Intravenous Iloprost Guidelines. November 2020

Transcription

1 Index No: MMG31 (Formerly MM31) Intravenous Iloprost Guidelines Version: 3.0 Date ratified: Ratified by: (Name of Committee) Name of originator/author, job title and department: November 2017 Medicines Management Committee Emma Hunt, Clinical Pharmacist, Pharmacy Director Lead (Trust-wide policies) Medical Director Associate Medical Director (local Policies) Name of responsible committee for the Medicines Management Committee policy: Date issued for publication: December 2017 Review date: August 2020 Expiry date: (Date 3 months following review date) Equality impact assessed by: (name, job title and department) Date impact assessed: CQC Fundamental Standards: November 2020 This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a N/A Regulation 12: Safe Care and Treatment 1

2 CONTRIBUTION LIST Individuals involved in developing the document Name Emma Hunt Anthony Bartlett Designation Pharmacist Pharmacist Circulated to the following individuals for consultation Name Chaman Verma Dr Anoop Kuttikat Dr Vijay Bahal Dr Singh Brar Mary Breslin Mr Al-Hamali Sheron Watts Jan Oliver Joanne Milton Jacqueline Barker Designation Equality and Diversity Impact Assessment Lead Rheumatology Consultant Vascular Consultant Vascular Consultant Vascular Nurse Specialist Consultant Surgeon Manager Endoscopy Unit Sister SECU Sister DAW Ward Manager DCW 2

3 Index No. MMG31 Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this process. Name Job Title Signature Date Local Committee approval (where applicable) Name of Committee Name of Chairperson Date of Approval Pharmacy Clinical Services Group Karen Moody February 2014 Medicines Management Committee Robin Lee March 2014 Change History Version Date Author Reason 1.0 Jun 2011 Emma Hunt Original document 2.0 Dec 2013 Anthony Bartlett Transferred from Medicines Management Policy MM31 to Medicines Management Guidelines format Rewording and clarification of dosing and administration sections Redesign of prescription chart and administration record 3.0 November 2017 Impact Assessment Sue Hussain No longer administered at KGH by vascular team This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a. A translation service is available for this policy. The Interpretation/Translation Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide policies. 3

4 CONTENTS 1.0 Introduction Indications, contraindications and warnings Indication and durations of treatment Contraindications Precautions/Warnings Interactions Pregnancy and Breastfeeding Prescribing iloprost Dose Preparation of the infusion for administration Administration Monitoring Monitoring arrangements for compliance and effectiveness 5.0 Plan for dissemination and implementation References 8 Appendix A Iloprost prescription and administration record 9 8 4

5 1.0 INTRODUCTION Iloprost is a prostacyclin analogue that acts as a vasodilator and as a platelet aggregator inhibitor. This guideline describes how iloprost should be prescribed and administered. PLEASE NOTE THIS IS AN UNLICENSED PRODUCT The prescriber is required to explain to the patient that this medicine is unlicensed. 2.0 Indications, contraindications and warnings 2.1 Indications and approximate duration of treatment (Table 1): Indication Severe Raynaud s syndrome secondary to systemic sclerosis for ulcer healing and pain relief. Severe Raynaud s syndrome (with digital ulcers) Number of days (6 hour infusion each day) The following durations of treatment are recommendations; however, the doctor can stop or continue treatment if they feel it is clinically appropriate. 2.2 Contraindications: Pregnancy Lactation Hypersensitivity to iloprost Conditions where the effects of iloprost on platelets might increase the risk of haemorrhage Severe coronary heart disease or unstable angina Myocardial infarction within the last six months Acute or chronic congestive cardiac failure (NYHA type II to IV) Arrhythmias of prognostic significance Suspected pulmonary congestion 2.3 Precautions/Warnings: In-patients with low blood pressure care should be taken to avoid further hypotension. There is a possibility that the patient may develop orthostatic hypotension. On contact with skin, iloprost may cause long lasting erythema. Suitable precautions should therefore be taken to avoid contact with the skin. In the event of such contact, the affected area should be washed immediately with copious amounts of water or saline. 5

