Fiasp FlexTouch SC Injection

Fiasp FlexTouch is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Each ml suspension contains 100 IU (equivalent to 3.50 mg) Insulin Aspart (rDNA) BP as 30% soluble Insulin Aspart and 70% protamine-crystallised Insulin Aspart.

Fiasp FlexTouch protamine and Fiasp FlexTouch is a sterile suspension of human insulin analog containing 30% soluble Fiasp FlexTouch and 70% protamine-crystallised Fiasp FlexTouch. It is a blood glucose lowering agent with an earlier onset and an intermediate duration of action. Fiasp FlexTouch is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology.

The primary activity of Insulin Aspart is the regulation of glucose metabolism. Insulin Aspart bind to the insulin receptors on muscle and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Dosage of Insulin Aspart is individual and determined by the physician in accordance with the needs of the patient. In patients with type 2 diabetes, Insulin Aspart can be given in mono therapy or in combination with oral antidiabetic drugs when the blood glucose is inadequately controlled with those oral antidiabetic drugs alone. For patients with type 2 diabetes, the recommended starting dose of Insulin Aspart is 6 IU at breakfast and 6 IU at dinner (evening meal). Insulin Aspart can also be initiated once daily with 12 IU at dinner (evening meal). When using Insulin Aspart 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. If twice daily dosing with Insulin Aspart results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).

The dose should not be increased if hypoglycemia occurred within three days. Dose adjustments can be made once a week until target HbA1c is reached. In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 IU/kg/day. Insulin Aspart may fully or partially meet this requirement. When transferring a patient from biphasic human insulin to Insulin Aspart, start with the same dose and regimen. Then titrate according to individual needs (according to the titration guidelines in table above). Insulin Aspart can be used in elderly patients; however there is limited experience with the use of Insulin Aspart in combination with OADs in patients older than 75 years.

Cartridge:

• Insert the Cartridge into the pen correctly and equip the needle.
• Adjust the dosage button to get correct dose. After removal of the needle cap and discharge the air bubbles in the cartridge, it is ready to be injected in order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

Vial:

• Firstly, clean your hands. Shake or rotate the vial gently to mix the solution uniformly and check if the insulin has the normal appearance.
• If using a new bottle, then flip off the plastic protective cap and wipe the rubber stopper with an alcohol swab.
• Draw air into your syringe equal to the amount of needed. Puncture the needle into the vial and inject the air.
• Turn the bottle and syringe upside down. Withdraw correct dose 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: Choose the area such as upper arm, thigh, buttock and abdomen, etc. To avoid tissue damage, choose a site for each injection that is at least 1 cm from the previous injection site.

Injection Method: 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. Pinch the skin with finger & puncture the needle into skin and inject insulin. Then pull the needle out and apply gentle pressure over the injected site for several seconds. Do not rub the injection site.

A number of drugs affect glucose metabolism and may require dose adjustment. The following substances may reduce the Fiasp FlexTouch as well as Fiasp FlexTouch requirements: Oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates and sulfonamide antibiotics. The following substances may increase the Fiasp FlexTouch as well as Fiasp FlexTouch requirements: Thiazides, glucocorticoids, thyroid hormones, beta-sympathomimetics, growth hormone and danazol. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose lowering effect of insulin.

Insulin Insulin Aspart is contraindicated-

• during episodes of hypoglycemia
• in patients with hypersensitivity to Insulin Aspart or one of its excipients

Side effects of Fiasp FlexTouch are hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus and rash.

Pregnancy category B. There are no restrictions on treatment with Insulin Aspart during lactation. Insulin treatment of the nursing mother should not affect the baby. However, dosage may need to be adjusted.

Dose adjustment and monitoring: Blood glucose should be monitored in all patients treated with insulin. Fiasp FlexTouch regimens should be modified cautiously and only under medical supervision.

Renal Impairment: Decreased dose may be necessary.
Hepatic Impairment: Decreased dose may be necessary.

A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered. Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously. 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.

Rapid Acting Insulin

Store at 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.