Fiasp Penfill 100 Iu/ml 3 Ml Cartridge (5 Pc)

FIASP PENFILL 100 IU/ML 3 ML CARTRIDGE

FIASP PENFILL 100 IU/ML 3 ML CARTRIDGE is a rapid-acting insulin analog used for the management of diabetes mellitus.

Name

• Brand Name: FIASP PENFILL
• Common Name: Insulin Aspart (recombinant DNA origin)

Composition

Each milliliter (mL) of the solution contains 100 units of Insulin Aspart. Each 3 mL cartridge contains 300 units of insulin aspart.

Uses

FIASP PENFILL is prescribed to improve glycemic control in adults, adolescents, and children aged 1 year and above with type 1 and type 2 diabetes mellitus. It is a fast-acting insulin that helps lower blood sugar levels after meals and reduces the risk of serious diabetes complications.

Dosage and Administration

FIASP is a mealtime insulin administered via subcutaneous injection.

• Timing: It should be injected up to 2 minutes before the start of a meal, with the option to administer up to 20 minutes after starting the meal. Some sources also suggest administering 5-10 minutes before a meal or at least 10 minutes before meals.
• Injection Sites: Common injection sites include the abdomen, thigh, or upper arm. It is important to rotate injection sites regularly within the same region to reduce the risk of lipodystrophy.
• Regimen: FIASP is typically used in combination with intermediate-acting or long-acting insulin given at least once daily.
• Individualized Dose: Dosing is individualized based on the patient's needs, blood glucose monitoring results, and glycemic control goals.

Side Effects

• Common Side Effects: The most common side effect is low blood sugar levels (hypoglycemia), which can manifest as lightheadedness, dizziness, anxiety, nervousness, tiredness, hunger, visual disturbances, shaking, sweating, or pale skin. Other common side effects include rash, redness, inflammation, bruising or itching at the injection site, weight gain, and swelling in hands and feet.
• Serious Side Effects: Serious side effects can include severe hypoglycemia (potentially leading to disorientation, seizures, loss of consciousness, brain damage, and death), serious allergic reactions (widespread skin rashes, shortness of breath, wheezing, swelling of the face, lips or tongue, fast pulse), low potassium in the blood (hypokalemia), and heart problems like swelling, rapid weight gain, or feeling short of breath, especially when used with thiazolidinediones.

Precautions

• Hypoglycemia: FIASP is contraindicated during episodes of hypoglycemia. Always carry a fast-acting source of sugar to treat low blood sugar.
• Never Share: Never share an insulin pen, cartridge, or syringe with another person, even if the needle is changed, due to the risk of transmitting blood-borne pathogens.
• Visual Impairment: Use Penfill cartridges with caution in patients with visual impairment.
• Inspection: Visually inspect FIASP before use; it should be clear and colorless. Do not use if particulate matter or coloration is seen.
• Drug Interactions: Certain medicines, including oral antidiabetics, MAOIs, beta-blockers, ACE inhibitors, salicylates, anabolic steroids, sulfonamides, GLP-1 receptor agonists, oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, danazol, octreotide, lanreotide, and alcohol, may affect insulin requirements.
• Pregnancy and Breastfeeding: FIASP can be used during pregnancy, but close monitoring of blood sugar levels is recommended as insulin needs may change. There are no restrictions on treatment with FIASP during breastfeeding.
• Heart Failure: Inform your doctor if you experience signs of heart failure, especially if taking thiazolidinediones.

Storage

• Unopened Cartridges: Store unopened FIASP PENFILL cartridges in a refrigerator (2°C–8°C or 36°F–46°F). Do not freeze. Keep the cartridge in the outer carton to protect from light.
• Opened/In-Use Cartridges: Once opened or in use, FIASP PENFILL can be stored at room temperature (not above 30°C or 86°F) for up to 4 weeks (28 days). Do not refrigerate FIASP Penfill cartridges after first use. Keep the cartridge in its carton to protect from light when not in use. Discard any remaining medicine after 4 weeks.

What is FIASP PENFILL used for?

FIASP PENFILL (insulin aspart) is a fast-acting insulin used to treat diabetes mellitus in adults, adolescents, and children aged 1 year and above. It helps to control blood sugar levels after meals and is used for both type 1 and type 2 diabetes. FIASP helps lower blood sugar levels and reduce the risk of diabetes complications.

How does FIASP PENFILL work?

FIASP PENFILL contains insulin aspart, a rapid-acting insulin. It works by increasing insulin levels in your body, which helps your body absorb and store sugar from your bloodstream and stops your liver from making more glucose. Fiasp is formulated with niacinamide (vitamin B3) and L-arginine, which allows for quicker absorption into the bloodstream compared to other insulin aspart products, typically starting to work within 2.5 to 20 minutes after injection. Its maximum effect occurs between 1 and 3 hours after injection, and the effect lasts for 3-5 hours.

What is the usual dosage for FIASP PENFILL?

