NovoRapid Vials (NovoLog Vials)

What is NovoRapid® (NovoLog) and what is it used for?

NovoRapid is an insulin solution that that is injected under the skin (subcutaneously). It is commonly injected in the abdomen, thigh, upper arm or buttock. A doctor or diabetes educator should instruct you on how to properly inject insulin.

NovoRapid is typically taken immediately before meals however it may also be taken after meals. NovoRapid is a short-acting insulin that is often used in combination with a long-acting or intermediate insulin. Glucose levels should be tested regularly to find the right dosage that works best for a patient.

The dosage amount is commonly based on body weight, usually between 0.5 – 1.0 units per kg body weight per day. When taken with meals, 50-70% of the insulin requirement may be a combination of 50-70% of the NovoRapid insulin and the remainder with a long-acting or intermediate insulin.

A pump system can be used with NovoRapid Insulin to provide continuous insulin infusion under the skin (subcutaneously) or into a vein (intravenously) by a doctor or nurse.

Is there a difference between NovoRapid and NovoLog?

No. NovoRapid and NovoLog are the same rapid-acting insulin by Novo Nordisk however are marketed under two different names. NovoLog is the brand name used in the United States for this medication and NovoRapid is the name used outside of the US (including Canada).

How does NovoRapid work?

Insulin is a hormone that is naturally produced by the pancreas in our bodies. For those with diabetes, the body does not produce enough insulin or use it effectively to manage blood glucose levels.

NovoRapid is very similar to the insulin produced in our body however it provides faster absorption than human insulin. Similar to human insulin, NovoRapid insulin helps glucose to enter the cells through the bloodstream. With the use of insulin, patients can experience a reduction in symptoms and complications associated with diabetes.

NovoRapid will start lowering blood glucose levels 10 to 20 minutes after use. It has a maximum effect between 1-3 hours and can last for up to 3-5 hours.

What are the ingredients in NovoRapid® insulin?

The active ingredient is insulin aspart. Non-medical ingredients include: sodium chloride, zinc chloride, metacresol, phenol, glycerol, disodium phosphate dihydrate, hydrochloric acid, sodium hydroxide and water for injection.

NovoRapid® Usage

• Check the label on your insulin medication before use to ensure you have the right type of insulin.
• Should be injected immediately before meals for fast onset of action. Injection of insulin should be 5-10 minutes within starting your meal).
• NovoRapid insulin should be injected in the front of the thigh, abdomen, upper arm or the buttocks. Insulin will work quicker if injected into the abdomen.
• Blood sugar levels should be measured regularly.
• Due to NovoRapids fast onset of action it should be taken within 5-10 minutes of starting your meal. When necessary, NovoRaid can also be taken soon after a meal.
• To prevent contamination always use a new needle with every injection.

Do not use NovoRapid if:

• you feel a hypoglycemia reaction coming on.
• you are allergic to insulin aspart or any of its ingredients.
• insulin vial has been damaged or crushed
• the protective cap is either loose or missing
• insulin has not been stored correctly or has been previously frozen
• does not appear water-clear or colorless

Storing Insulin

• Insulin should be kept out of reach from children and pets.
• NovoRapid insulin can be stored in the refrigerator between 2°C-8°C.
• Do not store near a cooling element for freezer.
• Do not freeze insulin.
• Keep away from extreme heat or direct sunlight.
• Do not use NovoRapid® insulin after expiry date printed on label or carton.
• Do not dispose of medication down wastewater (ie toilet, sink) or in the trash bin.
• Speak to your pharmacist about how to properly dispose of medication. This can help protect the environment.

What have studies shown about NovoRapid?

In a study involving 1,954 patients with type 1 diabetes (the body cannot produce insulin), and 182 patients with type 2 diabetes (the body is unable to use insulin effectively), NovoRapid had shown almost identical results to human insulin. The study measured the level of a substance called glycated hemoglobin (HbA1c), which allows us to understand how well blood glucose is managed. Over 6 months, the results had shown NovoRapid to decrease HbA1c levels by 0.12% and by 0.15% more than the insulin produced naturally in our body.

NovoRapid has also shown similar results in children of at least 1 year of age. The safety of NovoRapid was also found in studies involving 349 pregnant women with type 1 or gestational diabetes (diabetes caused by pregnancy).

Side Effects

A side effect is any unwanted response when taking medication in normal doses. Like any medication, side effects can occur.

With the guidance and precautions by doctors and healthcare professionals, patients can experience safe and effective use.

The most common side effect with NovoRapid, as with any insulin, is hypoglycemia (low blood sugar levels).

If hypoglycemia is not treated early it can result in loss of consciousness, coma and can even be fatal.

Seek medical attention immediately if you suddenly feel unwell, start vomiting, have difficulty breathing, dizziness, start sweating or rapid heartbeat or if you are experiencing serious allergic reactions.

Vision problems may occur. Vision disturbance may happen at the start of your treatment but eventually go away.

If you inject into the same site repeatedly, the fatty tissue under the skin may become thick (lipohypertrophy) or shrink (lipoatrophy). By rotating the site of injection you can avoid these skin issues from happening. If you notice any pitting or thickening of the skin, notify your doctor as these can change the absorption of insulin if these reactions become more severe.

Patients may experience swollen joints caused from water retention. This often happens around the ankles or other joints.

If you have diabetic retinopathy (changes in eye background) and your blood sugar levels improve quickly then your retinopathy may get worse.

Painful neuropathy is usually transient. If your blood glucose levels improve quickly you may experience nerve related pain.

If you experience any serous side effects or side effects not listed, it’s important to notify your doctor.

Warnings & Precautions

To ensure proper usage and avoid side effects, speak with your doctor or pharmacist before taking this medication.

The injection site should be changed after every injection.

NovoRapid is safe to be used by pregnant women however should be taken with the guidance of a doctor.

Diabetes patients are recommended to monitor glucose levels regularly.

Any adjustments to insulin dosages should be made cautiously and under the guidance of a doctor.

Insulin should never be injected directly into a vein.

Do not share your prescription insulin with others, even if the needle has been changed. This can lead to spreading infections or blood pathogens. Your medicine may also be harmful to their health.

Let your doctor know if you:

• have existing issues with your liver or kidney; or with your adrenal, pituitary or thyroid glands.
• drink alcohol (including beer or wine) as this can impact your blood sugar levels and insulin dosage requirements.
• suffer from vomiting or diarrhea as this may indicate you need less insulin than usual.
• exercise more frequently or harder than usual.
• change your diet drastically.
• If you are ill. Continue insulin regimen as usual.
• travel abroad. Travelling across other time zones may require adjusting your insulin schedule. Before you travel check with your doctor or pharmacist on packing or if the destination country sells NovoRapid.
• are pregnant, breastfeeding or planning on having a baby.

Drive or use heavy machinery or tools. If you experience signs of hypoglycemia this can impact your concentration. Speak with your doctor on whether you should drive or use machines based on your condition and if you experience hypoglycemia.

Thiazolidinediones are a class of oral antidiabetic drugs that when used together with insulin may increase risk of oedema and heart failure. Let your doctor know if you experience shortness of breath, any localized swelling or signs of heart failure.

Hypokalemia (low potassium) is a possible side effect that can be experienced when taking insulin. You may be more at risk if you are taking drugs that lower potassium or you experiencing diarrhea which will cause potassium loss.

Due to NovoRapid® rapid onset, hypoglycemia may occur. This can happen early after injection when compared to soluble human insulin.

Let your doctor know of any medications you may be taking. This should also include over-the-counter medications, natural supplements, vitamins & minters, and any other medications you are taking.

The following medications may interact with NovoRapid®. It’s important to notify your doctor or pharmacist if you are taking any prescription medications especially those that can affect blood sugar levels such as:

• Other medicines for diabetes treatment
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors
• Salicylates (used for pain relief and lower fever)
• Anabolic steroids such as testosterone
• Sulfonamides (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, salbutamol, terbutaline used to treat asthma)
• Growth hormone
• Danazol (medicine acting on ovulation)
• Octreotide and lanreotide
• Beta-blockers (used to treat high blood pressure)

Hypoglycemia

Causes of hypoglycemia (low blood sugar) include:

• Taking too much insulin
• Eating too little or skipping meals
• Exercising more than normal

Symptoms of hypoglycemia include: cold sweats, cool pale skin, rapid heartbeat, feeling ill, hunger, changes in vision, tiredness or weakness, tremors, anxiety, confusion, headaches, difficulty concentrating.

If you get any of these, consume a sugary snack such as a handful of jellybeans, hard candy, a sugary drink or pop (non diet) or a glucose tablet.

Instruct your family and friends on what to do if you lose consciousness. Since you can’t consume sugar orally at the risk of choking, you will require an injection of glucagon. You will need to ingest a sugary snack immediately when you regain consciousness. If you do not respond then you will need to be treated at the hospital.

Severe hypoglycemia can lead to temporary or permanent brain damage or even death.

If you experience hypoglycemia that makes you lose consciousness or get frequent hypoglycemia, inform your doctor.

Your insulin dose, timing, diet and exercise may require adjusting.

Hyperglycemia

Diabetics may experience hyperglycemia if blood sugar gets too high. This can happen when:

• you forget to take insulin
• you repeatedly take less insulin than required such as insulin rationing
• you eat more than usual
• you exercise less than usual

Warning signs for hyperglycemia may appear gradually and can include: increased urination, thirst, loss of appetite, illness (nausea or vomiting), drowsiness or feeling tired, dry mouth, flushed dry skin, fruit (acetone) smelling breath.

These may be signs of ketoacidosis which is a very serious condition which can result in diabetic coma or death.

If you experience any of these symptoms, test your blood glucose levels, test your urine for ketones and seek medical attention immediately.