Levemir Flexpen 1X3ml

Introduction About LEVEMIR FLEXPEN

LEVEMIR FLEXPEN contains Insulin Detemir which belongs to the group of medicines called Antidiabetic drugs. It is used in the management of hyperglycaemia in adults, adolescents and children aged 1 year and above.

LEVEMIR FLEXPEN is not recommended for use if you have low blood sugar and diabetes ketoacidosis (a complication of diabetes). LEVEMIR FLEXPEN should be used with caution in patients with liver, kidney disease. Consult your doctor before using it.

LEVEMIR FLEXPEN can be used during pregnancy if clinically needed. It should be used with caution in breastfeeding women and in elderly patients above 65 years of age. Consult your doctor before using it.

The most common side effects of using LEVEMIR FLEXPEN are low blood sugar (cold sweat, pale skin, headache, rapid heartbeat, nausea, drowsiness), injection site reactions, itching, rash, weight gain, swollen hands and feet, etc. Contact your doctor if any of the symptoms deteriorate.

Uses Of LEVEMIR FLEXPEN

• Management of diabetes mellitus (Type I and II)

How LEVEMIR FLEXPEN Works

LEVEMIR FLEXPEN lowers blood glucose by enhancing uptake of glucose into skeletal muscle and fat and by inhibiting the production of glucose in liver.

How to use LEVEMIR FLEXPEN

Use LEVEMIR FLEXPEN under careful medical supervision. Inject LEVEMIR 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.

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

Consult your doctor

LEVEMIR FLEXPEN can be used during pregnancy if clinically needed. If you are pregnant or are planning to have a baby, contact your doctor for advice before using LEVEMIR FLEXPEN. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly management of hypoglycaemia (low blood sugar), is important for the health of your baby.

Breastfeeding

Use with Caution

LEVEMIR FLEXPEN should be used with caution in breastfeeding women and you may require adjustments in insulin dose and diet. Consult your doctor before using LEVEMIR FLEXPEN.

Driving and Using Machines

Use with Caution

LEVEMIR FLEXPEN might affect your concentration and ability to react. Do not drive or use machines after using LEVEMIR FLEXPEN.

Alcohol

Consult your doctor

Avoid consumption of alcohol while receiving LEVEMIR FLEXPEN as it can raise or lower your blood sugar levels.

Kidney

Use with Caution

LEVEMIR FLEXPEN should be used with caution in patients with kidney disease. Consult your doctor before using LEVEMIR FLEXPEN.

Liver

Use with Caution

LEVEMIR FLEXPEN should be used with caution in patients with liver disease. Consult your doctor before using LEVEMIR FLEXPEN.

Allergy

Contraindicated

Do not use LEVEMIR FLEXPEN if you are allergic to insulin detemir or any of the other ingredients in this medicine.

Use In Pediatrics

Consult your doctor

The safety and efficacy of LEVEMIR FLEXPEN in children (below 1 year of age) have not been established. Consult your child’s doctor for advice.

Use In Geriatrics

Use with Caution

LEVEMIR FLEXPEN should be used with caution in patients above 65 years of age and may require dose adjustment. Consult your doctor before using LEVEMIR FLEXPEN.

Interactions

A, Drug-Drug interactions:

Before using LEVEMIR FLEXPEN, inform your doctor if you are taking any of the following medicines:

• other antidiabetic agents (Ex. metformin, repaglinide, pioglitazone, liraglutide, sitagliptin, dapaglifozin)
• antidepressants (Ex. phenelzine, selegiline, fluoxetine)
• heart medicines (Ex. metoprolol, atenolol, benazepril, captopril, losartan, clonidine, guanethidine, reserpine, disopyramide, hydrochlorothiazide)
• pain killers (Ex. aspirin)
• medicines used to manage hormone problems and muscle loss (Ex. testosterone, stanozolol)
• antibiotics (Ex. sulfadiazine, sulfamethizole)
• contraceptive agents (Ex. desogestrel, ethinyl estradiol)
• medicines used to manage inflammation (Ex. prednisone, dexamethasone)
• medicines used to manage thyroid gland disorders (Ex. levothyroxine, liothyronine, liotrix)
• anti-asthmatics (Ex. epinephrine, salbutamol, terbutaline)
• medicines used for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes (Ex. somatropin)
• danazol (medicine acting on ovulation)
• octreotide and lanreotide (used for management of acromegaly)
• fibrates (used to lower cholesterol levels) Ex. clofibrate
• pentoxifylline (used to manage poor blood circulation in leg)
• antipsychotic agents (such as olanzapine, clozapine, chlorpromazine)
• glucagon (used to manage very low blood sugar)
• isoniazid (an anti-TB medicine)
• niacin (vitamin supplement)
• protease inhibitors (antiviral drugs) Ex. darunavir
• lithium (used for depression)
• pentamidine (used to manage fungal pneumonia)

Overdosage:

If you or anyone else accidentally inject too much of LEVEMIR FLEXPEN, consult your doctor immediately or visit the nearby hospital. Symptoms of LEVEMIR FLEXPEN overdose are low blood levels of sugar and potassium.

