Pharmacovigilance

Dear Healthcare Professional Letter on the correct use of Humalog 200 Units/ml KwikPen (insulin lispro) to minimise the risk of medication errors

10.09.2015

Ely Lilly d.o.o. Croatia, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is informing health care professionals on the new information on safe use of insulin lispro, the insulin analogue that is taken at meal times, available in the strength of 200 Units/ml (Humalog 200 Units/ml KwikPen) to treat the diabetes in adults.

Summary

The solution for injection of insulin lispro of 200 Units/ml should be used exclusively in pre-filled pen Humalog 200 Units/ml (KwikPen).

The transfer of higher strengths of lispro 200 Units/ml from a pre-filled pen Humalog 200 Units/KwikPen in some other insulin delivery system may result in overdosing and severe hypoglycaemia.

It is important to inform patients who use Humalog 200 Units/ml KwikPen with this risk and advise them not to transfer insulin from a pre-filled pen Humalog 200 Units/ml KwikPen into syringe or insulin pump to be used.

When transferring from one Humalog strength to another it is not necessary to recalculate the dose - the window for dose selection in both pens display the insulin lispro unit numbers that should be injected. The unnecessary recalculation of dose may lead to either a too low/ or too high dose and consequently to hyperglycaemia or hypoglycaemia.

When prescribing Humalog KwikPen, a clear strength of the medicine should be indicated.

Further information

The European Commission has authorised Humalog 200 Units/ml KwikPen to treat adult patients with diabetes that need insulin to maintain the normal glucose level. This medicine should be reserved to treat patients with diabetes who need daily doses of fast acting insulin higher than 20 units. Humalog 200 Units/ml KwikPen contains 600 Units insulin lispro in 3 ml solution for injection, which is a double insulin concentration that is taken with meal in ratio of usual 100 Units/ml. The letter should inform healthcare professionals on the specific characteristics of package and pre-filled pen of Humalog 200 Units/ml KwikPen, that patients should be informed of, by using the attached information for patients, so that they could distinguish it from the package and pre-filled pen of Humalog 100 Units/ml KwikPen.

Here you may view the Dear Healthcare Professional Letter.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.

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