ECN Protocol Book. Antiemetic Guidelines for Adult Patients Receiving Chemotherapy and Radiotherapy

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ECN Protocol Book Antiemetic Guidelines f Adult Patients Receiving Chemotherapy and Radiotherapy Name of person presenting document: Reason f document development: Names of development team: Specify

1 ECN Protocol Book Antiemetic Guidelines f Adult Patients Receiving Chemotherapy and Radiotherapy Name of person presenting document: Reason f document development: Names of development team: Specify groups of staff to whom the document relates: Approved by: Date approved: Next Review date: Netty Wood, Lead Pharmacist, ECN Netwk required guidelines ECN Oncology Pharmacy Group Clinicians within ECN Cancer pharmacy staff within ECN Chemotherapy nursing staff within ECN ECN Chemotherapy Board Version No: 1 Responsibility f review: Lead Pharmacist, Essex Cancer Netwk Page 1 of 8

2 Contents Introduction...3 Definition...3 Contributing Risk Facts...3 Aim of therapy...3 Antiemetic Selection...4 Breakthrough Management...5 Exclusion of other causes...5 Antiemetic Infmation...6 Emetic Potential f Individual Drugs...7 Radiotherapy...8 References:...8 Page 2 of 8

3 Introduction Chemotherapy Induced Nausea and Vomiting (CINV) is one of the most frequently experienced side effects encountered by chemotherapy patients. Patients will often find the symptoms distressing, and develop anxiety about the potential f such symptoms to recur on future cycles of chemotherapy. Modern drug treatment can successfully control CINV f the majity of patients. Scope: These guidelines are intended to suppt health professionals in the management and prevention of chemotherapy and radiotherapy induced nausea and vomiting. They are not intended to address nausea and vomiting in palliative care. This guidance applies to adults only. These guidelines are intended to cover adult solid tumour and haemato-oncology patients receiving chemotherapy within the Essex Cancer Netwk. These guidelines are intended to provide a framewk to suppt clinical practice, they can not cover every clinical situation and good common clinical sense and clinical experience will be required when approaching the management of individual patients. These guidelines have purposefully chosen not to recommend one specific 5HT 3 antagonist. Definition Acute Delayed Anticipaty Breakthrough Refracty N&V experienced during the first 24-hour period immediately after chemotherapy administration N&V that occurs me than 24 hours after chemotherapy and may continue f up to 6 7 days after chemotherapy. N&V that occurs pri to the beginning of a new cycle of chemotherapy. It is either a learned response following CINV on a previous cycle an anxiety response. It is most common after 3 to 4 cycles of chemotherapy with very badly controlled acute delayed symptoms. Development of symptoms (nausea vomiting), despite standard anti-emetic therapy, which require treatment with an additional pharmacological agent Patients who have failed on both standard and rescue medication Contributing Risk Facts Patients with 3 me risk facts should be considered to receive additional cover Po control with pri chemotherapy Female sex Younger age <50 years A low chronic alcohol intake pri histy of. Histy of sickness: pregnancy/travelling/surgery Anxiety Smoking Radiation to gastrointestinal (GI) tract, liver, brain Other medications: Various medications can cause nausea and vomiting such as Anaesthetic Agents, Anti-depressants, Anti-microbials, Anti-fungals, Iron, Levdopa, Carbodopa, NSAIDs. Aim of therapy The aim of antiemetic therapy is to prevent nausea and vomiting. Prophylactic antiemetic treatment should be given pri to chemotherapy, should be given regularly and should continue f at least 48hrs after treatment has finished. PRN antiemetics should always be available, preferably using drugs with a different mode of action to the regular antiemetics and should also be available via a route not dependant on GI absption, such as parenteral, rectal buccal, as this may be compromised in patients experiencing breakthrough nausea and/ vomiting. Optimal emetic control in the acute phase is essential to prevent nausea and vomiting in the delayed phases and to reduce the chances of anticipaty vomiting developing in later cycles of treatment. Page 3 of 8

