BYETTA PACKAGE INSERT PDF
Patient Information Leaflet. Package leaflet: Information for the patient. Byetta 5 micrograms solution for injection in pre-filled pen. Byetta 10 micrograms solution . Learn about BYETTA, the BYETTA Pen. in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components. PRODUCT MONOGRAPH. BYETTA® exenatide injection. µg/mL. mL prefilled pen (60 doses of 5 µg/dose) and. mL prefilled pen.
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Changes in glucose tolerance occur more commonly in patients receiving 50 mcg or more of ethinyl estradiol or equivalent per day in combined oral contraceptives COCswhich are not commonly used in practice since the marketing of lower dose COCs, patches, injections and rings. Your email has been sent. Monitor blood glucose more carefully during initiation or discontinuation of hormone replacement or hormonal contraceptive treatment. Following subcutaneous injection to patients with type 2 diabetes mellitus, exenatide reaches peak plasma concentrations in roughly 2 hours.
Some beta-blockers, particularly non-selective beta-blockers such as propranolol, have been noted to potentiate insulin-induced hypoglycemia and a delay in recovery of blood glucose to normal levels.
Official BYETTA® (exenatide) injection Healthcare Professional Website
The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. Moderate Cyclosporine has been reported to cause hyperglycemia. However, incretin mimetics have been shown to slow gastric emptying. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
The exenatide Byetta pen-injector must be primed prior to the first use. Some patients may require adjustment to their hypoglycemic medications over time. Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: Beta-blockers also exert complex actions on the body’s ability to regulate blood glucose. According to OBRA, the use of antidiabetic medications should include monitoring e. You may report side effects related to AstraZeneca products by clicking here. Patients with diabetes treated with pegvisomant and antidiabetic agents may be more likely to experience hypoglycemia.
Do NOT mix exenatide with insulin. Thus, salicylates can decrease blood glucose concentrations.
Monitor patients on antidiabetic therapy for blood glucose control if niacin nicotinic acid is added or lnsert to the medication regimen and adjust dosages as clinically warranted Nicotine: Stop taking BYETTA and call your healthcare provider right away if you have pain in your stomach area abdomen that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back.
Early warning signs of hypoglycemia may be less obvious in patients with hypoglycemia unawareness which can be due to a long history of diabetes where deficiencies in the release or response to counter regulatory hormones existwith autonomic neuropathy, intensified diabetes control, or taking beta-blockers, guanethidine, or reserpine.
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Taking an oral contraceptive OC at least 1 hour before an incretin mimetic injection should reduce the risk of an effect on contraceptive or hormonal absorption. Lanreotide inhibits the secretion of insulin and packave.
Moderate The risk of hypoglycemia is increased when exenatide is used in combination with insulins or insulin secretagogues such as the sulfonylureas. Because exenatide has a short elimination half-life and a high molecular weight, if it is excreted in human milk, it will probably be in low concentrations.
Moderate Tegaserod can enhance gastric emptying in patients with diabetes. The presence or absence of a concomitant progestin may influence the significance of any hormonal effect on glucose homeostasis.
Exenatide mimics the enhancement of glucose-dependent insulin secretion and other antihyperglycemic actions of incretins. Replace the blue cap after injection.
Hypoglycemia was not increased when regular-release exenatide injection solution was combined with metformin without a sulfonylurea.
Postmarketing reports of serious hypersensitivity reactions eg anaphylaxis and angioedema. After first use, the Byetta Pen injector can be kept at a temperature not to exceed 77 degrees F 25 degrees C.
Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate: Inflammation of the pancreas pancreatitis may happen, which may be severe and lead to death. The hyperglycemic effect of diazoxide is expected to be antagonized by certain antidiabetic agents e. Concurrent treatment with prandial insulin has not been studied and cannot be recommended.
Moderate Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with ijsert and an antidiabetic agent.
Type 2 Diabetes Medication | BYETTA® (exenatide) injection
In animal developmental studies rabbits, miceexenatide caused cleft palate, irregular skeletal ossification, and an increased number of neonatal deaths. Moderate Salicylates, by inhibiting prostaglandin E2 synthesis, can indirectly increase insulin secretion.
Moderate Patients with diabetes mellitus should be monitored closely during pacage recombinant rhGH therapy. Extended-release exenatide suspension is contraindicated in patients with a personal isnert family history of certain types of thyroid cancer, specifically thyroid C-cell tumors such as medullary thyroid carcinoma MTCor in insertt with multiple endocrine neoplasia syndrome type 2 MEN 2.
Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Dosage adjustments of anti-diabetic medications should be considered. Moderate Hypoglycemia, including symptomatic episodes, has been noted in post-marketing reports with linezolid in patients btetta diabetes mellitus receiving therapy with antidiabetic agents, such as insulin and oral hypoglycemic agents. Exenatide regular-release injection solution Byetta: Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide during pregnancy and lactation, in association with maternal effects.
Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. For treatment of cold symptoms, nasal decongestants may be preferable for short term, limited use 1 to 3 days as an alternative to systemic decongestants in patients taking medications for diabetes.
Go to Patient Site. Moderate Monitor patients receiving octreotide concomitantly with insulin or other antidiabetic agents for changes in psckage control and adjust doses of these medications accordingly. In patients with ESRD receiving dialysis, exenatide was poorly tolerated due to gastrointestinal side effects nausea, vomiting, diarrhea. Send the page ” ” to a friend, relative, colleague or yourself.