6 2.4 Interactions: Because of the possibility of interactions, no other drug should be added to infusion solution. Iloprost will potentiate the hypotensive effects of other anti-hypertensive medication. There is a theoretical risk that the patient will be at a higher risk of bleeding due to the effect iloprost has on platelet function. If bleeding occurs, the infusion should be stopped. Use with caution if the patient is on anti-coagulants or heparin. 2.5 Pregnancy and Breastfeeding: Iloprost must not be given to pregnant or breast feeding women. Reasonable measures to exclude pregnancy prior to treatment with iloprost should be undertaken. 3.0 Prescribing iloprost Iloprost should only be prescribed for patients who can be monitored in hospital either as an inpatient or in outpatient clinics with adequate facilities. Iloprost is administered as a course of daily intravenous infusions, each given over 6 hours, into a peripheral vein or a central venous catheter. 3.1 Dose The dose is adjusted according to individual tolerability within the range of 0.5 to 2 nanograms/kg/min On days 1 to 3 the infusion rate should be started at 0.5nanograms/kg/min and then titrated up until the optimum rate (according to patient weight and tolerability) is achieved. The optimal rate of infusion is reached by gradually increasing the infusion rate in increments (see 3.3) every 30 minutes until the patient experiences unacceptable side effects (see 3.4) or the maximum dose is achieved If the patient experiences adverse side effects, the infusion rate should be reduced to the previous rate and continue until a dose is achieved that is acceptable to the patient. This is the optimal infusion rate From day 4 administer the infusion should be started and continued at the optimal infusion rate determined on days 1-3 Doses should be halved in patients with liver cirrhosis or those undergoing haemodialysis 3.2 Preparation of the infusion for administration Iloprost must be diluted before use and given by intravenous infusion only. For each daily infusion, prepare a 200nanogram/ml solution by adding the contents of one 50microgram of iloprost to a 250ml bag of sodium chloride 0.9% 3.3 Administration 6

7 Iloprost is administered as an intravenous Infusion given over 6 hours using a volumetric pump. The 6 hour infusion is repeated once daily for the prescribed course. Table 2: Example infusion rates for a 200nanogram/ml solution Patient s weight (kg) Initial rate (0.5nanograms /kg/min) Step 2 (1nanogram /kg/min) Step 3 (1.5nanograms /kg/min) Maximum rate* (2nanograms /kg/min) ml/hr 13.5ml/hr 20.3ml/hr 27ml/hr ml/hr 15ml/hr 22.5ml/hr 30ml/hr ml/hr 16.5ml/hr 24.8ml/hr 33ml/hr 60 9ml/hr 18ml/hr 27ml/hr 36ml/hr ml/hr 19.5ml/hr 29.3ml/hr 39ml/hr ml/hr 21ml/hr 31.5ml/hr 42ml/hr ml/hr 22.5ml/hr 33.8ml/hr 45ml/hr 80 12ml/hr 24ml/hr 36ml/hr 48ml/hr ml/hr 25.5ml/hr 38.3ml/hr 50ml/hr* ml/hr 27ml/hr 40.5ml/hr 50ml/hr* ml/hr 28.5ml/hr 42.8ml/hr 50ml/hr* ml/hr 30ml/hr 45ml/hr 50ml/hr* *For patients who weigh less than 75kg the optimum rate seldom exceeds 40ml/hour. For patients who weigh more than 75kg, 50ml/hour is the maximum rate The rate of the infusion may be increased every 30 minutes according to patient tolerability to 30 minutes initial rate, check blood pressure and pulse, then if dose tolerated to 60 minutes step 2 rate, check blood pressure and pulse, then if dose tolerated to 90 minutes step 3 rate, check blood pressure and pulse, then if dose tolerated to 120 minutes maximum rate, check blood pressure and pulse, then if dose tolerated continue until the total infusion time reaches 6 hours If unacceptable side effects occur at any stage, reduce the rate by 10ml/hour. The infusion should be run at the optimum rate for the rest of the infusion time. After a total of six hours stop the infusion. Repeat on days 2 and 3 to confirm the optimal rate. From day 4, use the optimal rate of infusion established on days 1, 2 and 3, until the end of the treatment period. 3.4 Monitoring: 7

8 Monitor blood pressure, heart rate and oxygen saturations at the start of the infusion and at 30 minute intervals during the infusion. However, more frequent monitoring can be undertaken if required. A reduction in the oxygen saturations could indicate symptoms of pulmonary oedema. The most common side effects are facial flushing and headaches. Malaise, nausea, vomiting, abdominal pain, diarrhoea, sweating, a sensation of warmth and weakness are likely to occur during prolonged infusion. Pain in the affected limb, paraesthesia, tiredness, increased temperature, fever, chill, states of confusion, apathy, sedation, agitation, lowering or increase of blood pressure, tachycardias, arrhythmias, extrasystoles and restlessness have been reported. Arthralgia and allergic reactions may occur. All of the side effects usually disappear quickly with dose reduction. Isolated cases of dyspnoea and bronchial asthma have been reported and individual cases of pulmonary oedema or heart failure have been observed in elderly patients with advanced arteriosclerosis. Iloprost may provoke angina, especially in patients with coronary heart disease. Reddening and pain may occur at the infusion site. 4.0 Monitoring arrangements for compliance and effectiveness Adherence to the prescribing element of these guidelines will be monitored at the point of supply for each prescription by a clinical pharmacist during routine prescription screening activities. 5.0 Plan for dissemination and implementation This policy will be implemented and disseminated via the following methods: Placed on the hospital intranet sites briefing to relevant clinicians and pharmacy staff 6.0 References Iloprost Injection Data Sheet. Bayer Health Care.March 2012 Summary of Product Characteristics: Iloprost Trometamol, Bayer Healthcare November 2014 Northampton General Hospital Guidelines for the prescribing, supply and administration of Iloprost in Adult patients. Review date: April

