Pramlintide, a synthetic analog of human amylin, is an antidiabetic agent.1, 2
Pramlintide acetate is used as an adjunct to preprandial insulin therapy for the management of type 1 diabetes mellitus in patients who have not achieved adequate glycemic control with insulin therapy.1, 3 Pramlintide also is used as an adjunct to therapy with preprandial insulin with or without concomitant metformin and/or a sulfonylurea for the management of type 2 diabetes mellitus in patients who have not achieved adequate glycemic control with insulin given alone or in combination with metformin and/or a sulfonylurea.1
Efficacy of pramlintide as adjunctive therapy in the management of type 1 diabetes mellitus is supported by results from several long-term (26-52 weeks), randomized, placebo-controlled studies.1 In patients receiving flexible- or fixed-dose insulin therapy, addition of pramlintide (30 or 60 mcg subcutaneously prior to major meals) to insulin therapy improved glycemic control, as evidenced by reductions of 0.43 or 0.1% in glycosylated hemoglobin (HbA1c) at 6 months with pramlintide or placebo, respectively.1 In a dose-titration study, addition of pramlintide (initiated at a dosage of 15 mcg subcutaneously prior to major meals and increased in 15-mcg increments to 30 or 60 mcg per dose based on patient tolerance) to a reduced dosage of preprandial insulin (30-50% lower dosage than that of the existing regimen) resulted in reductions in HbA1c that were equivalent to those achieved in patients maintained on their existing insulin regimens and placebo.1
Efficacy of pramlintide as adjunctive therapy in the management of type 2 diabetes mellitus is supported by results from several long-term (26-52 weeks), randomized, placebo-controlled studies.1 Addition of pramlintide (120 mcg subcutaneously prior to major meals) to existing antidiabetic therapy (i.e., a fixed-dose insulin regimen used alone or in combination with metformin and/or a sulfonylurea) resulted in improved glycemic control, as evidenced by reductions of 0.57 or 0.17% in HbA1c at 6 months with pramlintide or placebo, respectively.1
Concomitant pramlintide and insulin therapy increases the risk of severe insulin-induced hypoglycemia, particularly in patients with type 1 diabetes mellitus .1, 6, 8, 10
Pramlintide acetate is administered subcutaneously into the abdominal wall or thigh immediately before each major meal (i.e., a meal providing at least 250 kcal or containing at least 30 g of carbohydrate);1, 4 administration into the arm is not recommended because of variable absorption.1
Pramlintide and insulin should be administered as separate injections.1 Mixing pramlintide and short- or long-acting insulin in the same syringe has resulted in alterations in the pharmacokinetics of pramlintide in some studies1, 13 but not others;12 the manufacturer states that pramlintide injection should not be mixed with any type of insulin.1, 4, 5 Pramlintide injection sites should be rotated and should be more than 2 inches away from insulin injection sites.1
A conventional U-100 insulin syringe (preferably a 0.3-mL size for optimal accuracy) should be used to withdraw the appropriate dose of pramlintide from the vial.1, 4 The syringe should be filled to the unit mark that corresponds to the volume of solution to be administered (see Table 1).1, 4
Pramlintide Dose (mcg) | Required Volume of Pramlintide Acetate Injection (mL) | Unit Mark on U-100 Insulin Syringe That Corresponds to Required Injection Volume |
|---|---|---|
15 | 0.025 | 2.5 |
30 | 0.05 | 5 |
45 | 0.075 | 7.5 |
60 | 0.1 | 10 |
120 | 0.2 | 20 |
Dosage of pramlintide acetate is expressed in terms of pramlintide.1
For management of type 1 diabetes mellitus in patients who have not achieved adequate glycemic control with rapid-acting or short-acting insulin at mealtimes, the usual initial dosage of pramlintide as adjunctive therapy is 15 mcg given subcutaneously immediately before each major meal (i.e., a meal providing at least 250 kcal or containing at least 30 g of carbohydrate).1, 4, 14 The maximum daily dosage of pramlintide has not been established;14 however, in clinical studies in patients with type 1 diabetes mellitus, pramlintide has been administered up to 4 times daily before each major meal.2, 8, 9, 14
