LEEDS TEACHING HOSPITALS TRUST

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1 LEEDS TEACHING HOSPITALS TRUST Guidelines for the prevention of serious hypersensitivity reactions in paediatric oncology patients Guideline Detail Publication date: September 2016 Next Review date: January 2019 Status: Contents Summary of Guideline These guidelines aim to identify which drugs are likely to cause hypersensitivity reactions in patients and what prophylactic measures can be implemented to prevent these reactions occurring. These guidelines will not review the management of hypersensitivity or anaphylaxis reactions - see the current LTHT Guideline on the Management of Anaphylaxis in Children [ ] Aims To improve the prevention of serious hypersensitivity reactions in paediatric oncology patients Objectives To provide evidence-based recommendations for appropriate management of serious hypersensitivity reactions in paediatric oncology patients Background Certain groups of drugs have a higher risk of hypersensitivity reactions, and it is important to identify these drugs before administration so appropriate steps can be taken to reduce the likelihood of a reaction. The list of drugs causing possible hypersensitivity reactions is only guidance and new agents that are available should be reviewed before use in paediatric oncology. It is also important to remember that almost any drug can cause a hypersensitivity reaction, and patients may need pre-medication for drugs not listed below for example ciclosporin. Diagnosis N/A Investigation N/A Treatment / Management

2 Drug Onset of reaction Pre-medication Rituximab True hypersensitivity reactions can occur within a few minutes of starting the infusion, though they can occur at any point during the infusion. All patients receiving rituximab should be premedicated with with paracetamol and chlorphenamine 30 minutes before starting the rituximab. If a reaction has occurred and further treatment is required, then hydrocortisone should be added in to the premedication. Gemtuzumab Gemtuzumab administration can result in severe hypersensitivity reactions (including anaphylaxis). In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of gemtuzumab. All patients receiving gemtuzumab should be pre-medicated with paracetamol and chlorphenamine 30 minutes before starting the gemtuzumab infusion. If a reaction has occurred and further treatment is required, then hydrocortisone should be added in to the premedication. Alemtuzumab Hypersensitivity reactions occur commonly with alemtuzumab and can occur at any point during the infusion. They may occur even if premedication has been given. Pre-medication with chlorphenamine, hydrocortisone and paracetamol is recommended minutes prior to infusion. Mifamurtide Chills and rigors commonly occur after administration Premedication should occur with paracetamol and if

3 Carboplatin though not commonly during the infusion. Any chills and rigors that occur more than eight hours after should not be attributed to the drug. The incidence of carboplatin allergy could be as high as 40%. It can occur during the infusion and can be graded from grade I to IV: I: Mild rash II: Urticaria III:Bronchospasm IV:Allergic Shock It is important to remember that the chance of a reactions increases as a patient receives more carboplatin infusions. they occur, the reactions may be treated with paracetamol first line and then with pethidine 0.5mg/kg (max 25mg) second line. Steroids should not be used due to the potential antagonistic effect they may have on the efficacy of the mifamurtide For mild reactions: premedicate with chlorphenamine and also increase the infusion time (grade I). Consider adding hydrocortisone if mild reactions not controlled with chlorphenamine alone. For serious reactions then substituting carboplatin for another drug eg cisplatin or cyclophosphamide is an option and must be discussed with the consultant. Always refer to toxicity modification details in the trial protocol. ATG(Anti ThymocyteGlobulin) A test dose of ATG should always be given prior to treatment to determine whether the patient is Desensitisation may be considered in some patients. It is recommended to administer pre-medication with intravenous corticosteroids,

4 allergic to rabbit/horse proteins. Do not premedicate prior to the test dose. Patients should be carefully monitored during the infusion. Particular attention must be paid to monitoring the patient for any symptoms of anaphylactic shock. Close monitoring of the patient must continue during the infusion and for a period of time following the end of the infusion until the patient is stable antihistamines and paracetamol prior to infusion of rabbit antihuman thymocyte globulin. If a reaction occurs, the infusion rate can be extended from 12 to 18 hours Audit and Monitoring Compliance This guideline will be monitored via an exceptions system, with all significant adverse responses to chemotherapy being recorded via the Datix system and reviewed at the Leeds Children s Chemotherapy Group meeting, which will agree actions arising from the recommendations, and monitor the progress of the actions. Provenance: Author name (s)/ Post and address (es) Rachel Boys (Paediatric Oncology Pharmacist) Clinical condition: Severe hypersensitivity reactions Target patient group: Paediatric and Teenage and Young Adult Oncology Target professional group (clinical competence): Paediatric and Teenage and Young Adult Oncology Consultants, Pharmacists and Nursing Staff Evidence Base: References and Evidence levels: A. Meta-analyses, randomised controlled trials/systematic reviews of RCTs B. Robust experimental or observational studies C. Expert consensus. D. Leeds consensus. (where no national guidance exists or there is wide disagreement with a level C recommendation or where national guidance documents contradict each other)

5 1. SOP for Paediatric administration of alemtuzumab. 2. Mylotarg Data sheet Wyeth Revised 04/10 3. MabThera Data sheet Roche Revised 09/04/ LGG2 version th September Thymoglobuline Summary of Product Characteristics last updated on the emc: 08/12/2009