Myxredlin: Uses, Side Effects and Dosage

What is Myxredlin used for?

• The treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia (high blood sugar).
• Myxredlin, administered intravenously, may be used for the treatment of emergencies, such as diabetic coma and pre-coma, and in diabetics undergoing surgery.

How does Myxredlin work?

Myxredlin is human insulin used to treat diabetes.

What are the ingredients in Myxredlin?

Medicinal ingredients: The active ingredient is Insulin Human which is produced by recombinant DNA methods using a yeast (Pichia pastoris) and followed by unique purification processes. Human Insulin is structurally identical to natural human insulin.

Serious Warnings and Precautions

• Hypoglycemia is the most common adverse effect of insulin including Myxredlin.
• If hypoglycemic or hyperglycemic reactions are not treated they can result in the loss of consciousness, coma or death.
• Glucose monitoring is recommended for all patients with diabetes.
• Any change of insulin should be made cautiously and only under medical supervision. This may result in dosage adjustment.
• Myxredlin should not be used if it is not clear and colourless.

Non-medicinal ingredients: Dibasic Sodium Phosphate Anhydrous, Monobasic Sodium Phosphate Monohydrate, Sodium Chloride and Water for Injection.

Myxredlin comes in the following dosage forms:

Myxredlin is presented as a ready-to-use solution for infusion supplied in 100 ml plastic bags. Each mL contains 1 IU of Insulin Human.

Do not use Myxredlin if:

• You feel a hypoglycemic reaction (low blood sugar) coming on. (see ‘What are possible side effects from using Myxredlin?’ for more about hypoglycemia).
• You are allergic (hypersensitive) to Insulin, Human Biosynthetic, metacresol or any of the other ingredients in this insulin. Look out for the signs of an allergic reaction (see ‘What are possible side effects from using Myxredlin?’).
• The insulin has not been stored correctly or if it has been frozen (see ‘How to store Myxredlin?’).
• The insulin does not appear water-clear and colourless.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Myxredlin. Talk about any health conditions or problems you may have, including if you:

• Have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands, your doctor may decide to alter your insulin dose.

• Drink alcohol (including wine and beer) watch for signs your need for insulin may change as your blood sugar level may rise or fall.

• Have an infection, fever or have had an operation you may need more insulin than usual.
• Suffer from diarrhea, vomiting or eat less than usual you may need less insulin than usual.
• Exercise more than usual or if you want to change your usual diet.
• Are ill: continue taking your insulin. Your need for insulin may change.
• Go abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travel.

• Are pregnant, or planning a pregnancy or are breastfeeding please contact your doctor for advice.

• Drive or use tools or machines: watch for signs of a hypoglycemia. Your ability to concentrate or to react will be less during a hypoglycemic reaction. Please keep this in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). Never drive or use machinery if you feel a hypoglycemia coming on.

Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypoglycemic reactions or if you find it hard to recognize hypoglycemias.

Thiazolidinediones (class of oral antidiabetic drugs) used together with insulin may increase risk of oedema and heart failure. Inform your doctor as soon as possible if you experience localised swelling (oedema) or signs of heart failure such as unusual shortness of breath.

Hypokalemia (low potassium) is a possible side effect with all insulins. You might be more at risk if you are on potassium lowering drugs or losing potassium (e.g. diarrhea).

Other warnings you should know about:

If you take any of the medicines below, your blood sugar level may fall (hypoglycemia)

• Other medicines for the treatment of diabetes.
• Monoamine oxidase inhibitors (MAOI) (used to treat depression).
• Beta-blockers (used to treat high blood pressure).
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure).
• Salicylates (used to relieve pain and lower fever).
• Anabolic steroids (such as testosterone).
• Sulphonamides (used to treat infections).

If you take any of the medicines below, your blood sugar level may rise (hyperglycemia)

• Oral contraceptives (birth control pills).
• Thiazides (used to treat high blood pressure or excessive fluid retention).
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation).
• Thyroid hormones (used to treat thyroid gland disorders).
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma).
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes).
• Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycemia.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Myxredlin:

Some medicines affect the way glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines, which may affect your insulin treatment. Tell your doctor, Diabetes Nurse Educator or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you are using any medicine as mentioned below that affects your blood sugar level.

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, pitted or thickened area (see ‘How to take Myxredlin’). Tell your healthcare professional if you notice any skin changes at the injection site. Tell your healthcare professional if you are currently injecting into these affected areas before you start injecting in a different area. A sudden change of site may result in hypoglycemia. Your healthcare professional may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

How to take Myxredlin:

This medicine is given by doctors or nurses in a health care setting. It is given by intravenous infusion, through an injection into a vein.

The doctor decides the number of units to be administered, and for how long, based on your medical needs.

Causes of a hyperglycemia

You get a hyperglycemia if your blood sugar gets too high.

This might happen:

• If you forget to take insulin.
• If you repeatedly take less insulin than you need.
• If you eat more than usual.
• If you exercise less than usual.

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed dry skin; a dry mouth and a fruity (acetone) smelling breath.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don't treat it, this could lead to diabetic coma and death.

Overdose:

Causes of a hypoglycemia

You get a hypoglycemia if your blood sugar gets too low.

This might happen:

• If you take too much insulin.
• If you eat too little or miss a meal.
• If you exercise more than usual.

The warning signs of a hypoglycemia may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; and difficulty concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest. Don't take any insulin if you feel a hypoglycemia coming on. Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must turn you on your side and get medical help right away. They must not give you anything to eat or drink as it could choke you.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon you will need to eat glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or hospital emergency after an injection of glucagon:

you need to find the reason for your hypoglycemia in order to avoid getting more.

• If severe hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have a hypoglycemia that makes you pass out, or if you get a lot of hypoglycemias, talk to your doctor. The amount or timing of your insulin dose, the amount of food you eat or the amount of exercise you do, may need to be adjusted.

What are possible side effects from using Myxredlin?

These are not all the possible side effects you may have when taking Myxredlin. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, Myxredlin can cause side effects, although not everybody gets them. Myxredlin may cause low blood sugar (hypoglycemia) (see the advice in ‘How to take Myxredlin’).

Less commonly reported side effects

(1 to 10 users in 1000)

Signs of allergy

Hives and rash may occur.

Seek medical advice immediately

• If the above signs of allergy appear or
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Myxredlin or one of its ingredients (called a generalized allergic reaction) (see also the warning in ‘Do not use Myxredlin if’).

Vision problems

When you first start your insulin treatment it may disturb your vision, but the disturbance is usually temporary.

Swollen joints

When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Painful neuropathy (nerve related pain)

If your blood glucose levels improve very fast it may cause burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Very rarely reported side effects

(less than 1 in 10,000)

Diabetic retinopathy (eye background changes)

If you think you, or a person you are caring for, have taken too much Myxredlin, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

If any of the side effects get serious, or if you notice any side effects, including those not listed in this leaflet, please tell your doctor, Diabetes Nurse Educator or pharmacist.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Do not use this medicine after the expiry date, which is stated on the infusion bag and carton labels

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect- canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

after ‘EXP’. The expiry date refers to the last day of that month.

Before opening, store infusion bag contained within a cardboard carton at 2-8°C. If needed, infusion bag may be removed from the original carton and stored at room temperature (up to 25°C) for up to 25 days, but not exceeding the original expiry date.

After opening, the product should be used immediately. Any unused solution should be discarded in accordance with local requirements.

Do not use this medicinal product if you notice that the solution is not clear, and colourless.

Do not use if the infusion bag is damaged. In case of leaks, discard in accordance with local requirements.

Do not use this medicinal product if has been frozen

Keep out of reach and sight of children.

If you want more information about Myxredlin:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html; the manufacturer’s website Error! Hyperlink reference not valid.or by calling 1-800-719-9955.

Date of Initial Authorization: August 3, 2022