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Papers Trust Board - 30 January 2020

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 30/01/2020 9:00 - 11:45 Conference Room, Heartbeat Education
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2020/Papers-Trust-Board-30-January-2020.pdf

UHS register of interests June 2025

Description: Employee Name Aarvold, Dr Alice Beatrice Rachel Aarvold, Dr Alice Beatrice Rachel Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/UHS-register-of-interests-June-2025.pdf

Annual-report-and-quality-account-2019-20

Description: ANNUAL REPORT AND ACCOUNTS 2019/20 Incorporating the quality account 2019/20 Page 2 University Hospital Southampton NHS Foundation Trust A
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/annual-report-and-quality-account-2019-202.pdf

Hospital trust teams shortlisted for prestigious medical awards

Description: Two teams of clinicians at University Hospital Southampton NHS Foundation Trust have been shortlisted for prestigious national medical awards for their
Url: /AboutTheTrust/Newsandpublications/Latestnews/2017/March-2017/Hospital-trust-teams-shortlisted-for-prestigious-medical-awards.aspx

Communicating risk: words or numbers?

Description: Is it better to communicate risks to patients with words or statistics?
Url: /HealthProfessionals/Clinical-law-updates/Communicating-risk-words-or-numbers.aspx

Toothache and incapacity

Description: Mr Wheeler considers two cases where people who didn't have capacity experienced delays in receiving dental treatment.
Url: /HealthProfessionals/Clinical-law-updates/Toothache-and-incapacity.aspx

Compulsory treatment for diabetes

Description: The Court of Protection considers whether a patient should be treated for diabetes against his wishes.
Url: /HealthProfessionals/Clinical-law-updates/Compulsory-treatment-for-diabetes.aspx

AMS FLIER summary 2022 - cohort 3 applications open

Description: Future Leaders in Innovation, Enterprise and Research (FLIER) Programme The Academy of Medical Sciences is pioneering a unique programme to develop leaders of the future who can create collaborations across academia, industry, the NHS and government to drive innovation. The programme equips these future leaders with skills to help solve the biggest health challenges we will face, and enable them to seize opportunities afforded to us by new discoveries in science, technology and medicine. The Academy invites you to participate by promoting the scheme and nominating candidates for the third cohort. Applications are now open until 18 March 2022. All application materials can be found here. Who will take part? FLIER is aimed at those in the middle of their career, established within their own sector with the seniority to effect organisational change. They will have an emerging vision of how cross-sector working and collaboration could help maximise opportunities and solve the future challenges of research and healthcare. They will be looking to explore and shape their vision in dialogue with colleagues across sectors. Profiles of our first and second cohorts can be found on our website. We are looking for key characteristics including motivation, vision and potential to make a difference and lead change across the sectors, learning agility, and creative, innovative and radical thinking. Participants will be chosen through a competitive selection process. The FLIER Programme The programme was developed by a cross-sector Task Force of current leaders, and is delivered in partnership with bespoke leadership, talent and engagement specialists Cirrus. The two-year programme brings together cohorts of emerging leaders drawn from across academia, industry, the NHS, regulators, science media writers, government/policy organisations and entrepreneurs. The journey includes: • Residential and one-day meetings will expose candidates to current national and international leaders across the wider scientific and health ecosystem • Face-to-face and virtual workshops • Regular tailored coaching sessions from professionals at the fore-front of