Fiasp 100 Iu/ml Inj Vial 10 Ml

FIASP 100 IU/ML INJ VIAL 10 ML

Name

• Common Name: Insulin Aspart
• Brand Name: FIASP (Fast-acting Insulin Aspart)

Composition

FIASP 100 IU/ML INJ VIAL contains 100 units of Insulin Aspart per milliliter (U-100) as its active ingredient. The formulation also includes niacinamide (Vitamin B3) and L-Arginine, which contribute to its rapid action. Other excipients may include glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, and water for injections, with hydrochloric acid and/or sodium hydroxide for pH adjustment.

Uses

FIASP is a rapid-acting insulin analog indicated to improve glycemic control in adult and pediatric patients (aged 1 year and above) with diabetes mellitus (Type 1 and Type 2). It is primarily used as a mealtime insulin to help manage blood sugar levels, especially after meals, and to reduce the risk of diabetes-related complications.

Dosage and Administration

FIASP dosage is individualized based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goals.

• Subcutaneous Injection: Inject at the start of a meal or within 20 minutes after starting a meal.
  • Administer into the abdomen, upper arm, or thigh.
  • Rotate injection sites within the same region to reduce the risk of lipodystrophy.
• Insulin Pump: FIASP can be used for continuous subcutaneous insulin infusion in compatible pump systems. Patients should refer to the pump user manual and receive comprehensive instruction from a healthcare professional.
• Intravenous Infusion: Administer intravenously only under medical supervision with close monitoring of blood glucose and potassium levels.
• FIASP should generally be used in conjunction with an intermediate-acting or long-acting insulin.

Side Effects

Common Side Effects:

• Low blood sugar (hypoglycemia)
• Weight gain
• Injection site reactions (pain, redness, itching, swelling)
• Lipodystrophy (skin thickening or pits at the injection site)
• Nausea, diarrhea
• Upper respiratory tract infections, headache, runny nose, fever (especially in children)

Serious Side Effects:

• Severe hypoglycemia (can be life-threatening)
• Severe allergic reactions (e.g., generalized skin rash, facial edema, difficulty breathing, wheezing)
• Low potassium levels (hypokalemia), which can lead to muscle weakness, fatigue, muscle cramps, irregular heartbeat, and potentially be life-threatening.

Precautions

• Never Share: Do not share FIASP pens, cartridges, or vials with other patients, even if the needle is changed, due to the risk of transmitting blood-borne pathogens.
• Insulin Regimen Changes: Any changes to the insulin regimen (e.g., strength, manufacturer, type, injection site) should be made under close medical supervision with increased blood glucose monitoring.
• Hypoglycemia Awareness: Patients should be educated on the symptoms of hypoglycemia and always carry a quick source of sugar.
• Injection Site: Avoid injecting into areas of lipodystrophy or localized cutaneous amyloidosis, as this can affect insulin absorption. Rotate injection sites consistently.
• Hypokalemia: Monitor potassium levels, especially in patients at risk for hypokalemia.
• Contraindications: FIASP is contraindicated during episodes of hypoglycemia and in patients with known hypersensitivity to insulin aspart or any of its excipients.
• Drug Interactions: Exercise caution with concomitant use of thiazolidinediones (TZDs) as it may lead to fluid retention and heart failure. Alcohol can also affect the hypoglycemic action of insulin.
• Medication Errors: Always check the insulin label before each injection to prevent accidental mix-ups with other insulin products.

Storage

• Unopened Vials: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) until the expiration date. If stored outside of refrigeration (below 86°F/30°C), they should be used within 4 weeks (28 days).
• Opened (In-use) Vials: Can be stored at room temperature (below 86°F/30°C) or in the refrigerator (36°F to 46°F/2°C to 8°C) for a maximum of 4 weeks (28 days).
• Do Not Freeze: Discard FIASP if it has been frozen, as freezing can permanently alter its effectiveness.
• Protect from Light: Keep the vial in its carton to protect it from light.
• Insulin Pump Use: When used in an insulin pump system, FIASP from a vial can be used for a maximum of 6 days. Do not expose FIASP in the pump reservoir to temperatures greater than 98.6°F (37°C).

What is FIASP used for?

FIASP 100 IU/ML INJ VIAL is a rapid-acting insulin analog primarily used to improve blood sugar control in adults and children (aged 2 years and above) with type 1 and type 2 diabetes mellitus. It is particularly effective for managing high blood sugar levels after meals.

How does FIASP work?

FIASP contains insulin aspart, which is a modified form of human insulin designed for faster absorption. It works by helping your body's cells, particularly in muscle and fat tissue, absorb sugar (glucose) from the bloodstream to use for energy. It also helps to stop the liver from producing additional sugar. FIASP is formulated with niacinamide (vitamin B3) to speed up its action, allowing it to enter the bloodstream in approximately 2.5 minutes and start working quickly to lower blood sugar.

