Dulaglutide

Dulaglutide is a prescription medication used along with diet and exercise to treat type 2 diabetes. Dulaglutide belongs to a group of drugs called called incretin mimetics. These work by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy.

Dulaglutide is available as an injectable form to be given just under the skin, once a week. Dulaglutide can be administered at any time of day, with or without food.

Common side effects of dulaglutide include nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Dulaglutide is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with a diet and exercise program.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dulaglutide may be found in some form under the following brand names:

• Trulicity

Serious side effects have been reported with dulaglutide. See the “Dulaglutide Precautions” section.

Common side effects of dulaglutide include the following:

• nausea
• diarrhea
• vomiting
• abdominal pain
• decreased appetite
• fatigue
• indigestion (dyspepsia)

This is not a complete list of dulaglutide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• sulfonylureas
• other medications used to treat diabetes
• insulin

Dulaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. This becomes important with those medications that require monitoring of drug levels. If you are taking any medications that require monitoring of drug levels, your doctor may need to monitor your medications.

This is not a complete list of dulaglutide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with dulaglutide including the following:

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take dulaglutide with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use dulaglutide. Signs and symptoms of low blood sugar may include:

• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heart beat
• sweating
• feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

Kidney problems. Dulaglutide may cause new or worse problems with kidney function, including kidney failure. Dialysis or kidney transplant may be needed. While taking dulaglutide: Call your healthcare provider right away if you have:

• nausea
• vomiting
• diarrhea that will not go away
• or if you cannot take liquids by mouth. You may be at increased risk for kidney problems. 

Severe allergic reactions can happen with dulaglutide. Stop taking dulaglutide, and get medical help right away if you have any symptom of a severe allergic reaction. Do not use dulaglutide if you have had an allergic reaction to dulaglutide or any of the other ingredients in it. 

Symptoms of a severe allergic reaction with dulaglutide may include:

• swelling of your face, lips, tongue, or throat
• problems breathing or swallowing
• severe rash or itching
• fainting or feeling dizzy
• very rapid heartbeat

Pancreatitis. Dulaglutide may cause inflammation of the pancreas (pancreatitis), a potentially life-threatening condition. Tell your doctor right away if you have severe stomach pain and vomiting.

Dulaglutide is not recommended to be used in patients with pre-existing severe gastrointestinal disease. Dulaglutide may be associated with gastrointestinal adverse effects that may be severe.

Do not take dulaglutide if you:

• are allergic to dulaglutide or to any of its ingredients
• you have type I diabetes (insulin-dependent)
• have a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dulaglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking dulaglutide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dulaglutide or to any of its ingredients
• have or have had pancreatitis
• have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had kidney problems
• have liver problems
• have Multiple Endocrine Neoplasia syndrome type 2
• are pregnant or plan to become pregnant
• breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Dulaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dulaglutide falls into category C.  There are no well-controlled studies that have been done in pregnant women. Dulaglutide should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if dulaglutide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using dulaglutide.

Take dulaglutide exactly as prescribed.

Dulaglutide comes as an injectable form to be given just under the skin, once a week. Dulaglutide can be administered at any time of day, with or without food.

Dulaglutide should be injected subcutaneously in the abdomen, thigh, or upper arm.

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more
days before.

If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the
next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

Administration Techniques:

Prior to initiation of dulaglutide, patients should be trained by their healthcare professional on proper injection
technique. Training reduces the risk of administration errors such as improper injection site, needle sticks, and incomplete
dosing.

When using dulaglutide with insulin, patients should administer as separate injections and never mix the products. It is acceptable to inject dulaglutide and insulin in the same body region but the injections should not be adjacent to each other.

When injecting in the same body region, patients should use a different injection site each week.
Do not administer dulaglutide intravenously (vein) or intramuscularly (muscle). 

Always inspect dulaglutide solution for particulate matter and discoloration prior to administration.
 

General Information:

Follow your healthcare provider's instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with dulaglutide, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.

Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication

The dose range of Trulicity (dulaglutide) is .75 mg to 1.5 mg once weekly.

If you take too much dulaglutide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store dulaglutide in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep this and all medicines out of the reach of children.
• Do not use dulaglutide beyond the expiration date.
• If needed, each single-dose pen or prefilled syringe can be kept at room temperature,not to exceed 86°F (30°C) for a total of 14 days.
• Do not freeze dulaglutide. Do not use dulaglutide if it has been frozen.
• Protect dulaglutide from light.
• Store dulaglutide in the original carton until time of administration.
• Discard the dulaglutide single-dose pen or prefilled syringe after use in a puncture -resistant container.

WARNING: RISK OF THYROID C-CELL TUMORS
In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether dulaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies.

Dulaglutide is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with dulaglutide. Counsel regarding the risk factors and symptoms of thyroid tumors.