ORAL AND PARENTERAL METHOTREXATE RHEUMATOLOGY LOCAL SAFETY MONITORING SCHEDULE

Transcription

1 ORAL AND PARENTERAL METHOTREXATE RHEUMATOLOGY LOCAL SAFETY MONITORING SCHEDULE This lcal safety-mnitring schedule supprts clinicians under the Lcal Enhanced Service fr High Risk Drug Mnitring (frmerly Near Patient Testing). Aligning clinical and prescribing respnsibility enhances patient safety because the individual signing the prescriptin will als be respnsible fr ensuring that any necessary mnitring has been undertaken and will have access t the results f this. The prescriber and specialist assume jint clinical respnsibility fr the drug and the cnsequences f its use. Specialist details GP details Patient details Name: Name: Name: Address:RJAH NHS Fundatin Trust Address: Cntact number: NHS Cntact number: Cntact number: DOB Signature Signature INTRODUCTION Methtrexate is an anti-metablite and flate antagnist. Licensed indicatins: rheumatid arthritis; psriasis Unlicensed indicatins: psriatic arthritis; juvenile idipathic arthritis; cnnective tissue disease (SLE, mysitis and vasculitis); sarcidsis ADULT DOSAGE AND ADMINISTRATION Rheumatlgy: dse range is 5mg t 25mg ONCE each week. Always prescribe ral methtrexate in multiples f 2.5mg tablet strength. The 10mg tablets must NOT be used. Patients n s/c methtrexate may have supplies made thrugh the hspital via a hmecare cmpany. Once weekly dsing it is gd practice t specify the day f administratin n the prescriptin, and state Take ONCE a week n xxxxday t avid cnfusin. Dse adjusted, as recmmended, by specialist accrding t respnse. Dses utside these ranges may be cnsidered with prir agreement f initiating specialist and GP. Lwer dses shuld be used in the frail elderly r if there is significant renal r hepatic impairment. Methtrexate may take up t 12 weeks t take effect, s sterids/nsaids may be needed initially. Flic acid: Flic acid is always c-prescribed alngside methtrexate, t reduce the risk f gastrintestinal and haematlgical txicity. A typical dse is flic acid 5mg nce each week, taken tw t three days after methtrexate dse. Smetimes the dse/frequency f flic acid is increased and ccasinally flinic acid is used instead.

2 MONITORING Arrange and recrd n-ging mnitring as agreed with the specialist Check FBC, U&E s, LFT s every 2 weeks until n stable dse fr 6 weeks, Once n stable dse repeat mnthly fr 3 mnths and thereafter at least every 12 weeks. Mre frequent mnitring is apprpriate in patients at higher risk f txicity. Mnthly mnitring lnger term at least 12 mnths shuld cntinue fr methtrexate/leflunmide cmbinatins Dse increases shuld be mnitred by FBC, U&E s, and LFT s every 2 weeks until n a stable dse fr 6 weeks then revert back t previus schedule. CRP & ESR may be dne every 3 mnths SPECIALIST RESPONSIBILITIES Prvide GP with clear written advice n required dsage and frequency f bth methtrexate and flic acid, written mnitring guidelines and drug infrmatin. Check fr interactins with ther medicines. Prvide the patient/carer with relevant (written) infrmatin n use side effects and need fr mnitring f infectin. Advise n need fr adequate cntraceptin, fr bth male and female patients Prvide shared care mnitring recrd bklet if required. In patients with a clinical suspicin f parenchymal lung disease, frmal lung functin testing and apprpriate imaging (chest radigraph with r withut high reslutin CT imaging) shuld be perfrmed and referral t a respiratry specialist be cnsidered. Backgrund lung disease shuld nt be cnsidered an abslute cntraindicatin t methtrexate use, althugh in patients with pr respiratry reserve (in whm an acute pneumnitis wuld be mre hazardus), cautin is advised. Fr any patient currently smking access t smking cessatin services shuld be ffered. Arrange pre-treatment baseline investigatins Height, weight and bld pressure. FBC U&E s LFT s ESR &CRP Varicella Zster IgG in suspected nn-immune patients and ntify general practitiner as apprpriate. Hepatitis B & C and HIV serlgy Review results f safety mnitring and request additinal tests as required Review in clinic as apprpriate t assess respnse t treatment and the need t cntinue therapy sending a written summary t the GP whenever the patient is reviewed. Identify and reprt adverse events t the GP and the MHRA (via yellw card). Prvide any ther advice r infrmatin fr the GP if required.

