INTRODUCTION

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) contains Insulin Degludec which belongs to group of medicines called Antidiabetics. TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is used to treat diabetes mellitus (high blood sugar) in adults, adolescents and children (aged 1 year and above).

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is also used in combination with oral/other injectable antidiabetic medicines to treat type-2 diabetes mellitus. The medicine is also indicated for use to treat type 1 diabetes mellitus when used in combination with meal-related rapid-acting insulin medicines in affected individuals.

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is not recommended for use in patients allergic to Insulin Degludec.

Before administering TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), inform your doctor if you have abnormally low/high blood sugar levels, eye disorders /poor eyesight, liver, and/or kidney problems.

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution during pregnancy and in women planning for pregnancy. It is also advised to be administered with caution in breastfeeding women.

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) should be used with caution in children and adolescents (aged 1 to 18 years) and is advised to be used with caution in elderly patients (aged 65 years and above) after consulting your doctor.

The most common side effects associated with the use of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) are low blood sugar levels (associated with symptoms such as sweating, tiredness, dizziness, and/or feeling increased hunger), and injection site reaction (such as pain, redness, itchy welts, swelling, and/or itching). Consult your doctor if any of these symptoms worsen.

USES OF TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

• Treats diabetes mellitus (high blood sugar) in adults, adolescents and children (aged 1 year and above)
• Treats type 1 diabetes mellitus when used in combination with meal-related rapid-acting insulin medicines in affected individuals

HOW TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) WORKS

TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) works by enhancing the body tissues to rapidly uptake glucose from the blood which results in controlled blood glucose level thus treating diabetes mellitus and its associated symptoms in affected individuals.

DIRECTIONS FOR USE

Administer TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) as advised by your physician. It is given under the skin (subcutaneously) at specific areas such as front of the thighs, upper arms, or the front of the waist (abdomen). Keep changing the site of injection each day to reduce the risk of developing lumps and skin pitting. Insert the needle into the skin as per your doctor’s advice. Ensure that you can see the dose counter properly. Gently press and hold down the dose button until the dose counter value returns to zero. Leave the needle under the skin for minimum 6 seconds. Pull out the pen straight up from the skin. If blood oozes out at the injection site, press gently with a cotton swab. Do not rub the bleeding area. Always dispose of the used needles in the appropriate sharp’s container to reduce the risk of infection, contamination, insulin leakage, blocked needle issues, and inaccurate dosing. Your doctor will decide the correct dose and duration for you depending upon your age, body weight, stress, physical activity, and disease condition.

SIDE EFFECTS OF TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

HOW TO MANAGE SIDE EFFECTS

Serious hypoglycaemia (very low blood sugar):

Try to have high sugar snack (such as sweets, biscuits or fruit juice). Measure your blood sugar if possible and take rest. Wait until the signs of too low blood sugar disappears or when your blood sugar level has settled.        

Diarrhoea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult and inform your doctor if the symptom worsens.

Nausea:

Take TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) with/just after a meal. Stick to simple meals. Avoid eating oil rich/spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, and drink slowly in between meals. Consult your doctor if the condition worsens.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) at a time when you can sit down (or lie down) when the symptoms are at their worst. Avoid driving or using tools or machinery until you feel well.

Itchy Skin:

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool your skin. Wear loose clothing and avoid tight clothes, or clothes made from wool or synthetic fabrics. Avoid using perfumed soaps, deodorants or moisturizers and use a skin softener regularly.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before using TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), inform your doctor, if you are taking any of the following medicine:

• other medicines for diabetes such as oral diabetic medicines (Ex. pioglitazone, metformin), injectable diabetic medicine (Ex. insulin lispro)
• sulphonamides (medicines used to treat infections) Ex. sulfadiazine, sulfamethizole
• anabolic steroids (medicines used to treat deficiency or malfunction of sex hormones) such as testosterone
• beta-blockers (medicines used to treat high blood pressure) Ex. Metoprolol
• salicylates (medicines used to treat pain and mild fever) Ex. acetylsalicylic acid or aspirin
• monoamine oxidase (MAO) inhibitors (medicines used to treat depression) Ex. isocarboxazid
• angiotensin converting enzyme (ACE) inhibitors (medicines used to treat some heart problems or high blood pressure) Ex. enalapril
• medicine used to treat endometriosis Ex. danazol
• medicines used to contraception such as oral contraceptives Ex. desogestrel, ethinyl estradiol
• medicines used to treat thyroid problems Ex. thyroid hormones
• medicines used to treat for growth hormone deficiency Ex. growth hormone,
• medicines used to treat inflammation such as glucocorticoids Ex. cortisone
• sympathomimetics (medicines used to stimulate sympathetic nervous system) Ex. epinephrine/adrenaline, salbutamol, terbutaline
• thiazides (medicines used to treat the high blood pressure high blood pressure or water retention in the body) Ex. chlorothiazide
• medicines used to treat acromegaly (excess production of growth hormone) Ex. octreotide, lanreotide

Overdosage:

If you or anyone else accidentally administers too much of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are low blood sugar associated with symptoms such as sweating, tiredness, dizziness, increased hunger, and/or tingling lips.

SYNOPSIS

MORE INFORMATION

• Keep TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) out of reach in children
• Store TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) in a refrigerator at 2-8°C

FAQs ABOUT TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)

Q. What TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is used for?

A. TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is used to treat diabetes mellitus (high blood sugar) in adults, adolescents and children (aged 1 year and above). It is also used in combination with oral/other injectable antidiabetic medicines to treat type-2 diabetes mellitus. The medicine is also indicated for use to treat type 1 diabetes mellitus when used in combination with meal-related rapid-acting insulin medicines in affected individuals.

Q. What happens if TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) is administered more than its required dose?

A. If you or anyone else accidentally administers too much of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED), consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are low blood sugar associated with symptoms such as sweating, tiredness, dizziness, increased hunger, and/or tingling lips.

Q. What are the side effects seen associated with the use of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED)?

A. The most common side effects associated with the use of TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) are low blood sugar levels (associated with symptoms such as sweating, tiredness, dizziness, and/or feeling increased hunger), and injection site reaction (such as pain, redness, itchy welts, swelling, and/or itching). Consult your doctor if any of these symptoms worsen.

Q. How TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) works?

A. TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) helps in lowering blood glucose levels where Insulin Degludec works by enhancing the body tissues to rapidly uptake glucose from the blood which results in controlled blood glucose level treating diabetes mellitus and its associated symptoms in affected individuals.

Q. Can TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) be administered in pregnant women?

A. Yes, TRESIBA 100IU FLEX TOUCH PEN(PREFILLED) can be administered but with caution during pregnancy and in women planning for pregnancy. Consult your doctor before administering the medicine.

REFERENCES

1. David Levy. Insulin and non-insulin agents. The Hands-on Guide to Diabetes Care in Hospital. Third edition 2016. Page – 93.

2. Sanjay Kalra, Yashdeep Gupta. Clinical use of Insulin Degludec: Practical Experience and Pragmatic Suggestions. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. March 2015. [Accessed on 2nd August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382770/

3. Novo Nordisk A/S. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Assessed on 2nd August 2022] https://www.medicines.org.uk/emc/files/pil.7936.pdf

USEFUL DIAGNOSTIC TESTS

• Glycated haemoglobin (A1C) test