Humulin R (U500) insulin: Prescribing Guidance

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1 Leeds Humulin R (U500) insulin: Prescribing Guidance Amber Drug Level 2 We have started your patient on Humulin R (U500) insulin for the treatment of diabetic patients with marked insulin resistance requiring high doses of insulin. It contains 500units of insulin per ml. It allows for large doses (i.e. units) to be administered in a reasonable volume. We will continue to see the patient and prescribe Humulin R insulin until they are initially stable. After this period the GP will be asked to take over prescribing and monitoring responsibilities under this amber drug protocol. The link to Humulin R Insulin 500 units /ml on the Leeds formulary can be found here Drug: Indication: Humulin R (U500) insulin (unlicensed product) Diabetic patients with marked insulin resistance requiring high doses of insulin Classification: Amber Level 2 Monitoring: Routine monitoring for diabetic patients on insulin should continue. Prescribing Information The following is a summary of prescribing information only. Consult the BNF and SPC for full and current prescribing information. Link to Leeds formulary. The following information has been added only if it differs from the BNF and SPC Approved name: Formulation: Humulin R insulin 20ml vial (500 units / ml). Dose and administration: Humulin R U-500 is usually given two or three times daily before meals. The dosage and time of Humulin R U-500 should be individualised and determined, based on the physician s advice, in accordance with the needs of the patient. The injection of Humulin R U-500 should be followed by a meal within approximately 30 minutes of administration. Humulin R is manufactured by Lilly and is currently licensed in the US, but not in the UK. Pharmacies can purchase Humulin R (U500) insulin from IDIS Pharmaceuticals. Humulin R (U-500) is a sterile solution containing 500 units/ml of human soluble insulin. It consists of zinc-insulin crystals dissolved in a clear fluid. It is unmodified by any agent that might prolong its action; however, the US Summary of Product

2 Characteristics states it takes effect rapidly (it starts working about 30 minutes after a subcutaneous injection) but has a relatively long duration of activity following a single dose (up to 24 hours). Adverse drug reactions: Similar to other insulins Cautions/Contra-indications: Similar to other insulins Interactions: Similar to other insulins Pregnancy/breast-feeding: Similar to other insulins Important information: Humulin R can be administered by subcutaneous (sc) injection or via a continuous subcutaneous insulin infusion pump. Humulin R can be combined with an oral agent (e.g. metformin), and it may be administered as a subcutaneous (s/c) injection up to three times a day. The patient s diabetologist will advise on this. There are no 500unit / ml insulin syringes. It is therefore recommended by the hospital diabetes team that when Humulin R is given by sc injection it is administered using a 1mL syringe & an orange needle. The patient should have been given a handheld information sheet on the product by the hospital diabetes team which will contain information on the patient s dose in units and in mls. (see Appendix 1) Please note 1mL graduated syringes are not prescribable on the NHS within Primary Care. There is currently no formal route for the supply of these items in Primary Care. Agreement for supply will be organised on an individual patient basis in liaison with the diabetes nurse and Primary Care. Potential routes include: GP practices supplying patients with syringes from their supplies Community nursing teams providing patients with syringes from their supplies. Communication Communication Contact Names and Details Medicines Information: Medicines Information Patient Helpline phone number: Specialist who makes request via switchboard: LGI SJUH Prepared by: Tommaso Malavenda, Clinical Pharmacist Dr Michael Mansfield, Consultant Diabetologist

3 Specific to Humulin R (U500) insulin of Specialist Secondary care clinician responsibilities Diagnosis of condition and ensuring other treatment options have been fully explored To initiate treatment Liaison with the General Practitioner (GP) to take over prescribing of the amber medicine using a written request Advising GP on dose to be prescribed Outlining to the GP when therapy may be reduced and stopped assuming no relapse in patient s condition. Review periods to be agreed Responding to issues raised by GP of GP GP responsibilities Checking for allergies, interactions and contra-indications when taking over prescribing and when changing any treatment Prescribing after receiving request from secondary care clinician Monitoring the patient s overall health and wellbeing, observing patient for evidence of ADRs and liaising with secondary care clinician if necessary. Routine disease monitoring should continue Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient s physical health status that may affect prescribing or appropriateness of the amber medicine Reducing/stopping treatment in line with secondary care clinician s original request of patient & carer Patient/carer responsibilities To be responsible for injecting Humulin R 500 units / ml as prescribed To understand the potential for adverse events and report these to the GP To check with the community pharmacist that there are no interactions with Humulin R 500 units / ml, when buying any over the counter medicines or herbal/homoeopathic products To check with dentists or other specialists who may prescribe medicines that there are no interactions with Humulin R 500 units / ml To contact the GP, Specialist or Medicines Information patient helpline if further information or advice is needed about Humulin R 500 units / ml To show the patient held information sheet regarding to any healthcare professional involved in their care

4 Patient held information sheet regarding. Nearly all insulin in use in the UK comes as a standard concentration of 100 units/ml. An exception to this is which contains insulin at 5 times the usual concentration, at 500 units/ml. Humulin R is manufactured by Lilly and is licensed in the US but not the UK Patients on very high doses of insulin are sometimes recommended to use Humulin R U500 insulin as it makes injection of very big doses easier and there is evidence that in selected patients it helps achieve better glucose control. It is usually given twice daily and Humulin R U500 insulin used in this way has a profile of action similar to an intermediate acting insulin. It is available only as a 20mL vial. It is only ever delivered by the subcutaneous route and in hospital a standard 1ml syringe should be used (not an insulin syringe). Humulin R U500 is not available as cartridges to be given by pens. Humulin R U500 should be prescribed in ml e.g. 0.16mL, and annotated with the dose in units. For example an in-patient prescription is shown below: for administration (sc) of only use a 1ml syringe. don t use a standard insulin syringe for Because Humulin R U500 has a non-standard concentration of insulin there is considerable potential for confusion and errors in its prescription, administration by health care staff and in the information given to patients. With risk therefore to patients of under or overdosing. When a patient is admitted to hospital, if there is any doubt about the correct dose of Humulin R or the correct way to prescribe it, it is almost certainly safer not to prescribe it at all but to seek specialist input from the diabetes team as soon as possible. Please see the table overleaf for the relationship between dose of insulin in units and the volume of insulin in ml and for dosing information for this patient.

5 The patient named below has been prescribed. Addressograph label On (date) this patient s current doses of are: Time Dose of Humulin R U500 insulin (units) Volume of (ml) Use this chart below to help complete these boxes correctly. Dose of Humulin R U500 insulin (units) Volume of (ml) Use only this on prescription See above for more information on prescribing safely.

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