4 Antiemetic Selection Emetogenic Potential Low Risk of emesis in < 10% Pre Chemotherapy Schedule (f each day of chemotherapy) No routine antiemetics usually necessary. Post Chemotherapy (day after chemotherapy finished) Domperidone 20mg tds prn PO 5/7 Or Metoclopramide 10mg tds prn PO 5/7 Action f Antiemetic Failure If no routine antiemetics taken: 1st line antiemetics f breakthrough. Treat on subsequent courses the same. If routine antiemetics taken: 2nd line antiemetics f breakthrough. Manage subsequent cycles as moderate emetogenic. Moderate Risk of emesis in 10-30% Dexamethasone 8mg PO/IV Dexamethasone 8mg od PO 2/7 ( 8mg od 1/7, 4mg od 1/7) Domperidone 20mg tds PO prn 5/7 Metoclopramide 10mg tds PO prn 5/7 Commence with 2nd line antiemetics f breakthrough. Manage subsequent cycles as high emetogenic. High Risk of emesis in 30-90% Dexamethasone 20mg PO/IV Dexamethasone 8mg od PO 2/7 ( 8mg od 1/7, 4mg od 1/7) Domperidone 20mg tds PO prn 5/7 Metoclopramide 10mg tds PO prn 5/7 Commence with 3rd line anti-emetics f breakthrough. Consider including these as part of take home medication. Manage subsequent cycles as severe emetogenic. Consider Prochlperazine 3mg bd buccal prn 5/7 Severe Risk of emesis in nearly all patients >90% Anticipaty Nausea and Vomiting Dexamethasone 12mg PO/IV Aprepitant 125mg PO, fosapripitant (IV), long acting 5HT 3 antagonist (omit other 5HT 3 antagonist) If nausea and vomiting is well controlled during and after chemotherapy, anticipaty nausea and vomiting is unlikely to occur. Dexamethasone 8mg od PO 3/7 Aprepitant 80mg od PO 2/7 (omit if given long acting 5HT 3 antagonist) Domperidone 20mg tds PO prn 5/7 Metoclopramide 10mg tds PO prn 5/7 Consider Prochlperazine 3mg bd buccal prn 5/7 Commence with 3rd line anti-emetics f breakthrough. Consider including these as part of take home medication. Continuous subcutaneous infusions may be indicated f poly controlled patients. Lazepam 1mg ally, sublingually IV 30 minutes befe chemotherapy is given. Patients may benefit from al lazepam the night befe and/ on the mning of chemotherapy Page 4 of 8

5 Notes: Sht acting 5HT 3 antagonists are interchangeable and choice of drug should be based on cost. Doses should be in line with relevant SPC. Oral antiemetics are as effective as intravenous administration and may be given pri to chemotherapy (at least 30 minutes befe chemotherapy.) Using antiemetics with the same mode of action should be avoided where possible as this increases the risk of side effects as a result of overlapping toxicities. Where steroids are part of the chemotherapy regimen e.g. in lymphomas, it may be appropriate f the antiemetic steroids (e.g. dexamethasone) to be omitted. The risks and benefits of steroids should be considered in patients with co-existing diseases, such as diabetes, and where appropriate should be avoided if possible. Domperidone is recommended in younger patients because of the increased risk of dystonic reactions with metoclopramide. F multi-day regimens, give antiemetics as per Pre Chemotherapy Schedule (f each day of chemotherapy). Breakthrough Management Anti-emetic failure is described as: 4 hours of moderate to severe nausea 2 me episodes of vomiting and/ retching in 24 hours There are 3 key steps f successful management Exclusion of other causes Treatment accding to the cause Planning f the next cycle Table 2: Action f antiemetic failure (Breakthrough Management) 1st line Domperidone 20mg tds PO Or Domperidone 60mg bd PR Metoclopramide 10mg tds PO/IV/SC 2nd line Levomepromazine 6.25mg bd po Or Cyclizine 50mg tds PO/IV/SC Prochlperazine 3mg bd Buccal 3rd line Haloperidol 1mg-3mg tds PO/IV Levomepromazine 6.25mg to 12.5mg bd PO/SC Continuous subcutaneous infusions may be useful f poly controlled emesis +/- Lazepam 1mg PO/IV/SL qds prn Useful where anxiety may be contributing to nausea and vomiting Exclusion of other causes It is easy to assume that nausea and vomiting in a patient who has recently received chemotherapy is the result of their chemotherapy. However there are several other causes of nausea and vomiting many of which will commonly present in cancer patients and should therefe be excluded: Other medications Constipation Bowel Obstruction Anxiety Metabolic Abnmalities (eg Renal Failure) Hyper-calcaemia Peptic Ulcer Disease Radiotherapy Metastases / Raised Intra Cranial Pressure Fluid and electrolyte imbalances (hypercalcaemia, Renal Failure) If another cause is identified this should be crected treated. Page 5 of 8

