Bydureon Bcise

Bydureon Bcise is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus and should be used along with diet and exercise.

• Bydureon Bcise is not recommended as the first choice of medicine for treating diabetes.
• Bydureon Bcise is not for use in people with type 1 diabetes.
• Bydureon Bcise and Bydureon are long-acting forms of the medicine in Byetta (exenatide). Bydureon Bcise should not be used at the same time as Byetta or Bydureon.
• It is not known if Bydureon Bcise can be used in people who have had pancreatitis.
• It is not known if Bydureon Bcise is safe and effective for use in children.

WARNING

RISK OF THYROID C-CELL TUMORS

• Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether Bydureon Bcise causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.
• Bydureon Bcise 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 for MTC with the use of Bydureon Bcise and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with Bydureon Bcise.

Bydureon Bcise may cause serious side effects, including:

• inflammation of your pancreas (pancreatitis). Stop using Bydureon Bcise and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Bydureon Bcise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
  • dizziness or light-headedness
  • blurred vision
  • anxiety, irritability, or mood changes
  • sweating
  • slurred speech
  • hunger
  • confusion or drowsiness
  • shakiness
  • weakness
  • headache
  • fast heartbeat
  • feeling jittery
• kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse or kidney failure.
• stomach problems. Other medicines like Bydureon Bcise may cause severe stomach problems. It is not known if Bydureon Bcise causes or worsens stomach problems.
• low blood platelet count (drug-induced thrombocytopenia). Bydureon Bcise may cause the number of platelets in your blood to be reduced. When your platelet count is too low, your body cannot form blood clots. You could have serious bleeding that could lead to death. Stop using Bydureon Bcise and call your healthcare provider right away if you have unusual bleeding or bruising. Your blood platelet count may continue to be low for about 10 weeks after stopping Bydureon Bcise.
• serious allergic reactions. Stop using Bydureon Bcise and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
• injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use Bydureon. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.
• gallbladder problems. Gallbladder problems have happened in some people who take Bydureon or other medicines like Bydureon. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include: pain in the right or middle upper stomach area, nausea and vomiting, fever, or your skin or the white part of your eyes turns yellow.

The most common side effects of Bydureon Bcise may include a bump (nodule) at the injection site and nausea.

Nausea is most common when you first start using Bydureon Bcise but decreases over time in most people as their body gets used to the medicine.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Bydureon Bcise.

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

Recommended Dosing

• The recommended dose of Bydureon Bcise is 2 mg subcutaneously once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
• The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before the new day of administration.

Missed Dose

• If a dose is missed, administer the dose as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
• If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume Bydureon Bcise with the next regularly scheduled dose.

Administration Instructions

• Bydureon Bcise is intended for patient self-administration. Prior to initiation, train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered.
• Remove the autoinjector from the refrigerator 15 minutes prior to mixing the injection, in order to reach room temperature.
• Mix by shaking vigorously for at least 15 seconds. After mixing, Bydureon Bcise should appear as an opaque, white to off-white suspension, evenly mixed with no residual medicine along the side, bottom or top of the inspection window.
• Inspect visually for particulate matter and discoloration prior to administration (Bydureon Bcise contains microspheres which appear as white to off-white particles). Do not use if foreign particulate matter is present or if discoloration is observed. Refer patients to the accompanying Instructions for Use for disposal information.
• Administer Bydureon Bcise immediately after the autoinjector is prepared as a subcutaneous injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region.
• Do not administer Bydureon Bcise intravenously or intramuscularly.
• Refer patients to the accompanying Instructions for Use for complete administration instructions with illustrations].

Initiating Bydureon Bcise Therapy

Prior treatment with an immediate-or extended-release exenatide product is not required when initiating Bydureon Bcise therapy. Discontinue an immediate-or extended-release exenatide product prior to initiation of Bydureon Bcise.

Patients changing from immediate-release exenatide to Bydureon Bcise may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations.

Patients changing from another extended-release exenatide product to Bydureon Bcise may do so at the next regularly scheduled dose.

Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Bydureon Bcise and Other Exenatide-Containing Products

• Limited data with exenatide, the active ingredient in Bydureon Bcise, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
• There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
• There is no information regarding the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production.
• Exenatide, the active ingredient in Bydureon Bcise was present in the milk of lactating mice. However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear.