Generic Name: albiglutide (AL-bi-GLOO-tide)
Brand Name: Tanzeum
Similar medicines have been shown to cause thyroid cancer in rats and mice. The risk increased with high doses and prolonged use. It is not known if Tanzeum may cause thyroid cancer in humans.
Do not use Tanzeum if you or a family member has had medullary thyroid carcinoma (MTC) (a certain type of thyroid cancer), or if you have multiple endocrine neoplasia syndrome type 2 (MEN2) (another type of cancer).
Contact your doctor immediately if you have a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
Tanzeum is used for:
Treating type 2 diabetes. It is used along with diet and exercise.
Tanzeum is a glucagon-like peptide (GLP)-1 receptor agonist. It works by increasing the amount of insulin that your body produces.
Do NOT use Tanzeum if:
- you are allergic to any ingredient in Tanzeum
- you or a family member has a history of MTC
- you have MEN2
- you have type 1 diabetes, pancreas inflammation (pancreatitis), or severe stomach or bowel problems
- you have diabetic ketoacidosis (high blood acid levels)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tanzeum:
Some medical conditions may interact with Tanzeum. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have stomach problems (eg, trouble digesting food, slowed emptying of the stomach)
- if you have a history of kidney problems, liver problems, or inflammation of the pancreas (pancreatitis)
- if you or a family member has a history of any thyroid cancer
- if you have never taken another medicine for type 2 diabetes
Some MEDICINES MAY INTERACT with Tanzeum. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Insulin or oral diabetes medicines (eg, glyburide) because the risk of low blood sugar may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tanzeum may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tanzeum:
Use Tanzeum as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tanzeum comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Tanzeum refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
- Use Tanzeum with or without food.
- Take Tanzeum on the same day each week.
- A health care provider will teach you how to use Tanzeum. Be sure you understand how to use Tanzeum. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use the proper technique taught to you by your health care provider. Inject deep under the skin, in the stomach area (abdomen), upper leg (thigh), or upper arm as directed by your doctor. Do NOT inject Tanzeum into a vein or muscle.
- Do not use Tanzeum if it contains particles, is cloudy or discolored, or if the pen is cracked or damaged.
- Use your dose within 8 hours after mixing.
- Use your dose right away after you attach the needle to the pen.
- Rotate injection sites as you have been told by your doctor.
- Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
- If you also give yourself insulin injections, do NOT mix Tanzeum in the same syringe as the insulin. Administer Tanzeum and insulin as 2 separate injections. Both injections may be given in the same body area, but you should not give the injections right next to each other.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Use Tanzeum on a regular schedule to get the most benefit from it.
- If you miss a dose of Tanzeum, use it as soon as possible. If you miss taking Tanzeum for more than 3 days, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Tanzeum.
Important safety information:
- Follow the diet and exercise program given to you by your health care provider.
- Do NOT take more than the recommended dose without checking with your doctor.
- Tell your doctor or dentist that you take Tanzeum before you receive any medical or dental care, emergency care, or surgery.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Tanzeum exactly as prescribed, tell your doctor.
- Tanzeum may increase the risk of low blood sugar when used with other medicines that can cause low blood sugar (eg, insulin, sulfonylureas). Low blood sugar may also be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. Tell your doctor right away if this happens.
- It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar, like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Pancreas inflammation (pancreatitis) has been reported in patients taking Tanzeum. Call your doctor right away if you develop severe or persistent stomach or back pain (with or without nausea or vomiting).
- Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away.
- Tanzeum may change the way that medicines taken by mouth are absorbed into your body. Be sure your doctor knows about all the medicines you take. Discuss any questions or concerns with your doctor.
- If diarrhea, nausea, or vomiting occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Dehydration may lead to new or worsening kidney problems.
- Lab tests may be performed while you use Tanzeum. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tanzeum while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using Tanzeum.
Possible side effects of Tanzeum:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cough; diarrhea; joint pain; nausea; pain, swelling, or redness at the injection site; stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; dizziness; fainting; fast heartbeat; unusual hoarseness); change in the amount of urine produced; severe stomach or back pain (with or without vomiting); symptoms of thyroid cancer (eg, lump or swelling in the neck, persistent hoarseness, shortness of breath, trouble swallowing).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Tanzeum:
Store in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Tanzeum may be stored at room temperature up to 86 degrees F (30 degrees C) for up to 4 weeks before use.
Store Tanzeum away from excessive heat and sunlight. Do not use Tanzeum if it has been frozen or overheated (above 86 degrees F). Keep the pen dry. Do not store Tanzeum with a needle attached to the pen. Do not use Tanzeum past the expiration date on the carton. Keep Tanzeum out of the reach of children and away from pets.
- If you have any questions about Tanzeum, please talk with your doctor, pharmacist, or other health care provider.
- Tanzeum is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Tanzeum or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tanzeum. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tanzeum. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Tanzeum.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.