Trulicity (Dulaglutide)

Trulicity (Dulaglutide)

Trulicity is an FDA-approved and brand-name prescription medication. In combination with exercise and diet, it is used by patients with type 2 diabetes to improve blood sugar levels. It is also used to reduce the risk of cardiovascular issues (problems with blood vessels or heart) such as heart attack or stroke in patients who have multiple cardiovascular risk factors or heart disease.

USAGE & STORAGE

Trulicity is not approved to be used by anyone under 18 years of age.

Each Trulicity injection pen is prefilled for one use only. Pen should be disposed of after use even if there is still medication inside.

When disposing of Trulicity, patients should use a puncture-proof “sharps” container. Follow US state or local laws when disposing of medication.

Keep medication away from children and pets.

Before using Trulicity, review patient guides and instruction sheets included with the medication. Follow instructions as provided by your doctor and pharmacist and ask questions if you do not fully understand the instructions.

Trulicity is administered by injection taken subcutaneously (under the skin). The frequency of each dose should be taken at the same time of day once per week.

Trulicity can be taken with or without meals.

It is injected under the skin of the abdomen (stomach), thigh or upper arm. A healthcare professional such as your doctor or nurse will show you how to properly inject.

Rotate injection sites and avoid injecting into the same area twice as this can lead to complications.

Blood sugar (glucose) levels can be affected by a variety of factors including:

• alcohol
• illness
• skipping meals
• stress
• exercise

If you experience low blood sugar (hypoglycemia), you may experience the following:

• confusion
• anxiety
• shakiness
• dizziness
• hunger
• increased thirst
• increased urination

If you have any of the symptoms mentioned above, you should consume a glucose tablet, sugary food (i.e. hard candy, raisins, crackers) or sugary drink (i.e. fruit juice, non-diet soda).

I you experience severe hypoglycemia, your doctor may prescribe a glucagon emergency kit. Close family or friends should be instructed on how to administer the glucagon injection in the event you lose consciousness and cannot consume anything orally.

How to store Trulicity

The effectiveness of this medication can depend on how and where it’s stored.

Trulicity should be stored in a refrigerator in its original packaging or at room temperature (no higher than 86°F/30°C).

Do not freeze or store medication near cooling element.

Throw away if medication becomes frozen and do not use if previously frozen.

Do not keep medication past the expiration date that should be found on the label.

Trulicity may be stored at room temperature for up to 2 weeks (14 days).

Store away from direct light.

Dosage

Typically your doctor will likely start you on a low dosage and adjust it over time while they monitor how your body responds and find the dosage that is right for you.

The following information describes common dosages for Trulicity however it’s important to follow the dosage prescribed by your doctor.

Trulicity contains an active drug named dulaglutide. It come in a single-dose prefilled pen that contains a liquid solution.

Trulicity pens come in two strengths:

• 0.75 mg of dulaglutide in 0.5 mL of solution
• 1.5 mg of dulaglutide in 0.5 mL of solution

Trulicity pens contains a single dose and designed to deliver the entire dose in a single injection.

Dosage for lowering blood glucose levels in type 2 diabetes

Typically the starting dose for lowering blood sugar levels is 0.75mg taken once per week. If your blood glucose levels need to be lowered more then the dosage my be increased to 1.5mg once per week.

If blood sugar levels are still too high after at least 4 weeks while taking 1.5mg weekly then your doctor may increase the dosage to 3mg once per week.

If your blood sugar levels are still too high, your doctor may increase your dosage further to 4.5mg but only after you’ve been taking 3mg per week for at least 4 weeks.

Dosage for reducing cardiovascular risks in type 2 diabetes

The recommended dose for reducing cardiovascular risks is the same as it is for lowering blood glucose levels for those with type 2 diabetes.

Trulicity and metformin

Trulicity is usually taken with metformin (Riomet, Glumetza) which is a medication often used to lower blood sugar levels for type 2 diabetics. Metformin is usually taken once or twice per day. Your doctor may prescribe both Trulicity and Metformin together to lower blood sugar levels.

SIDE EFFECTS

Similar to taking any insulin medication, Trulicity may have side effects that range from mild to severe. The information below does not cover all side effects experienced by those who have taken this medication.

To familiarize yourself with all side effects, read the patient guides and speak to your doctor or pharmacists about the possible risks. Your doctor may adjust your dosage and provide tips on how to deal with side effects.

Common Side Effects

The more common side effects experienced when taking Trulicity include:

• diarrhea
• fatigue
• nausea
• constipation
• vomiting
• abdominal pain
• decreased appetite

Typically these side effects go away within a few days or weeks. Consult your doctor if these side effects worsen or do not go away.

