► Apidra SoloStar (insulin glulisine) - Practical Medicine

Apidra SoloStar (insulin glulisine) - solution for injection

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Apidra SoloStar solution for injection; 100 U / ml; 5 pre-filled pens of 3 ml Sanofi-aventis 126.31 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:insulin glulisine

The drug is available on prescription

What is Apidra SoloStar?

An antidiabetic medicine that reduces blood Glucose (a hypoglycaemic agent). The product contains insulin glulisine (a human insulin analogue) with a rapid onset of action.

What does Apidra SoloStar contain and how does it work?

The active substance of the preparation is an insulin analogue of human insulin, insulin glulisine, produced by genetic engineering (the gene of human insulin, after a slight modification, is introduced into a bacterial cellE. coli using the recombinant DNA method). Insulin glulisine is characterized by earlier onset and shorter duration of action than human insulin. Insulin is used to reduce blood glucose in the course of diabetes. It reduces blood glucose, exerts anabolic effects and reduces catabolism. Insulin binds to the appropriate receptors on the surface of liver cells, muscle tissue cells and adipose tissue and facilitates the uptake of glucose by these cells. Increases glycogen synthesis in muscle tissue and in the liver. It also inhibits the process of glucose release by the liver (reduces glycogenolysis and glyconeogenesis). Increases fat synthesis in adipose tissue and liver, reduces lipolysis. Increases amino acid uptake and protein synthesis. It increases the transport of potassium to the cells. Endogenous insulin is secreted by beta-cells of the pancreas in a glucose-dependent manner. When the blood glucose is high, the stimulation of insulin secretion occurs and when the glucose concentration decreases, insulin secretion is suppressed. The effect of the preparation in diabetic patients improves glycemic control by reducing fasting blood glucose and after a meal.
The product contains glulisine insulin characterized by faster absorption, and therefore an earlier onset and a shorter duration of action than human insulin. After subcutaneous administration, the onset of action begins after 10-20 minutes. The speed and duration of action of the insulin preparation are determined by the characteristics of its absorption from the subcutaneous tissue (the plasma half-life of insulin is several minutes).

When should I use Apidra SoloStar?

The preparation is indicated for the treatment of adults, adolescents and children after the age of 6 who have diabetes and require insulin.

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
The contraindication to the preparation is hypoglycaemia.

Take special care with Apidra SoloStar?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation.In some situations it may be necessary to carry out specific check-ups.
Any change in the way diabetes is treated, including any change in the insulin preparation used to another, requires close medical supervision. Such a change may involve the need to adjust the dose. Your doctor will advise you how to proceed and adjust the dose accordingly; you should follow the doctor's instructions. The need to adjust the dose may also apply to oral hypoglycaemic agents used concomitantly.
The product should be used strictly according to the doctor's instructions and it must not be interrupted abruptly. Discontinuation of therapy, particularly in the treatment of type 1 diabetes, use of too low doses or skipping doses may lead to hyperglycaemia. The first symptoms of hyperglycaemia usually occur gradually over several hours or days and may include: increased thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite and the smell of acetone in the exhaled breath. In the course of type 1 diabetes, untreated hyperglycemia may lead to ketoacidosis, which is life-threatening.
When the insulin dose is too high in relation to the need, hypoglycaemia may occur. After any change in the insulin preparation, early symptoms of hypoglycaemia may be less pronounced or different from those experienced with the previous type of insulin.
Other causes that may affect the change, reduction or total disappearance of early warning symptoms of hypoglycaemia include:
· Prolonged diabetes
· Intensive treatment with insulin
· Diabetic neuropathy
· Taking other medicines (eg beta-blockers)
· Change in the animal insulin used for human insulin.
In these cases, severe hypoglycaemia (sometimes with loss of consciousness) may occur before the patient becomes aware of it.
Physical effort or a change in the pattern of meals may require dose adjustment. Exercise directly after a meal may increase the risk of hypoglycaemia.
Possible hypoglycaemia may occur earlier after the use of preparations containing rapid-acting insulin analogues than with soluble human insulin.
Insulin requirements may change during illness or emotional disturbances. You should remain under the careful supervision of a doctor who will advise you to perform the appropriate tests and adjust your insulin dose.
Unsatisfied hypoglycaemia or hyperglycemia can lead to unconsciousness, coma and death.
The SoloStar pre-filled pen should be used according to the manufacturer's instructions contained in the package leaflet.
In order to avoid mistakes, always check on your pen label that it contains the corr ect insulin before you give the injection.
Combination therapy with insulin and pioglitazone may result in heart failure , especially in those with risk factors for its development. If the doctor recommends the use of insulin in combination with pioglitazone, it is necessary to observe the patient for signs of heart failure, including edema or weight gain. In the event of cardiovascular symptoms, a doctor should be consulted immediately as it may be necessary to discontinue pioglitazone.
There are no data on the safety of the preparation in children under 6 years of age.
Additional information about the other ingredients of the preparation:
· The preparation contains metacresol, which may cause allergic reactions.

