Jylamvo 2 mg/ml oral solution (Methotrexate) Guide for Healthcare Professionals. Information to minimise the risk of medication error

Transcription

1 2 mg/ml oral solution (Methotrexate) Guide for Healthcare Professionals Information to minimise the risk of medication error NOTE: Special warnings and precautions for use - This oral solution contains 2 in each ml of solution - The scaling of the dosing syringe is in ml and not mg - Care must be taken that the correct dosing volume is prescribed. - Patients with rheumatological or dermatological diseases must be informed unequivocally that treatment is to be taken just once a week and not daily. - Incorrect use of can result in severe and even fatal adverse reactions. - Medical staff and patients must be clearly instructed. Date HPRA Approval: September 2017 Page 1 of 7

2 1. Purpose of this guide This Guide is provided by Therakind Ltd for doctors, nurses and other healthcare professionals who prescribe, dispense or work with patients who use (Methotrexate) and is intended to ensure that the medicine is used correctly. The main objective of this guide is to help mitigate against the potential risk of medication errors. Please be aware of the special warnings and precautions for use detailed on the cover of this guide. All healthcare professionals are further referred to the Summary of Product Characteristics (SmPC) and Patient Leaflet (PL) accompanying this Guide for full prescribing information. 2. Prescribing ( 2mg/ml) is available as an oral solution that contains 2 mg/ml of is taken once a week (on the same day each week) to treat: Rheumatoid arthritis [RA] Juvenile idiopathic arthritis [JIA] Psoriasis Only for acute lymphoblastic leukaemia (ALL) should the medicine be taken at higher doses and more frequently. The prescribing physician is responsible for determining which patients are suitable for home or selfadministration of. Each patient/carer should be assessed to determine whether they are able to measure the dose correctly. Only after such an assessment should patients/carers start to administer at home. Potential causes for medication errors with this product include: Inadvertent daily dosing (in arthritis and psoriasis indications) Overdose due to confusing mg and ml 3. Working out and measuring the correct dose Children: dosing is prescribed by body surface area (BSA) (please see appendix A). Adults: dosing is prescribed as a fixed dose. Dosing syringe: One syringe is provided with the product which must be used to withdraw the dose: a 10ml syringe with major graduations at every 1ml and minor graduations at every 0.25 ml. This allows delivery of the required dose volume range appropriately and accurately. Detailed instructions on measuring and administering the correct dose with the syringe are provided in the Package Leaflet and SmPC. Points to consider: The syringe is graduated in ml while the dose is expressed in mg Each ml of solution contains 2 mg Prescribe in mg and ml in order to avoid overdosing due to medication error; For arthritis and psoriasis patients, include the day of the week that the patient should take the dose on the prescription. Date HPRA Approval: September 2017 Page 2 of 7

3 The tables in Appendix A are provided to assist in working out dosage in mg and ml (by BSA) for children/adolescents being treated for JIA and ALL, respectively 4. What to discuss with patients for home use or self-administration Direct the patient/carer to the Package Leaflet and especially section 3 for instructions on how the patient should take the medication. It is important to carefully explain to patient/carer When and how they should take their dose How to withdraw a dose from the bottle using the syringe provided to ensure it is accurately measured To only use the syringe provided with the product That this product is cytotoxic and that both the product and syringe must be handled and disposed of carefully and safely (See additional points on handling and disposing of, section 6) The types of side effects/symptoms that might indicate the early signs of overdose toxicity such as bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and reduced urinary output (see section 4 of Package Leaflet) and advise them to contact a doctor/pharmacist immediately if they experience those side effects That they should tell their doctor immediately or contact the nearest hospital casualty department if they have any signs or symptoms of overdose (eg. bleeding etc) or if they know or suspect that they (or someone else) have taken too much and that they should write down what they took and when The patient/carer should be assessed to ensure they are able to withdraw and measure the prescribed dose correctly using the syringe provided. Only following this should patients/carers start to self-administer at home. For arthritis and psoriasis patients, it is very important to remind the patient/carer and to be sure that they have understood: The need to maintain the prescribed dosing regimen of That greater doses may be associated with an increased risk of side effects, the potential for severe side effects and even death That it is a weekly regime ( is never taken every day for arthritis or skin diseases) Which same day of the week the dose should be taken on each week 5. PHARMACISTS - Dispensing ( 2mg/ml) Recommendations for dispensing: Always double check the prescription describes an appropriate dose in mg and ml Ensure the day of the week the dose should be taken is included on the label, if appropriate Open the container and show the actual medication and syringe to the patient/carer Reiterate the dosing regime with the patient/carer and show them the ml gradations on the syringe as you explain the dosing Emphasize that they should only use the dosing syringe provided with the product to measure the dose Check to see they have understood The importance of adhering to the correct dose and frequency should be discussed with the patient/carer Date HPRA Approval: September 2017 Page 3 of 7

