Apidra SoloStar

Apidra SoloStar

insulin glulisine

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Insulin glulisine.
Description
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Insulin glulisine is produced by recombinant DNA technology in Escherichia coli.
Excipients/Inactive Ingredients: Metacresol, Sodium chloride, Trometamol, Polysorbate 20, Hydrochloric acid, concentrated, Sodium hydroxide, Water for injections.
Action
Pharmacotherapeutic Group: Drugs used in diabetes, insulins and analogues for injection, fast-acting. ATC Code: A10AB06.
Pharmacology: Pharmacodynamics: Mechanism of action: Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin. Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism. Insulins 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.
Studies in healthy volunteers and patients with diabetes demonstrated that insulin glulisine is more rapid in onset of action and of shorter duration of action than regular human insulin when given subcutaneously. When insulin glulisine is injected subcutaneously, the glucose lowering activity will begin within 10-20 minutes. The glucose-lowering activities of insulin glulisine and regular human insulin are equipotent when administered by intravenous route. One unit of insulin glulisine has the same glucose-lowering activity as one unit of regular human insulin.
Dose proportionality: In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displayed dose-proportional glucose lowering effect in the therapeutic relevant dose range 0.075 to 0.15 Units/kg, and less than proportional increase in glucose lowering effect with 0.3 Units/kg or higher, like human insulin.
Insulin glulisine takes effect about twice as fast as regular human insulin and completes the glucose lowering effect about 2 hours earlier than regular human insulin.
A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 Units/kg, at different times in relation to a 15-minute standard meal. Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycaemic control compared to regular human insulin given 30 minutes before the meal. When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the meal. Insulin glulisine administered 15 minutes after starting the meal gives similar glycaemic control as regular human insulin given 2 minutes before the meal (see Figure 1).

Click on icon to see table/diagram/image

Figure 1: Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus. Insulin glulisine given 2 minutes (GLULISINE pre) before the start of a meal compared to regular human insulin given 30 minutes (REGULAR 30 min) before the start of the meal (figure 1A) and compared to regular human insulin given 2 minutes (REGULAR pre) before a meal (figure 1B). Insulin glulisine given 15 minutes (GLULISINE post) after start of a meal compared to regular human insulin given 2 minutes (REGULAR pre) before start of the meal (figure 1C). On the x-axis, zero (arrow) is the start of a 15-minute meal.
Obesity: A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties. In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427mg/kg for insulin glulisine, 121 minutes and 354mg/kg for lispro, 150 minutes and 197mg/kg for regular human insulin (see Figure 2).

