Dulaglutide (Subcutaneous route)
In male and female rats, dulaglutide caused 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 of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. 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). Counsel patients regarding the potential risk of MTC with use of dulaglutide and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with dulaglutide .
Glucagon-Like Peptide-1 Receptor Agonist
Uses of This Medicine:
Dulaglutide injection is used to treat type 2 diabetes mellitus. Dulaglutide is used together with diet and exercise to help control your blood sugar.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of dulaglutide injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dulaglutide injection in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Thioctic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diabetic ketoacidosis (ketones in the blood) or
- Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.
- Gastroparesis (stomach does not empty food normally), severe or
- Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
- Medullary thyroid carcinoma (a type of thyroid cancer), personal or family history of or
- Stomach or bowel disease, severe—Should not be used in patients with these conditions.
- Kidney disease or
- Thyroid tumor—Use with caution. May make these conditions worse.
- Pancreatitis (inflammation of the pancreas), history of—It is not known if this medicine will be safe in patients with this condition.
Proper Use of This Medicine:
When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
You will be using dulaglutide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.
This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
If you use this medicine with insulin, do not mix them into the same syringe. It is acceptable to inject this medicine and insulin in the same body area, but the shots should not be right next to each other.
Allow the medicine to warm at room temperature before you inject it. If the medicine in the pen has changed color, looks cloudy, or if you see particles in it, do not use it.
Use a new needle each time you inject your medicine.
This medicine also works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to use the doses at the same day each week.
Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.
Throw away used needles in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.
Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For diabetes mellitus:
- Adults—0.75 milligram (mg) injected under the skin once a week. Your doctor may increase your dose to 1.5 mg once a week as needed and until your blood sugar is controlled.
- Children—Use is not recommended.
- For diabetes mellitus:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, use it as soon as possible within 3 days after your missed dose. If you miss a dose by more than 3 days, wait until your next regular weekly dose.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store your new, unused medicine pen or prefilled syringe in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the opened medicine pen or prefilled syringe in the refrigerator, or at room temperature for up to 14 days.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are using dulaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
Check with your doctor right away if you have the following symptoms while using this medicine: a mass in the neck, difficulty with swallowing, hoarseness, or troubled breathing. These may be symptoms of a serious thyroid problem.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.
This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use dulaglutide with other medicines that can lower blood sugar, such as insulin, metformin, or a sulfonylurea. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
- Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
- If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
- Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.
- If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
Side Effects of This Medicine:
- Incidence not known
- change in urination
- cold sweats
- cool, pale skin
- difficulty with breathing or swallowing
- fast heartbeat
- increased hunger
- loss of appetite
- lump in the neck
- muscle twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- rapid weight gain
- reddening of the skin, especially around the ears
- slurred speech
- swelling of the eyes or inside of the nose
- swelling of the face, ankles, or hands
- trouble breathing
- unusual tiredness or weakness
- yellow eyes or skin
- More common
- Less common
- Acid or sour stomach
- decreased appetite
- general feeling of discomfort or illness
- heartburn or indigestion
- lack or loss of strength
- stomach discomfort, upset, or pain
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017