Apidra Solostar

Each mL of the solution for injection contains insulin glulisine 100 units equivalent to 3.49 mg. Each pen contains 3 mL of solution, equivalent to 300 units.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially "sodium-free".
Excipients/Inactive Ingredients: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.

Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.

Always use this medicine exactly as the doctor has told the patient. Check with the doctor or pharmacist if the patient is not sure. Based on the patient's life-style and the results of blood sugar (glucose) tests and previous insulin usage, the doctor will determine how much Apidra will be needed.
Apidra is a short-acting insulin. The doctor may advice to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
If switching from another insulin to insulin glulisine, the dosage may have to be adjusted by the doctor.
Many factors may influence the blood sugar level. The patient should know these factors so that they are able to react correctly to changes in the blood sugar level and to prevent it from becoming too high or too low.
Method of administration: Apidra Solostar should be taken shortly (0-15 min) before or soon after meals. Apidra Solostar is injected under the skin (SC). The doctor will show Apidra Solostar can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be slightly quicker if the insulin is injected into the abdomen. As for all insulins, injection sites and infusion sites within an injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Missed Dose: If the patient has missed a dose of Apidra or if they have not injected enough insulin, the blood sugar level may become too high (hyperglycaemia). Check the blood sugar frequently.
Do not take a double dose to make up for a forgotten dose.

If too much Apidra Solostar is injected, blood sugar level may become too low (hypoglycemia).
Check blood sugar frequently. In general, to prevent hypoglycemia, the patient must eat more food and monitor blood sugar.

If patient is allergic to insulin glulisine or any of the other ingredients of this medicine (listed in Description).
If patient's blood sugar is too low (hypoglycaemia).

Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed by the physician.
If the patient has liver or kidney problems, inform the physician as a lower dose may be needed.
Travel: Before traveling consult the doctor. The patient may need to talk about the availability of the insulin in the country the patient is visiting; supplies of insulin, injection syringes; correct storage of the insulin while traveling; timing of meals and insulin administration while traveling; the possible effects of changing to different time zones; possible new health risks in the countries to be visited; what to do in emergency situations when the patient feels unwell or becomes ill.
Illnesses and Injuries: In the following situations, management of diabetes may require extra care: If the patient is ill or has a major injury, the blood sugar level may increase (hyperglycemia); not eating enough, blood sugar level may become too low (hypoglycemia).
If the patient has type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking insulin and continue taking enough carbohydrates.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Inform the physician as soon as possible if the patient experience signs of heart failure eg, unusual shortness of breath or rapid increase in weight or localized swelling (edema).
Apidra Solostar contains metacresol, which may cause allergic reactions.
If the patient stopped using Apidra Solostar, this could lead to severe hyperglycemia (very high blood sugar) and ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking Apidra Solostar without consulting a physician.
Effects on the Ability to Drive or Operate Machinery: The ability to concentrate or react may be reduced if the patient have hypoglycemia (low blood sugar levels) or hyperglycemia (high blood sugar levels).
Keep this possible problem in mind in all situations where the patient might put himself and others at risk (eg, driving a car or operating machines). Contact the physician for advice on driving if there are frequent episodes of hypoglycemia and/or the first warning symptoms which help recognize hypoglycemia are reduced or absent.
Use in Pregnancy & lactation: If the patient is pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Inform the doctor if the patient is planning to become pregnant, or if already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Careful control of diabetes, and prevention of hypoglycaemia, is important for the health of the baby.
There are no or limited data on the use of Apidra in pregnant women.
If the patient is breast-feeding consult the doctor as it may require adjustments in the insulin doses and diet.
Use in Children: There is insufficient clinical information on the use of Apidra Solostar in children <6 years.

If the patient is pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Inform the doctor if the patient is planning to become pregnant, or if already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Careful control of diabetes, and prevention of hypoglycaemia, is important for the health of the baby.
There are no or limited data on the use of Apidra in pregnant women.
If the patient is breast-feeding consult the doctor as it may require adjustments in the insulin doses and diet.

Hypoglycemia (low blood sugar) can be very serious. Hypoglycaemia is a very commonly reported side effect (may affect more than 1 on 10 people). Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. If the blood sugar level falls too much the patient may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If the patient have symptoms of low blood sugar, take actions to increase the blood sugar level immediately.
If the patient experience the following symptoms, contact the doctor immediately: Systemic allergic reactions are side effects reported uncommonly (may affect up to 1 in 100 people).
Generalised allergy to insulin: Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. These could be symptoms of severe cases of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood. The frequency of hyperglycaemia cannot be estimated. If the blood sugar level is too high, this tells that the patient may need more insulin than they have injected. This can be serious if the blood glucose level becomes very high.
Other side effects: Common reported side effects (may affect up to 1 in 10 people): Skin and allergic reactions at the injection site reactions at the injection site may occur (such as reddening, unusually intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.
Rare reported side effect (may affect up to 1 in 1,000 people): Skin changes at the injection site (lipodystrophy).
If the patient injected the insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that is injected in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
Side effects where the frequency cannot be estimated from the available data: Eye reactions: A marked change (improvement or worsening) in the blood sugar control can disturb the vision temporarily. If the patient has proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in here. By reporting side effects it can help provide more information on the safety of this medicine.