leadership development • Mentorship from a research leader and tailored 1-1 coaching • Cross-sector immersion experiences with an array of other organisations. • The second year will involve a cross-sector project. This will be an opportunity to apply acquired strategic and higher-level operational skills to a work-based project while being supported by colleagues, a coach and a mentor. The programme has secured funding from the Dennis and Mireille Gillings Foundation and the Department of Business, Energy and Industrial Strategy. Participating organisations will also make a modest contribution. What makes FLIER unique? In the scoping work for this programme it was identified that the life sciences ecosystem in the UK has an outstanding range of assets, including a strong academic sector, big pharma and burgeoning biotech, medtech and engineering sectors, a single national healthcare system, and an engaged Government. But a gap was identified in terms of developing future leaders who will be able to work across key sectors. Collaborative working between the life sciences sectors, is critical to ensure that the UK capitalises on our assets and drives innovation to stay globally competitive. The programme is set apart from other leadership programmes by focusing on the creation of collaborations across sectors, thereby addressing what the future scientific landscape needs. FLIER supports potential leaders who are looking to progress to leadership roles which span sectors and through the programme gives them access to new networks and a deeper cross-sector understanding. The benefits of taking part in FLIER Participants benefit from the programme by: • Establishing strong and long-lasting cross-sector networks of peers and senior leaders. • Developing a practical, in-depth understanding of the cultures and drivers of other sectors within health and life sciences beyond their own, and the tools and contacts to create meaningful collaborations and enact change in the current research landscape. • Increasing their understanding of effective leadership skills, participants will be supported to harness their potential through bespoke 360 feedback and a proven combination of interactive workshops, coaching, mentoring and self-directed learning. • Access to financial management training through a specially designed module delivered by a Business School, plus in-depth sessions on business cycles, governance and maximising human capital. • Practical experience of collaborative working to complete a work-based cross-sector project. Organisations participating in FLIER benefit from: • An employee who has the skills to galvanise innovation and create opportunities to contribute to the success of their own organisation and as role models, in turn influencing the leadership by the next generation of employees • New cross-sector networks created by their employee • Benefits generated by the outcome of a challenging cross-sector project in year two • Opportunities to showcase their organisation to future leaders in other sectors • Potential input from emerging leaders in other sectors to solve complex problems within their own organisation How can organisations be involved in the programme? Nominating applicants - Organisations can put forward candidates to apply for a place on the programme, FLIER will be open for applications in February 2022 with the first workshop taking place in June 2022. The Academy is committed to working towards equity, diversity and inclusion and we actively encourage applications from candidates with underrepresented protected characteristics under the Equality Act 2010. Candidates will be selected through a competitive process, including an interview stage. We request a contribution of £5k per participant; a small number of bursaries are available, please contact the office for more information. For further information please contact Dr Rachel Macdonald, Head of Programmes, by email (rachel.macdonald@acmedsci.ac.uk).
Url: /Media/Southampton-Clinical-Research/Grants/AMS-FLIER-summary-2022-cohort-3-applications-open.pdf