During initiation of pramlintide therapy, the dosage of insulin in the existing preprandial insulin regimen, including rapid-acting or short-acting insulin given alone or in fixed combination with a longer-acting insulin, should be reduced by 50% to reduce the risk of severe insulin-induced hypoglycemia .1, 4 Patients should monitor blood glucose concentrations frequently, including before and after meals and at bedtime.1, 4, 5 When no clinically important nausea has occurred for at least 3 days at the current dosage level, the maintenance dosage of pramlintide may be increased in increments of 15 mcg under medical supervision to 30, 45, or 60 mcg before each major meal.1, 4 If the 30-mcg dosage of pramlintide is not tolerated, discontinuance of the drug should be considered.1, 4 If nausea persists at the 45- or 60-mcg dosage level, dosage should be reduced to 30 mcg before each major meal.1, 4 Once the maintenance dosage of pramlintide has been attained and nausea (if experienced) has subsided, the dosage of preprandial insulin should be adjusted under medical supervision to achieve optimal glycemic control.1, 4
During dosage adjustments, patients should have their insulin and pramlintide dosages assessed by their clinician at least once a week until a maintenance dosage of pramlintide is achieved, the drug is well tolerated, and blood glucose concentrations are stable.1 Once a maintenance dosage has been attained, patients should contact their clinician if recurrent nausea or hypoglycemia occurs.1, 4
If a patient misses a dose of pramlintide, the dose should be omitted, and the next dose should be taken at the regularly scheduled time.1, 4 A dose of pramlintide should be omitted if a meal is skipped or if the meal provides less than 250 kcal or contains less than 30 g of carbohydrate.4
If pramlintide is reinitiated following an interruption in therapy, such as for surgery or other coexisting conditions, the recommended initial dosage and dosage titration schedule should be employed.1, 4
For management of type 2 diabetes mellitus in patients who have not achieved adequate glycemic control with preprandial insulin therapy used with or without metformin and/or a sulfonylurea, the usual initial dosage of pramlintide as adjunctive therapy is 60 mcg given subcutaneously immediately before each major meal (i.e., a meal providing at least 250 kcal or containing at least 30 g of carbohydrate).1, 4 The maximum daily dosage of pramlintide has not been established;14 however, in clinical studies in patients with type 2 diabetes mellitus, pramlintide has been administered up to 3 times daily before each major meal.8, 14
During initiation of pramlintide therapy, the dosage of insulin in the existing preprandial insulin regimen, including rapid-acting or short-acting insulin given alone or in fixed combination with a longer-acting insulin, should be reduced by 50% to reduce the risk of severe insulin-induced hypoglycemia. 1, 4 Patients should monitor blood glucose concentrations frequently, including before and after meals and at bedtime.1, 4, 5 When no clinically important nausea has occurred for 3-7 days, the maintenance dosage of pramlintide may be increased under medical supervision to 120 mcg before each major meal.1 If nausea is persistent at the 120-mcg dosage level, dosage should be reduced to 60 mcg before each major meal.1, 4 Once the maintenance dosage of pramlintide has been achieved and nausea (if experienced) has subsided, the dosage of preprandial insulin should be adjusted under medical supervision to achieve optimal glycemic control.1, 4, 5
During dosage adjustments, patients should have their insulin and pramlintide dosages assessed by their clinician at least once a week until a maintenance dosage of pramlintide is achieved, the drug is well tolerated, and blood glucose concentrations are stable.1 Once a maintenance dosage has been achieved, patients should contact their clinician if recurrent nausea or hypoglycemia occurs.1, 4
If a patient misses a dose of pramlintide, the dose should be omitted, and the next dose should be taken at the regularly scheduled time.1, 4 A dose of pramlintide should be omitted if a meal is skipped or if the meal provides less than 250 kcal or contains less than 30 g of carbohydrate.4
