Insulin Lispro

Registered South African indications:

• Diabetes mellitus

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Hypoglycaemia

Cautions 

• Severe renal impairment
• Severe hepatic impairment
• Elderly
• Conditions making early warning symptoms of hypoglycaemia different or less pronounced (eg. diabetic nerve disease, long duration of diabetes, intensified insulin therapy)
• Illness or infection
• Emotional disturbance or stress
• Patients at risk of cardiac heart failure
• Visual impairment
• Blindness
• Hypokalemia
• Exercise taken immediately after a meal
• Increased physical activity
• Dietary changes
• Driving and use of machinery

Forms avail. in SA and covered in this monograph: inj

Insulin-dependent diabetes mellitus 

• See link: General prescribing points on the principles of insulin dosing

The dosage should be determined by the healthcare professional, according to the requirements of the patient

See Additional Prescribing Points

Forms avail. in SA and covered in this monograph: inj

Insulin-dependent diabetes mellitus 

• See link: General prescribing points on the principles of insulin dosing

The dosage should be determined by the healthcare professional, according to the requirements of the patient

Pregnancy

• Safe
• Data on a large amount of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn
• It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy
• Insulin requirements usually fall during the first trimester and increase during the second and third trimesters
• Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose control as well as general health, is essential in pregnant patients with diabetes

Breastfeeding

• Compatible 
• Patients with diabetes who are breastfeeding may require adjustments in insulin dose, diet or both
• Human insulin is excreted in human breast milk. For this reason, caution should be exercised when insulin lispro is administered to breastfeeding mothers

Fertility

• Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies

Renal impairment

• eGFR >30-89 ml/min/1.73 m²: No dose adjustment recommended
• eGFR <29 ml/min/1.73 m²: Caution; dose adjustment recommended
  Adjust insulin dose according to blood glucose ranges

Hepatic impairment

• Mild to moderate (Child-Pugh Classes A & B): No dose adjustment recommended
• Severe (Child-Pugh Class C): Caution; dose adjustment recommended 
  Adjust insulin dose according to blood glucose ranges

Elderly

• Caution; dose adjustment recommended
  The dose of insulin lispro should be adjusted according to blood glucose measures
  Close monitoring of blood sugar changes is essential
  Avoid aggressive glucose control

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - At all times

Cardiovascular Disorders

• Heart failure

Endocrine and Metabolic Disorders

• Severe hypoglycaemia
• Hyperglycaemia
• Diabetic ketoacidosis
• Weight gain

Skin and Subcutaneous Tissue Disorders

• Redness, swelling and itching at injection site

Immune, Blood and Lymphatic System Disorders

• Generalised insulin allergy (potentially life-threatening)
  - Rash over the entire body
  - Shortness of breath
  - Wheezing
  - Reduction in blood pressure
  - Rapid pulse
  - Sweating

Others

• Lipodystrophy at injection site
• Hypertrophy at injection site
• Peripheral oedema
• Loss of consciousness

• Oral contraceptives
• Corticosteroids
• Thyroid replacement therapy
• Danazol
• Beta2 stimulants
• Ritodrine
• Salbutamol
• Terbutaline
• Oral hypoglycemics
• Pioglitazone
• Salicylates
• Aspirin
• Sulpha antibiotics
• Monoamine oxidase inhibitors
• Selective serotonin reuptake inhibitors
• Captopril
• Enalapril
• Angiotensin II receptor blockers
• Beta-blockers
• Octreotide
• Alcohol

Diabetes mellitus

• Blood glucose
• HbA1C
• Renal function
• Hepatic function

Gestational diabetes mellitus

• Blood glucose 4 times daily (1 fasting and 3 after meals)

Method of administration

• Insulin lispro should be given subcutaneously
• Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Injection sites should be rotated so that the same site is not used for more than approximately once a month
• When administered subcutaneously, care should be taken when injecting insulin lispro to ensure that a blood vessel has not been entered.
• After injection, the injection site should not be massaged
• Patients must be educated to use the proper injection techniques

Storage instructions

• Store in a refrigerator between 2-8^oC. Do not freeze

Vials, cartridges or pens in use

• Vials: If refrigeration is not possible, the vial in use can be stored at or below 30^oC for 28 days. Do not expose to excessive heat or sunlight
• Cartridges and disposable pens: If currently in use they should NOT be refrigerated, but kept cool (at or below 30^oC) and away from heat and sunlight
• Unrefrigerated cartridges and disposable pens should be discarded after 28 days, even if they still contain product
• Do not use product after the expiry date

Instructions for use and handling

• To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed. The patient should discard the needle after every injection
• The insulin lispro solution should be clear and colourless. Insulin lispro should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible
• Insulin lispro pens should not be used if any part looks broken or damaged
• Any unused product or waste material should be disposed of in accordance with local requirements

Insulin lispro replaces the insufficiency of insulin secreted by the β-cells of the pancreas. Insulin lispro has a rapid onset of action (approximately 15 minutes) and has a shorter duration of activity (2 to 5 hours) when compared to soluble insulin.

Injection (per ml) 100u

• Humalog (Eli Lilly) originator

Injection (per ml) 200u

• Humalog 200 units/ml Kwikpen (Eli Lilly) originator