Serious Side Effects

Any serious side effects associated with taking Trulicity do not occur often. Inform your doctor immediately if you experience any severe side effects. Call 911 if you feel the symptoms are life-threatening.

Serious side effects can include:

• shortness of breath
• urinating less frequent
• pancreatitis
• dark urine
• severe digestive problems
• severe allergic reactions
• hypoglycemia
• increased risk of thyroid cancer

There is a warning on the Trulicity carton about the risk of thyroid cancer. This is the strongest warning provided by the Food & Drug Administration. This is the most serious warning issued by the FDA to detail the dangers of a medication.

Side Effect Details

The following information details some of the side effects that may be experienced by patients when taking Trulicity.

Allergic Reaction

Allergic reactions can occur if patients are allergic to insulin or any of the ingredients in a drug. In clinical trials, 0.5% of patients experienced an allergic reaction, some of which were severe.

Mild symptoms of an allergic reaction may include:

• itchiness
• flushing (redness and warmth in the skin)
• skin rash

Serious symptoms of an allergic reaction may include:

• swelling under the skin (typically lips, eyelids, hands or feet)
• difficulty breathing
• increased/rapid heartbeat
• dizziness
• losing consciousness

If you experience any of the symptoms mentioned above, please contact your doctor immediately. If you feel symptoms are life-threatening, seek medical emergency or call 911.

Weight Loss

Patients taking Trulicity may lose weight, even though Trulicity is not intended for weight loss.

In a clinical study, people who took Trulicity for a 26 week period lost 3-5 pounds compared to those who took metformin who lost 5 pounds.

Weight loss can also vary depending on other drugs that may be taken along with Trulicity.

If you have any concerns about losing weight, consult your doctor.

Pancreatitis

Pancreatitis is a severe inflammation of the pancreas. However rare, this was a very serious side effect that was experienced during clinical studies.

During clinical studies, 1.4 cases in every 1000 patients taking Trulicity for 1 year experienced pancreatitis. 0.88 cases ouf of 1000 who took other diabetes medication experienced pancreatitis.

Symptoms of pancreatitis include:

• loss of appetite
• vomiting
• rapid heart rate
• fever
• nausea
• severe abdominal pain

Inform your doctor if you experience any symptoms and they persist. Your doctor may adjust your treatment depending on the severity and frequency of symptoms. Your doctor may remove Trulicity from your treatment if you experience pancreatitis.

Nausea

Nausea is a common side effect experienced with those taking Trulicity.

During clinical studies, nausea occurred in:

• 12.4% – 21.2% of those taking Trulicity
• 5.3% of those who took the placebo

Patients also experienced burping and vomiting during clinical trials.

Vomiting occurred in:

• 6% – 12.7% of people who were taking Trulicity
• 2.3% of those who were taking a placebo

Inform your doctor if you experiencing vomiting, burping or nausea while taking Trulicity. They may adjust your treatment to reduce these symptoms. The dose of Trulicity also impacted the percentage of those who experienced side effects.

Injection Site Reactions

During clinical trials, 0.5% of people experienced injection site reactions. These site reactions included redness, bruising, pain and rashes. None of of the people taking the placebo experienced any injection site reactions.

Inform your doctor if you experience any injection site reactions.

Constipation

Constipation is another side effect experienced with Trulicity users. In clinical studies, constipation was experienced by:

• 3.7% – 3.9% of people who took Trulicity experienced constipation
• 0.7% of people who took the placebo

Inform your doctor if you experience constipation. Your doctor may adjust your dosage or treatment to reduce side effects.

Digestive Problems

Some people have experienced digestive problems while taking Trulicity. In clinical studies, digestive problems were found in:

• 31.6% – 41% of people who were taking Trulicity
• 21.3% of people who took the placebo

Digestive problems were more common with those taking 1.5mg of Trulicity compared to those taking 0.75mg of Trulicity.

Symptoms of digestive problems include:

• vomiting
• constipation
• abdominal pain
• nausea
• diarrhea
• fatigue
• lack of appetite
• severe diarrhea lasting longer than a few days
• severe vomiting lasting longer than a few days
• dehydrating
• bloating

Speak with your doctor if you experience severe digestive problems. Your doctor may choose to adjust your treatment.

Hypoglycemia (low blood sugar levels)

Hypoglycemia (low blood sugar levels) is a side effect that can be experienced with most insulin medications. Patients taking Trulicity were more likely to experience hypoglycemia if they were using it in combination with other diabetes drugs such as insulin and sulfonylureas.

Symptoms of hypoglycemia include:

• tremors
• hunger
• sweating
• rapid or irregular heartbeat
• dizziness
• confusion
• headache

In clinical studies, 20-21% of patients experienced hypoglycemia when Trulicity was taken in combination with sulfonylurea (glipizide, glimepiride or glyburide).