If pramlintide is reinitiated following an interruption in therapy, such as for surgery or other coexisting conditions, the recommended initial dosage and dosage titration schedule should be employed.1, 4
The manufacturer of pramlintide recommends discontinuance of the drug if patients demonstrate recurrent unexplained hypoglycemia that requires medical assistance, persistent clinically important nausea, or noncompliance with self-monitoring of blood glucose concentrations, insulin dosage adjustments, or scheduled clinician contacts or recommended clinic visits.1
Dosage requirements in patients with moderate or severe renal impairment (creatinine clearance exceeding 20 mL/minute, but 50 mL/minute or less) are not altered.1 Pramlintide has not been studied in patients undergoing peritoneal dialysis or hemodialysis.1, 14
Severe insulin-induced hypoglycemia has been reported in patients receiving concomitant therapy with pramlintide and insulin .1, 3, 6, 7, 8, 9, 10, 11 While pramlintide alone does not cause hypoglycemia, concomitant pramlintide and insulin therapy increases the risk of severe insulin-induced hypoglycemia, particularly in patients with type 1 diabetes mellitus.1, 6, 8, 10 Severe hypoglycemia with combined insulin and pramlintide therapy generally occurs within 3 hours following injection of pramlintide.1 In clinical trials, a transient increase in the rate of severe hypoglycemia was seen during the first 4 weeks of pramlintide treatment.3, 7, 8, 9
If severe hypoglycemia occurs while operating a motor vehicle or heavy machinery, or while engaging in other high-risk activities, serious injuries may occur.1, 6
The manufacturer states appropriate patient selection, careful patient instruction, and frequent pre-meal and post-meal glucose monitoring combined with insulin dose adjustments, specifically an initial 50% reduction in pre-meal doses of short-acting insulin, are important for reducing the risk for severe hypoglycemia. 1
Early symptoms of hypoglycemia may be altered or decreased in patients with long-standing diabetes mellitus or diabetic neuropathy, or those receiving intensive antidiabetic drug (e.g., insulin) regimens or drugs such as β-adrenergic blocking agents, clonidine, guanethidine, or reserpine.1
Patients and responsible family members should be properly instructed in the early detection, treatment, and symptoms of hypoglycemia, such as hunger, headache, sweating, tremor, irritability, or difficulty concentrating.1 Rapid reductions in blood glucose concentrations may precipitate symptoms of hypoglycemia, regardless of glucose concentration.1
Hypoglycemia also may occur when pramlintide is used concomitantly with oral antidiabetic agents, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide anti-infective agents.1 The addition of pramlintide to therapy with one or more of these agents, or other agents that can increase the risk of hypoglycemia, may necessitate further insulin dose adjustments and particularly close monitoring of blood glucose.1
Pramlintide does not alter the counterregulatory hormonal response to insulin-induced hypoglycemia and does not appear to alter perception of hypoglycemic symptoms at plasma glucose concentrations as low as 45 mg/dL.1
The incidences of severe hypoglycemia in patients with type 1 or type 2 diabetes mellitus receiving combined pramlintide and insulin therapy are shown in Table 2 and Table 3, respectively.1, 14
Parameter | Long-term Studies (No Insulin Dose Reduction during Initiation) Placebo + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Placebo + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Symlin® + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Symlin® + Insulin | Open-label Study (Insulin Dose Reduction during Initiation) Symlin® + Insulin | Open-label Study (Insulin Dose Reduction during Initiation) Symlin® + Insulin |
|---|---|---|---|---|---|---|
Severe Hypoglycemia | 0-3 Months (n=284) | >3-6 Months (n=251) | 0-3 Months (n=292) | >3-6 Months (n=255) | 0-3 Months (n=166) | >3-6 Months (n=150) |
Patient-ascertaineda Incidence (%) | 2.1 | 2.4 | 8.2 | 4.7 | 0.6 | 0.7 |
Medically assistedb Incidence (%) | 0.7 | 1.2 | 1.7 | 0.4 | 0.6 | 0.7 |
aPatient-ascertained hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate) and/or requiring the administration of glucagon injection, IV glucose, or other medical intervention.
