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INTRODUCTION
NOVORAPID FLEXPEN contains Insulin Aspart which belongs to the group of medicines called Antidiabetic agents. It is used to treat diabetes mellitus (both type I and type II).
Diabetes mellitus is a chronic disease characterized by abnormally high levels of glucose in the blood. It is caused either due to inadequate production of a hormone called insulin (produced by the pancreas to metabolize glucose) in the body or due to inadequate sensitivity of body cells to the actions of insulin.
NOVORAPID FLEXPEN is a fast-acting medicine where it begins to lower blood sugar levels within 10-20 minutes after administration and its effects may last up to 3-4 hours. NOVORAPID FLEXPEN is suitable for use both in adults and in children (aged 1 year or older).
Talk to your doctor before starting therapy with NOVORAPID FLEXPEN if you have any liver, kidney or heart problems. You must also inform your doctor if you have any hormonal problems, made sudden changes to your diet or perform the intense exercise as a precaution.
Do not use this medicine if you have hypoglycemia (low blood sugar levels). Consult your doctor before using this medicine if you are pregnant or breastfeeding.
The most common side effects of injecting NOVORAPID FLEXPEN are low blood sugar levels, pain, redness, itching, swelling or thickening at the injection site, lump formation under the skin and swelling of body parts. Consult your doctor if any of these side effects troubles you.
USES OF NOVORAPID FLEXPEN
- Treats diabetes mellitus (both type I and type II)
HOW NOVORAPID FLEXPEN WORKS
NOVORAPID FLEXPEN helps your body to make utilize of the circulating blood glucose. It helps in the transport of glucose from the blood into the muscles and fat tissues. It also stops the production of glucose by the liver. As a result, it controls blood sugar levels and improve sugar control in patients with diabetes mellitus.
DIRECTIONS FOR USE
Always inject this medicine into your thighs, buttocks, upper arm, or abdomen (i.e., subcutaneously). Do not administer this medicine into the vein or muscle directly. It should be administered at least 10 minutes before meals. Eat a meal or snack containing carbohydrates within 20 minutes of the injection to avoid low blood sugar.
Before administration, roll the vial/cartridge between your hands until the liquid becomes uniformly white and cloudy. While injecting, keep the needle under the skin for at least 6 seconds to make sure that the entire dose is injected.
Prior to the administration, visualize the cartridge/vial for any visible particulate matter and discolouration. Discard the needle and syringe after use and do not share your needles with others to avoid the risk of transmission of infections.
Avoid repeatedly injecting the medicine at the same site to prevent skin damage. Instead, rotate the injection site. Make sure to consult your doctor before changing the injection site as a precaution.
Consult your doctor before mixing NOVORAPID FLEXPEN with other insulins. Do not stop therapy with NOVORAPID FLEXPEN without consulting your doctor. Your doctor will decide correct dose and frequency of administration depending upon your age, body weight and health condition.
SIDE EFFECTS OF NOVORAPID FLEXPEN
COMMON
- Injection site reactions (such as pain, redness, itching or swelling)
- Lipodystrophy (shrinkage of fat tissues beneath the skin)
- Lumps under the skin
- Weight gain, swelling of body parts
- Hypoglycemia (Low blood sugar levels)
UNCOMMON
- diabetic retinopathy (eye diseases due to diabetes)
- swelling around the ankles and other joints
RARE
- problem in vision
- painful neuropathy (pain caused by nerve damage)
Consult your doctor immediately if you experience any of the following side effects:
- allergic reaction (generalized skin rash with itching, sweating, and swelling of layers under the skin, difficulties in breathing, palpitation, vomiting, stomach upset, reduction in blood pressure and fainting /loss of consciousness)
- signs of severe hypoglycemia (such as cold sweats, cool pale skin, headache, rapid heartbeat, nausea, increased hunger, temporary vision changes, drowsiness, tiredness and weakness, nervousness or tremor, anxiety, confusion and difficulty in concentrating)
HOW TO MANAGE SIDE EFFECTS
Hypoglycemia
Have foods rich in sugars such as fruit juices, glucose drinks, candies, honey or biscuits. Check your blood sugar after 10 minutes. If not gained an optimum level, take another sugary snack, or a drink and check the blood sugar again. Consult your doctor if there is no improvement in your condition.
Injection Site Reactions
Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor. Do not inject this medicine at the same site. Always rotate injection sites within the same region from one injection to the next to reduce skin damage.
WARNING & PRECAUTIONS
PREGNANCY
Monitoring requiredNOVORAPID FLEXPEN can be used during pregnancy if prescribed by the physician. Therefore, consult your doctor before administration.
