Basalog One

Insulin glargine (rDNA origin).

Each mL of prefilled pen contains: Insulin glargine (rDNA) 100 IU, m-cresol (as preservative) 2.7 mg.
Each 3 mL cartridge contains solution for injection, equivalent to 300 IU.
Insulin glargine is produced in Pichia pastoris by recombinant DNA technology.
(Each 100 units is equivalent to 3.64 mg insulin glargine).
Excipients/Inactive Ingredients: Glycerol, metacresol, zinc chloride, hydrochloric acid, sodium hydroxide and water for injection.
Excipients q.s.

Pharmacotherapeutic Group: Drugs used in diabetes. Insulins and analogues for injection, long acting. ATC Code: A10AE04.
Pharmacology: Pharmacodynamics: Mechanism of Action: Insulin glargine is a human insulin analogue designed to have low solubility at neutral pH. It is completely soluble at the acidic pH of the injection solution (pH 4). After injection into subcutaneous tissue, the acidic solution is neutralised leading to formation of micro precipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action. Insulin receptor binding: insulin glargine is very similar to human insulin with respect to insulin receptor binding kinetics and can therefore, be considered to mediate a similar effect via the insulin receptor.
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
Clinical Studies-Efficacy Results: The clinical efficacy of BASALOG was accessed in a open label, randomised, multi-centric, comparative, phase 3 study in Type 1 Diabetes Mellitus patients with Lantus.
The results established non-inferiority of BASALOG compared to the reference product (Lantus), with respect to change in HbA1c. The changes in FPG, PPG and 7-point glucose were comparable between the 2 study arms. The proportion of patients who achieved target HbA1c <7% was comparable between groups. Mean insulin dose was also comparable between the 2 arms. Compliance was good during the study, with average compliance >98% for both basal and pre-meal soluble insulin which was comparable for both study arms. Overall the 2 study treatments were comparable with respect to efficacy.
This study established the non inferiority of BASALOG compared to Lantus with respect to primary efficacy parameter HbA1c and also supports the safety and efficacy of BASALOG in the treatment of patients of diabetes mellitus.
The following data for clinical efficacy in the patients administered with Insulin glargine is summarised from the publicly available information of Lantus.
In clinical pharmacology studies, intravenous insulin glargine and human insulin have shown to be equipotent when given at the same doses. As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
In euglycemic clamp studies in healthy subjects or in patients with type1 diabetes, the onset of action of subcutaneous insulin glargine was slower than neutral protamine Hagedorn (NPH) human insulin. The efficacy profile of insulin glargine was relatively constant with no pronounced peak and the duration of its effect was prolonged compared to NPH human insulin.
The longer duration of action (up to 24 hours) of insulin glargine is directly related to its slower rate of absorption and supports once daily subcutaneous administration. The time course of action of insulins, including insulin glargine, may vary between individuals and/or within the same individual.
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar on administration of after intravenous insulin glargine and human insulin both in healthy volunteers and in patients with type 1 diabetes.
In an another 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients, in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography. No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
Paediatric Population: In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal bolus insulin regimen where regular human insulin was used before each meal. Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Similar effects on glycohaemoglobin and the incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group. There was less severe hypoglycaemia in the insulin glargine group as well. One hundred and forty three patients treated with insulin glargine in this study continued treatment with insulin glargine in an uncontrolled extension study with mean duration of follow up of 2 years. No new safety signals were seen during this extended treatment with insulin glargine.
A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed. As in the paediatric study described previously, fasting plasma glucose reduction from baseline was greater in the insulin glargine group than in the NPH group. HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM vs 4.1 mM. Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine / lispro group vs 52% in the NPH / regular group.
A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin. Both groups received bolus insulin before meals. The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)]. Glycohaemoglobin and glucose variabilities were comparable in both treatment groups. No new safety signals were observed in this study.
Pharmacokinetics: A randomised, double blind, single dose, 3-way crossover Euglycaemic clamp study in subjects with Type 1 diabetes mellitus is conducted to compare the relative Pharmacokinetics and Pharmacodynamics properties of BASALOG with Lantus. This comparative study showed that BASALOG is bioequivalent to Lantus.
The following data for the pharmacokinetics in various subjects administered with Insulin glargine is summarised from publicly available information of Lantus.
In healthy subjects and in diabetic patients, insulin glargine serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin. Concentrations were thus consistent with the time profile of the Pharmacodynamics activity of insulin glargine. Insulin glargine injected once daily will reach steady state levels in 2 to 4 days after the first dose. When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
In patient with diabetes, insulin glargine is partly degraded in the subcutaneous tissue at the A carboxyl terminus of the chain with formation of the active metabolites 21^A-Gly-insulin and 21^A -Gly-des-30⁸-Thr-insulin. Unchanged insulin glargine and degradation products are also present in plasma. In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Paediatric Population: Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study. Plasma "trough" levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Toxicology: Preclinical Safety Data: Nonclinical data of insulin glargine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

For the treatment of adults, adolescents and children of 2 years or above with diabetes mellitus, where treatment with insulin is required.