6 Antiemetic Infmation Please refer to BNF/SPC f me infmation 5HT3 antagonist Aprepitant Cyclizine Dexamethasone Domperidone Haloperidol Levomepromazine Lazepam Metoclopramide Prochlperazine Patients may complain of constipation and headaches. Patients need to be advised accdingly, ie Senna/Milpar to relieve constipation, Paracetamol to relieve headache. If severe substitute alternative 5HT 3 (side effects are class effect and patient may still experience with alternative 5HT 3 ) alternative anti-emetic Significant drug interactions on CYP3A4 and CYP2C9 enzyme systems and drug interactions need to be checked. The maximum recommended dose of Dexamethasone with Aprepitant is 12mg per day. Common side effects include hiccups, dyspepsia, diarrhoea, constipation, asthenia, headache, dizziness. cyclizine should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic disease, severe heart failure, epilepsy and in males with possible prostatic hypertrophy. Urticaria, drug rash, drowsiness, headache, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia and audity and visual hallucinations have been repted, particularly when dosage recommendations have been exceeded. Cticosteroids can cause sleep disturbances, hyperactivity and excessive appetite. They also produce glucose-intolerance, use with care in patients with diabetes mellitus. Patients may experience perineal discomft if the drug is given by iv bolus. This is avoided by iv infusion. Domperidone should not be used when stimulation of the gastric motility could be harmful eg gastro-intestinal haemrhage, mechanical obstruction perfation. Domperidone can increase in prolactin levels. Caution in patients with liver disease renal failure, epilepsy, disturbed thyroid function patients with risk facts f cardiac arrhythmias. Haloperidol can interact with some anti-epileptics. Side effects include extra pyramidal symptoms, tardive dyskinesia, cardiac effects, dry mouth and constipation. Avoid in patients with liver dysfunction. Inhibits cytochrome P-450. Common side effects are somnolence, asthenia, dry mouth, hypotension, photosensitivity and skin reactions. Can cause drowsiness and may affect perfmance of skilled tasks (driving) Can rarely cause agitation the development of extra-pyramidal symptoms. These can occur up to 24 hours after a dose and may vary from facial grimacing and dystonic movements to odd feelings in the mouth, restlessness, somnolence and irritability. Treat with procyclidine 10mg iv stat diazepam (diazemuls) 10mg iv stat, discontinue metoclopramide and do not re-use. Particular caution should be exercised when giving metoclopramide to patients under the age of 20 years. Bowel transit time may be reduced and some patients experience diarrhoea. Substitute with cyclizine. Prochlperazine should be avoided in patients with liver renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. A mild leukopenia occurs in up to 30% of patients on prolonged high dosage Page 6 of 8

