea+, Vomiting++, Nausea++ | ||||
| General disorders and administration site conditions | Fever++ |
* Anaphylactic shock including potential fatal outcome
** From post-marketing experience
+ Uncommon G3/4
++ Common G3/4
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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