Insulin is a hormone produced in our body that lowers blood sugar levels in the blood.
Patients with type 1 or type 2 diabetes either do not produce enough insulin or their bodies do not use it efficiently.
Insulin degludec is an ultra long acting basal insulin analogue that was developed by Novo Nordisk under the brand name Tresiba. This modified insulin is different than human insulin by one amino acid.
What is Tresiba?
Tresiba (insulin degludec) is a long-acting insulin that lowers blood glucose levels for adults with either type 1 or type 2 diabetes mellitus. It begins to start working several hours after injection and continues to working evenly up to 24 hours.
Tresiba is available in two forms: single multi-dose vial or single-patient-use FlexTouch pen.
The two pens come in two different strengths:
TRESIBA USAGE & STORAGE
How is Tresiba used?
Follow instructions as directed by your doctor or pharmacist. Read labels, medication guides and information sheets to familiarize yourself with this medication. Any your doctor any questions or if you do not understand instructions.
A medical professional will instruct you on how to administer your insulin.
Tresiba is injected under the skin (subcutaneously) once a day.
The injection pen has a dose counter which decrements after every application.
When using insulin you should be aware of symptoms of low blood sugar (hypoglycemia). Symptoms include: irritability, hunger, confusion, dizziness, anxiety or shakiness. Treat hypoglycemia by eating a sugary snack or beverage such as jelly beans, hard candies, raisins, crackers, juice or non-diet soda.
In severe cases, diabetics can lose consciousness from hypoglycemia. Your doctor may prescribe a glucagon kit if this happens. Familiarize yourself with it and instruct friends and family on how to administer the glucagon injection if you pass out. It is hazardous to consume anything orally if this happens as it could lead to choking.
Also pay attention for signs of high blood sugar (hyperglycemia). Symptoms may include increased urination and thirst.
Factors such as stress, illness, alcohol, exercise, skipping means or surgery can impact blood sugar levels. Consult your doctor before modifying your insulin dosage and schedule.
Tresiba should be used as part of your insulin treatment program. Patients should also make dietary changes, weight management and exercise according to their doctors instructions.
Tresiba for Patients with Type 1 Diabetes
- Dose should be individualized based on a patients needs. Tresiba should be used in combination with a rapid or short-acting insulin.
Tresiba for Patients with Type 2 Diabetes
- Initial dose: 10 units injected once per day.
- dosage should be adjusted based on patients metabolic needs, blood glucose results and glycemic goals. Dose increments should not be made sooner than 3-4 days.
- when adjusting your Tresiba insulin regimen, you should also adjust the dosage for anti-diabetic medications and short-acting insulin.
- closely monitor blood glucose levels in order to minimize hypoglycemia, especially when adjusting your insulin regimen
- Initial dose: 1/3 to 1/2 the total daily dose injected
- Usually the total daily dose is 0.2-0.4 units of insulin per kg of body weight
Current insulin users
- Initiate at the same scheduled injection of long-acting or intermediate-acting insulin
- Monitor blood glucose levels to minimize the effects of hypoglycemia
- Your dosage may need to be adjusted based on your blood glucose levels, metabolic needs and glycemic goals
- Dose increases should happen no sooner than 3-4 days
- When changing insulin regimen, you may need to adjust your short-acting insulin as well
How to store Tresiba?
Do not store insulin near a cooling element or freeze. Insulin that has been previously frozen should be discarded.
Keep insulin away from direct light or heat.
Storing unused/unopened Tresiba:
-Keep refrigerated until expiration date on label
-Store at room temperature and use within 56 days (8 weeks)
Storing in use/opened Tresiba:
- Keep refrigerated until expiration date or store at room temperature for up to 56 days (8 weeks)
- Do not store injection pen with needle attached
- Do not use insulin if it has changed colors or appears cloudy. Contact your doctor if you believe your medication is compromised.
Keep medication away from children or pets.