7 Emetic Potential f Individual Drugs The individual emetogenicity of chemotherapy agents has been derived from Kris et al American Society of Clinical Oncology Guideline f Antiemetics in Oncology: Update 2006 Combination Chemotherapy When assessing the emetogenicity of combination chemotherapy: 1. Start at Low emesis then a. F each drug with an emetogenic risk >30% increase one level. Do this f all drugs with an emetogenic risk >30% b. F a drug with an emetogenicity 10-30% the emetogenicity should be increased one level c. F a drug with an emetogenicity < 10% no adjustment is necessary. Example: 3 drug combination with 2 drugs high emesis (30% -90% risk) and one low emesis = Severe overall F regimen emetogenicity please see ECN approved list Table 3: Emetic Potential f Individual Drugs Low emesis (<10% incidence) Moderate Emesis (10%-30% incidence) High Emesis (30% to 90% incidence) Severe Emesis (>90% incidence) Alemtuzumab Arsenic Altretamine Busulfan high doses Asparaginase Btezomib Amsacrine Carmustine > 250mg/m2 Bevacizumab Carmustine <100mg/m2 Carboplatin Cisplatin >60mg/m2 Bleomycin Caelyx (liposomal doxubicin) Carmustine >100mg/m2 Cyclophosphamide >1500mg/m2 Busulfan <10mg Cetuximab Cisplatin < 60mg/m2 Capecitabine Cyclophosphamide Cyclophosphamide Dacarbazine <750mg/m2 >750mg/m2 - <1500mg/m2 Cetuximab Cytarabine <900mg/m2 Cytarabine > 900mg/m2 Ifosfamide >3g/m2 Chlambucil Daunubicin <50mg/m2 Dactinomycin Cladrabine Docetaxel Daunubicin > 50mg/m2 Etoposide Doxubicin <60mg/m2 Doxubicin > 60mg/m2 Fludarabine Gemcitabine Epirubicin Fluouracil Methotrexate Estramustine 250mg/m2 -<1000mg/m2 Gefitnib Mitomycin C Idarubicin Gemtuzumab Mitoxantrone Ifosfamide <3g/m2 Hydroxyurea Paclitaxel Irinotecan Imatinib Procarbazine Lomustine Liposomal Daunubicin Temozolomide Melphalan IV >100mg/m2 Liposomal Doxubicin Topotecan Methotrexate >1000mg/m2 Melphalan al Oxaliplatin Mercaptopurine Streptozocin Methotrexate <250mg/m2 Vinelbine Oral Pentostatin Rituximab Thioguanine Trastuzumab Vinblastine Vincristine Vindesine Vinelbine Page 7 of 8

8 Radiotherapy Table 5: Risk associated irradiated area and the recommended antiemetic guideline Risk Level Minimal Irradiated Area Head and neck, extremities, cranium and breast Pre-Radiotherapy Antiemetic 1 hour befe each fraction No routine antiemetics usually necessary, Consider: Domperidone 20mg tds PO Metoclopramide 10mg tds PO Rescue Antiemetic Domperidone 20mg tds PO Metoclopramide 10mg tds PO Where anti-dopamine agent has been used: Low Lower thax region and pelvis Cranium (radiosurgery) and cranospinal Domperidone 20mg tds PO Metoclopramide 10mg tds PO Consider: Where a 5HT 3 has been used: Cyclizine 50mg tds PO/IV/SC Prochlperazine 10mg tds PO Moderate High Upper abdomen hemibody irradiation, upper abdomen, abdominal-pelvic, mantle, craniospinal irradiation, and cranial radiosurgery Total body irradiation (TBI) and Dexamethasone 8mg PO/IV and Levomepromazine 6.25mg to 12.5mg bd PO/SC Haloperidol 1mg-3mg tds PO/IV/SC Levomepromazine 6.25mg to 12.5mg bd PO/SC Metoclopramide 10mg tds prn Continue f 24 hours after fraction References: Hesketh PJ, Kris MG, Grunberg SM et al. Proposal f classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 1997:15(1); Gralla RJ, Osoba D, Kris MG, et al. Recommendations f the Use of Antiemetics: Evidence-Based, Clinical Practice Guidelines. J Clin Oncol 1999:17; Gralla RJ, Roila F et al. The 2004 Perugia Antiemetic Consensus Guideline Process: methods, procedures and participants. Suppt Care Cancer (2005) 13: Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology Guideline f Antiemetics in Oncology: Update J Clin Oncol 2006:24(18)ASCO special article. Recommendation f the use of antiemetics: Evidence Based, clinical practice guidelines. J of Clinical Oncology, Vol 17 No 9, 1999: Hesketh, p., Proposal f classifying the acute emetogenicity of cancer chemotherapy. J of Clinical Oncology, Vol 15 No 1, 1997: Stoner. N., Anti-emetic policy f the prophylaxis of chemotherapy induced nausea and vomiting. Churchill Hospital 2003 Protocol (Oncology and Haematology) - Antiemetic Prescription. Addenbrook s NHS trust Perugia International Cancer Conference VII March 2004 updated September 2005 MASCC Page 8 of 8

Guidelines for the Use of Anti-Emetics with Chemotherapy

Guidelines for the Use of Anti-Emetics with The purpose of this document is to provide guidance on the rational use of anti-emetics for prevention and treatment of chemotherapy-induced nausea and vomiting