Signs include cold sweat, cool pale skin, headache, rapid heartbeat, nausea, feeling very hungry, temporary changes in vision, drowsiness, unusual tiredness and weakness, nervousness or tremor, feeling anxious, feeling confused, difficulty in concentrating. Severe low blood sugar can lead to unconsciousness and can cause brain damage (temporary or permanent) and even death if unmanageed.

Synopsis

More Information

• Keep LEVEMIR FLEXPEN out of reach of children
• Store LEVEMIR FLEXPEN in a refrigerator (2-8°C)

FAQs About LEVEMIR FLEXPEN

Q: How often can I use LEVEMIR FLEXPEN?

A: Use LEVEMIR FLEXPEN as advised by your physician. When LEVEMIR FLEXPEN is used in combination with tablets for diabetes and/or in combination with injectable anti-diabetic products, other than insulin, this medicine should be administered once or twice a day. The injection can be given at any time during the day, but at the same time each day. For patients who require twice daily dosing to optimize blood sugar control, the evening dose can be administered in the evening or at bedtime.

Q: What to do if I experience low blood sugar during management with LEVEMIR FLEXPEN?

A: If you experience low blood sugar while taking LEVEMIR FLEXPEN, drink fruit juice or have glucose tablets or another sugary snack, like sweets or biscuits. Measure your blood sugar and take rest. Always keep glucose tablets or high sugar snacks with you. Consult your doctor if blood sugar levels do not stabilize.

Q: Can I use LEVEMIR FLEXPEN during pregnancy?

A: LEVEMIR FLEXPEN can be used during pregnancy if clinically needed. If you are pregnant or are planning to have a baby, contact your doctor for advice before using this medicine. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly management of hypoglycaemia (low blood sugar), is important for the health of your baby.

Q: How quickly can LEVEMIR FLEXPEN act?

A: LEVEMIR FLEXPEN has a long and constant blood-sugar-lowering action within 3 to 4 hours after injection. It provides up to 24 hours of background insulin coverage. Consult your doctor for more information.

Q: What if I forget to take a dose of LEVEMIR FLEXPEN?

A: If you forget to use a dose of LEVEMIR FLEXPEN, your blood sugar may get too high (hyperglycemia). You might experience flushed or dry skin, feeling sleepy or tired, dry mouth, fruity breath, frequent urination, feeling thirsty, loss of appetite, nausea or vomiting (signs of a very serious condition called diabetic ketoacidosis- a build-up of blood acid levels because the body is breaking down fat instead of sugar). In case of hyperglycemia, test your blood sugar level and take a correction dose of LEVEMIR FLEXPEN if you have been taught how to do this and test your urine for ketones if you can, then seek medical advice immediately.

Q: Can I stop taking LEVEMIR FLEXPEN?

A: Do not stop using LEVEMIR FLEXPEN without talking to your doctor. If you stop using LEVEMIR FLEXPEN, it could lead to a very high blood sugar level (severe hyperglycemia) and ketoacidosis (a build-up of blood acid levels because the body is breaking down fat instead of sugar).

References

1. KD Tripathi. Insulin, Oral Anti diabetic Drugs and Glucagon. Essentials of medical pharmacology. Eighth Edition. 2019. Page –288.

2. Therese M. Chapman & Caroline M. Perry. Insulin Detemir- A Review of its Use in the Management of Type 1 and 2 Diabetes Mellitus. Springer link. September 2012. [Accessed on 27th January 2024] https://link.springer.com/article/10.2165/00003495-200464220-00008?error=cookies_not_supported&code=fe1c09a8-2599-42af-bb11-930cca8ed0ea

3. Novo Nordisk A/S. Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes. NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in January 2017] [Accessed on 27th January 2024] https://clinicaltrials.gov/ct2/show/NCT00604344

4. Novo Nordisk A/S. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 27th January 2024] https://www.medicines.org.uk/emc/files/pil.5536.pdf, https://www.medicines.org.uk/emc/product/5536/smpc

5. Novo Nordisk Inc. Levemir (insulin detemir injection). [Revised in July 2022] [Accessed on 27th January 2024] https://www.novo-pi.com/fiasp.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)

Author Details

Written By Srilekha. R - B.Pharm

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

Last updated on 29 Jan 2024 | 06:28 PM(IST)