What is the usual dosage for FIASP?

The dosage of FIASP is highly individualized and determined by your healthcare provider based on your metabolic needs, blood glucose monitoring results, and glycemic control goals. For individuals with type 1 diabetes, the total daily insulin dose typically ranges from 0.4 to 1 unit per kilogram of body weight. For those with type 2 diabetes, the total daily dose is usually between 0.3 and 0.5 units per kilogram of body weight. FIASP is a mealtime insulin, typically injected subcutaneously (under the skin) at the start of a meal or within 20 minutes after beginning a meal. It is generally used in combination with an intermediate- or long-acting insulin. FIASP can also be used in compatible insulin pumps.

What are the possible side effects of FIASP?

The most common side effect of FIASP is low blood sugar (hypoglycemia), which can be serious. Symptoms of mild-to-moderate hypoglycemia can include dizziness, blurred vision, anxiety, irritability, sweating, headache, shakiness, fast heartbeat, hunger, and confusion. Other common side effects include reactions at the injection site such as pain, redness, itching, swelling, bruising, skin thickening, or pits (lipodystrophy), and weight gain. Less common side effects reported in children include cold or flu symptoms, headache, runny nose, fever, and vomiting. Serious but less common side effects can include severe allergic reactions (anaphylaxis) and low potassium levels (hypokalemia). Fluid retention and heart failure can also occur when FIASP is used with certain other medications called thiazolidinediones (TZDs).

Is FIASP safe during pregnancy or breastfeeding?

FIASP can be used during pregnancy, but intensified blood glucose control and monitoring are recommended throughout pregnancy and when planning conception. Insulin requirements may change during pregnancy, typically decreasing in the first trimester and increasing in the second and third trimesters. It is not known if FIASP passes into breast milk. However, insulin treatment for a breastfeeding mother is not expected to pose a risk to the baby, though the insulin dosage may need adjustment.

Can FIASP be taken with other medications?

Yes, FIASP can interact with various medications. Certain drugs can increase the risk of low blood sugar (hypoglycemia) when taken with FIASP, including other antidiabetic agents, ACE inhibitors, some antidepressants (monoamine oxidase inhibitors), salicylates, and sulfonamide antibiotics. Conversely, some medications, such as corticosteroids, diuretics, oral contraceptives, and thyroid hormones, may increase your insulin requirements. Beta-blockers can mask the symptoms of hypoglycemia, making it harder to recognize low blood sugar. It is crucial to inform your healthcare provider about all prescription and over-the-counter medications, supplements, and vitamins you are taking.

What precautions should be taken while using FIASP?

Always check the insulin label carefully before each injection to avoid accidental mix-ups with other insulin products. Never share your FIASP pens, cartridges, or needles with another person, even if the needle is changed, as this poses a risk of transmitting blood-borne pathogens. Rotate your injection sites within the chosen area (e.g., abdomen, thigh, upper arm) with each injection to help prevent skin problems like thickening or pits (lipodystrophy). You should monitor your blood sugar levels closely, especially when there are changes in your diet, exercise routine, or other medications. Always carry a source of sugar, such as glucose tablets or juice, to treat mild-to-moderate low blood sugar if it occurs. Inform your healthcare provider if you have kidney or liver problems, heart failure, or low potassium levels. It's advisable to avoid or limit alcohol consumption, as alcohol can affect how FIASP lowers your blood sugar. Do not drive or operate heavy machinery until you know how FIASP affects your blood sugar.

What happens if a dose of FIASP is missed?

If you miss a dose of FIASP, you should monitor your blood sugar levels to determine if an insulin dose is needed. If your blood sugar is not high, you will likely skip the missed dose and take your regular dose of FIASP at your next meal. Continue to monitor your blood sugar as recommended by your doctor. If you have any concerns about when to take your next dose after missing one, consult your doctor or pharmacist.

How should FIASP be stored?

Unopened FIASP vials, FlexTouch pens, and PenFill cartridges should be stored in a refrigerator (36°F to 46°F [2°C to 8°C]) until their expiration date. They can also be stored at room temperature (below 86°F [30°C]) for up to 28 days if unopened. Unopened PumpCart cartridges can be stored at room temperature for a maximum of 18 days.

Once opened (in-use):

• Vials and FlexTouch pens can be stored at room temperature (below 86°F [30°C]) or in the refrigerator (36°F to 46°F [2°C to 8°C]) for a maximum of 28 days.
• PenFill cartridges can be stored at room temperature (not above 86°F [30°C]) for up to 28 days. Do not refrigerate opened PenFill cartridges.
• PumpCart cartridges can be kept at room temperature (below 98.6°F [37°C]) for up to 4 days, with a maximum of 18 days including the time spent in the pump. Do not refrigerate opened PumpCart cartridges.

It is important not to freeze FIASP and to protect it from direct sunlight and heat.