- Place used needles and syringes in a puncture-proof “sharps” container
- Do not throw medication into household trash or down waste water (i.e. sink, toilet)
As with any insulin, side effects may occur. Tresiba may cause mild or severe side effects. The lists do not provide all of them.
For more information on possible side effects, speak to your doctor or pharmacist who can also provide information on how to deal with side effects.
Most side effects are temporary and go away within a few days or weeks. If they symptoms are severe consult your doctor immediately.
Mild Side Effects
Tresiba may cause mild side effects which may include:
- low blood sugar (hypoglycemia)
- weight gain
- flu-like symptoms (abdominal cramps, fever, chills, vomiting)
- upper respiratory infections (i.e. common cold)
Less mild side effects include:
-injection site reactions such as swelling, itchiness, redness or pain
-lipodystrophy (pitting or thickening of skin at injection site)
-swelling in legs, feet or ankles
These side effects have occurred in less than 5% of participants in clinical studies
Serious Side Effects
Serious side effects may occur when taking Tresiba. Contact your doctor immediately if you experience serious side effects or 911 if you feel the symptoms are life-threatening and believe it’s a medical emergency.
Serious side effects include:
- severe allergic reaction
- severe hypoglycemia (extremely low blood glucose levels)
- hypokalemia (low level of potassium in blood)
Side Effects in Children
Side effects are similar between children and adults. Children may have more complications dealing with hypoglycemia or low blood sugar levels.
Clinical studies have shown that children with type 1 diabetes had shown hypoglycemia to be experienced more in children than adults. During a 1 year trial, 17.8% of children reported hypoglycemia while taking Tresiba, in contrast to adults with 12.3%.
Tresiba Side Effects in Detail
As with taking any medication, patients should be aware of their drug allergies and if they are allergic to any ingredients.
Mild allergic reactions include:
- skin rash
- flushing (redness and warmth of skin)
Severe allergic reactions may include:
- swelling of tongue, mouth or throat
- difficulty speaking
- swelling under the skin (eyelids, lips, feet or hands)
- difficulty breathing/wheezing
Seek medical attention immediately if you feel you are experiencing a severe allergic reaction. Call 911 if you feel they are life-threatening. Speak to your doctor on what to do if you experience a severe allergic reaction.
Weight Loss or Weight Gain
Weight gain is a common side effect when taking insulin which includes Tresiba. Since insulin assists to the liver, muscle and fat cells in removing sugar from the blood and store it for future use. Over time this may lead to weight gain.
Studies that included patients with type 1 diabetes taking Tresiba found that the average patient gained 4 pounds over a period of 1 year. Patients with type 2 diabetes gained an average of 6.6 pounds in 1 year.
Speak to you doctor if you have concerns about weight gain. A healthy diet and regular exercise may be recommended along with your treatment.
Inform your doctor if you are taking thiazolidinedione (THZ) which include rosiglitazone (Avandia) and pioglitazone (Actos) . When used in combination with insulin, it can lead to heart failure and weight gain is usually a symptom.
If you are unexpectedly losing weight while taking Tresiba, inform your doctor so they can examine why this is happening. This may require an adjustment to your insulin dosage.
While insulin does not cause side effects related to the eyes, diabetes itself can.
If blood sugar levels are not controlled for a long period of time then this may result in developing problems such as glaucoma, cataracts or diabetic retinopathy (damage to the retina in the back of your eye). Get your eyes regularly checked to ensure you are not susceptible to any of these problems.
Hypoglycemia may also affect your eyes, such as causing blurred vision.
Hypoglycemia (low blood sugar) is a common side effect with taking any insulin medication.
Several factors may lead to hypoglycemia, such as consuming alcohol, exercise more than usual or skipping meals. It also important to note that hyperglycemia (high blood sugar levels) or hypoglycemia (low blood sugar levels) can be a result of changes in your treatment such as new dosage, introducing a new insulin or injecting into areas that are pitted or thickened.