3 PRIMARY CARE RESPONSIBILITIES Ensure the crrect frmulatin f methtrexate is prescribed. The hspital specialist usually prescribes parenteral methtrexate (and shuld be added t the hspital nly sectin f the medicines list). Oral and parenteral methtrexate must nt be prescribed cncmitantly. Prescribe ral methtrexate (2.5mg tablets nly) nce each week (specifying the day as utlined abve nt Mnday); as required r as directed instructins are unsuitable. Ensure an ral methtrexate dse is prescribed as XX tablets f 2.5mg. Ensure n drug interactins with ther medicines. Check patient is using adequate cntraceptin, bth male and female patients. Mnitring f the drug as utlined n page 2 as per the BSR (British Sciety f Rheumatlgists) guidelines and in cnjunctin with the Specialist Rheumatlgist. Cntinue t prescribe Methtrexate if patient is having regular apprpriate bld mnitring and mnitring results are within acceptable range. Repeat prescriptins shuld be remved frm the surgery repeats pile and retained separately fr prescribers t review prir t signing. Maximum 28 days supply. These guidelines set ut t prvide a standard mnitring template. It is essential that each patient is cnsidered n an individual basis and mnitring frequency is apprpriately reviewed, fr example in elderly patients, thse with a histry f drug-related txicity, c-mrbidity and plypharmacy mre frequent mnitring may be apprpriate. Patients n cmbinatin DMARD therapy may need mre frequent mnitring. Please check the lcal Safety Mnitring Schedule fr each drug. Reprt any adverse drug reactins t the initiating specialist and the usual bdies (e.g. MHRA) yellw frm. Administer Influenza vaccine annually unless therwise advised by the initiating specialist Check the patient has had ne dse f Pneumcccal vaccine administered as a single dse f the plysaccharide PPV-23 (Pneumvax) ideally this shuld be administered prir t the initiatin f DMARD s hwever, if this is nt pssible it shuld be administered irrespective. Varicella Zster Shingles Nn immune patients shuld avid cntact with peple with chicken px r shingles; cnsider passive immunisatin using varicella immunglbulin (VSIG) if expsure is suspected (cntact Public Health England /Bld Transfusin Service fr advice) cnsider active immunisatin f nn-immune subjects befre starting immunsuppressin (after discussin with specialist) Varicella infectin can be severe in immunsuppressed patients and early systemic antiviral and supprtive therapy may be required. Suspend methtrexate if pssible until recvered Cnsider active immunisatin befre starting immunsuppressin inpatients ver the age f 69 years. Ask abut ral ulceratin / sre thrat, unexplained rash r unusual bruising at every cnsultatin. If a patient develps symptms/signs f systemic infectin, this shuld be treated prmptly and methtrexate withheld until the infectin has cleared. Ensure a clinician updates the patient s recrd fllwing specialist review