BREASTFEEDING
SafeNOVORAPID FLEXPEN is considered safe for use during breastfeeding. However, consult your doctor before administration.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any heavy tools or machines if your ability is affected by NOVORAPID FLEXPEN.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while undergoing therapy with this medicine as it could aggravate your existing disease condition.
KIDNEY
Use with CautionNOVORAPID FLEXPEN should be used with caution in patients with kidney problems. Therefore, consult your doctor before administration.
LIVER
Use with CautionNOVORAPID FLEXPEN should be used with caution in patients with liver problems. Therefore, consult your doctor before administration.
ALLERGY
ContraindicatedTalk to your doctor before receiving NOVORAPID FLEXPEN if you are allergic to Insulin Aspart or to any other insulin types (Ex. Lente, ultra-Lente).
HEART DISEASE
Use with CautionNOVORAPID FLEXPEN should be used with caution in patients with heart problems. Therefore, consult your doctor before administration.
USE IN PEDIATRICS
Consult your doctorNOVORAPID FLEXPEN can be used in children (aged 1 year or older) and in adolescents (aged below 18 years) if prescribed by the physician. Therefore, consult your doctor before administration.
USE IN GERIATRICS
Use with CautionNOVORAPID FLEXPEN should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before administration. Proper dose adjustments and careful monitoring of blood glucose levels and kidney functions are required in such patients
OTHERS
NOVORAPID FLEXPEN is not recommended for use if you:
- have or at risk of developing hypoglycemia (low blood sugar levels)
Talk to your doctor before injecting NOVORAPID FLEXPEN if you:
- have problems in the adrenal, pituitary or thyroid gland
- have recently changed your diet plan and lifestyle
- are exercising more than usual
- recently became ill or had infections
- are planning to go abroad (as mealtime and injection timings may get changed)
INTERACTIONS
A. Drug-Drug interactions:
Before undergoing therapy with NOVORAPID FLEXPEN, inform your doctor if you are taking any of the following medicines such as:
- other medicines used to treat diabetes such as sulfonylureas (Ex. tolbutamide, glibenclamide, glipizide), biguanides (Ex. metformin, phenformin), thiazolidinediones (Ex. pioglitazone), DPP-4 inhibitors (Ex. sitagliptin, vildagliptin) or SGLT-2 inhibitors (Ex. remogliflozin)
- medicines used to treat depression such as monoamine oxidase inhibitors (Ex. rasagiline, selegiline, phenelzine)
- medicines used to treat high blood pressure and other heart problems such as beta-blockers (Ex. propranolol, atenolol, nebivolol) or ACE inhibitors (Ex. captopril, enalapril, lisinopril)
- salicylates (used to relieve pain or fever) Ex. aspirin
- anabolic steroids (used to build muscle and improve athlete performance) Ex. testosterone, nandrolone, oxandrolone
- sulfonamide antibiotics (used to treat bacterial infections) Ex. sulfasalazine, sulfadiazine, sulfamethoxazole
- oral contraceptives (birth control pills) Ex. mifepristone,
- thiazide diuretics (used to increase urine output and reduce blood pressure) Ex. chlorothiazide, hydrochlorothiazide
- glucocorticoids (used to treat inflammation) Ex. cortisone, betamethasone, beclomethasone, dexamethasone, budesonide, prednisone
- thyroid hormone (used to treat thyroid disorders) Ex. thyroxine, triiodothyronine
- sympathomimetic agents (used to treat asthma or other circulatory disorders) Ex. ephedrine, adrenaline, salbutamol, or terbutaline
- growth hormone (a hormone used to increase skeletal and somatic growth in the body)
- danazol (a medicine used to treat endometriosis)
- octreotide (used to treat diarrhea)
- lanreotide (a medicine used to treat abnormal body growth)
B. Interaction with food or drink:
NOVORAPID FLEXPEN should be administered at least 10 minutes before a meal.
Overdosage:
If you or anyone else took too much of this medicine, contact your doctor immediately or go to a hospital straight away as it may cause severe hypoglycemia. Symptoms of hypoglycemia might include fainting, feel unwell, sweating, vomiting, difficulty in breathing, fast heartbeat, and dizziness.