9 Appendix A Iloprost Infusion Prescription Surname Forename DOB Hospital number Attach addressograph Weight (kg) Allergies Prescription Dose Total no of days (see table 1) Maintain systolic BP above Prescribers signature Prescribers name Contact number/bleep Date Days 1-3 Days 4+ Iloprost 50micrograms in 250ml sodium chloride 0.9% Total infusion duration: 6 hours each day Start at 0.5nanograms/kg/min Titrate dose up every 30minutes until the patient experiences unacceptable side effects or the maximum dose is achieved.mmhg Use the optimal rate of infusion established on days 1, 2 and 3, until the end of the treatment period: Optimal rate: Infusion rate calculations Step Dose Calculation* (or see table 2) Infusion rate of 200nanograms/ml solution Initial Step 2 Step 3 Max rate 0.5 nanograms/kg/min 1 nanogram/kg/min 1.5 nanogram/kg/min 2 nanogram/kg/min Dose x Weight (kg) x ml/hr..ml/hr..ml/hr..ml/hr (Maximum 50ml/hr) valid only if 200nanogram/ml solution used 9

10 Intravenous iloprost administration and monitoring Day 1 Surname Forename DOB Hospital number Attach addressograph Weight (kg) Date of infusion Allergies The rate of the infusion may be increased every 30 minutes according to patient tolerability to 30 minutes initial rate, check blood pressure and pulse, then if dose tolerated to 60 minutes step 2 rate, check blood pressure and pulse, then if dose tolerated to 90 minutes step 3 rate, check blood pressure and pulse, then if dose tolerated to 120 minutes maximum rate, check blood pressure and pulse, then if dose tolerated continue until the total infusion time reaches 6 hours If unacceptable side effects occur at any stage, reduce the rate by 10ml/hour. The infusion should be run at the optimum rate for the rest of the infusion time. After a total of six hours stop the infusion. Date.. Time Current infusion Rate (ml/hr) Pulse BP Oxygen sats Adverse Effects New infusion rate (ml/hr) Sig /check Maximum tolerated infusion rate:.. 10

11 Intravenous iloprost administration and monitoring Day 2 Surname Forename DOB Hospital number Attach addressograph Weight (kg) Date of infusion Allergies The rate of the infusion may be increased every 30 minutes according to patient tolerability to 30 minutes initial rate, check blood pressure and pulse, then if dose tolerated to 60 minutes step 2 rate, check blood pressure and pulse, then if dose tolerated to 90 minutes step 3 rate, check blood pressure and pulse, then if dose tolerated to 120 minutes maximum rate, check blood pressure and pulse, then if dose tolerated continue until the total infusion time reaches 6 hours If unacceptable side effects occur at any stage, reduce the rate by 10ml/hour. The infusion should be run at the optimum rate for the rest of the infusion time. After a total of six hours stop the infusion. Date.. Time Current infusion Rate (ml/hr) Pulse BP Oxygen sats Adverse Effects New infusion rate (ml/hr) Sig /check Maximum tolerated infusion rate:.. 11

12 Intravenous iloprost administration and monitoring Day 3 Surname Forename DOB Hospital number Attach addressograph Weight (kg) Date of infusion Allergies The rate of the infusion may be increased every 30 minutes according to patient tolerability to 30 minutes initial rate, check blood pressure and pulse, then if dose tolerated to 60 minutes step 2 rate, check blood pressure and pulse, then if dose tolerated to 90 minutes step 3 rate, check blood pressure and pulse, then if dose tolerated to 120 minutes maximum rate, check blood pressure and pulse, then if dose tolerated continue until the total infusion time reaches 6 hours If unacceptable side effects occur at any stage, reduce the rate by 10ml/hour. The infusion should be run at the optimum rate for the rest of the infusion time. After a total of six hours stop the infusion. Date.. Time Current infusion Rate (ml/hr) Pulse BP Oxygen sats Adverse Effects New infusion rate (ml/hr) Sig /check Maximum tolerated infusion rate:.. 12

13 Intravenous iloprost administration and monitoring Day 4 onwards Surname Forename DOB Hospital number Attach addressograph Weight (kg) Date of infusion Allergies Time Current infusion Rate (ml/hr) Pulse BP Oxygen sats Adverse Effects New infusion rate (ml/hr) Sig /check 13