bMedically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.14
Parameter | Long-term Studies (No Insulin Dose Reduction during Initiation) Placebo + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Placebo + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Symlin® + Insulin | Long-term Studies (No Insulin Dose Reduction during Initiation) Symlin® + Insulin | Open-label Study (Insulin Dose Reduction during Initiation) Symlin® + Insulin | Open-label Study (Insulin Dose Reduction during Initiation) Symlin® + Insulin |
|---|---|---|---|---|---|---|
Severe Hypoglycemia | 0-3 Months (n=538) | >3-6 Months (n=470) | 0-3 Months (n=716) | >3-6 Months (n=576) | 0-3 Months (n=265) | >3-6 Months (n=213) |
Patient-ascertaineda Incidence (%) | 10.8 | 8.7 | 16.8 | 11.1 | 5.7 | 3.8 |
Medically assistedb Incidence (%) | 3.3 | 4.3 | 7.3 | 5.2 | 2.3 | 0.9 |
aPatient-ascertained hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate) and/or requiring the administration of glucagon injection, IV glucose, or other medical intervention.
bMedically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.14
Both patient-ascertained and medically assisted severe hypoglycemia appeared to occur at an increased rate in (1) patients with type 1 compared with type 2 diabetes mellitus, (2) long-term placebo-controlled studies in which insulin dosage reduction was not allowed during initiation of pramlintide therapy compared with open-label clinical practice studies, and (3) during the first 3 months of combined therapy compared with months 3-6 of the studies.1, 14
Before pramlintide therapy is instituted, the patient's glycosylated hemoglobin (HbA1c), current insulin regimen, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, and body weight should be assessed.1 Pramlintide therapy should only be considered in patients with type 1 or 2 diabetes mellitus who are receiving insulin and have failed to achieve adequate glycemic control despite individualized insulin management; such patients should be receiving ongoing care under the guidance of a clinician skilled in the use of insulin and supported by a diabetes educator.1
The manufacturer states that use of pramlintide should not be considered in patients who have demonstrated poor compliance with their current insulin regimen or with prescribed self-monitoring of blood glucose concentrations, those with an HbA1c exceeding 9%, those who have had recurrent episodes of hypoglycemia requiring medical assistance during the previous 6 months, those with hypoglycemic unawareness, those with a documented diagnosis of gastroparesis, those who require therapy with drugs that stimulate GI motility, or pediatric patients.1, 14
In controlled clinical trials of up to 12 months' duration, potential systemic allergic reactions were reported with pramlintide therapy in 5% each of patients with type 1 or 2 diabetes mellitus; similar reactions were reported in 5 or 4% of placebo-treated patients with type 1 or 2 diabetes mellitus, respectively.1, 14 Pramlintide therapy was not withdrawn in any patient as a result of such systemic allergic reactions.1
Patients receiving pramlintide may experience local allergic reactions, such as redness, swelling, or itching at the site of injection.1 These reactions usually resolve in a few days to a few weeks and may in some patients be related to factors other than pramlintide, such as improper skin injection technique or irritants in a skin cleansing agent.1
Category C.
Not known whether pramlintide is distributed into milk.1 Pramlintide should be administered to nursing women only if it is determined by a clinician that the potential benefit outweighs the risk to the infant.1
Safety and efficacy not established in children younger than 17 years of age.1, 14 Pediatric patients should not be considered for pramlintide therapy.1
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 Pharmacokinetic studies have not been conducted in geriatric patients.1 No consistent age-related differences in the activity of pramlintide have been observed in geriatric patients.1 Both pramlintide and insulin regimens should be carefully managed to obviate an increased risk of hypoglycemia.1 Pramlintide should only be used in patients known to fully understand and adhere to proper insulin adjustments and glucose monitoring.1
Pramlintide has not been studied in patients with hepatic impairment.1 The manufacturer states that hepatic dysfunction is not expected to affect blood concentrations of pramlintide due to the marked degree of renal metabolism.1
