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Insulet ASPInsulet ASP

Insulet ASP

Insulin Aspart (Recombinant DNA)

Insulet ASP: The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulins, including Insulin Aspart, bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
Insulet ASP 30/70: The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulins, including Insulin Aspart, bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Product Details

Presentation

Insulet ASP Injection: Each ml solution contains Insulin Aspart (Recombinant DNA) BP 100 units (equivalent to 3.5 mg) as soluble Insulin Aspart.
Insulet ASP 30/70 Injection: Each ml biphasic suspension contains Insulin Aspart (Recombinant DNA) BP 100 units (equivalent to 3.5 mg) as 30% Soluble Insulin Aspart and 70% protamine-crystallised Insulin Aspart.

Pharmacology

Insulet ASP: The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulins, including Insulin Aspart, bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
Insulet ASP 30/70: The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulins, including Insulin Aspart, bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Indication

Insulet ASP is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Insulet ASP 30/70 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Dosage & Administration

Insulet ASP: Insulet ASP dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. Moreover Insulet ASP can be used for continuous subcutaneous insulin infusion (CSII) in pump systems or be administered intravenously by healthcare professionals. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day. In a basal-bolus treatment regimen 50-70% of this requirement may be provided by Insulet ASP and the remainder by intermediate-acting or long-acting insulin. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

Insulet ASP 30/70: Insulet ASP 30/70 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.
In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1.0 Unit/kg/day. Insulet ASP 30/70 may fully or partially meet this requirement.
In patients with type 2 diabetes, Insulet ASP 30/70 can be given as monotherapy. Insulet ASP 30/70 can also be given in combination with, oral antidiabetic drugs if the patient's blood glucose is inadequately controlled with these oral antidiabetic drugs alone.

How to start:
Insulin naive patients: For patients with type 2 diabetes, the recommended starting dose of Insulet ASP 30/70 is 6 Units at breakfast and 6 Units at dinner (evening meal). Insulet ASP 30/70 can also be initiated once daily with 12 units at dinner (evening meal).

How to intensify: Insulet ASP 30/70 can be intensified from once daily to twice daily. When using Insulet ASP 30/70 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses.
From Insulet ASP 30/70 twice daily to thrice daily: If twice daily dosing with Insulet ASP 30/70 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses. The dinner doses remain unchanged.

How to adjust the dose:
- Adjust the dose of Insulet ASP 30/70 on the basis of the lowest pre-meal blood glucose level from the three previous days
- Dose adjustment can be made once a week until target HbA1c is reached
- The dose should not be increased if hypoglycemia occurred within three days
- Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness

The following titration guideline is recommended for dose adjustments:































Pre-meal blood glucose level of Insulet ASP 30/70 Dose adjustment
< 4.4 mmol/l < 80 mg/dl - 2 units
4.4 – 6.1 mmol/l 80 – 110 mg/dl 0
6.2 – 7.8 mmol/l 111 – 140 mg/dl + 2 units
7.9 – 10 mmol/l 141 – 180 mg/dl + 4 units
> 10 mmol/l > 180 mg/dl + 6 units

Transfer from other insulin medicinal products:
Insulin Aspart products are equipotent to their respective human insulin products, in regards to hypoglycemic effect, receptor affinity and effect on lipogenesis. Patients currently treated with human insulin can be transferred to Insulet ASP on a unit for unit basis when administered just before a meal. Any change to insulin therapy should be made under medical supervision and blood glucose should be monitored.
When transferring a patient from biphasic human insulin to Insulet ASP 30/70, start with the same dose and regimen. Then titrate according to individual needs (See the above titration guideline). As with all insulin products close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.

Method of administration:

Preparation before use:
- Clean your hands
- Shake or rotate the vial gently
- In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab
- Draw air into your syringe equal to the amount of medicine needed. Puncture the needle into the vial and inject the air
- Turn the bottle and syringe upside down and withdraw correct dose of medicine into the syringe
- Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles

Injection site:
Subcutaneous Injection:
Insulet ASP is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. When Insulet ASP is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action is 3 to 5 hours. Due to the faster onset of action, Insulet ASP should generally be given immediately before a meal. When necessary Insulet ASP can be given soon after a meal.

Injection method (Incase of subcutaneous Injection):
- Cleanse the skin with alcohol where the injection is to be made
- Put the needle in such a position as to form 45° angle with the skin
- Puncture the needle into skin and inject the medicine
- Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected
- Pull the needle out and apply gentle pressure over the injected site for several seconds
- Do not rub the injection site

Continuous Subcutaneous Insulin Infusion (CSII):
Insulet ASP may be used for CSII in pump systems suitable for insulin infusion. CSII should be administered in the abdominal wall. Infusion sites should be rotated. When used with an insulin infusion pump, Insulet ASP should not be mixed with any other insulin medicinal products. Patients administering Insulet ASP by CSII must have an alternative insulin delivery method available in case of pump system failure.

Intravenous use:
If necessary, Insulet ASP can be administered intravenously which should be carried out by healthcare professionals. For intravenous use, infusion systems with Insulet ASP 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/ml Insulin Aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/l potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hours. Although stable over time, a certainamount of insulin will be initially adsorbed to the infusion bag. Monitoring of blood glucose is necessary during insulin infusion.