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.

Symptoms: Insulin glargine overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
Management: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

Hypersensitivity to the active substance or to any of the excipients.

BASALOG One is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Insulin glargine administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin glargine dose in order to correct a tendency to hyper- or hypoglycaemia. (see Adverse Reactions).
Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and, may therefore change when the treatment regimen is changed. Due to more sustained basal insulin supply with BASALOG One, less nocturnal but early morning hypoglycaemia can be expected.
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients: in whom glycaemic control is markedly improved, in whom hypoglycaemia develops gradually, who are elderly, who are transferred from animal insulin to human insulin, in whom an autonomic neuropathy is present, with a long history of diabetes, suffering from a psychiatric illness, receiving concurrent treatment with certain other medicinal products (see Interactions).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia. The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia. If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include: change in the injection area, improved insulin sensitivity (eg, by removal of stress factors), unaccustomed, increased or prolonged physical activity, intercurrent illness (eg, vomiting, diarrhoea), inadequate food intake, missed meals, alcohol consumption, certain uncompensated endocrine disorders, (eg, in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), concomitant treatment with certain other medicinal products.
BASALOG One contains metacresol, which may cause allergic reactions.
Intercurrent illness: Intercurrent illnesses requires intensive metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis; even if they are able to eat only little or no food, or in conditions where they are vomiting and they must never omit insulin entirely.
Combination of BASALOG One with Pioglitazone: Cases of cardiac failure have been reported in public domain, when pioglitazone was used in combination with insulin glargine, 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 BASALOG One 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.
Effects on Ability to Drive and Use Machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating machines).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. It should be considered whether it is advisable to drive or operate machines in these circumstances.

Pregnancy: No clinical data on insulin glargine exposed during pregnancies from controlled clinical trials are available. Moderate data on pregnant women (between 300-1000) exposed to marketed insulin glargine indicate no specific adverse effects on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Animal data do not indicate reproductive toxicity.
Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.
The use of insulin glargine may be considered during pregnancy, if necessary.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
Breast feeding: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn or infant are anticipated since insulin glargine as a peptide is digested into amino acids in the human gastrointestinal tract. Breastfeeding women may require adjustments in insulin dose and diet.
Fertility: Animal studies do not indicate direct harmful effects with respect to fertility

In a clinical study done by Biocon, the adverse events for BASALOG One were found to be similar in nature, frequency and severity as compared to the reference product (Lantus).
Hypoglycaemic events were the most common adverse events in both the treatment groups. Apart from hypoglycaemia, pyrexia was the next most common adverse event with 3 events in each study arm. Retinal adverse events reported in this study were comparable between the treatment groups. The abnormalities in the laboratory parameters were comparable between the 2 study arms and all of them were considered not clinically significant. Antibodies against BASALOG One were observed with the same frequency as compared to the reference product (Lantus).
The following data for adverse events is summarised from the publicly available information of Lantus.
Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
The following related adverse reactions from clinical investigations are listed as follows by sytem organ class and in order of decreasing incidence: Side effects reported very commonly (>1/10): Metabolism and nutrition disorders: hypoglycaemia.
Side effects reported commonly (>1/100 to <1/10): Skin and subcutaneous tissue disorders: lipohypertrophy. General disorders and administration site conditions: injection site reactions.
Side effects reported uncommonly (>1/1000 to <1/100): Skin and subcutaneous tissue disorders: lipoatrophy.
Side effects reported rare (>1/10,000 to <1/1,000): Immune system disorders: Allergic reactions.
Eye disorders: visual impairment, retinopathy.
General disorders and administration site conditions: Oedema.
Side effects reported very rare (<1/10,000): Nervous system disorders: Dysgeusia.
Musculoskeletal and connective tissue disorders: myalgia.
Metabolism and Nutrition Disorders: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life-threatening. In many patients, the signs and symptoms of neuroglycopaenia are preceded by signs of adrenergic counter regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Immune System Disorders: Immediate-type allergic reactions to insulin glargine are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio oedema, bronchospasm, hypotension and shock, and may be life threatening.
Insulin glargine administration may cause insulin glargine antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Eye Disorders: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensive of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Skin and Subcutaneous Tissue Disorders: As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
General Disorders and Administration Site Conditions: Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. Rarely, insulin glargine may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Paediatric Population: In general, the safety profile for children and adolescents (18 years of age) is similar to the safety profile for adults. The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (18 years of age) than in adults. No safety data from clinical studies are available in children below 2 years of age.