Click on icon to see table/diagram/image

Figure 2: Glucose infusion rates (GIR) after subcutaneous injection of 0.3 Units/kg of insulin glulisine (GLULISINE) or insulin lispro (LISPRO) or regular human insulin (REGULAR) in an obese population.
Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/m²) has demonstrated that rapid action is generally maintained across a wide range of body mass indices (BMI), while total glucose lowering effect decreases with increasing obesity.
The average total GIR AUC between 0-1 hour was 102±75 mg/kg and 158±100 mg/kg with 0.2 and 0.4 Units/kg insulin glulisine, respectively, and was 83.1±72.8 mg/kg and 112.3±70.8 mg/kg with 0.2 and 0.4 Units/kg insulin lispro respectively.
A phase I study in 18 obese patients with type 2 diabetes mellitus (BMI between 35 and 40 kg/m2) with insulin glulisine and insulin lispro [90% CI: 0.81, 0.95 (p=<0.01)] has shown that insulin glulisine effectively controls diurnal postprandial blood glucose excursions.
Clinical efficacy and safety: Type 1 diabetes mellitus: Adults: In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycaemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint. Comparable self-monitored blood glucose values were observed. No increase in the basal insulin dose was needed with insulin glulisine, in contrast to insulin lispro.
A 12-week phase III clinical study performed in patients with type 1 diabetes mellitus receiving insulin glargine as basal therapy indicate that the immediate post-meal administration of insulin glulisine provides efficacy that was comparable to immediate pre-meal insulin glulisine (0-15 minutes) or regular insulin (30-45 minutes).
In the per-protocol population there was a significantly larger observed reduction in GHb in the pre-meal glulisine group compared with the regular insulin group.
Type 1 diabetes mellitus: Paediatric: A 26-week phase III clinical study compared insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in children (4-5 years: n=9; 6-7 years: n=32 and 8-11 years: n=149) and adolescents (12-17 years: n=382) with type 1 diabetes mellitus using insulin glargine or NPH as basal insulin. Insulin glulisine was comparable to insulin lispro for glycaemic control as reflected by changes in glycated haemoglobin (GHb expressed as HbA1c equivalent) from baseline to endpoint and by self-monitored blood glucose values.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Type 2 diabetes mellitus: Adults: A 26-week phase III clinical study followed by a 26-week extension safety study was conducted to compare insulin glulisine (0-15 minutes before a meal) with regular human insulin (30-45 minutes before a meal) injected subcutaneously in patients with type 2 diabetes mellitus also using NPH insulin as basal insulin. The average body mass index (BMI) of patients was 34.55 kg/m2. Insulin glulisine was shown to be comparable to regular human insulin with regard to glycated haemoglobin (expressed as HbA1c equivalent) changes from baseline to the 6-month endpoint (-0.46% for insulin glulisine and -0.30% for regular human insulin, p=0.0029) and from baseline to the 12-month endpoint (-0.23% for insulin glulisine and -0.13% for regular human insulin, difference not significant). In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycaemic agents at randomization and were instructed to continue to use them at the same dose.
Race and Gender: In controlled clinical studies in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Pharmacokinetics: In insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favours more rapid absorption.
In a study with 18 male subjects with diabetes mellitus type 1, aged 21 to 50 years, insulin glulisine displays dose-proportionality for early, maximum and total exposure in the dose range 0.075 to 0.4 Units/kg.
Absorption and bioavailability: Pharmacokinetic profiles in healthy volunteers and diabetes patients (type 1 or 2) demonstrated that absorption of insulin glulisine was about twice as fast with a peak concentration approximately twice as high as compared to regular human insulin.
In a study in patients with type 1 diabetes mellitus after subcutaneous administration of 0.15 Units/kg, for insulin glulisine the Tmax was 55 minutes and Cmax was 82 ± 1.3 μUnits/ml compared to a Tmax of 82 minutes and a Cmax of 46 ± 1.3 μUnits/ml for regular human insulin. The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see Figure 3).