Does this preparation affect the ability to drive vehicles?
It should be taken into account that in the case of hypoglycaemia or hyperglycaemia or vision disorders, psychophysical fitness, including the speed of reaction, may be impaired. This creates a hazard when driving or operating equipment / machines. The possibility of hypoglycaemia should be prevented. This is particularly important in patients who have frequent episodes of hypoglycaemia or when the early symptoms of hypoglycaemia are low or absent. In such cases, you should consult a doctor and determine if it is possible to drive vehicles and operate equipment / machines in your case.

Dosage of Apidra SoloStar

It is a solution for injection in a SoloStar pre-filled pen and is intended for subcutaneous use.The preparation is given subcutaneously, under the skin of the abdomen, in the thigh or the deltoid region. The injection sites within one anatomical area should be changed after each injection. Injection into the abdominal wall provides faster absorption of insulin than when injected elsewhere. The beginning of the preparation's action is faster than in the case of soluble human insulin. The beginning and duration of the preparation may vary depending on many factors (injection site, dose, temperature, blood flow, physical activity). Care should be taken not to insert the needle into the blood vessel. The injection site should not be massaged. Before using the pen, please read the instructions for its use included in the package leaflet.
Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
The strength of the preparation is expressed in units. These units refer only to this preparation and are not the same as international units (IU) or units expressing the potency of other insulin analogues.
The doctor will recommend the dosage individually; the recommended dose of insulin should be administered subcutaneously shortly (0-15 min) before or after a meal or by continuous subcutaneous infusion into the abdominal wall.
In elderly people, progressive deterioration of renal function may lead to a reduction in insulin requirements.
Impaired renal or hepatic function may reduce the need for insulin.
There are no data on the safety of the preparation in children under 6 years of age.

Can I use Apidra SoloStar during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Caution should be exercised when pregnant women use the product. Insulin does not penetrate the placental barrier. Both hypoglycaemia and hyperglycemia occurring in the course of maladjusted diabetes can be a threat to the fetus. Therefore, during pregnancy and during its planning period regular blood glucose control and appropriate dosage adjustment are recommended - strictly according to the doctor's instructions. During the first trimester of pregnancy, the insulin requirement usually decreases and then gradually increases during the second and third trimester of pregnancy. After delivery, the insulin requirement drops sharply (the risk of hypoglycaemia increases).
During breastfeeding, it may be necessary to adjust the dose of insulin and / or diet.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter. During the period of application, taking any other medicines can only take place with the consent of the doctor or on his recommendation.
Other medicines may increase or decrease the need for insulin and may need to be adjusted by your doctor. Decreasing the need for insulin may increase the risk of hypoglycaemia. Insulin requirements may be reduced by drugs such as: oral antidiabetic agents, monoamine oxidase inhibitors (MAO inhibitors), Fluoxetine , Pentoxifylline , propoxyphene, angiotensin converting enzyme inhibitors (e.g., Captopril , Enalapril ), disopyramide, fibrates, salicylates (e.g. Acetylsalicylic acid ) and sulfonamides.
Insulin requirements may increase under the influence of drugs such as: corticosteroid s, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (eg in oral contraceptives), phenothiazine derivatives, somatotropin (growth hormone), sympathomimetics ( e.g. adrenaline, Salbutamol , terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotics (e.g., olanzapine and clozapine).
Beta-blocking agents, clonidine, and lithium salts may both potentiate or weaken the action of insulin.Pentamidine may cause hypoglycaemia, which may be followed by hyperglycaemia.
Sympatholytics, such as, for example, beta-blockers, clonidine, guanethidine or reserpine may cause complete elimination or reduction of compensatory responses associated with stimulation of adrenergic receptors. Symptoms of hypoglycaemia may not be clear and may go unnoticed.
Alcohol may increase or prolong or weaken the hypoglycemic effect of insulin.

What side effects can occur?

Like all medicines, Apidra SoloStar can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The most common side effect is hypoglycaemia, occurring when the insulin dose is too high in relation to the need. Symptoms of hypoglycaemia usually appear suddenly. They may include: cold sweats, cool pale skin, fatigue, tremors, anxiety, unusual tiredness, difficulty concentrating, dizziness, hunger, blurred vision, headache, nausea and palpitation. Severe hypoglycaemia may lead to unconsciousness, convulsions, impaired brain function and even death. Common: edema, injection site reactions (redness, swelling, pruritus, pain), local allergic reactions. Rare lipodystrophy (loss of fat at the site of insulin injection). In addition, generalized hypersensitivity reactions may occur, including Anaphylactic reactions : rash, urticaria, profuse sweating, nausea, vomiting, angioneurotic edema , bronchospasm, increased heart rate, hypotension, loss of consciousness; Severe anaphylactic reactions can be life-threatening.

Other preparations on the Polish market containing insulin glulisine

Apidra (solution for injection)