Preparation before use:
- Clean your hands
- Insulet ASP 30/70 is a suspension that must be resuspended immediately before use. The vial should be rolled gently in your hands in a horizontal position 10 times to mix it. The rolling procedure must be repeated untill the suspension appears uniformly white and cloudy. Inject immediately.
- In case of using a new vial, flip off the plastic protective cap and wipe the rubber plug with an alcohol swab
- Draw air into your syringe equal to the amount of medicine needed. Puncture the needle into the vial and inject the air
- Turn the bottle and syringe upside down and withdraw correct dose of medicine into the syringe
- Before pulling out the needle, check if there are any bubbles remain in the syringe. If so, put the syringe upright and tap the syringe to discharge the air bubbles

Injection site:
Insulet ASP 30/70 is for subcutaneous administration only. Insulet ASP 30/70 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoidregion may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. The influence of different injection sites on the absorption of Insulet ASP 30/70 has not been investigated. As with all insulin the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. After subcutaneous administration, the onset of action will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after injection. The duration of action is up to 24 hours. Insulet ASP 30/70 should generally be given immediately before a meal. When necessary, Insulet ASP 30/70 can be given soon after a meal.

Contraindications

Insulin Aspart: Insulin Aspart is contraindicated in hypoglycemia and with hypersensitivity to Insulin Aspart or any of its excipients.
Insulin Aspart 30/70: Insulin Aspart 30/70 is contraindicated in hypoglycemia and with hypersensitivity to Insulin Aspart or any of its excipients.

Warning & Precautions

Insulet ASP:
Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times.

Hyperglycemia:
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to Hyperglycemia and diabetic ketoacidosis. Usually the first symptoms of Hyperglycemia develop gradually over a period of hours or days.
Hypoglycemia:
Omission of a meal or unplanned, strenuous physical exercise may lead to Hypoglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of Hypoglycemia or if Hypoglycemia is suspected Insulet ASP must not be injected. After stabilisation of patient’s blood glucose, adjustment of the dose should be considered.
Adverse reactions:
The most frequently reported adverse reaction during treatment is Hypoglycemia. The frequencies of Hypoglycemia vary with patient population, dose regimens and level of glycaemic control. Hypersensitivity and allergic reaction may also occur.
Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times.

Insulet ASP 30/70:
Insulin Aspart 30/70 must not be administered intravenously, as it may result in severe Hypoglycemia. Intramuscular administration should be avoided. Insulin Aspart 30/70 should not be used in insulin infusion pumps.
Hyperglycemia:
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to Hyperglycemia and diabetic ketoacidosis. Usually the first symptoms of Hyperglycemia develop gradually over a period of hours or days.
Hypoglycemia:
Omission of a meal or unplanned, strenuous physical exercise may lead to Hypoglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of Hypoglycemia or if Hypoglycemia is suspected Insulin Aspart 30/70 must not be injected. After stabilisation of patient’s blood glucose, adjustment of the dose should be considered.
Adverse reactions:
The most frequently reported adverse reaction during treatment is Hypoglycemia. The frequencies of Hypoglycemia vary with patient population, dose regimens and level of glycaemic control. Hypersensitivity and allergic reaction may also occur.

Drug interaction

Insulet ASP:
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring:

- The following drugs may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics
- The following drugs may reduce the blood-glucose-lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics
- Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin
- Pentamidine may cause hypoglycemia, which may sometimes be followed by Hyperglycemia.
- The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine.

Insulet ASP 30/70:
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring:
- The following drugs may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics
- The following drugs may reduce the blood-glucose-lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics
- Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin
- Pentamidine may cause hypoglycemia, which may sometimes be followed by Hyperglycemia.
- The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine

Use in special groups

Insulet ASP:
Older Patients: Insulin Aspart can be used in older patients.
Renal and hepatic impairment: Renal or hepatic impairment may reduce the patient’s insulin requirements.
Paediatric population: Insulin Aspart can be used in children and adolescents aged 2 years and above.
Pregnancy: Pregnancy Category B. Female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking Insulin Aspart.
Lactation: There are no restrictions on treatment with Insulin Aspart during breast-feeding. However, the Insulin Aspart dose may need to be adjusted.

Insulet ASP 30/70:
Older Patients: Insulin Aspart 30/70 can be used in older patients.
Renal and hepatic impairment: Renal or hepatic impairment may reduce the patient’s insulin requirements.
Paediatric population: Insulin Aspart 30/70 can be used in children and adolescents aged 10 years and above.
Pregnancy: Pregnancy Category B. Female patients should be advised to tell their physician if they intend to become or if they become pregnant while taking Insulin Aspart 30/70.
Lactation: There are no restrictions on treatment with Insulin Aspart 30/70 during breast-feeding. However, the Insulin Aspart 30/70 dose may need to be adjusted.

Packing

Insulet ASP Injection: Each glass vial contains 3 ml solution.
Insulet ASP 30/70 Injection: Each glass vial contains 3 ml suspension.

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