Novomix 50 Flexpen 1X3ml

Introduction About NOVOMIX 50 FLEXPEN

NOVOMIX 50 FLEXPEN contains Biphasic Insulin Aspart and Insulin Aspart which belongs to the group of medicines called Antidiabetic agents. It improves glycemic control in patients with diabetes mellitus (both type I and type II). It helps your body to make utilize of the circulating blood glucose by transporting the circulating glucose from the blood into the muscles and fat tissues.

Biphasic Insulin Aspart is a pre-mixed combination of Insulin Aspart and Isophane (NPH) insulin. It is a fast-acting medicine where it begins to lower blood sugar levels within 10-20 minutes after administration. NOVOMIX 50 FLEXPEN is suitable for use both in adults and in children (aged 10 years or older).

Talk to your doctor before starting therapy with NOVOMIX 50 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 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 receiving NOVOMIX 50 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 effect troubles you.

Uses Of NOVOMIX 50 FLEXPEN

• Improves glycemic control in patients with diabetes mellitus (both type I and type II)

How NOVOMIX 50 FLEXPEN Works

Biphasic Insulin Aspart is a combination of Insulin Aspart and NPH. Insulin Aspart is a fast-acting insulin that mimics the natural release of insulin by the pancreas in response to meals. It also helps control the postprandial (after-meal) rise in blood glucose. NPH slows down the absorption and extend the action of insulin. It provides a prolonged and more sustained release of insulin, helping to manage blood sugar levels between meals and overnight. Collectively, they help in controlling both immediate post-meals rise in blood sugar and the basal (background) insulin needs throughout the day.

How to use NOVOMIX 50 FLEXPEN

Use NOVOMIX 50 FLEXPEN under careful medical supervision. Inject NOVOMIX 50 FLEXPEN 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 discoloration. 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 manage skin damage. Instead, rotate the injection site. Make sure to consult your doctor before changing the injection site as a precaution.

NOVOMIX 50 FLEXPEN should not be mixed with any other insulins before use. Do not stop therapy with NOVOMIX 50 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 NOVOMIX 50 FLEXPEN

How To Manage Side Effects

Hypoglycemia

Managing hypoglycemia, or low blood sugar, involves prompt action to raise blood glucose levels and manage complications. When experiencing hypoglycemia, individuals should quickly consume a source of rapidly-absorbed carbohydrates, such as glucose tablets, fruit juice, or regular soda. Waiting for about 15 minutes and rechecking blood sugar levels is crucial to ensure they rise to a safe range. If hypoglycemia persists, additional carbohydrate intake may be necessary. Once blood sugar levels stabilize, a small snack containing both carbohydrates and protein can help sustain them. Regular monitoring and consultation with a healthcare professional are essential for developing a personalized plan to manage hypoglycemia effectively. In severe cases, emergency assistance may be required.

Injection Site Reactions

Managing injection site reactions is essential for individuals who regularly administer injections. To alleviate discomfort and minimize potential issues, it is crucial to follow proper injection techniques. Rotate injection sites to manage overuse of a single area, allowing tissues to heal. Use a clean, sterile needle and syringe for each injection. Apply an ice pack to the injection site before and after administration to reduce pain and swelling. If redness, swelling, or irritation persists, consult a healthcare professional for guidance. It is essential to report any severe or persistent reactions to ensure appropriate adjustments to the injection routine and to manage potential complications.

Warning & Precautions

Pregnancy

Monitoring required

NOVOMIX 50 FLEXPEN can be used during pregnancy only if prescribed by the physician. Therefore, consult your doctor before administration.

Breastfeeding

Safe

NOVOMIX 50 FLEXPEN is considered safe for use during breastfeeding. However, consult your doctor before administration.

Driving and Using Machines

Use with Caution

Do not drive or operate any heavy tools or machines if your ability is affected by NOVOMIX 50 FLEXPEN.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking this medicine as it could aggravate your existing disease condition.

Kidney

Use with Caution

NOVOMIX 50 FLEXPEN should be used with caution in patients with kidney problems. Therefore, consult your doctor before administration.

Liver

Use with Caution

NOVOMIX 50 FLEXPEN should be used with caution in patients with liver problems. Therefore, consult your doctor before administration.

Allergy

Contraindicated

Talk to your doctor before receiving NOVOMIX 50 FLEXPEN if you are allergic to Insulin Aspart, Isophane insulin or to any other insulin types (Ex. Lente, ultra-Lente).

Heart Disease

Use with Caution

NOVOMIX 50 FLEXPEN should be taken with caution in patients with heart disease. Therefore, consult your doctor before administration.

Use In Pediatrics

Monitoring required

NOVOMIX 50 FLEXPEN can be used in children and adolescents (aged 10 years or above) if prescribed by the physician. Therefore, consult your doctor before administration.

