Insulin lispro subcutaneous
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing insulin lispro.
These products have been produced by recombinant technology using E.coli.
Patients and professionals should be aware that the 200units/ml strength is higher than that of other existing insulin products available in the UK.
Drugs List
Therapeutic Indications
Uses
Diabetes mellitus
Insulin lispro is a fast acting insulin that is usually given 3 or 4 times a day immediately before a meal or carbohydrate containing snack. It may be used in combination with intermediate or long-acting insulins.
Dosage
Dosage is individual and determined by the physician in accordance with the needs of the patient and adjusted to suit the patient's diet, physical activity and life-style.
Insulin lispro has a shorter duration of action (2 to 5 hours) compared with soluble insulin and a rapid onset of action. Different brands of insulin lispro will have variations in its onset of action and duration, dosing adjustments should be based on the manufacturer's recommendation.
Adults
The 200units/ml strength should be reserved for patients who require daily doses of more than 20units of rapid-acting insulin.
Children
Soluble insulin is preferred in children, but insulin lispro may be used when a faster onset of action is beneficial, for example, timing in relation to meals.
The 200unit/ml strength is not licensed for use in children under the age of 18 years old.
Additional Dosage Information
No dose conversion is required when changing from insulin lispro 100unit/ml injection solution to insulin lispro 200unit/ml injection solution and vice versa.
Administration
Subcutaneous administration should be in the upper arm, thighs, buttocks or abdomen. Injection sites must be rotated within a given injection area from one injection to the next.
100unit/ml strength
To be given by subcutaneous injection, or by continuous subcutaneous infusion pump.
Although not a recommended route, the 100unit/ml strength may also be given by intramuscular injection.
If necessary, the 100unit/ml strength may be given intravenously, for example for the control of blood glucose levels during ketoacidosis, acute illness or during intraoperative and postoperative periods. May also be given by intravenous injection or infusion by a healthcare professional. Frequent monitoring of blood glucose levels is needed.
Vials only: when mixing with human insulins; the shorter acting insulin lispro should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just before injection should be on the advice of the physician. However a consistent routine should be followed.
200unit/ml strength
To be given by subcutaneous injection only. The 200unit/ml pre filled pen must be the only delivery system used for the injection.
Contraindications
Hypoglycaemia
Precautions and Warnings
Children under 2 years
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Insulin requirements may be diminished by renal or hepatic impairment
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Not all available products are licensed for all age groups
Contains metacresol
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
Dose should be administered just before or after food
For single patient use only
Record name and batch number of administered product
Rotate injection sites within a given area to avoid lipodystrophy
Solution must not be drawn from cartridge or pre-filled pen into a syringe
Use designated delivery device only
Use only if the solution is clear and colourless
Hypoglycaemic symptoms may be masked or altered in long duration diabetes
Hypoglycaemic symptoms may be masked/altered in diabetic nerve disease
Hypoglycaemic symptoms may be masked/altered in intensified insulin therapy
Advise patient to report cutaneous amyloidosis symptoms
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Dose steps may not be equivalent between strengths/brands-see product info
Insulin requirements may increase during illness,puberty or emotional upset
Transfer from other brands of insulin may involve dosage adjustment
Pregnancy & breastfeeding: Insulin requirements may vary
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patient to contact doctor if travel between time zones is planned
Advise patient to read the leaflet in the pack
Advise patients of the warning signs of hypoglycaemia
Advise patients on adequate dietary control
Close medical supervision is required when transferring a patient from one type or brand of insulin to another. Changes in strength, brand, type, origin (animal, human, human analogue), and/or method of manufacture (recombinant DNA, animal source) may drive a need for a change in dosage.
To avoid dosing errors and potential overdose and hypoglycaemia, patients should be evaluated to check the insulin strength in use. 200unit/ml insulin must never be drawn into a syringe.
Patients with chronic hepatic impairment may have increased insulin requirements due to an increase in insulin resistance.
Patients using continuous subcutaneous insulin infusion (CSII) should be comprehensively instructed in the use of the pump system. Patients should have alternative insulin available in case of pump system failure. Insulin lispro should not be mixed with any other insulin in an infusion pump.
Monitor blood glucose after a change in injection site.
Some products contain magnets which may interfere with functions of an implantable electronic medical device, such as a pacemaker.
Pregnancy and Lactation
Pregnancy
Use insulin lispro with caution during pregnancy.
The manufacturer advises that insulin lispro can be used during pregnancy if clinically needed. Current data indicate no malformative or fetal/neonatal toxicity with the use of insulin lispro. Insulin requirements are usually decreased during the first trimester and increased during the second and third trimesters.
Older forms of insulin (human or porcine origin) are considered safe during pregnancy and insulin lispro may be classified similarly (Briggs, 2015).
Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3.
Lactation
Use insulin lispro with caution during breastfeeding.
The manufacturer advises that insulin lispro can be used during breastfeeding.
Insulin is a natural component of breast milk and insulin treatment of breastfeeding mothers should represent no risk to the infant. Insulin in breast milk is digested by the infant's gut (Briggs, 2015) and is thought to contribute to intestinal maturation and decrease the risk of contracting type 1 diabetes in breastfed infants (LactMed).
Proper insulin levels are required for lactation. Good glycaemic control decreases the delay in establishment of lactation that is observed in diabetic mothers as well as enhancing maternal serum and milk prolactin concentrations.
Counselling
Patients should be shown the container to confirm the version is the one they are expecting.
The patient should be advised to read and follow the instructions which accompany the product. In patients using the 200 unit/ml insulin lispro, only the 200 unit/ml pre filled pen must be used and must not be transferred to any other delivery system.
Rotate injection site area within a given area to avoid lipodystrophy.
Dose should be administered before or after food.
Advise patients on adequate dietary control.
Insulin requirements may increase during illness, puberty or emotional upset.
Advise patients of the warning signs of hypoglycaemia.
Advise female patients to consult their GP if pregnancy is suspected or planned.
Advise patient to contact doctor if travel between time zones is planned.
Advise impaired alertness may affect ability to drive or operate machinery.
Patients should be advised to take precautions to avoid hypoglycaemia before driving, especially in patients who have reduced or absent warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia
Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing Gov.uk website.
Advise patient to report cutaneous amyloidosis symptoms.
Side Effects
Anaphylactic reaction
Angioneurotic oedema
Anxiety
Breathing difficulties
Cognitive impairment
Cold sweat
Coma
Concentration difficulties
Confusion
Convulsions
Coolness of skin
Cutaneous amyloidosis
Death
Decrease in blood pressure
Drowsiness
Fatigue
Gastro-intestinal disturbances
Headache
Hunger
Hypersensitivity reactions
Hypoglycaemia
Increased pulse rate
Itching
Lipodystrophy (injection site)
Local reaction at injection site
Localised and generalised rash
Nausea
Nervousness
Oedema
Pallor
Palpitations
Paraesthesia
Peripheral neuropathy
Pruritus
Refraction anomalies
Slurred speech
Stinging, redness and swelling at injection site
Sweating
Tiredness
Tremor
Unconsciousness
Urticaria
Visual disturbances
Weakness
Worsening of diabetic retinopathy (temporary)
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Admelog 100 units/ml solution for injection in vial. Sanofi. Revised August 2021.
Summary of Product Characteristics: Admelog 100 units/ml solution for injection in cartridge. Sanofi. Revised August 2021.
Summary of Product Characteristics: Admelog 100 units/ml solution for injection in pre-filled pen. Sanofi. Revised August 2021.
Summary of Product Characteristics: Humalog 100U/ml, solution for injection in vial, Humalog 100U/ml, solution for injection in Cartridge, Humalog KwikPen 100U/ml, solution for injection. Eli Lilly and Co Ltd. Revised September 2020.
Summary of Product Characteristics: Humalog 100 Units/ml Junior KwikPen, solution for injection in pre-filled pen. Eli Lilly and Co Ltd. Revised September 2020.
Summary of Product Characteristics: Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen. Eli Lilly and Co Ltd. Revised September 2020.
Summary of Product Characteristics: Insulin lispro Sanofi 100 units/ml solution for injection in vial. Sanofi. Revised August 2020.
Summary of Product Characteristics: Insulin lispro Sanofi 100 units/ml solution for injection in cartridge. Sanofi. Revised August 2020.
Summary of Product Characteristics: Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen. Sanofi. Revised August 2020.
Summary of Product Characteristics: Lyumjev 100 units/ml solution for injection in vial, Lyumjev 100 units/ml solution for injection in cartridge, Lyumjev 100 units/ml KwikPen solution for injection in pre-filled pen, Lyumjev 100 units/ml Junior KwikPen solution for injection in pre-filled pen. Eli Lilly and Co Ltd. Revised August 2020.
Summary of Product Characteristics: Lyumjev 100 units/ml Tempo Pen solution for injection in a pre-filled pen. Eli Lilly and Co Ltd. Revised April 2022.
Summary of Product Characteristics: Lyumjev 200 units/ml KwikPen solution for injection in pre-filled pen. Eli Lilly and Co Ltd. Revised August 2020.
MHRA Drug Safety Update September 2020
Available at: https://www.mhra.gov.uk
Last accessed: 16 December 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 May 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Insulin Last revised: March 2022
Last accessed: 24 May 2022
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