A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (eg, epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (eg, clozapine and olanzapine) and protease inhibitors.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

Special Precautions for Disposal and Other Handling: BASALOG One must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no visible solid particles. Since BASALOG One is a solution; it does not require re-suspension before use. Any used medicinal products should be discarded as per the local requirements.
Incompatibilities: BASALOG One must not be mixed with other medicinal products. It is important to ensure that syringes do not contain traces of any other material.

Store in a refrigerator at temperature between 2°C to 8°C.
It should not be allowed to freeze.
During use: Do not refrigerate.
The solution can be kept at room temperature (up to 30°C) for up to 28 days once the pen has been put to use.
Do not expose to excessive heat or direct sunlight.
Before first use, store the cartons containing the pen in the refrigerator at 2°C - 8°C (36°F - 46°F). DO NOT freeze.
Once the patient take a pen out of the refrigerator, allow it to reach room temperature (around 25°C) naturally before first use. Cold insulin is painful to inject.
Always store the pen with the cap on, to avoid any contamination.
After first use, store the pen at room temperature up to 30°C (86°F).
Use the pen within 28 days from first use. Dispose of the pen after 28 days.
DO NOT refrigerate the pen after first use.
Store at room temperature between uses.
NEVER leave the needle attached to the pen during storage.
This could lead to contamination or needle blockage.

