You have a higher chance of getting severe low blood sugar if you: Tell your healthcare provider about all the medicines you take. When 1000 mg acetaminophen was given within 0, 1, and 2 hours after a 120 mcg Symlin injection in patients with type 2 diabetes (n=24), acetaminophen Cmax decreased by 29%, 23%, and 20%, respectively compared to placebo. Injection sites should be rotated so that the same site is not used repeatedly. Pharmacokinetics. All rights reserved. This product information is intended for US Health Care Professionals Only. Safety and effectiveness of Symlin in pediatric patients have not been established. No consistent differences in the efficacy and safety of Symlin have been observed in older patients, but greater sensitivity in some older individuals cannot be ruled out. Pramlintide (trade name Symlin) is an injectable amylin analogue drug for diabetes (both type 1 and 2), developed by Amylin Pharmaceuticals (now a wholly owned subsidiary of AstraZeneca). Adverse reactions (excluding hypoglycemia, which is discussed separately below) commonly associated with Symlin when coadministered with a fixed dose of insulin in the 26- to 52-week, placebo-controlled trials in patients with type 1 diabetes and patients with type 2 diabetes on mealtime insulin are presented in Table 1 and Table 2, respectively. Select one or more newsletters to continue. SYMLIN slows the rate at which food is released from the stomach to the small intestine following a meal and, thus, it reduces the initial postprandial increase in plasma glucose. Pramlintide has a short half-life (approximately 48 minutes in healthy individuals). Symlin therapy should be discontinued if there is: Symlin should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit. Slowing the rate of digestionGlucagon is the hormone which works in tandem with to insulin to control blood glucose levels. Therefore, when introducing Symlin therapy, appropriate precautions need to be taken to avoid increasing the risk for severe hypoglycemia. Call your healthcare provider if you have severe low blood sugar or if you have low blood sugar more often than normal. MECHANISM OF ACTION; Amylin; Amylin is a hormone secreted by the pancreas; Amylin is secreted with insulin in response to food consumption; Pramlintide is a synthetic version of amylin; Amylin has the following physiological effects; Slows gastric emptying (the rate at which food is emptied from the stomach into the small intestine) (No Insulin Dose-Reduction During Initiation), Refrigerated or Temperature up to 86°F (30°C), Symlin can cause serious side effects, including. Symlin has been studied in patients ranging in age from 15 to 84 years of age, including 769 patients ≥65 to 75 years of age and 87 patients ≥75 years of age. An increased frequency of mild-to-moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia. Overall exposure (AUC) to pramlintide is relatively constant with repeat dosing of Symlin, indicating no bioaccumulation. Table 7 summarizes the 6-month results for the dose-titration study. Symlin and insulin should always be administered as separate injections. Oxybutynin has a dual mechanism of action. FlagThis product information is intended for US Health Care Professionals only. Pramlintide is a synthetic form of the hormone amylin, which works to reduce post meal blood glucose levels by: 1. SYMLIN should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring. This affects how fast sugar enters your blood after eating. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression of endogenous glucose output from the liver. Do not repeat Step 1 through 4 before each dose. Contraction of the smooth muscle of the bladder is stimulated by the release of acetylcholine by the nerves within the bladder and the attachment of the acetylcholine to receptors on the surface of the bladder's muscle cells. Two disposable multidose pen-injectors pramlintide acetate 1000 mcg/mL, 1.5 mL. SD: standard deviation; LSM: least squares mean; SE: standard error; U: Units. Other compounds from the gut, called Incretins, also lower the glucose level, as well as affects other biologic areas. If you are having problems using your SymlinPen, go to www.Symlin.com or call Information Support at 1-800-236-9933. Please see US full Prescribing Information, including Boxed WARNING regarding severe hypoglycemia, Medication Guide, and Instructions for Use for SYMLIN. LSM Change in HbA1c at Week 29 Relative to Baseline (%), Placebo-Subtracted LSM change in HbA1c at 6 Months (%) (SE), Mean Insulin Doses at Baseline: Mealtime/Bolus (U) (SD), Mean Percent Change in Insulin Doses (U) at 6 Months: Mealtime/Bolus (SE), Mean Insulin Doses at Baseline: Basal (U) (SD). Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Two 2.7 mL disposable multidose pen-injectors 60•120 mcg NDC 0310-6627-02, Two disposable multidose pen-injectors pramlintide acetate 1000 mcg/mL, 2.7 mL, metformin, Trulicity, Victoza, Tresiba, Lantus, Levemir, Novolog, Basaglar, Toujeo. As is recommended for all patients, Symlin and insulin regimens should be carefully managed to minimize the risk of severe hypoglycemia. THE ROLE OF INCRETINS. Pramlintide lowers blood sugar in three ways. If a Symlin dose is missed, wait until the next scheduled dose and administer the usual amount. A two-year carcinogenicity study was conducted in CD-1 mice with doses of 0.2, 0.5, and 1.2 mg/kg/day of pramlintide (32, 67, and 159 times the exposure resulting from the human dose of 360 mcg/day based on area under the plasma concentration curve or AUC, respectively). What is the most important information I should know about Symlin? In some instances, these reactions may be related to factors other than Symlin, such as irritants in a skin cleansing agent or improper injection technique. It is designed to mimic the activity of the naturally occurring hormone amylin, which is secreted together with insulin and … SYMLIN ® (pramlintide acetate) injection is an adjunctive treatment for adults with type 1 or type 2 diabetes who have failed to achieve desired glucose control despite optimal insulin therapy. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. You can ask your pharmacist or healthcare provider for information about Symlin that is written for health professionals. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine). Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1). Proper patient selection is critical to the safe and effective use of SYMLIN. In human studies, pramlintide, acting as an amylin analog, slows gastric emptying, reduces the postprandial rise in plasma glucagon, and modulates satiety leading to decreased caloric intake. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. This inhibition is temporary and while these enzymes still continue digest carbs, the rate at which they do so is greatly reduced. Symlin did not significantly affect acetaminophen Tmax or Cmax when acetaminophen was administered 1 to 2 hours before Symlin injection. Symlin has not been studied in patients with end-stage renal disease [see Clinical Pharmacology (12.3)]. Symlin is not recommended for patients taking other medications that alter gastrointestinal motility [see Drug Interactions (7.3)]. In animal reproduction studies, congenital abnormalities were observed in fetuses of pregnant rats but not in fetuses of pregnant rabbits exposed during organogenesis to pramlintide at 10 times the clinical dose of 360 mcg/day, based on exposure (see Data). Use caution when administering with medications that may increase susceptibility to hypoglycemia. In addition, reinforce the importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Pramlintide acetate is soluble in water. Pramlintide was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. It is not known if Symlin is safe and effective in children. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. AstraZeneca Pharmaceuticals LP AMYLIN ACTIONS Animal studies. For doses of 15 mcg, 30 mcg, 45 mcg, and 60 mcg. Gradual titration of the Symlin dose minimizes the incidence and severity of nausea [see Dosage and Administration (2)]. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection. There may be new information. Amylin is a pancreatic β -cell hormone that produces effects in several different organ systems. If the 30 mcg dose is not tolerated, discontinuation of Symlin therapy should be considered. Increase the Symlin dose from 60 to 120 mcg prior to each major meal when no clinically significant nausea has occurred for at least 3 days. Do not share your SymlinPen with other people, even if the needle has been changed. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. [Brand] is a [registered] trademark of the AstraZeneca group of companies. Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Instruct patients on the proper injection technique and proper storage of Symlin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In these studies, insulin adjustments were minimized in order to isolate the Symlin effect with insulin adjustments allowed, at the investigator's discretion, when excessive hypoglycemia was encountered. SYMLIN is always used with insulin … Mechanism of Action SYMLIN, by acting as an amylinomimetic agent, has the following effects: 1) modulation of gastric emptying; 2) prevention of the postprandial rise in plasma glucagon; and 3) satiety leading to decreased caloric intake and potential weight loss. Symlin (pramlintide) is a man-made form of a hormone that occurs naturally in the body. Synthetic analog of the polypeptide pancreatic hormone amylin, which slows gastric emptying, supresses glucagon, and regulate appetite. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. Pramlintide is a synthetic form of the hormone amylin, which works to reduce post meal blood glucose levels by: Inhibiting the action of glucagon; Slowing the rate of digestion All other trademarks are property of their respective owners. Symlin and insulin must not be mixed and must be administered as separate injections [see Dosage and Administration (2.4), Warnings and Precautions (5.4), and Clinical Pharmacology (12.3)]. The physiological effects of endogenous amylin and the administered pramlintide are similar. Keep Symlin and all medicines out of the reach of children. We encourage you to read the privacy policy of every website you visit. Injections administered with 6.0-mm and 12.7-mm needles yielded similar bioavailability. Subcutaneous use only. A single, subcutaneous dose of 30 mcg of Symlin to patients with type 1 diabetes and 120 mcg of Symlin to patients with type 2 diabetes administered 1 hour prior to an unlimited buffet meal was associated with reductions in total caloric intake (placebo-subtracted mean changes of ~21% and 23%, respectively), which occurred without decreases in meal duration. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake. Patients with a mean baseline HbA1c of 8.1% (range 6.5%-10.7%) were randomized to receive either Symlin or placebo, both administered before major meals as add-on to insulin therapy. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at po… If SYMLIN-associated severe hypoglycemia occurs, it is usually seen within the first 2 to 3 hours following SYMLIN injection. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).
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