The dosage of FIASP PENFILL is individualized and determined by your doctor based on your blood sugar levels. It is a mealtime insulin that can be injected at the start of a meal, with the option to inject up to 20 minutes after starting a meal. FIASP should normally be used in combination with intermediate-acting or long-acting insulin preparations. Your doctor will advise on how much FIASP you will need at each meal and when to check your blood sugar levels. For type 1 diabetes, the usual total daily insulin requirement is 0.4 to 1 unit per kg of body weight per day, while for type 2 diabetes, it can be 0.3 to 0.5 units per kg per day, combining both fast-acting and long-acting insulins.

What are the possible side effects of FIASP PENFILL?

The most common side effect when using insulin, including FIASP, is low blood sugar levels (hypoglycemia). Symptoms can include anxiety, irritability, mood changes, dizziness, sweating, blurred vision, hunger, confusion, headache, shakiness, and a fast heartbeat.

Other common side effects may include:

• Reactions at the injection site such as rash, redness, inflammation, bruising, or itching. These usually disappear within a few weeks.
• Weight gain.
• Low potassium levels (hypokalemia).
• Swelling in your hands and feet (edema).
• Thickening or hollowing of the skin (lipodystrophy) or lumps under the skin (cutaneous amyloidosis) at the injection site.

Serious, but rare, side effects can include severe allergic reactions (anaphylaxis) with symptoms like widespread skin rash, shortness of breath, wheezing, swelling of the face, lips, or tongue, and a fast pulse. If you experience any severe or continuing reactions, you should contact your doctor immediately.

Is FIASP PENFILL safe during pregnancy or breastfeeding?

FIASP PENFILL can be used during pregnancy. However, managing diabetes during pregnancy can be more difficult, as insulin needs typically decrease in the first trimester and increase in the last six months. Your doctor will discuss the risks and benefits and will recommend intensified blood glucose control and monitoring throughout pregnancy. There are no restrictions on treatment with FIASP during breastfeeding, and insulin treatment of the breastfeeding mother presents no risk to the baby, though the dose may need adjustment.

Can FIASP PENFILL be taken with other medications?

Yes, FIASP PENFILL can interact with other medications, which may require adjustment of your insulin dose.

Some medications can increase the risk of low blood sugar (hypoglycemia) when taken with FIASP, including:

• Other antidiabetic agents (oral and injectable).
• ACE inhibitors, angiotensin II receptor blocking agents.
• Certain antidepressants (monoamine oxidase inhibitors or MAOIs).
• Beta-blockers, which can also mask the symptoms of hypoglycemia.
• Salicylates (e.g., aspirin), sulfonamide antibiotics, disopyramide, fibrates, fluoxetine, pentoxifylline, and pramlintide.
• Somatostatin analogs (e.g., octreotide, lanreotide), which can either increase or decrease insulin requirements.

Other medications can decrease the blood glucose-lowering effect of FIASP, potentially increasing insulin requirements:

• Oral contraceptives, thiazide diuretics, glucocorticoids (corticosteroids).
• Thyroid hormones, sympathomimetics (used for asthma), growth hormone, and danazol.
• Atypical antipsychotics (e.g., olanzapine and clozapine) and estrogens.

Alcohol can either intensify or reduce the hypoglycemic effect of insulin, and it is generally advised to avoid or limit alcohol intake. Taking thiazolidinediones (TZDs) with insulin may increase the risk of fluid retention and heart failure, so your doctor will monitor for these signs. Always tell your doctor, pharmacist, or diabetes education nurse about all medicines you are taking, including over-the-counter drugs and supplements, to avoid potential interactions.

What precautions should be taken with FIASP PENFILL?

• Never share pens or cartridges: Do not share your FIASP Penfill cartridge or delivery device with another person, even if the needle is changed, as this poses a risk for transmitting blood-borne pathogens.
• Injection site rotation: Rotate your injection sites regularly within the same chosen region (abdomen, thighs, or upper arms) to reduce the risk of developing lipodystrophy (pits or thickening of the skin) or localized cutaneous amyloidosis (lumps under the skin). Do not inject into damaged, bruised, tender, thickened, or scarred skin.
• Blood sugar monitoring: Monitor your blood sugar levels frequently, especially when starting treatment, making dose adjustments, or if you feel unwell.
• Hypoglycemia awareness: Be aware of the symptoms of low blood sugar and always carry sugary food or fruit juice with you to treat a hypo quickly.
• Visual impairment: Use Penfill cartridges with caution if you have visual impairment.
• Storage and appearance: Always check the insulin label before administration to ensure it is the correct type. Inspect the cartridge before each use; the solution should be clear and colorless. Do not use it if it appears thickened, colored, has solid bits, or if the cartridge is damaged.

What happens if a dose is missed?

If you miss a dose of FIASP, you should monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal. If you have concerns about a missed dose, consult your doctor or pharmacist.

How should FIASP PENFILL be stored?

Unused FIASP PENFILL cartridges should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) until their expiration date. They should not be frozen.

Once a FIASP PENFILL cartridge is in use (opened), it should be stored at room temperature (not above 30°C or 86°F) for a maximum of 4 weeks (28 days). Do not refrigerate FIASP PENFILL cartridges after first use. Always keep the cartridge in its carton or with the pen cap on to protect it from light. Discard any in-use cartridge after 4 weeks, even if there is still medicine left.