Use In Geriatrics

Use with Caution

NOVOMIX 50 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.

Interactions

A. Drug-Drug interactions:

Before NOVOMIX 50 FLEXPEN is administered, inform your doctor if you are taking any of the following medicines such as:

• other antidiabetic agents (Ex. tolbutamide, glibenclamide, glipizide), biguanides (Ex. metformin, phenformin), thiazolidinediones (Ex. pioglitazone), DPP-4 inhibitors (Ex. sitagliptin, vildagliptin) or SGLT-2 inhibitors (Ex. remogliflozin)
• antidepressants (Ex. rasagiline, selegiline, phenelzine)
• Heart medicines (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 (Ex. sulfasalazine, sulfadiazine, sulfamethoxazole)
• oral contraceptives (birth control pills) Ex. mifepristone,
• thiazide diuretics (Ex. chlorothiazide, hydrochlorothiazide)
• glucocorticoids (used to manage inflammation) Ex. cortisone, betamethasone, beclomethasone, dexamethasone, budesonide, prednisone
• thyroid hormones (used to manage thyroid deficiency) Ex. thyroxine, triiodothyronine
• sympathomimetic agents (used to manage 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 for endometriosis)
• octreotide (used to manage diarrhea)
• lanreotide (a medicine used to manage abnormal body growth)

B. Interaction with food or drink:

NOVOMIX 50 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

More Information

• Keep out of reach of children
• Store the unopened pack in the refrigerator at 2-8°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 NOVOMIX 50 FLEXPEN

Q: Should NOVOMIX 50 FLEXPEN be refrigerated?

A: Yes. An unopened pack must be stored in the refrigerator (2-8°C). During use or while carrying as a spare, keep it at room temperature to ensure uniform resuspension.

Q: Can NOVOMIX 50 FLEXPEN be mixed with other insulins?

A: No. NOVOMIX 50 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 NOVOMIX 50 FLEXPEN safe during pregnancy?

A: Yes. NOVOMIX 50 FLEXPEN can be used during pregnancy if prescribed by the physician. Therefore, consult your doctor before administration.

Q: How long does it take for NOVOMIX 50 FLEXPEN to start working?

A: NOVOMIX 50 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 24 hours.

Q: Can NOVOMIX 50 FLEXPEN be given intravenously?

A: No. NOVOMIX 50 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 NOVOMIX 50 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 NOVOMIX 50 FLEXPEN used for?

A: NOVOMIX 50 FLEXPEN improves glycemic control in patients with diabetes mellitus (both type I and type II). It helps your body to make utilize of the circulating blood glucose by transporting the circulating glucose from the blood into the muscles and fat tissues.

Q: What are the most common side effects of taking NOVOMIX 50 FLEXPEN?

A: The most common side effects of receiving NOVOMIX 50 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 effect troubles you.

Q: Can I stop therapy with NOVOMIX 50 FLEXPEN without consulting your doctor?

A: No. You should not stop therapy with NOVOMIX 50 FLEXPEN without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using NOVOMIX 50 FLEXPEN, consult your doctor for advice.

Q: Will taking a higher dose of NOVOMIX 50 FLEXPEN be more effective?

A: No, taking a higher dose of NOVOMIX 50 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 NOVOMIX 50 FLEXPEN?

A: It is not advisable to take medicines to control blood pressure while taking NOVOMIX 50 FLEXPEN without consulting your doctor. Therefore, consult your doctor before taking any antihypertensive medications along with NOVOMIX 50 FLEXPEN as they have known interactions with NOVOMIX 50 FLEXPEN.

References

1. KD. Tripathi. Insulin, Oral Hypoglycemic Drugs and Glucagon. Essentials of medical pharmacology. Seventh edition. 2013. Page – 263-264 & 266-269.

2. Paul Valensi. Biphasic insulin aspart 30/70 (BIAsp 30) in the treatment of type 1 and type 2 diabetes. NIH. National Library of Medicine. National Center for Biotechnology. PMC. PubMed Central. June 2009. [Accessed on 20th January 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3048020/

3. Novo Nordisk A/S. NovoMix® 30 FlexPen® 100 units/ml suspension for injection in a pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine. European Medicines Compendium. [Revised in September 2022]. [Accessed on 20th January 2024] https://www.medicines.org.uk/emc/files/pil.1600.pdf

Useful Diagnostic Tests

• HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
• Blood Glucose Fasting (FBS)
• Insulin-Fasting
• Netmeds Diabetic Checkup
• Advance Diabetes Monitoring (Senior Female)
• Jaanch Diabetic Profile Basic

Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)

Last updated on 27 Jan 2024 | 10:45 AM(IST)