- In a 1 year clinical study with patients having type 1 diabetes and taking Tresiba, found that 12.3% had an episode of severe hypoglycemia
- In a 1 year clinical study including patients with type 2 diabetes taking Tresiba, found that 0.3% of adults experienced at least one episode of hypoglycemia
- In another study, 4.5% of adults with type 2 diabetes experienced at least one episode of hypoglycemia.
- Another study had shown that 4.5% adults with type 2 diabetes had also had experienced severe hypoglycemia. In this study participants were also taking other medications including oral medications and insulin aspart (ie NovoLog, Fiasp).
Symptoms of hypoglycemia may include:
- heart palpitations
Symptoms of severe hypoglycemia may include:
- difficulty concentrating
- slurred speech
- argumentative or irrational behavior
- coordination problems
If hypoglycemia is not look after, it can lead to more serious complications such as seizures, coma or even death.
If you feel you are experiencing symptoms of hypoglycemia, consume a glucose tablet; a sugar snack such as jelly beans, raisins, candy, fruit juice or soda (non-diet).
For patients experiencing severe hypoglycemia, doctors may prescribe a glucagon kit. This is used if an individual experiences loss of consciousness and cannot take sugar orally. In addition to patients learning when to administer, friends and family should also be told how and when to use it.
Blood glucose levels should be tested regularly to help detect the possible onset of hypoglycemia.
Hypokalemia (low potassium levels)
Hypokalemia is when patients experience low levels of potassium in the blood. This side effect can happen when taking any insulin including Tresiba.
Symptoms of hypokalemia may include:
- irregular heartbeat
- muscle weakness
- muscle cramps
- urinating more often
Consult your doctor if you experience symptoms of hypokalemia. You doctor may want to test potassium levels in your blood.
WARNINGS & PRECAUTIONS
Speak to your doctor before taking Tresiba to discuss risks, safety and how to manage side effects. Discuss any existing medical conditions especially if you have any heart, kidney or liver problems; are pregnant or breast feeding.
Do not inject Tresiba into skin that tender, bruised, pitted, lumpy, scaly, thickened or damaged.
Never share injection pens with others as this can lead to spreading infections or disease.
Before taking Tresiba, make sure you not allergic to insulin degludec or any ingredients contained in this medication.
Tresiba should not be given to children under the age of one.
Inform your doctor if you pregnant or breastfeeding. Controlling diabetes during pregnancy is important since high blood sugar levels can affect both mother and baby. Be sure to follow your doctors instructions on taking Tresiba during pregnancy.
It is unknown whether Tresiba insulin passes through breastmilk or how it affects children who are breastfed. Speak to your doctor about the benefits and risks associated with taking Tresiba while breastfeeding.
Let your doctor know if you are taking any other prescription medication, over-the-counter drugs, herbal supplements or vitamins as they may interact with your treatment.
Taking other drugs, vaccines or even foods can impact how the drug works.
Possible drug interactions may include but not limited to:
- fluoxetine (Prozac, Sarafem)
- isocarboxazid (Marplan)
- monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil)
- HIV medications
- atazanavir (Reyataz)
- darunavir (Prezista)
- fosamprenavir (Lexiva)
- ritonavir (Norvir)
- canagliflozin (Invokana)
- dapagliflozin (Farxiga)
- exenatide (Byetta, Bydureon)
- linagliptin (Tradjenta)
- liraglutide (Victoza, Saxenda)
The list above does not include all possible drugs. Your doctor or pharmacist should provide more information on possible drug interactions with Tresiba.
You may not be prescribed Tresiba if you have existing medical conditions or based on other factors including:
Tresiba may lead to patients experiencing low blood sugar levels. If you already have kidney or liver complications, your doctor may need to adjust your treatment. Speak to your doctor about what you should be aware of when taking insulin with your pre-existing complications.
Alcohol may lead to hypoglycemia since it lowers blood sugar levels. Speak to you doctor about the effects of alcohol on diabetes.