Apidra

Apidra is a rapidly acting insulin analogue that has been particularly used for continuous subcutaneous insulin infusion (CSII) by a pump. It is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). 

This parenteral blood glucose-lowering agent is widely prescribed for:

• the treatment of adult patients with diabetes mellitus where treatment with insulin is required
• the treatment of pediatric patients with type 1 diabetes mellitus who require a short-acting insulin

Apidra has a more rapid onset of action and a shorter duration of action than regular human insulin after subcutaneous administration. This insulin is generally used in regimens that include a longer-acting insulin or basal insulin analogue to maintain adequate glucose control. It can also be used with oral hypoglycemic agents.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Solution

Before using Apidra, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious complications. If you have had any allergic reactions to any medicine then you must tell your doctor about that. The use of insulin glulisine is contraindicated in those patients who are hypersensitive to this drug or to any ingredient in the formulation.

Make sure you inform your doctor if you have any other medical problems, especially:

• Emotional disturbances
• Fever
• Illness
• Active infection
• Stress—these conditions may increase your blood sugar.
• Hypoglycemia (low blood sugar)—this medicine should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
• Hypokalemia (low potassium in the blood)
• Any trouble with your kidney or liver—the effects of insulin glulisine may be increased because of the slower removal of the medicine from the body.

Because of drug-drug interactions, certain medicines should not be used along with this medicine. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

Besides, the following drug interactions should be considered before you start receiving this insulin therapy:

Drugs which may enhance the blood glucose lowering effect and increase susceptibility to hypoglycemia include:

• Oral antidiabetic agents
• ACE inhibitors
• Disopyramide
• Fibrates
• Fluoxetine
• MAO inhibitors
• Pentoxifylline
• Propoxyphene
• Salicylates
• Sulfonamide antibiotics

Drugs which may reduce the blood glucose lowering effect include:

• Corticosteroids
• Danazol
• Diazoxide
• Diuretics
• Glucagon
• Isoniazid
• Estrogens and progestogens (e.g. in oral contraceptives)
• Phenothiazine derivatives
• Somatropin
• Sympathomimetic agents (e.g. epinephrine, salbutamol, terbutaline)
• Protease inhibitors
• Atypical antipsychotic medications (e.g. olanzapine and clozapine)

Drugs which may enhance or decrease the insulin requirements include:

• Somatostatin analogs
• Thyroid hormones

Drugs which may either potentiate or weaken the blood-glucose-lowering effect of insulin include:

• Alcohol
• Beta-blockers
• Clonidine
• Lithium salts

Drug which may cause hypoglycemia, that may sometimes be followed by hyperglycemia – Pentamidine

The signs of hypoglycemia may be reduced or absent due to concurrent use of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine.

Thiazolidinediones (TZDs), alone or in combination with other antidiabetic agents (including insulin), can cause heart failure and edema. To avoid the risk of developing new or worsening heart failure, the use of TZDs in combination therapy with insulin is not indicated for the treatment of type 2 diabetes mellitus.

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans. But animal reproduction studies are not always predictive of human response.

Thus, this medicine should be used during pregnancy only if clearly needed. Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

To use Apidra properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice.

The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well; however, this insulin should normally be used in regimens that include a longer-acting insulin or basal insulin analogue.

Insulin glulisine is intended for subcutaneous administration by injection and for use as a continuous subcutaneous insulin infusion (CSII) in pump systems suitable for insulin infusion. In addition, it needs to be administered within 15 minutes before or within 20 minutes after starting a meal, so that dose can be altered according to the quantity of food consumed.

The instructions for using insulin glulisine in a pump or with an injection pen must be followed carefully. To prevent the possible transmission of disease, it is instructed not to reuse needles and never share an injection pen or cartridge with another patient, even if the needle on the injection pen is changed.

If you have missed a dose, or if you have not injected enough insulin, your blood sugar level may increase significantly (hyperglycemia). You should never take a double dose to make up for a forgotten dose.

An opened vial should be kept refrigerated or unrefrigerated (15 - 25°C) for up to 28 days away from direct heat and light. In addition, all kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

Before using Apidra, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better control of the blood sugar level in diabetics:

As with all insulin preparations, the time course of this medicine action may vary in different individuals or at different times in the same individual and is dependent on the site of injection, blood supply, temperature, and physical activity. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan.

Hypoglycemia is the most common adverse effect of insulin therapy, including insulin glulisine. Thus, glucose monitoring is recommended for all patients with diabetes.

Mild to moderate hypoglycemia can be treated by consuming foods or drinks that contain sugar. Patients should always carry a quick source of sugar, such as candy, juice, or glucose tablets.

Severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious may require an injection of glucagon or should be treated with intravenous administration of glucose by medical personnel.

Additional caution should be exercised in patients with a long history of diabetes on insulin who might be prone to develop hypoglycemia and in patients with a previous history of cardiac ischemic disorders who might be prone to develop cardiac adverse events.

Insulin glulisine given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. It can also be used alone in insulin infusion pump therapy to maintain adequate glucose control.

Accidental mix-ups between insulin glulisine and other insulins, particularly long-acting insulins, have been reported. To avoid medication errors between insulin glulisine and other insulins, patients should be instructed to always check the insulin label before each injection

As with all insulins, injection sites and infusion sites within an injection area (abdomen, thigh, buttock or deltoid) should be rotated from one injection to the next.

This insulin product shall not be used if it is not water-clear and colorless or if it has formed a deposit of solid particles on the wall of the vial or cartridge.

You should contact your doctor about the advisability of driving if you have frequent episodes of hypoglycemia and/or warning signs of hypoglycemia. Any change of insulin should be made cautiously and only under medical supervision.

As with many medications, there are several potential side effects associated with Apidra. These side effects usually go away during the treatment episode as your body adjusts to the medicine.

Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. Without immediate medical help, serious reactions or even death could occur.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

• Abnormal behavior (anxiety, irritability, restlessness, confusion or nervousness)
• Fatigue
• Tingling in your hands, feet, lips, or tongue
• Tremor (shaking)
• Unsteady gait (walking)
• Dizziness, light-headedness, or drowsiness
• Headache
• Blurred vision
• Slurred speech
• Palpitation (rapid heartbeat)
• Cold sweat
• Pale skin
• Nightmares or trouble sleeping
• Nausea
• Hunger

Signs of severe hypoglycemia can include:

• Disorientation
• Convulsions
• Loss of consciousness
• Seizures

Possible reactions on the skin at the injection site injecting insulin can cause the following reactions on the skin at the injection site:

• Redness, itching, stinging, swelling, and erythema sometimes occurs at the injection site, especially at the beginning.
• Lipodystrophy of the subcutaneous fat around the injection site may occur if the same site is injected repeatedly.

In rare cases, a patient may be allergic to an insulin product. Urticaria, angioedema, and anaphylaxis are manifestations. Severe insulin allergies may be life threatening. If you think you are having an allergic reaction, seek medical help immediately.

Signs of insulin allergy include:

• Rashes all over your body
• Shortness of breath,
• Wheezing (troubled breathing)
• Sweating
• Low blood pressure

Some patients develop short-lived dependent edema due to sodium retention when insulin therapy is started.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.