Albiglutide Subcutaneous

Name: Albiglutide Subcutaneous

Before Using albiglutide

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 albiglutide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to albiglutide 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of albiglutide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albiglutide injection in the elderly.

Pregnancy

Pregnancy Category Explanation
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.

Breast Feeding

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.

Interactions with Medicines

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 albiglutide, 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 albiglutide 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.

  • Lanreotide
  • Octreotide
  • Pasireotide
  • Thioctic Acid

Using albiglutide 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.

  • Acebutolol
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Esmolol
  • Insulin
  • Insulin Aspart, Recombinant
  • Insulin Bovine
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Lispro, Recombinant
  • Labetalol
  • Levobunolol
  • Metipranolol
  • Metoprolol
  • Nadolol
  • Nebivolol
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Practolol
  • Propranolol
  • Simvastatin
  • Sotalol
  • Timolol

Interactions with Food/Tobacco/Alcohol

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 albiglutide. 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
  • Stomach or bowel disease, severe or
  • Medullary thyroid carcinoma (a type of thyroid cancer), history of—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 albiglutide will be safe in patients with this condition.

Uses

Albiglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Albiglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and decreasing the amount of sugar your liver makes.

Albiglutide is not a substitute for insulin if you need insulin treatment.

How to use Albiglutide Pen Injector

Read the Medication Guide and the Instructions for Use Leaflet provided by your pharmacist before you start using albiglutide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the location of the injection site each time to lessen injury under the skin. Learn how to store and discard medical supplies safely. Consult your pharmacist for more details.

Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 7 days. Do not inject into a vein or muscle. It may be used with or without meals.

If you are also using insulin, give albiglutide and insulin as separate injections. Do not mix them. You may inject these medications in the same area of the body, but the injection sites should not be next to each other.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

The dosage is based on your medical condition and response to treatment. Your doctor will start you on a low dose first to decrease your risk of stomach/abdominal side effects, and gradually increase your dose. Follow your doctor's instructions carefully.

Tell your doctor if your condition does not improve or if it worsens (such as if your blood sugar remains high or increases).

Side Effects

See also Warning section.

Injection site pain, vomiting, and stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as persistent nausea/vomiting, severe stomach/abdominal pain).

Although albiglutide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, headache, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication(s).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Albiglutide Pen Injector side effects by likelihood and severity.

Precautions

See also Warning section.

Before taking albiglutide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, disease of the pancreas (pancreatitis), a certain stomach/intestinal disorder (gastroparesis).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Tell your doctor if you are pregnant or plan to become pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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