Posology: BASALOG One contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
BASALOG One should be administered once daily at any time but at the same time each day.
The BASALOG One dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, BASALOG One can also be given together with orally active antidiabetic medicinal products.
Elderly Population (≥65 years old): In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Renal Impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Hepatic Impairment: In patients with hepatic impairment, insulin requirements may be diminished due to capacity for gluconeogenesis and reduced insulin metabolism.
Paediatric Population: Safety and efficacy of insulin glargine have been established in adolescents and children of 2 years and above. No clinical study safety data are available in children below 2 years of age.
Initiation of BASALOG One Therapy: The recommended starting dose of BASALOG One in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
Based on published information the recommended starting dose on an average is 10 IU once daily and subsequently adjusted according to the patient's need to a total daily dose ranging from 2 to 100 IU, however doses needs to be individualised by the prescriber for a particular patient.
Transition From Other Insulins to BASALOG One: When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with BASALOG One, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products). To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from twice daily NPH insulin to a once daily regimen with BASALOG One should reduce their daily dose of basal insulin by 20% to 30% during the first week of treatment. During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually. As with other insulin analogues, patients with high insulin doses may experience an improved insulin response with BASALOG One because of antibodies to human insulin. Close metabolic monitoring is recommended during transition and in the initial weeks thereafter. With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo or hyperglycaemia (see Precautions).
Interchangeability and Automatic Substitution: BASALOG One has been developed as a similar biological medicinal product to Lantus and has been shown to have a comparable quality, safety and efficacy profile to Lantus. Therefore, interchangeability with the reference product Lantus may be considered if this is in agreement with the treating physician. However, automatic substitution (i.e. the practice by which a different product to that specified on the prescription is dispensed to the patient without the prior informed consent of the treating physician) and active substance-based prescription cannot apply to biologicals, including biosimilars. Such a differentiating approach towards biologicals ensures that treating physicians can make informed decision about treatments is in the interest of patient's safety.
Method of Administration: Insulin glargine is administered subcutaneously and should not be given intravenously. The prolonged duration of action of insulin glargine is dependent on injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of insulin glargine. The prolonged duration of action of insulin glargine is dependent on injection into subcutaneous space. As with all insulins, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from one injection to the next.
Handling of the prefilled pen: For detailed instructions, refer to the Instruction for Use (IFU), prescribing information provided with the prefilled pen under Patient Counselling Information.
Preparation and handling: BASALOG One should be inspected visually prior to administration. BASALOG One must only be used if the solution is clear and colourless with no visible particles.
Mixing and diluting: BASALOG One must not be diluted or mixed with any other insulin or solution. Mixing or diluting can change its time or action profile and the solution may become cloudy.