Patients with moderate or severe renal impairment (creatinine clearance exceeding 20 mL/minute, but 50 mL/minute or less) did not experience increased pramlintide exposure or reduced pramlintide clearance compared with patients with normal renal function.1 Dosage requirements in patients with moderate or severe renal impairment (creatinine clearance exceeding 20 mL/minute, but 50 mL/minute or less) are not altered.1 Pramlintide has not been studied in dialysis patients.1
Adverse effects reported in at least 5% of patients with type 1 diabetes mellitus receiving pramlintide acetate in clinical trials include hypoglycemia, nausea, anorexia, inflicted injury, vomiting, arthralgia, fatigue, allergic reaction, and dizziness.1 Adverse effects reported in at least 5% of patients with type 2 diabetes mellitus receiving pramlintide acetate in clinical trials include hypoglycemia, nausea, headache, anorexia, vomiting, abdominal pain, fatigue, dizziness, cough, and pharyngitis.1
Potential pharmacokinetic interaction (pramlintide-induced slowing of gastric emptying may influence the effects of drugs that alter GI motility [i.e., anticholinergic agents such as atropine]).1 Patients using these drugs have not been studied in clinical trials of pramlintide.1
Drugs That Alter Intestinal Absorption of Nutrients
Potential pharmacokinetic interaction (pramlintide-induced slowing of gastric emptying may influence the effects of drugs that slow the intestinal absorption of nutrients [i.e., α-glucosidase inhibitors]).1 Patients using these drugs have not been studied in clinical trials of pramlintide.1
Drugs That May Potentiate Hypoglycemic Effects
Potential pharmacologic interaction (increased risk of hypoglycemia) with concomitant oral antidiabetic agents, angiotensin-converting enzyme (ACE) inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates, or sulfonamide anti-infectives.1 When pramlintide therapy is administered in conjunction with existing antidiabetic therapy (e.g., insulin, sulfonylurea) or other drugs that potentiate hypoglycemia, additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary.1 No formal interaction studies have been performed to assess the effect of pramlintide on the pharmacokinetics of oral antidiabetic agents.1
Effects on GI Absorption of Drugs
Potential pharmacokinetic interaction (delayed absorption of concomitantly administered oral drugs).1 When the rapid onset of a concomitantly orally administered drug is a critical determinant of effectiveness, as with analgesics, the drug should be administered at least 1 hour prior to or 2 hours after pramlintide injection.1
Potential pharmacokinetic interaction (peak plasma acetaminophen concentration decreased by 29% and time to peak plasma concentration delayed by 48-72 minutes).1, 14 The change in time to peak plasma concentration of acetaminophen is dependent on the time of acetaminophen administration relative to that of pramlintide injection.1 Pramlintide did not substantially affect time to peak plasma concentration when acetaminophen was administered 1-2 hours before pramlintide injection, but it increased the time to peak plasma concentration when acetaminophen was administered simultaneously with or up to 2 hours following pramlintide injection.1 Area under the concentration-time curve (AUC) of acetaminophen was not markedly changed.1
Potential pharmacologic interaction (increased risk of severe hypoglycemia).1 In clinical trials, the concomitant use of sulfonylureas and biguanides did not alter the adverse event profile of pramlintide.1
Sympatholytic agents (e.g., β-adrenergic blocking agents, clonidine, guanethidine, reserpine) may alter or decrease manifestations of hypoglycemia.1
Pramlintide is a synthetic analog of amylin, a glucoregulatory hormone synthesized by pancreatic β-cells and released with insulin in response to a meal.1, 2 Pramlintide, a 37-amino acid polypeptide, differs structurally from human amylin by the replacement of alanine, serine, and serine at positions 25, 28, and 29, respectively, with proline.1 In patients with type 1 or 2 diabetes mellitus who require insulin therapy, secretion of amylin from pancreatic β-cells in response to a meal is reduced.1, 3
Pramlintide is an amylinomimetic agent that has physiologic actions equivalent to those of human amylin.1, 3 Pramlintide inhibits inappropriately high glucagon secretion during episodes of hyperglycemia (e.g., after a meal) in patients with type 1 or 2 diabetes mellitus1, 2, 3 but does not impair the normal glucagon response to hypoglycemia.3 In addition, pramlintide slows gastric emptying and reduces the rate of glucose absorption from a meal without altering the net absorption of ingested carbohydrate and other nutrients.1, 3 Use of pramlintide in combination with insulin in patients with type 1 or 2 diabetes mellitus prevents the initial postprandial glucose excursions usually observed with insulin therapy alone.1, 3