4 Withhld methtrexate and cntact specialist if: White cell Cunt <3.5 x10 9 /l Neutrphils <1.6 x 10 9 /l Unexplained esinphilia >0.5 x 10 9 /l Platelet cunt < 140 x 10 9 /l Mean cell vlume >105 f/l Creatinine Increase by > 30% ver 12 mnths and /r calculated GFR<60ml/min/1.73m 2 ALT and / r AST >100 U/l Unexplained reductin in albumin <30 g/l Please nte: A rapidly increasing r decreasing trend in any values shuld prmpt cautin and extra vigilance. Sme patients may have abnrmal baseline values, specialist will advise. Results shuld be recrded in the patient s shared care-mnitring bklet if issued. ADVERSE EFFECTS, PRECAUTIONS AND CONTRA-INDICATIONS Myelsuppressin &decreased resistance t infectin: especially respiratry / urinary tract r shingles / chickenpx. Temprarily withhld methtrexate if patient is systemically unwell with significant infectin and / r requiring anti-infective medicatin. Hepattxicity: methtrexate may be hepattxic and shuld be prescribe with cautin if there is evidence f impaired synthetic functin. Nausea: cmmnly encuntered, may reslve with dse reductin and/r additin f anti-emetic medicatin r change by changing methtrexate t subcut Alpecia, stmatitis, and diarrhea: cntact the initiating specialist if severe r persistent. Respiratry functin: infrequently, methtrexate can cause interstitial pneumnitis and fibrsis. Patients cmplaining f unexplained dyspnea r unexplained nn-prductive cugh shuld be referred immediately t the initiating specialist. If pneumnitis strngly suspected STOP METHOTREXATE cntact n-call medical registrar. Alchl: patients are advised that alchl cnsumptin shuld be avided r kept t a minimum due t the increased ptential fr liver txicity. Nephrtxicity: dse adjustment t 50% if stage 3 CKD and cntraindicated if mre severe. Vaccines: Avid immunisatin with live vaccines during treatment. Cnsider Live vaccines (varicella and Shingles) prir t cmmencing methtrexate as recmmended by the rheumatlgist. (See Green Bk re zster vaccine) Chrnic r recurrent infectins especially respiratry r urinary tract CONTRAINDICATIONS INCLUDE Hypersensitivity t methtrexate Severe renal impairment (CKD stage 4/5) Severe anaemia, leucpenia r thrmbcytpenia Untreated flate deficiency Histry f alchl abuse/cirrhsis Pregnancy: female patients must be advised nt t cnceive whilst receiving methtrexate. A reliable frm f cntraceptin shuld be used by men and wmen whilst n methtrexate and fr at least 3 mnths after discntinuing it. Discntinue methtrexate and refer immediately if a patient r partner discvers they are pregnant whilst taking methtrexate. There is limited data hwever that suggests that methtrexate is cmpatible with paternal expsure Breast Feeding: Wmen being treated with methtrexate shuld nt breastfeed

5 COMMON DRUG INTERACTIONS D NOT prescribe cncmitant Trimethprim r C-trimxazle due t risk f pancytpenia C-prescriptin f drugs with ptential marrw suppressive, hepattxic r nephrtxic effects is nt advisable. NSAIDs, & aspirin (<300mg): unlikely t cause any clinically significant adverse effects and treatment can be cntinued Herbal remedies: avid if pssible due t unknwn interactin ptential Clzapine may cause increased risk f a granulcytsis COMMUNICATION Fr any queries relating t this patient s treatment with methtrexate, please cntact the cnsultant named at the tp f this dcument. This infrmatin is nt inclusive f all prescribing infrmatin, ptential adverse effects and drug interactins Please refer t full prescribing data in the SPC r the BNF REFERENCES 1. GMC: Prescribing guidance: Shared care 20/10/2014) 2. NMC: Standards f prficiency fr nurse and midwife prescribers Publicatins/NMC-Standards-prficiency-nurse-and-midwife-prescribers.pdf (accessed 3/11/2014) Chakravarty, K., McDnald, H., Pullar, T. et al. (2008) BSR/BHPR guideline fr disease-mdifying anti-rheumatic drug (DMARD) therapy in cnsultatin with the British Assciatin f Dermatlgists. Rheumatlgy 47(6), BSR and BHPR guideline fr the prescriptin and mnitring f nn-bilgic disease-mdifying anti-rheumatic drugs. Ledingham J, Gullick N, Irving K, Grdkin R, Aris M, Burke J, Grdn P, Christidis D, Gallway S, Hayes E, et al. Rheumatlgy (Oxfrd) Jun 1; 56(6): BSR AND BHPR guideline n prescribing drugs in pregnancy and breastfeeding Part I: standard and bilgic disease mdifying anti-rheumatic drugs and crticsterids.. Flint J, Panchal S, et al. Rheumatlgy (Oxfrd). 2016; 55: BSR and BHPR guideline n prescribing drugs in pregnancy and breastfeeding part II: analgesics and ther drugs used in rheumatlgy practice. Flint J, Panchal S, et al. Rheumatlgy (Oxfrd). 2016:55: