Insulin Degludec (Subcutaneous)

Overview

Used to treat patients who have diabetes mellitus (otherwise known as type one diabetes), Insulin Degludec slowly releases insulin into the body over 24 hours. Insulin is a hormone that helps the body to process food into energy, including using blood glucose (blood sugars) as a quick source of energy. Insulin also enables the body to store energy for future use. Patients with diabetes mellitus are unable to generate enough insulin, or their bodies do not use insulin normally. This leads to extremes in the levels of sugar in their blood - particularly, having too much sugar in the blood. Insulin Deguludec is a long-lasting form of insulin that helps to regulate a patient's blood sugars.

Only available on prescription from a qualified physician, Insulin Deguludec is available in solution for subcutaneous (under the skin) injection. Insulin Deguludec is commonly known under the US brand name Tresiba.

Conditions Treated

  • Diabetes mellitus

Type Of Medicine

  • Slow-release insulin injection

Side Effects

All medicines come with the risk of causing undesired side effects alongside their required actions. Not all of the following side effects may appear when a patient takes Insulin Degludec. Some side effects, however, may require immediate medical advice.

The following side effects require immediate medical attention. Patients should contact their physician as soon as they notice any of the below:

  • Unusual rapid weight gain or weight loss

Other side effects from using Insulin Degludec may occur which do not require medical assistance. They may change or disappear over time as the patient's body acclimatises to the medicine over the course of treatment. Patients who are concerned about the following side effects should consult their physician or pharmacist for ways to reduce their impact. Patients who find that these side effects are persistent or particularly bothersome should seek some advice on ways to prevent or reduce their effects.

  • Dry mouth

Some patients may experience side effects not listed here. Patients who notice other side effects not listed should contact a healthcare professional to find out more and get advice. New side effects can also be reported by calling the FDA on 1-800-FDA-1088.

Dosage

Different patients will receive different doses of Insulin Degludec, depending on their condition and medical history. Patients should always follow the instructions on the label and their physician's advice to the letter when using this medicine. The following information covers typical doses. Patients who do not see their dose instructions here should always follow the advice of their physician and not change their dosage unless instructed to by a qualified physician.

The specific dosage assigned to each patient will depend on the strength of the formulation prescribed, the number of doses required daily, the time given between doses, and the total length of treatment.

For the treatment of type one diabetes, injections given to adults and children over the age of one are based on the patient's blood sugar levels, and will be assessed by a physician. Children under the age of one are usually not treated with Insulin Degludec, but a physician may decide to prescribe it.

For the treatment of type two diabetes (a less common use), injections given to adults and children over the age of one are based on the patient's blood sugar levels, as determined by a physician. Any use and dosage in children under the age of one should be carefully determined by a qualified physician.

Patients who forget to take a dose of Insulin Degludec should take one as soon as they remember, unless it is almost time for their next scheduled dose. In that case, they should skip the missed dose and continue to take their regular doses. Patients should never double dose.

Patients taking Insulin Degludec should always make sure there is at least eight hours left between doses, including when they have missed a dose.

Major drug interactions

Some medicines should never be used together as they may cause serious side effects by interacting with one another. Other medicines can be used in combination even if there is a risk of interaction. A patient's physician should thoroughly evaluate the risk of interactions and may want to adjust the dose, time between doses or frequency of use of one or more of their medicines to mitigate the risks. Patients should tell their physician about any medicines they may be taking, including prescription and over the counter medications, herbal remedies and supplements. Patients should tell their physician if they are taking any of the following medicines in particular. These medicines have been selected on the basis of their risk of creating serious or significant interactions with Insulin Degludec.

The following medicines are typically not recommended for use with Insulin Degludec on the basis of their risk of creating interactions. A physician may, in some cases, still decide to prescribe them together. They may then change how the patient takes one or more of their medicines to reduce the risks.

  • Flumequine

The following medicines carry a heightened risk of causing serious specific side effects when used with Insulin Degludec. In some cases, using both medicines may still be the best course of treatment, as determined by a physician. If both medicines are prescribed, a doctor may choose to alter the dose, frequency or timings for one or more of the patient's medicines to reduce the risk of interactions.

  • Atenolol

Some medicines should not be used around the time of drinking or eating, or around eating certain foods as interactions may be created. The following information about these kinds of interactions is based on the most significant known triggers and should not be considered all-inclusive.

The following substances are not recommended at the same time as taking Insulin Degludec, but may be sometimes unavoidable. If a patient needs to take them together, their physician should look at ways to reduce the risks through changing the dosage, the frequency or the timing of doses to try to reduce the risk of interactions. They may also provide advice about using alcohol, tobacco or eating certain foods.

  • Ethanol

Patients who also have other medical problems may also experience problems while taking Insulin Degludec. Patients who have any of the following conditions should seek advice from their physician.

  • Low blood sugar (hypoglycemia). Patients experiencing low blood sugars should never take insulin as it may reduce their blood sugar to dangerously low levels.

Warnings

Patients should never share insulin patients, under any circumstances. Pens are not safe for use by more than one patient, as sharing pens or needles can lead to the transmission of blood borne viruses, including hepatitis and HIV.

Patients taking Insulin Degludec should be regularly reviewed by their physician, especially over the first few weeks of use. Physicians may require regular blood tests to check for side effects and measure progress on the patient's blood sugar levels.

Patients should always follow the instructions given by healthcare professionals, particularly about:

  • Counselling family members will need to know what to do if serious side effects occur. Patients with diabetes also typically require counselling that focuses on any changes in diabetes medicine dosing as a result of lifestyle alterations (such as changes in exercise and diet). Counselling on family planning and contraception is also usually given to female patients, as there are a number of issues that can occur in pregnant patients who have diabetes.

Taking too much Insulin Degludec can lead to hypoglycemia (low blood sugar), which can be dangerous. Hypoglycemia can also be triggered by using other medicines for diabetes at the same time as using Insulin Degludec, by missing or delaying meal times or snacks, by exercising more than normal, or by drinking alcohol. Patients should be coached to recognise the symptoms of low blood sugar before they lead to unconsciousness. Different patients may experience different symptoms of hypoglycemia. Patients should monitor their own condition closely and learn to recognize their own specific symptoms so they can be treated as fast as possible.

Common symptoms experienced by patients with low blood sugar include:

  • Behavior that makes them appear drunk

Patients who recognize they have low blood sugar should eat something sugary immediately, such as sugar cubes, fruit juice, glucose tablets or gels, honey, corn syrup, regular soft drinks, or sugar in solution to relieve their symptoms. Patients who do not quickly experience an improvement should seek medical attention immediately. If a patient starts to convulse (have a seizure) or becomes unconscious, someone should dial for emergency assistance as quickly as possible. Diabetes patients and their family members should know how to use a glucagon kit, along with a needle or syringe, for these kinds of emergencies.

Hyperglycemia (or high blood sugar) can happen if a patient does not use enough Insulin Degludec in a dose or skips a dose completely, overeats, ignores their diet plan, has an infection of fever, or does not exercise the normal amount.

Symptoms of hyperglycemia include:

  • Drowsiness

Patients who notice they have any of these symptoms should assess their blood sugar level and then contact their physician for further advice.

New patients on Insulin Degludec should be aware that it may cause blood sugar instabilities while their body adjusts. They should not operate machinery, drive or do anything else that requires alertness for safety until they know how their body reacts to this medicine.

Insulin Degludec has also been known to cause extreme allergic reactions, including life-threatening anaphylactic shock, which requires urgent medical assistance. Patients who experience a rash, swelling of their tongue, face or throat, itching, difficulty breathing, or pain in the chest should contact a physician immediately.

Insulin Degludec can also lower the levels of potassium found in the blood, which can be dangerous in some patients. Patients should not use salt substitutes, supplements or other medicines that contain potassium unless first agreed with their physician.

Patients should also be made aware that using Insulin Degludec with other diabetes medications (including Actos®, Avandia®, pioglitazone, Actoplus Met® and rosiglitazone) can lead to serious issues, such as edema (fluid retention) and heart problems. Patients who are rapidly gaining weight, experiencing shortness of breath, have discomfort or chest pain, feel extremely tired or weak, have an irregular heartbeat, or unusually high swelling around their ankles, wrists, hands or feet should contact their physician immediately.

When deciding whether to take any medicine, the benefits should be carefully weighed against the risks in a conversation between the patient (or the parent of a child patient) and their physician. Physicians should consider the risk of allergic reactions, as well as the potential for side effects or drug interactions occurring.

Patients should fully inform their physician about all other medicines and substances they are taking, including prescription and over the counter medications, herbal remedies, vitamins, supplements and narcotics. They should also tell their physician if they have ever experienced an allergic reaction (of any degree) to any medicine or an insulin medicine. They should also discuss any food allergies, as well as allergies to preservatives, dyes or animals. Patients should be reminded to always read the instruction labels on over the counter medicines.

Studies have not shown a link between use in children over the age of one and pediatric-specific issues that would prevent the action of this type of insulin. Studies have not, however, established the efficacy or safety of using Insulin Degludec in children under the age of one.

Few studies have been conducted into the relationship between older age and the effects of Insulin Degludec, but no specific geriatric issues have been established to date. Elderly patients are, however, more likely to experience issues with regulating their blood sugar levels (particularly age-related hypoglycemia) which may require a physician's adjustments to the dosage instructions for elderly patients taking Insulin Degludec.

Animal studies into the use of Insulin Degludec in pregnancy have shown an adverse effect, but there have been no adequate human studies to show a link between using the medicine and issues in pregnancy. Patients should always follow their physician's advice.

Similarly, there have been no adequate studies into the relationship between taking Insulin Degludec and breastfeeding in female patients. Physicians should carefully weigh up the risks against the benefits with their patient before deciding to prescribe Insulin Degludec to female patients who are pregnant or breastfeeding.

Storage

Always keep medicines out of the reach of children, infants and vulnerable adults. Medicines should always be stored in their original packaging. Patients should never keep old, unwanted or expired medicines, and should talk to their pharmacist or physician to find out about local take-back programs where old medicines can be safely disposed.

Insulin Degludec should be stored in the fridge or at room temperature for up to 56 days, providing it is kept unopened in the FlexTouch disposable pre-filled pen. Protect them from direct sunlight and ensure they do not freeze.

The FlexTouch disposable pre-filled pen that a patient is currently using should be kept at room temperature, away from direct sunlight and heat in a cool place for up to 56 days. Do not store in the fridge.

Summary

Insulin is a hormone that acts on the body to reduce the levels of blood sugar (blood glucose), stabilising and regulating the body's processes. Insulin Degludec works slowly over the course of 24 hours after injection to gradually release insulin evenly.

Insulin Degludec helps diabetes patients with type one diabetes (a more common use) as well as type two diabetes to control their blood sugar levels. It may also be used for other conditions, not listed in this medicine guide.

Patients should be fully informed as to the risks of using Insulin Degludec, regularly monitor their condition, and attend all review appointments with their physician to assess their progress while taking this medicine. Patients should never share needles, syringes or injection devices, even if the needle has been changed.