Pramlintide reduces food intake and increases satiety, possibly resulting in weight loss.1, 3
Pramlintide is metabolized in the kidneys principally by lysis of the terminal lysine group to form a pharmacologically active, 36-amino acid polypeptide fragment.1
Provide information regarding the potential risks and advantages of pramlintide therapy.1 Provide instruction regarding recognition and management of hypoglycemia and hyperglycemia and assessment of other diabetes complications.1
Importance of advising patients regarding increased risk of severe hypoglycemia with concomitant use of pramlintide and insulin, particularly patients with type 1 diabetes mellitus; hypoglycemia usually occurs within 3 hours of pramlintide injection.1 Potential for serious injuries if severe hypoglycemia occurs while operating a motor vehicle or heavy machinery or while engaging in other high-risk activities.1, 6
Importance of frequent pre and post-meal glucose monitoring combined with insulin dose adjustments, specifically an initial 50% reduction in pre-meal doses of short-acting insulin, for reducing the risk for severe hypoglycemia.1 Potential for hypoglycemia when pramlintide is used concomitantly with oral antidiabetic agents or other drugs that potentiate hypoglycemia.1 Importance of reviewing the symptoms, treatment, and conditions that predispose to development of hypoglycemia when initiating pramlintide treatment.1
Importance of advising patients about risk of nausea, particularly upon initiation of pramlintide therapy.1
Importance of advising patients about potential reduction in appetite, food intake, and/or body weight with pramlintide therapy.1
Importance of reading manufacturer's medication guide prior to initiating therapy with pramlintide.1
Provide instruction regarding the timing of pramlintide dosing, including with concomitant oral drugs, such as analgesics.1
Improtance of providing instruction on proper injection technique and of 1 administering pramlintide as a subcutaneous injection in the thigh or abdomen, not in the arm, immediately before each major meal.1 Importance of administering pramlintide and insulin as separate injections given at least 2 inches apart.1 Importance of not mixing pramlintide with insulin.1 Importance of administering pramlintide using a U-100 insulin syringe (preferably a 0.3-mL size for optimal accuracy) filled to the unit mark that corresponds to the volume to be injected.1 Importance of using a new syringe and needle with each pramlintide and insulin injection.1
Provide instruction on proper storage of pramlintide acetate injection.1 Importance of storing unopened pramlintide acetate injection at 2-8°C and protected from light, and opened pramlintide acetate injection at 2-8°C or at room temperature (not exceeding 25°C).1 Importance of discarding pramlintide 28 days after first use, regardless of storage conditions.1 Importance of not freezing pramlintide and of discarding the drug if it has been frozen or overheated.1
Provide instruction regarding management of special situations, such as intercurrent conditions (i.e., illness or stress), inadequate or omitted insulin or pramlintide doses, inadvertent administration of increased insulin or pramlintide doses, and inadequate food intake or missed meals.1
Provide instruction regarding self-monitoring of blood glucose, periodic glycosylated hemoglobin (HbA1c) monitoring, adherence to meal planning, and regular physical exercise.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions December 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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3. Kruger DF, Gloster MA. Pramlintide for the treatment of insulin-requiring diabetes mellitus: rationale and review of clinical data. Drugs . 2004; 64:1419-32. [PubMed 15212559]
4. Amylin Pharmaceuticals. Symlin® (pramlintide acetate) injection medication guide. San Diego, CA; 2005 June.
5. Institute for Safe Medication Practices. Symlin insulin adjunct present safety issues. Huntington Valley, PA; 2005 Jun. 16. From ISMP website: [Web]
6. Hussar DA. New drugs: exenatide, pramlintide acetate, and micafungin sodium. J Am Pharm Assoc (Wash DC) . 2005 Jul-Aug; 45:524-7.
7. Hollander PA, Levy P, Fineman MS et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care . 2003; 26:784-90. [PubMed 12610038]
8. Kleppinger EL, Vivian EM. Pramlintide for the treatment of diabetes mellitus. Ann Pharmacother . 2003 Jul-Aug; 37:1082-9.
9. Ratner RE, Dickey R, Fineman M et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabet Med . 2004; 21:1204-12. [PubMed 15498087]
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14. Amylin Pharmaceuticals, Inc., San Diego, CA: Personal Communication.