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust the insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when starting or stopping taking another medicine. Tell the physician or pharmacist if taking, have recently taken, or might have taken any other medicine. Before taking a medicine, ask the physician if it can affect blood sugar level and what action, if any, may need to be taken.
Medicines that may Cause Blood Sugar Level to Fall (Hypoglycemia): All other medicines used to treat diabetes, angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), disopyramide (used to treat certain heart conditions), fluoxetine (used to treat depression), fibrates (used to lower high levels of blood lipids), MAOIs (used to treat depression), pentoxifylline, propoxyphene, salicylates (eg, aspirin, used to relieve pain and lower fever) and sulfonamide antibiotics.
Medicines that may Cause Blood Level to Rise (Hyperglycemia): Corticosteroids (eg, cortisone used to treat inflammation), danazol (medicine acting on ovulation), diazoxide (used to treat high blood pressure), diuretics (used to treat high blood pressure or excessive fluid retention), glucagon (pancreatic hormone used to treat severe hypoglycemia), isoniazid (used to treat tuberculosis), estrogens and progestogens (eg, in the contraceptive pill used for birth control), phenothiazine derivatives (used to treat psychiatric disorders), somatropin (growth hormone), sympathomimetic medicines [eg, epinephrine (adrenaline) or salbutamol, terbutaline used to treat asthma], thyroid hormones (used to treat thyroid gland disorders), protease inhibitors (used to treat HIV), atypical antipsychotic medicines (eg, olanzapine and clozapine).
Blood Sugar Level may Either Rise or Fall with: Beta-blockers (used to treat high blood pressure), clonidine (used to treat high blood pressure), and lithium salts (used to treat psychiatric disorders). Pentamidine (used to treat some infections caused by parasites) may cause hypoglycemia which may sometimes be followed by hyperglycemia.
Beta-blockers like other sympatholytic medicines (eg, clonidine, guanethidine and reserpine) may weaken or suppress entirely the 1st warning symptoms which help to recognize a hypoglycemia.
If the patient is not sure whether to take one of these medicines, ask the physician or pharmacist.
Blood sugar levels may either rise or fall with alcohol.

Instructions for Use: Solostar is a pre-filled pen for injection of insulin. Talk with the healthcare professional about proper injection technique before using Solostar:
Doses can be set from 1-80 units in steps of 1 unit. Each pen contains multiple doses.
To prevent the possible transmission of disease, each pen must be used by 1 patient only. Before use, always attach a new needle and perform a safety test. Only use needles that are compatible for use with Solostar. Look at the cartridge sealed in the disposable pen injector before using. Use only if the solution is clear, colorless and has no visible particles in it. Do not shake or mix before use. Always use a new pen if blood sugar control is unexpectedly getting worse. Never use Solostar if it is damaged or if uncertain that it is working properly. Always have a spare Solostar in case not sure it is lost or damaged.
Step 1. Check the Insulin: Check the label on the Solostar to make sure that the patient has 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 the insulin. Apidra Solostar is a clear insulin. Do not use this Solostar if the insulin is cloudy, colored 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.
Remove the protective seal from a new needle.
Line up the needle with the pen, and keep it straight as it is attached (screw or push on, depending on the needle type).
If the needle is not kept straight while attaching 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 an accurate dose is given by ensuring that the pen and needle work properly and by removing air bubbles.
Select a dose of 2 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.
The safety test may have to be performed several times before insulin is seen. If no insulin comes out, check for air bubbles and repeat the safety test 2 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, the Solostar may be damaged. Do not use this Solostar.
Step 4. Select the Dose: The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If a dose >80 units is needed, it should be given as ≥2 injections.
Check that the dose window shows "0" following the safety test.
Select the required dose. If the patient turns the selector past the desired dose, it can be turned back down.
Do not push the injection button while turning, as insulin will come out.
The dosage selector cannot be turned past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either the patient can inject what is remaining in the pen and complete the dose with a new Solostar or use a new Solostar for the full dose.
Step 5. Inject the Dose: Use the injection method as instructed by the 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 injected.
Keep the injection button pressed all the way in. Slowly count to 10 before withdrawing 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 have been used.
Step 6: Remove and Discard the Needle: Always remove the needle after each injection and store Apidra Solostar without a needle attached. This helps prevent contamination and/or infection, and 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.
Dispose of the needle safely, as instructed by the health care professional.
Always put the pen cap back on the pen, then store the pen until the next injection.
Maintenance: Protect Apidra Solostar from dust and dirt. Clean the outside of the pen by wiping it with a damp cloth. Do not soak, wash or lubricate the pen as this may damage it. Apidra Solostar is designed to work accurately and safely. It should be handled with care. Avoid situations where the pen might be damaged. If the patient's Apidra Solostar may be damaged, use a new one.
Do not use Apidra Solostar if it does not appear clear and colorless.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Discard as required by local authorities.

Not-in-Use Pens: Store in a refrigerator (2-8°C). Do not freeze. Do not put Apidra Solostar 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: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C away from direct heat or light. The pen in use must not be stored in a refrigerator. Do not use it after this time period.

Insulin Preparations

A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.

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