SYNOPSIS
| Drug | : | Insulin Aspart |
| Pharmacological Category | : | Antidiabetic agents |
| Therapeutic Indication | : | Diabetes mellitus |
| Dosage Forms | : | Injection, Cartridge, Pre-filled syringe, Flex Pen |
MORE INFORMATION
- Keep out of reach of children
- Store the unopened pack in the refrigerator at 2°C – 8°C. Do not freeze
- During use or when carried as a spare, keep it at room temperature
- Always place the vial/cartridge in the outer carton to protect from light
FAQs ABOUT NOVORAPID FLEXPEN
Q: Should NOVORAPID FLEXPEN be refrigerated?
A: Yes. An unopened pack must be stored in the refrigerator (2°C – 8°C). During use or while carrying as a spare, keep it at room temperature to ensure uniform resuspension.
Q: Can NOVORAPID FLEXPEN be mixed with other insulins?
A: No. NOVORAPID FLEXPEN is already a pre-mixed combination of regular insulin and isophane insulin and therefore should not be mixed with other insulins. For more information regarding the direction of use contact your doctor.
Q: Is NOVORAPID FLEXPEN safe during pregnancy?
A: Yes. NOVORAPID FLEXPEN can be used during pregnancy if prescribed by the physician. Therefore, consult your doctor before administration.
Q: How long does it take for NOVORAPID FLEXPEN to start working?
A: NOVORAPID FLEXPEN is a fast-acting medicine where it begins to lower blood sugar levels about 10 minutes post administration and its effect would last for about 3-5 hours.
Q: Can NOVORAPID FLEXPEN be given intravenously?
A: No. NOVORAPID FLEXPEN is meant for subcutaneous use only (i.e., thighs, buttocks, abdomen, or upper arms). It should not be directly injected into the vein or muscle as it may cause severe hypoglycemia.
Q: What is the best area for injecting NOVORAPID FLEXPEN? Should I inject it only at the same site every day?
A: The best place for injecting this medicine is front of your thighs, buttocks, abdomen, or upper arms. The insulin would work more quickly if it were injected into the waist (abdomen). Do not repeatedly inject the medicine on the same site. Instead, rotate the injection sites within the same area to avoid the risk of developing lumps or skin pitting.
Q: What is NOVORAPID FLEXPEN used for?
A: NOVORAPID FLEXPEN is used to treat diabetes mellitus (both type I and II).
Q: What are the most common side effects of taking NOVORAPID FLEXPEN?
A: The most common side effects of receiving NOVORAPID FLEXPEN are low blood sugar levels, pain, redness, itching, swelling or thickening at the injection site, lump formation under the skin and swelling of body parts. Consult your doctor if any of these side effects troubles you.
Q: Can I stop therapy with NOVORAPID FLEXPEN without consulting your doctor?
A: No. You should not stop therapy with NOVORAPID FLEXPEN without consulting your doctor because it may lead to the reversal of symptoms. If you feel better after using NOVORAPID FLEXPEN, consult your doctor for advice.
Q: Will taking a higher dose of NOVORAPID FLEXPEN be more effective?
A: No, taking a higher dose of NOVORAPID FLEXPEN will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
Q: Can I take medication for high blood pressure along with NOVORAPID FLEXPEN?
A: It is not advisable to take medicines to control blood pressure while taking NOVORAPID FLEXPEN without consulting your doctor. Therefore, consult your doctor before taking any antihypertensive medications along with NOVORAPID FLEXPEN as they have known interactions with NOVORAPID FLEXPEN.
REFERENCES
1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 265.
2. Rochelle Rubin; Niloufar R. Khanna; Lindsey A. McIver. Aspart Insulin. StatPearls. NIH. National Library of Medicine. National Center for Biotechnology. PMC. PubMed Central. November 2022. [Accessed on 20th February 2023]. https://www.ncbi.nlm.nih.gov/books/NBK500030/#:~:text=and%20adverse%20effects.-,Insulin%20aspart%20is%20a%20rapid%2Dacting%2C%20human%20insulin%20analog%20that,not%20an%20FDA%2Dapproved%20indication.
3. Novo Nordisk A/S. Fiasp® FlexTouch® 100 units/mL solution for injection in pre-filled pen insulin aspart. European Medicines Compendium. [Revised in August 2022]. [Accessed on 18th February 2023]. https://www.medicines.org.uk/emc/files/pil.2447.pdf
4. Novo Nordisk A/S. NovoRapid® 100 units/ml solution for injection in vial insulin aspart. European Medicines Compendium. [Revised in October 2022]. [Accessed on 18th February 2023]. https://www.medicines.org.uk/emc/files/pil.7919.pdf
USEFUL DIAGNOSTIC TESTS
- Glucose - Fasting Blood
- Glucose - Postprandial Blood
- Glycosylated Hemoglobin
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