69-71% of people experienced hypoglycemia when Trulicity was using with insulin. This percentage may vary based on the dosage given.

If you experience symptoms of hypoglycemia, consume a glucose tablet, sugary snack (raisins, sugar packet, jelly beans, hard candy) or a sugar drink (fruit juice or non-diet soda).

If patients are frequently experiencing hypoglycemia, they should inform their doctor immediately so they can adjust their treatment.

Thyroid Cancer

Trulicity has a boxed warning from the Food & Drug Administration (FDA) which is presented when drugs have serious side effects. Trulicity has a boxed warning to alert doctors and patients for the potential side effect of thyroid cancer.

It was found in animal testing in rats, that this medication increased the risk of thyroid tumors and thyroid cancer. It is not known whether there is an increased risk of thyroid tumors from Trulicity in humans.

You shouldn’t take Trulicity if you have a family history of medullary thyroid carcinoma (a rare type of cancer) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Symptoms of thyroid cancer include:

• difficulty swallowing
• lump in your neck
• shortness of breath
• hoarse voice that won’t improve

Inform your doctor immediately if you experience any of these symptoms. They may choose to recommend a treatment based on your individual needs.

Joint Pain (not a side effect)

Other diabetes medication such as Tradjenta (linagliptin) and Januvia (sitagliptin) may lead to severe joint pain. However, joint pain was not a side effect from clinical studies involving Trulicity.

Inform your doctor if you are feeling any joint pain while taking diabetes medication. Your doctor may adjust your medication or provide ways to help reduce the pain.

WARNINGS & PRECAUTIONS

You should not take Trulicity if you have a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

It is not known whether Trulicity causes thyroid tumors or thyroid cancer in human as concluded in animal studies.

Speak to your doctor about the possible risks or if you have any signs of tumors or thyroid cancer such as trouble swallowing, shortness of breath, a hoarse voice, swelling or a lump in your neck.

Do not use Trulicity if you are in a state of diabetic ketoacidosis.

Inform your doctor if you have ever had:

• pancreatitis
• a stomach or intestinal disorder;
• gastroesophageal reflux disease (GERD) or slow digestion;
• eye complications related to diabetes (retinopathy);
• kidney or liver disease
• if you have used either oral diabetes medication or insulin
• if you have been ill with diarrhea or vomiting

Before taking Trulicity you should inform you doctor of any existing allergies. This medication may contain ingredients that may cause an allergic reaction.

Prior to starting treatment using Trulicity, let your doctor know about your medical history, especially if you have a history of heart or kidney disease, pancreatitis, stomach/intestinal problems or certain eye complications (i.e. retinopathy).

Due not drive or operate heavy machinery while taking this medication as it may impact blood sugar levels that cause result in vision problems such as blurred vision, dizziness, drowsiness. Only drive or operate heavy machinery if you are certain you can do them safely and have clear vision and and mental alertness.

Limit alcohol usage while taking Trulicity as this can result in low blood sugar levels.

Inform your doctor or dentist that you are on this medication (including other drugs, over the counter medications and herbal supplements) prior to going into surgery.

Blood sugar levels may be affected by stress, illness, injury, surgery or infections. Inform your doctor if you experience any of these as this may require an adjust to your treatment, medications and blood sugar monitoring.

Pregnancy

If is unknown whether this medication will harm an unborn baby. Pregnancy may cause or worsen diabetes. Inform your doctor if you are pregnant or planning to be pregnant. Your doctor may modify your diabetes treatment during pregnancy such as diet and blood sugar monitoring. This medication should only be used when needed if a patient is pregnant.

Breastfeeding

It is unknown if this medication passes through breast milk and however may not be safe to use if patients are currently breastfeeding. Speak to your doctor about the risks of taking Trulicity if you are currently breastfeeding.

Drug Interactions

The following list of medications may interact with Trulicity. The list does not contain all possible drugs that may interact with Trulicity.

Inform your doctor or pharmacist about any medications, over-the-counter drugs or herbal supplements you are currently taking as this can help avoid any possible interactions.

Speak to your doctor or pharmacist if you have any concerns about possible drug interactions.

When Trulicity is taking with other diabetes medications it may result in hypoglycemia (low blood sugar levels).

The following are medications that my increase the risk of hypoglycemia:

• glimepiride (Amaryl)
• glipizide (Glucotrol, Glucotrol XL)
• glyburide (DiaBeta, Glynase)
• insulin detemir (Levemir)
• insulin glargine (Basaglar, Lantus, Toujeo)
• insulin degludec (Tresiba)