Trulicity (4pens)

Trulicity

What is Trulicity?

Trulicity (Dulaglutide) is an injectable prescription medication that is used along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes. It is also used to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.

Trulicity is not suitable for patients with type 1 diabetes

Trulicity: Use & Storage

Each Trulicity injection pen contains 1 dose and is prefilled for one use only and used 1 time each week. Pens should be disposed of after use even if there is still medicine inside.

When disposing of Trulicity, patients should use a puncture-proof “sharps” container. Follow 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 or pharmacist and ask for advice and resources regarding any prescriptions if you do not fully understand.

Trulicity is administered by injection once a week and taken subcutaneously (under the skin) in the stomach (abdomen), thigh, or upper arm. Trulicity is used 1 time each week on the same day each week at any time of the day. You may change the day of the week as long as your last dose was given 3 or more days before. You may want to mark your calendar to remind you when to take your next dose.

Trulicity can be taken with or without meals.

It is injected under the skin of the abdomen (stomach), thigh or upper arm. A healthcare provider 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, cookies) or sugary drink (i.e. fruit juice, non-diet soda).

If you experience severe hypoglycemia, your doctor may prescribe a glucagon emergency response 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 the refrigerator at 36°F to 46°F (2°C to 8°C). If needed, each single-dose pen can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.

Do not freeze or store medication near the cooling element. Protect the medication from direct light.

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

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

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 is a clear and colorless solution available as:

• 0.75 mg/0.5 mL solution in a single-dose pen
• 1.5 mg/0.5 mL solution in a single-dose pen
• 3 mg/0.5 mL solution in a single-dose pen
• 4.5 mg/0.5 mL solution in a single-dose pen

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

Adult Dosage:

The recommended starting dosage of Trulicity is 0.75 mg injected subcutaneously once weekly. Your healthcare provider may increase the dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase the dosage in 1.5 mg increments after at least 4 weeks on the current dosage. The maximum recommended dosage is 4.5 mg injected subcutaneously once weekly. Use this medication exactly as your healthcare provider tells you to.

Pediatric Dosage:

The recommended starting dosage of Trulicity is 0.75 mg injected subcutaneously once weekly. If additional glycemic control is needed, increase the dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage. Use this medication exactly as your healthcare provider tells you to.

Trulicity and metformin

Trulicity may be taken with metformin (Glucophage, Riomet, Glumetza etc.) 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.

Trulicity Side Effects

It’s important to understand that although Trulicity is FDA-approved, it comes with side effects that may or may not affect you.
Before using Trulicity, you should discuss possible side effects with your doctor or pharmacist.

The information below does not cover all the effects experienced by those who have taken this medication.

To familiarize yourself with all side effects, read the patient guides and speak to your healthcare provider 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

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 Trulicity or to any of the ingredients.

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

Trulicity is not approved for weight loss and should not be used for that purpose. However, some people in clinical studies lost weight while taking Trulicity, along with a healthy diet and exercise.If you’re looking to lose weight, talk to your doctor about creating a safe and effective weight management plan. This plan might still include Trulicity for your diabetes management, but it will also likely involve healthy eating and regular exercise.

Pancreatitis

Pancreatitis is a severe inflammation of the pancreas. However rare, Trulicity may increase the risk of pancreatitis, which is characterized by severe abdominal pain that may radiate to the back and be accompanied by vomiting. Additional 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 by 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 are 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 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 by 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 than 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
• irritability or mood changes

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 used with insulin. This percentage may vary based on the dosage given.

If you experience symptoms of hypoglycemia, consume a glucose tablet, a 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 carries a serious warning from the FDA regarding a potential side effect. This strongest warning, called a “boxed warning,” highlights the risk of thyroid cancer developing while using Trulicity.

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.

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 humans 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 problems 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 your 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, certain eye complications (i.e. retinopathy) or other problems with your health.

Do 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, and drowsiness. Only drive or operate heavy machinery if you are certain you can do them safely and have a clear vision 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 adjustment to your treatment, medications, and blood sugar monitoring.

Pregnancy

There is no clear information on whether this medication is safe for unborn babies. Pregnancy can sometimes affect your diabetes management. If you are pregnant or planning to become pregnant, talk to your doctor right away. They can discuss the risks and benefits of using this medication compared to other options. Your doctor will likely recommend adjusting your diabetes treatment plan, which might involve changes to your diet and blood sugar monitoring.

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 taken with other diabetes medications it may result in hypoglycemia (low blood sugar levels).

The following are medications that may 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)

Consult a Healthcare Provider for all Safety and Dosage Information

Regarding drug interactions, side effects and dosage: the above content is just a summary and not a complete list of important information. Always consult with your healthcare provider – doctor, nurse or pharmacist – on all safety information when considering treatment with Trulicity.