4 Refer the patient/carer to the list of side effects in section 4 of the Package Leaflet and advise that they should contact a doctor/pharmacist immediately if side effects are experienced Suggest that if the patient/carer does accidently make an error that they write down what they took and when and to contact a doctor immediately ( as a precaution ) Discuss safe handling and disposal of the product and syringe (See additional points on handling and disposing of Methotrexate, section 6) Points to consider: Methotrexate is never taken every day for arthritis or skin diseases, it is prescribed as a weekly dosing regime Weekly dosing should be taken on the same day of the week The syringe is marked in ml and not mg Dosing guidance by children/ adolescents BSA for JIA and ALL are provided in Appendix A 6. Additional points on handling and disposing of Methotrexate Wash hands before and after administering a dose. Disposable gloves should be worn when handling If comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water Keep the bottle tightly closed and wipe spillages immediately Wash the syringe immediately after use following the instructions in Section 3 of the Package Leaflet Women who are pregnant, planning to be or breast-feeding should not handle Store out of reach of children and ideally in a locked cabinet Any unused medicinal product and used bottles/syringes should be disposed of in accordance with local requirements for cytotoxic products 7. Follow-up visits and medication errors Patients should be monitored for signs and symptoms of overdose (these predominantly affect the haematopoietic and gastrointestinal systems), such as bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and reduced urinary output. 8. Therapeutic management of overdose Calcium folinate is the specific antidote for neutralising the adverse toxic effects of. In the event of overdose, a dose of calcium folinate equal to or higher than the offending dose of should be administered intravenously or intramuscularly within 1 hour, and dosing continued until serum levels of are below 10-7 mol/l. In the event of a massive overdose, hydration and alkalinisation of the urine may be required to prevent precipitation of and/or its metabolites in the renal tubules. Neither haemodialysis nor peritoneal dialysis has been shown to improve the elimination of. Effective clearance of is reported to be achieved with acute intermittent haemodialysis using a high-flux dialyser. Date HPRA Approval: September 2017 Page 4 of 7

5 9. Adverse event reporting ( 2mg/ml) even at the correct dose can cause Adverse Reactions and it is important to report any and all Adverse Events (even if the causal relationship is in doubt - if it is in doubt, then please state this in the report). Suspected adverse reactions should be reported to the HPRA using a Yellow Card obtained either from the HPRA, or electronically via the website at Adverse reactions can also be reported to the HPRA by calling (01) Adverse reactions can also be reported to Therakind (drugsafety@therakind.com) or their distributor Intrapharm Laboratories Ltd (see Medical Information enquiries contact details below for telephone, fax and contact details). 10. Where can I obtain more information? For all Medical Information enquiries or to report an Adverse Reaction, please see the contact details on the Therakind website ( or contact Therakind s Distributor, Intrapharm Laboratories on: Tel: +44 (0) Fax: +44 (0) medinfo@intrapharmlabs.com Additional copies of this Guide can be obtained using the above contact details. Date HPRA Approval: September 2017 Page 5 of 7

6 Body Surface Area (m 2 ) APPENDIX A Dosing Guidance for Children and Adolescents in the Treatment of JIA and ALL Dosing guidance for Juvenile Idiopathic Arthritis COMMONLY PRESCRIBED DOSES 10mg/m 2 15mg/m 2 20mg/m * * * * * * * * * * * * * * * * * * * * * dose rounded down Date HPRA Approval: September 2017 Page 6 of 7

7 Body Surface Area (m 2 ) Dosing guidance for Acute Lymphoblastic Leukaemia COMMONLY PRESCRIBED DOSES 20mg/m 2 30mg/m 2 40mg/m Date HPRA Approval: September 2017 Page 7 of 7