Click on icon to see table/diagram/image

Figure 3: Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 Units/kg.
In a study in patients with type 2 diabetes mellitus after subcutaneous administration of 0.2 Units/kg insulin glulisine, the Cmax was 91 μUnits/ml with the interquartile range from 78 to 104 μUnits/ml.
When insulin glulisine was injected subcutaneously into abdomen, deltoid and thigh, the concentration-time profiles were similar with a slightly faster absorption when administered in the abdomen compared to the thigh. Absorption from deltoid sites was in-between. The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra-subject variability (11%CV). Intravenous bolus administration of insulin glulisine resulted in a higher systemic exposure when compared to subcutaneous injection, with a Cmax approximately 40-fold higher.
Obesity: Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/m²) has demonstrated that rapid absorption and total exposure is generally maintained across a wide range of body mass indices.
The time to 10% of total INS exposure was reached earlier by approximately 5-6 min with insulin glulisine.
Distribution and elimination: The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration is similar with volumes of distribution of 13 l and 22 l and half-lives of 13 and 18 minutes, respectively.
After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes. In an across study analysis of insulin glulisine in either healthy subjects or subjects with type 1 or type 2 diabetes mellitus the apparent half-life ranged from 37 to 75 minutes (interquartile range).
Insulin glulisine shows low plasma protein binding, similar to human insulin.
Special populations: Renal impairment: In a clinical study performed in non-diabetic subjects covering a wide range of renal function (CrCl > 80 ml/min, 30-50 ml/min, < 30 ml/min), the rapid-acting properties of insulin glulisine were generally maintained. However, insulin requirements may be reduced in the presence of renal impairment.
Hepatic impairment: The pharmacokinetic properties have not been investigated in patients with impaired liver function.
Elderly: Very limited pharmacokinetic data are available for elderly patients with diabetes mellitus.
Children and adolescents: The pharmacokinetic and pharmacodynamic properties of insulin glulisine were investigated in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes mellitus. Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults.
Administered immediately before a test meal, insulin glulisine provided better postprandial control than regular human insulin, as in adults. The glucose excursion (AUC0-6h) was 641 mg·h·dl-1 for insulin glulisine and 801mg·h·dl-1 for regular human insulin.
Toxicology: Preclinical safety data: Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycaemia), different from regular human insulin or of clinical relevance for humans.
Indications/Uses
Treatment of adults, adolescents and children 6 years or older with diabetes mellitus, where treatment with insulin is required.
Dosage/Direction for Use
Posology: The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see Pharmacology: Pharmacodynamics under Actions).
Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
The dosage of Apidra should be individually adjusted.
Special Populations: Renal Impairment: The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function. In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Elderly: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus. Deterioration of renal function may lead to a decrease in insulin requirements.
Paediatric population: There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Method of Administration: Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used (see Precautions).
Subcutaneous use: Apidra should be given by subcutaneous injection shortly (0-15 min) before or soon after meals or by continuous subcutaneous pump infusion.
Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall. Injection sites and infusion sites within an injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next. The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables. Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see Pharmacology: Pharmacokinetics under Actions).
Care should be taken to ensure that a blood vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be educated to use proper injection techniques.
Mixing with insulins: When administered as a subcutaneous injection, Apidra must not be mixed with other medicinal products except NPH human insulin.
Before using SoloStar, the Instructions for Use under Patient Counselling Information must be read carefully.
Overdosage
Symptoms: Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
There are no specific data available concerning overdoses with insulin glulisine. However, hypoglycaemia may develop over sequential stages.
Management: Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 mg to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a healthcare professional. Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
After an injection of glucagon, the patient should be monitored in a hospital in order to find the reason for this severe hypoglycaemia and prevent other similar episodes.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Hypoglycaemia.
Special Precautions
Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, neutral protamine Hagedorn [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. Concomitant oral antidiabetic treatment may need to be adjusted.
Hyperglycaemia: The use of inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
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.
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, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Adjustment of dose may be also necessary if patients undertake increased physical activity or change their usual meal plan. Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Insulin requirements may be altered during illness or emotional disturbances. Medication errors: Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine. Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.
Excipients: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Apidra contains metacresol, which may cause allergic reactions.
Combination of Apidra 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 Apidra 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.
Handling of the SoloStar pre-filled pen: Apidra SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
Before using SoloStar, the Instructions for Use under Patient Counselling Information must be read carefully. SoloStar has to be used as recommended in these Instructions for Use under Patient Counselling Information.
Effects on the Ability to Drive or Operate Machinery: The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machines).
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 symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women.
Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Caution should be exercised when prescribing to pregnant women. Careful monitoring of glucose control is essential.
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.
Breast-feeding: It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration. Breast-feeding mothers may require adjustments in insulin dose and diet.
Fertility: Animal reproduction studies with insulin glulisine have not revealed any adverse effects on fertility.
Adverse Reactions
Summary of the Safety Profile: Hypoglycaemia, the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Tabulated list of adverse reactions: The following related adverse reactions from clinical investigations were listed as follows by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Metabolism and nutrition disorders: Symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycaemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Skin and subcutaneous tissue disorders: Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and normally they disappear during continued treatment.
Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
General disorders and administration site conditions: Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Drug Interactions
Studies on pharmacokinetic interactions have not been performed. Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glulisine and particularly close monitoring.
Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, estrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering activity 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.
Caution For Usage
Special precautions for disposal and other handling: Apidra SoloStar 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.
Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Apidra is a solution, it does not require resuspension before use.
Empty pens must never be reused and must be properly discarded.
To prevent any kind of contamination, the use of the pre-filled pen should remain strictly for a single patient use.
Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see Precautions).
Storage
Not in-use pens: Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not put Apidra next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
In-use pens: For storage conditions after first opening of the medicinal product, see as follows.
Shelf life after first use of the pen: The product may be stored for a maximum of 4 weeks below 25°C away from direct heat or direct light.
Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light.
Patient Counseling Information
Instruction for Use: Apidra solution for injection in a pre-filled pen.
SoloStar is a pre-filled pen for the injection of insulin. Your healthcare provider has decided that SoloStar is appropriate for you, based on your ability to handle SoloStar. Talk with your healthcare provider about proper injection technique before using SoloStar.
Read these instructions carefully before using your SoloStar. Ask for help if you have problems following all the instructions or handling the pen, for example if you have problems with your sight. Hold the pen. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right. You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.
Important information for use of SoloStar: Always attach a new needle before each use. Only use needles that have been approved for use with SoloStar.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the safety test before each injection.
This pen is only for your use. Do not share it with anyone else.
If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Never use SoloStar if it is damaged or if you are not sure that it is working properly.
Always have a spare SoloStar in case your SoloStar is lost or damaged.
Step 1. Check the insulin: Check the label on your SoloStar to make sure you have the correct insulin. The Apidra Solostar is blue. It has a dark blue injection button with a raised ring on the top.
Take off the pen cap.
Check the appearance of your insulin. Apidra is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Step 2. Attach the Needle: Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks. Before use of needle, carefully read the "Instructions for Use" accompanying the needle.
Wipe the Rubber Seal with alcohol.
Remove the protective seal from a new needle.
Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
Step 3. Perform a Safety test: Always perform the safety test before each injection. This ensures that you get an accurate dose by: ensuring that pen and needle work properly; removing air bubbles.
Select a dose of 2 units by turning the dosage selector.
Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.
Hold the pen with the needle pointing upwards.
Tap the insulin reservoir so that any air bubbles rise up towards the needle.
Press the injection button all the way in. Check if insulin comes out of the needle tip.
You may have to perform the safety test several times before insulin is seen.
If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them. If still no insulin comes out, the needle may be blocked. Change the needle and try again. If no insulin comes out after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.
Step 4. Select the dose: You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more
injections.
Check that the dose window shows "0" following the safety test.
Select your required dose. If you turn past your dose, you can turn back down.
Do not push the injection button while turning, as insulin will come out.
You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Step 5. Inject the dose: Use the injection method as instructed by your healthcare professional.
Insert the needle into the skin.
Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to "0" as you inject.
Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered. The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Step 6. Remove and discard the needle: Always remove the needle after each injection and store SoloStar without a needle attached.
This helps prevent: Contamination and/or infection; Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Dispose of the needle safely, as instructed by your healthcare professional.
Always put the pen cap back on the pen, then store the pen until your next injection.
Storage Instructions: Please check Storage as previously mentioned for instructions on how to store SoloStar.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject. Keep SoloStar out of the reach and sight of children.
Do not use SoloStar after the expiration date printed on the label of the pen or on the carton.
Protect SoloStar from light.
Discard your used SoloStar as required by your local authorities.
Maintenance: Protect your SoloStar from dust and dirt.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your SoloStar is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.
ATC Classification
A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Pre-filled pen (Solostar, soln for inj) (clear, colourless, aqueous solution) 300 U/3 mL x 5's.
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