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Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.
Transferring a patient to another type or brand of insulin: Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day, particularly nocturnal/fasting glucose control.
When mixing Humalog with a longer acting insulin, the shorter-acting Humalog 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 the injection should be on advice of the physician. However, a consistent routine must be followed.
Hypoglycaemia and hyperglycaemia: Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or medications such as beta-blockers.
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Injection technique: Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
Insulin requirements and dosage adjustment: Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human insulin.
Combination of Humalog with pioglitazone: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind, if treatment with the combination of pioglitazone and Humalog is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs.
Avoidance of medication errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups.
Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-free".
Instructions for use and handling (cartridge): To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.
Before using Humalog Kwikpen: Advise the patient to always check the pack and the label of the pre-filled pen for the name and type of the insulin when getting it from a pharmacy. Make sure get the Humalog KwikPen that that was advised by the doctor.
If the blood sugar levels are well controlled by the current insulin therapy, the warning symptoms may not be present when blood sugar is falling too low. Warning signs are listed under Side Effects. Patients should think carefully about when to have meals, how often to exercise and how much to do. Advise the patient to keep a close watch on blood sugar levels by testing the blood glucose often.
A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If hypoglycaemia often occur or have difficulty recognising it, advise the patient to discuss with a doctor.
The doctor, pharmacist or diabetes nurse must be informed if the patient recently became ill; have kidney or liver problem; or exercising more than usual.
The dose of insulin may change if the patient drinks alcohol.
Advise the patient to inform the doctor, pharmacist or diabetes nurse if there is a plan of going abroad. The time difference between countries may mean to have injections and meals at different times.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke, who were treated with pioglitazone and insulin, experienced the development of heart failure. If signs of heart failure is experienced such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema), advise the patient to inform the doctor immediately.
This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.
Skin changes at the injection site: The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if it's injected into a lumpy area (see Dosage & Administration). Advise the patient to contact a doctor if he/she is currently injecting into a lumpy area before starting to inject into a different area. Blood sugar may be checked more closely, and insulin or other antidiabetic medications dose may be adjusted.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