Ipilimumab Ver 1

Description: Chemotherapy Protocol SKIN CANCER IPILIMUMAB Regimen Skin – Ipilimumab Indication Ipilimumab is recommended, within its marketing authorisation, as an option for treating adults with previously untreated advanced (unresectable or metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. Ipilimumab is recommended as an option for treating advanced (unresectable or metastatic) melanoma in people who have received prior therapy, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. WHO performance status 0, 1 Toxicity Drug Ipilimumab Adverse Effect Colitis, diarrhoea, dermatitis, neuropathy, hypothyroidism, hepatotoxicity, infusion related reactions, hypophysitis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen FBC, LFT’s and U&E’s prior to day one of each cycle Blood pressure prior to treatment Thyroid function tests prior to staring treatment and then before each administration (cycle) or when clinically indicated. Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.1 (February 2015) Page 1 of 8 Skin - Ipilimumab Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Consider blood transfusion or erythropoietin if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL There is little need to adjust the dose of ipilimumab for haematological toxicity. Hepatic Impairment Immune related hepatic reactions are associated with ipimumab. For patients with elevated AST or ALT in the range of 5-8xULN or total bilirubin in the range of 3-5xULN that is suspected to be related to ipilimumab, the scheduled dose of ipilimumab should be withheld until the LFTs have resolved to these levels. Treatment may then be restarted. For patients with AST or ALT elevations greater than 8xULN or bilirubin greater than 5xULN that are suspected to be related to ipilimumab, then the ipilimumab must be permanently discontinued and appropriate supportive treatment initiated. Renal Impairment No dose reductions are necessary in mild to moderate renal impairment. Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Ipilimumab is associated with inflammatory adverse reactions resulting from increased or excessive immune activity, likely to be related to its pharmacology. Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Most occur during treatment, however, onset months after the last dose has been reported. Unless an alternate aetiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and ipilimumab-related. Early diagnosis and appropriate management are essential to minimise life threatening complications. Endocrine Ipilimumab can cause inflammation of the endocrine system organs, specifically hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism. This may present with nonspecific symptoms resembling other causes such as brain metastasis or underlying disease. If there are any signs of adrenal crisis such as severe dehydration, hypotension, or shock, immediate administration of intravenous corticosteroids with mineralocorticoid Version 1.1 (February 2015) Page 2 of 8 Skin - Ipilimumab activity is recommended, the patient must be evaluated for presence of sepsis or infections. If there are signs of adrenal insufficiency but the patient is not in crisis, further investigations should be considered including laboratory and imaging assessment. Evaluation of laboratory results to assess endocrine function may be performed before corticosteroid therapy is initiated. If pituitary imaging or laboratory tests of endocrine function are abnormal, a short course of high-dose corticosteroid therapy is recommended to treat the gland inflammation. The scheduled dose of ipilimumab should be omitted. It is currently unknown if the corticosteroid treatment reverses the gland dysfunction. Appropriate hormone replacement should also be initiated. Long-term hormone replacement therapy may be necessary. Once symptoms or laboratory abnormalities are controlled and overall patient improvement is evident, treatment with ipilimumab may be resumed and initiation of corticosteroid taper should be based on clinical judgment. Hypophysitis can present as a diffuse, heterogenous enlargement of the pituitary on a brain MRI but can be completely normal. When hypophysitis with pituitary dysfunction is suspected, blood tests including thyroid stimulating hormone (TSH), free T4, adrenocorticotropic stimulating hormone, cortisol, leutinizing hormone, and follicle-stimulating hormone should be obtained in women, and the first four plus testosterone in men. Typically the anterior pituitary axis is involved, affecting thyroid, gonadal, and adrenal function, but isolated axis dysfunction can be seen. Hypophysitis will cause low free T4 as well as TSH. Hypophysitis with clinically significant adrenal insufficiency and hypotension, dehydration, and electrolyte abnormalities such as hyponatremia and hyperkalemia constitutes adrenal crisis. Hospitalization and intravenous steroids with mineralocorticoid activity, such as methylprednisolone, should be initiated while waiting for laboratory results. Infection and sepsis should be ruled out with appropriate cultures and imaging. Prednisolone 1 mg/kg by mouth should be administered if patients are clinically stable. Steroids can usually be tapered over 30 days to achieve physiologic replacement levels. Thyroid hormone and/or testosterone replacement therapy may not be permanent, as the need for those hormones may wane over months in some patients. Cortisone replacement may also not be permanent in a modest portion of patients. Gastrointestinal Gastro-intestinal immune reactions include diarrhoea, increased frequency of bowel movements, abdominal pain or haematochezia, with or without fever. Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate causes. Immune-related colitis is often associated with evidence of mucosal inflammation, with or without ulcerations and lymphocytic and neutrophilic infiltration. NCI-CTC grade 1 or 2 diarrhoea or suspected mild to moderate colitis may continue on ipilimumab. Symptomatic treatment and close monitoring are advised. If mild to moderate symptoms recur or persist for 5-7 days, the scheduled dose of ipilimumab should be omitted and consideration given to prescribing prednisolone 1 mg/kg orally once a day. If resolution to NCI-CTC grades 0-1 or return to baseline occurs, the ipilimumab may be resumed at the next scheduled dose. Doses omitted due to an adverse reaction must not be replaced. Consider endoscopy to confirm or rule out colitis if there is persistent NCI-CTC grade 2 diarrhoea or NCI-CTC grade 1 - 2 diarrhoea with bleeding. Version 1.1 (February 2015) Page 3 of 8 Skin - Ipilimumab Ipilimumab must be discontinued if NCI-CTC grade 3 or 4 diarrhoea, colitis, peritoneal signs of bowel perforation, ileus or fever occur. High-dose intravenous corticosteroid therapy should be initiated immediately unless bowel perforation is present. Once diarrhoea and other symptoms are controlled, the initiation of corticosteroid taper should be based on clinical judgment (tapering over 6-8 weeks). In clinical trials, rapid tapering (over periods of less than 1 month) resulted in recurrence of diarrhoea or colitis in some patients. Consider alternative immunosuppressive therapy (eg single dose of infliximab 5mg/kg) if symptoms do not respond to steroids in 5-7 days. Neurological Unexplained motor neuropathy, muscle weakness, or sensory neuropathy lasting more than 4 days must be evaluated and other causes excluded. For patients with NCI-CTC grade 2, neuropathy likely related to be related to Ipilimumab omit the scheduled dose. If the neurologic symptoms resolve to baseline, the patient may resume treatment at the next scheduled dose. Ipilimumab must be permanently discontinued in patients with NCI-CTC grade 3 or 4, sensory neuropathy. Patients must be treated according to local guidelines for management of sensory neuropathy. Skin A diffuse, erythematous maculopapular rash that can be intensely pruritic was observed in 47% to 68% of patients, starting an average of 3 to 4 weeks after ipilimumab. NCI-CTC grade 1 or 2 skin reactions may remain on ipilimumab therapy with symptomatic treatment such as topical corticosteroids and antihistamines. For mild to moderate rash or pruritus that persists for 1 to 2 weeks and does not improve with topical corticosteroids consider oral corticosteroid therapy (e.g. prednisolone 1 mg/kg once a day). For patients with NCI-CTC grade 3 symptomatic skin reactions, the scheduled dose of ipilimumab should be omitted. If initial symptoms improve to NCI-CTC grade 1 or resolve then the ipilimumab therapy may be resumed at the next scheduled dose. Ipilimumab must be permanently discontinued in patients with a NCI-CTC grade 4 rash or grade 3 pruritus and consideration given to systemic corticosteroid therapy. Other Immune-Related Adverse Reactions The following additional adverse reactions, suspected to be immune-related, have been reported and include uveitis, eosinophilia, lipase elevation, and glomerulonephritis. In addition, iritis, haemolytic anaemia, amylase elevations, multi-organ failure, and pneumonitis have been reported. If these occur at NCI-CTC grade 3 or above then consider immediate high-dose corticosteroid therapy and discontinuation of ipilimumab. For ipilimumab-related uveitis, iritis, or episcleritis, topical corticosteroid eye drops should be considered as medically indicated. Version 1.1 (February 2015) Page 4 of 8 Skin - Ipilimumab Regimen 21 day cycle for 4 cycles Drug Ipilimumab Dose 3mg/kg Days 1 Route Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Dose Information Ipilimumab will be dose banded as per the CSCCN agreed bands Administration Information Extravasation Ipilimumab – neutral Other Ipilimumab should be administered using a low protein binding filter The final concentration of ipilimumab should be between 1-4mg/ml Additional Therapy No antiemetics are required When required for infusion related reactions - chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions - hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions - paracetamol 1000mg oral when required for the relief of infusion related reactions Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information The use of systemic corticosteroids, before starting treatment with ipilimumab should be avoided ipilimumab because of their potential interference with the pharmacodynamic activity and efficacy of ipilimumab. However, systemic corticosteroids can be used after starting ipilimumab to treat immune-related adverse reactions. The use of systemic corticosteroids after starting treatment does not appear to impair the efficacy of ipilimumab. Version 1.1 (February 2015) Page 5 of 8 Skin - Ipilimumab Coding Procurement – X71.5 Delivery – X72.2 References 1. NICE Technology Appraisal 319. Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma.July 2014. DOH:London 2. NICE Technology Appraisal 268. Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma. Dec 2012. DOH:London Version 1.1 (February 2015) Page 6 of 8 Skin - Ipilimumab REGIMEN SUMMARY Ipilimumab Day One 1. Ipilimumab 3mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes 2. Chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions 3. Hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions 4. Paracetamol 1000mg oral when required for the relief of infusion related reactions Version 1.1 (February 2015) Page 7 of 8 Skin - Ipilimumab DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.1 April 2015 Treatment for infusion related reactions changed to “as required” Dr Deborah Wright Pharmacist Prof C Ottensmeier Consultant Medical Oncologist 1 February 2015 None Dr Deborah Wright Pharmacist Dr M Wheater Consultant Medical Oncologist Prof C Ottensmeier Consultant Medical Oncologist Dr M Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.1 (February 2015) Page 8 of 8 Skin - Ipilimumab
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Skincancer/SkinIpilimumabVer1.pdf

Ruxolitinib

Description: Chemotherapy Protocol Myelofibrosis Ruxolitinib Regimen • Myelofibrosis – Ruxolitinib Indication • Ruxolitinib is recommended as an option for treating disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis, in people with intermediate-2 or high-risk disease. Toxicity Drug Ruxolitinib Adverse Effect Myelosuppression, infection, bruising, dizziness, headache, constipation, diarrhoea, hypertension, weight gain, hypercholesterolaemia, progressive multifocal leukoencephalopathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC, LFTs and U&Es prior to starting treatment and then every two to four weeks until the dose is stabilised. Once stabilised consider conducting these investigations every two to three months. • Check for active infections prior to starting treatment. Consider screening for latent tuberculosis or herpes zoster. Patients must be screened for HIV and HepB infection including HepBsAg and HepBcAb to detect latent infection at risk of reactivation with ruxolitinib. • FBC, LFTs and U&Es prior to starting treatment and then every two to four weeks until the dose is stabilised. Once stabilised consider conducting these investigations every two to three months. • Check for active infections prior to starting treatment. Consider screening for latent tuberculosis or herpes zoster. Patients must be screened for HIV and HepB infection including HepBsAg and HepBcAb to detect latent infection at risk of reactivation with ruxolitinib. Dose Modifications Management of adverse events may require dose reduction, temporary interruption, or discontinuation of treatment. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on Version 1 (January 2019) Page 1 of 7 Myelofibrosis - Ruxolitinib the clinical circumstances. Many patients are unsuitable for the recommended starting doses due to anaemia and other co-morbidities. Always discuss the starting dose with the relevant consultant. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependant on clinical circumstances and treatment intent. Note that the haemoglobin nearly always falls on initial therapy with ruxolitinib before plateau at around 6 weeks. Consider starting erythropoietin stimulation if the patient is symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). This may partially or wholly offset the need for transfusion. If patient becomes transfusion dependent on treatment, review of suitability of ruxolitinib continuation is needed. If unavoidable, consider iron chelation therapy according to guidelines. Neutrophils (x109/L) Ruxolitinib dose Less than 0.5 Discontinue Platelets (x109/L) Less than 50 50 - 100 Ruxolitinib dose Discontinue Consider dose reduction, ideally avoid treatment interruptions for thrombocytopenia Hepatic impairment In patients with any hepatic impairment the recommended starting dose based on platelet count should be reduced by approximately 50%, to be administered twice a day. Subsequent doses should be adjusted based on careful monitoring of safety and efficacy. Patients diagnosed with hepatic impairment while receiving ruxolitinib should have complete blood counts, including a white blood cell count differential, monitored at least every one to two weeks for the first 6 weeks after initiation of therapy with ruxolitinib and as clinically indicated thereafter once their liver function and blood counts have been stabilised. Renal Impairment Drug Renal impairment Guidance Ruxolitinib Mild / moderate Severe (CrCl less than 30ml/min) No dose adjustment required Recommended starting dose (based on platelet count) should be reduced by 50%. Version 1 (January 2019) Page 2 of 7 Myelofibrosis - Ruxolitinib Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC toxicities refer to manufacturer information. Infections Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Ruxolitinib therapy should not be started until active serious infections have resolved. Physicians should carefully observe patients receiving ruxolitinib for signs and symptoms of infections and initiate appropriate treatment promptly. There is a substantially increased risk of reactivation of Herpes Zoster (HZV). All patients should have HZV status checked before starting including HZV titres. All patients with history of shingles or seropositive should be commenced on aciclovir, the minimum dose is 400mg twice a day Educate patients about early signs and symptoms of herpes zoster, advising that the dose of acyclovir should be increased to 800mg three times a day and consultant notified in the event of reactivation. There is also need for vigilance for tuberculosis reactivation in view of case reports. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment. Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs). Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered. If PML is suspected, further dosing must be suspended until PML has been excluded. Skin Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib. Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions. A causal relationship to ruxolitinib has not been established. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. Lipid Abnormalities Treatment with ruxolitinib has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended Version 1 (January 2019) Page 3 of 7 Myelofibrosis - Ruxolitinib Regimen Idiopathic Myelofibrosis, 28 day cycle until disease progression, intolerance or patient chooses to stop treatment (12 cycles will be set in ARIA). Drug Ruxolitinib Platelets (x109/L) 50 – 99 100 - 200 more than 200 Starting Dose 5mg twice a day 15mg twice a day 20mg twice a day Maximum Dose 25mg twice a day Days 1-28 inclusive Administration Oral Post Polycythaemia Vera Myelofibrosis 28 day cycle until disease progression, intolerance or patient chooses to stop treatment (12 cycles will be set in ARIA). Drug Ruxolitinib Dose 10mg twice a day Days 1-28 inclusive Administration Oral Dose Information • If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5mg twice a day, up to the maximum dose of 25 mg twice a day. • The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at two week intervals. • The maximum dose of ruxolitinib is 25 mg twice daily. • Ruxolitinib should be taken every day at the same time, either with or without food. • Following interruption or discontinuation of ruxolitinib, symptoms of myelofibrosis may return over a period of approximately one week. There have been cases of patients discontinuing ruxolitinib who sustained more severe events, particularly in the presence of acute intercurrent illness. It has not been established whether abrupt discontinuation of ruxolitinib contributed to these events. Unless abrupt discontinuation is required, gradual tapering of the dose of ruxolitinib may be considered, although the utility of the tapering is unproven. Prednisolone given in modest dosage may help withdrawal symptoms during and after cessation of drug. Always discuss with patient’s consultant. • If a dose is missed the patient should not take an additional dose but rather the next dose that is due. Version 1 (January 2019) Page 4 of 7 Myelofibrosis - Ruxolitinib Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to ruxolitinib. • Ruxolitinib is associated with drug interactions. When ruxolitinib is administered with strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice a day. More frequent monitoring (eg twice a week) of haematological parameters and of clinic signs and symptoms of ruxolitinib related adverse drug reactions is recommended. It is inadvisable to prescribe ruxolitinib while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes and alternatives to the interacting drugs should be considered Coding • Procurement – X71.3 • Delivery – X72.2 References 1. The National Institute for Health and Clinical Excellence (2016) Technology Appraisal 386. Ruxolitinib for treating disease related splenomegaly or symptoms in adults with myelofibrosis. London:DOH. 2. Reilly et al. Use of JAK inhibitors in the management of myelofibrosis: a revision of the British Committee for Standards in Haematology Guidelines for Investigation and Management of Myelofibrosis. Br J Haem 2014; 167(3): 418-420. 3. Harrison C et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med (2012); 366 (9): 787-98. 4. Verstovsek S et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med (2012); 366 (9): 799-807. Version 1 (January 2019) Page 5 of 7 Myelofibrosis - Ruxolitinib REGIMEN SUMMARY Ruxolitinib Day One 1. Warning – Check Dose Administration Instructions The dose of ruxolitinib varies depending on the indication and the neutrophil and platelet count. The dose is set at the lowest possible starting dose of 5mg twice a day. This may need to be altered on cycle one and in subsequent cycles depending on the severity of the condition, co-morbidities and tolerance. Please refer to the protocol for further information Oral chemotherapy 2. Ruxolitinib 5mg twice a day continuous oral Administration Instructions The dose of ruxolitinib varies depending on the indication and the neutrophil and platelet count. The dose is set at the lowest possible starting dose of 5mg twice a day. This may need to be altered on cycle one and in subsequent cycles depending on the severity of the condition, co-morbidities and tolerance. Please refer to the protocol for further information. Oral chemotherapy. Version 1 (January 2019) Page 6 of 7 Myelofibrosis - Ruxolitinib Version Date 1 January 2019 DOCUMENT CONTROL Amendment Written By None Stuart Martin Pharmacist Approved By Dr Andrew Duncombe Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1 (January 2019) Page 7 of 7 Myelofibrosis - Ruxolitinib
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Myelofibrosis/Ruxolitinib.pdf

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Papers Trust Board - 30 January 2020

UHS register of interests June 2025

Annual-report-and-quality-account-2019-20

Hospital trust teams shortlisted for prestigious medical awards

Communicating risk: words or numbers?

Toothache and incapacity

Compulsory treatment for diabetes

AMS FLIER summary 2022 - cohort 3 applications open

Ipilimumab Ver 1

Ruxolitinib

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