Instructions for Use: Insulin Glargine Injection (rDNA Origin) 3 mL Prefilled Pen (100 IU/mL).
BASALOG One preflled disposable pen injector contains 300 units of insulin glargine (rDNA Origin). Please read all the instructions carefully before using BASALOG One (hereafter "pen"). If you are unable to read or follow all of the instructions completely on your own, seek the help of someone who has been trained to use the pen.
Please follow these instructions every time you use the pen. If you do not follow these instructions each time you use the pen, you may either get too much or too little insulin. This may affect your blood glucose level.
Before You Use the Pen for the First Time: Check that the carton is sealed with an intact hologram. After opening the carton check that the pen looks new and undamaged.
Each Time You Use the Pen: 1. Wash your hands with soap and water before you handle the pen.
2. Check the pen's label to ensure that you are taking the correct type of insulin. The pen has a purple label and a purple injection button.
3. Check the expiration date given on the pen's label.
4. Check the appearance of the drug in the cartridge. This is important especially if you take more than one type of insulin.
5. DO NOT use the pen if the drug in the cartridge appears cloudy, colored or has visible particles.
6. ALWAYS use a new Sterile disposable Hypodermic needle for each injection.
7. Select the injection location as recommended by your Health Care Professional (HCP).
8. ALWAYS put the pen cap back on the pen after use, and store the pen at room temperature in a cool, dry place.
Required Supplies: Make sure you have the following items: Pen; Sterile disposable hypodermic needle; 2 Alcohol Wipes*.
Needles Compatible with this Pen: BD UltraFine 31G, 5mm; BD UltraFine 32G, 4mm; Novofine 32, 6mm; Terumo Nanopass 33G, 5mm.
Step-By-Step Instructions: Preparing the Pen: A. 1. Inspect the pen: Check the purple-coloured label present on the pen for: a. Correct insulin type; b. Expiration date.
Check the Insulin through the cartridge holder for: a. Clear and colourless appearance of the solution.
b. Absence of cracks, breakage, or solution leakage.
B. 1. Hold the pen body with one hand.
2. With the other hand, pull off the pen cap.
3. Keep the pen cap aside for later use. (in Step Q).
C. 1. Remove an alcohol wipe from its package.
2. Wipe the rubber seal at the front end of the cartridge with the alcohol wipe.
Note: Use of an alcohol wipe reduces chance of infection.
Attaching a New Needle: D. 1. Take a new sterile disposable hypodermic needle.
2. Hold the outer needle cap with one hand.
3. With the other hand, pull off the protective tab from the outer needle cap.
Caution: DO NOT use the needle if the protective tab is damaged or missing. The needle may not be sterile.
E. 1. Hold the pen body facing upwards with one hand.
2. With the other hand, attach the outer needle cap straight on to the cartridge holder as shown (1).
Caution: DO NOT try to attach the outer needle cap in a tilted manner. This can bend or damage the needle.
3. Screw the outer needle cap in the clockwise direction, till it feels securely fixed on the pen (2).
F. 1. With a gentle pull, remove the outer needle cap.
2. Keep the outer needle cap. It is required to safely remove the needle later (in Step P).
G. 1. Carefully pull off and throw away the inner needle cap.
Caution: DO NOT re-use the inner needle cap to cover the needle. You may accidentally injure yourself. Only use the outer needle cap to cover the needle (in Step P).
Priming the pen Needle with 2 Units: H. 1. Turn the white-coloured dose knob to set 2 units.
"2" must be visible in the dose window, and align with the pointer on the pen body.
You will hear a "CLICK" for each unit dialed.
Note: If you turn past 2 units, then simply turn back the dose knob in the opposite direction to correct the dose.
I. 1. Hold the pen body facing upwards with one hand.
2. Tap the cartridge holder gently with your finger. This helps any large air bubbles present to rise to the top of the cartridge.
Note: Small bubbles may still be visible, and will not pose any problem.
J. 1. Hold the pen body facing upwards with one hand.
2. With your thumb, press the injection button in until it stops moving and the dose window shows "0".
3. Keep the injection button pressed down.
4. Priming is complete when you observe drops of insulin at the tip of the needle.
Note: If you do not see drops at the needle tip, repeat Steps H to J for a maximum of 4 times.
After 4 attempts, if insulin drops are still not visible at the needle-tip, it is likely that the needle is clogged.
Proceed directly to Step P to remove the needle. Then, return to Step D to attach the new needle and repeat priming (Step H).
Important: Always prime the pen needle before each injection to check insulin flow and avoid incomplete dose.
Setting the Dose: K. 1. Check that the dose window shows "0".
2. Look at the cartridge holder scale to estimate the insulin units left in the cartridge. If enough medication is not available in the cartridge, use a new pen to inject your required dose.
3. Turn the dose knob to set the required dose. The number in the dose window must align with the pointer on the pen body.
Note: Ensure that you hear "CLICK" as you set the desired dose.
The pen does not allow you to dial a dose beyond the units available within the cartridge.
Do not force the dose knob to turn beyond 80 units. 80 units is the maximum dose that you can inject in a single injection.
Caution: DO NOT push the injection button when turning the dose knob (during dose setting).
Select and Clean Injection Site: L. 1. Select the injection location as recommended by your Health Care Professional.
Note: Preferred injection locations on your body are both your arms, hips, thighs, and lower abdomen. It is advised to rotate your injection site for each injection.
M. 1. Clean the skin with an alcohol wipe, at the spot where you want to inject.
Injecting the Dose: N. 1. Insert the needle in a single continuous motion, as instructed by your Health Care Professional.
Caution: DO NOT inject with the needle at an angle.
O. 1. Place your thumb or finger on the injection button.
2. Press the injection button all the way in. The white dose-knob will turn and you will hear "Clicks" as you press down.
3. WAIT. Hold the injection button pressed in for an additional 10 seconds after the dose window shows "0". This pause ensures that all of the medication is delivered.
Caution: DO NOT press the injection button sideways or block the white dose-knob with your fingers. This will prevent you from injecting the medication.
If you don't keep the injection button pressed for 10 seconds after "0" is displayed in the dose window, it could result in an inaccurate dose and you may see drops of insulin at the injection site or at the needle tip.
Needle Removal and Disposal: P. 1. Take the outer needle cap that you had saved in Step F.
2. Hold the outer needle cap from its base and carefully cover the needle without touching it.
3. Squeeze the base of the outer needle cap while unscrewing the needle in a counter clockwise (left) direction (1). Keep twisting until the needle can be separated from the pen (2).
4. Discard this needle safely, as instructed by your Health Care Professional or as per local regulations in your country.
Note: It may take several twists to release the needle.
Q. 1. Replace the pen cap and store the pen at room temperature (under 86°F or 30°C) for next use. NEVER store with a used needle attached.
Required Storage: Always store the pen with the cap on, to avoid any contamination.
After first use, store the pen at room temperature up to 86°F (30°C).
Use the pen within 28 days from first use. Dispose of the pen after 28 days.
DO NOT refrigerate the pen after first use. Store at room temperature between uses.
NEVER leave the needle attached to the pen during storage. This could lead to contamination or needle blockage.
Care and Disposal: Always carry a spare insulin prefilled pen injector as recommended by your Health Care Professional, as a precautionary measure, in case your pen is lost or damaged.
Always use a new sterile disposable hypodermic needle for each injection.
Keep the pen away from moisture, dust, direct sunlight and places where the temperature may get too high or too low.
Discard an empty pen without the needle attached, as instructed by your Health Care Professional.
You can clean the outside of your pen by wiping it with a damp cloth.
DO NOT soak or wash your pen as this may damage it. Do not use alcohol, hydrogen peroxide, bleach or any other solvent to clean the pen. Also, do not apply lubricants such as oil, as this could damage the pen.
DO NOT share your pen with others. This pen is intended and recommended for use by one person only. Keep your pen and needles out of sight and reach of children.
DO NOT attempt to repair the pen by yourself. Remove the needle as described in Step P, make a note of the problem, and return the pen to the manufacturer. Use a new pen instead.
Your pen is designed to work accurately and safely. It must be handled with care. Avoid dropping the pen, as this can cause cartridge breakage or can damage the pen.

Insulin Preparations

A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.

C