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Pramlintide: Drug information

Pramlintide: Drug information
(For additional information see "Pramlintide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Insulin/glucose-lowering agents:

Pramlintide use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a pramlintide injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.

Brand Names: US
  • SymlinPen 120;
  • SymlinPen 60
Pharmacologic Category
  • Amylinomimetic;
  • Antidiabetic Agent
Dosing: Adult

Note: When initiating pramlintide, reduce current mealtime insulin dose (including premixed preparations) by 50% to avoid hypoglycemia. If pramlintide is discontinued for any reason, restart therapy with same initial titration protocol. If a dose is missed, wait until the next scheduled dose and administer the usual amount.

Diabetes mellitus, type 1

Diabetes mellitus, type 1: SUBQ: Initial: 15 mcg immediately prior to major meals; titrate in 15 mcg increments every 3 days (if no significant nausea occurs) to target dose of 30 to 60 mcg prior to major meals (consider discontinuation if intolerant of 30 mcg dose).

Diabetes mellitus, type 2

Diabetes mellitus, type 2: SUBQ: Initial: 60 mcg immediately prior to major meals; after 3 days, increase to 120 mcg prior to each major meal if no significant nausea occurs (if nausea occurs at 120 mcg dose, reduce to 60 mcg).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥15 mL/minute: No dosage adjustment necessary.

End-stage renal disease [ESRD]: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, need for adjustment not likely since undergoes minimal hepatic metabolism.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (5% to 13%)

Endocrine & metabolic: Severe hypoglycemia (type 1 diabetes ≤17%)

Gastrointestinal: Nausea (28% to 48%), anorexia (≤17%), vomiting (7% to 11%)

Miscellaneous: Accidental injury (8% to 14%)

1% to 10%:

Central nervous system: Fatigue (3% to 7%), dizziness (2% to 6%)

Endocrine & metabolic: Severe hypoglycemia (type 2 diabetes ≤8%)

Gastrointestinal: Abdominal pain (2% to 8%)

Hypersensitivity: Hypersensitivity reaction (≤6%)

Neuromuscular & skeletal: Arthralgia (2% to 7%)

Respiratory: Cough (2% to 6%), pharyngitis (3% to 5%)

Postmarketing and/or case reports: Injection site reaction, pancreatitis

Contraindications

Serious hypersensitivity to pramlintide or any component of the formulation; confirmed diagnosis of gastroparesis; hypoglycemia unawareness

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reactions: Injection site reactions, including erythema, edema, or pruritus, may occur; usually resolve in a few days to weeks.

Disease-related concerns:

• Bariatric surgery: Hypoglycemia: Use an antidiabetic agent without the potential for hypoglycemia if possible; hypoglycemia may occur after gastric bypass, sleeve gastrectomy, and gastric band. Insulin secretion and sensitivity may be partially or completely restored after these procedures (gastric bypass is most effective, followed by sleeve and finally band) (Korner 2009; Peterli 2012). First-phase insulin secretion and hepatic insulin sensitivity have been shown to be significantly improved in the immediate days after gastric bypass and sleeve gastrectomy. The restorative effects of these procedures on peripheral insulin sensitivity may occur later in the 3- to 12-month period postsurgery (Mingrone 2016).

• Gastroparesis: Avoid use in patients with conditions or concurrent medications likely to impair gastric motility (eg, anticholinergics); do not use in patients requiring medication(s) to stimulate gastric emptying.

Concurrent drug therapy issues:

• Insulin/glucose-lowering agents: [US Boxed Warning]: Coadministration with insulin may induce severe hypoglycemia (usually within 3 hours following administration); coadministration with insulin therapy is an approved indication, but does require an initial dosage reduction of insulin and frequent pre- and post-blood glucose monitoring to reduce risk of severe hypoglycemia. Concurrent use of other glucose-lowering agents may increase risk of hypoglycemia.

Dosage form specific issues:

• Multiple dose injection pens: According to the manufacturer and the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of transmission of blood-borne pathogens. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).

Other warnings/precautions:

• Appropriate use: Avoid use in patients with poor compliance with their insulin regimen and/or blood glucose monitoring. Do not use in patients with HbA1c levels more than 9%, recurrent episodes of severe hypoglycemia requiring assistance during the past 6 months, or hypoglycemia unawareness; obtain detailed history of glucose control (eg, HbA1c, incidence of hypoglycemia, glucose monitoring, and medication compliance) and body weight before initiating therapy. Use caution in patients with visual or dexterity impairment. Patients should use caution when driving or operating heavy machinery until effects on blood sugar are known.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous, as acetate:

SymlinPen 60: 1500 mcg/1.5 mL (1.5 mL) [contains metacresol]

SymlinPen 120: 2700 mcg/2.7 mL (2.7 mL) [contains metacresol]

Generic Equivalent Available: US

No

Pricing: US

Solution Pen-injector (SymlinPen 120 Subcutaneous)

2700 mcg/2.7 mL (per mL): $273.37

Solution Pen-injector (SymlinPen 60 Subcutaneous)

1500 mcg/1.5 mL (per mL): $414.36

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Subcutaneous: Do not mix with insulins; administer subcutaneously into abdominal or thigh areas at sites distinct from concomitant insulin injections (do not administer into arm due to variable absorption); rotate injection sites frequently. Allow solution to reach room temperature before administering; may reduce injection site reactions. For oral medications in which a rapid onset of action is desired, administer 1 hour before, or 2 hours after pramlintide, if possible.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.fda.gov/media/73053/download, must be dispensed with this medication.

Use: Labeled Indications

Diabetes mellitus, type 1 and type 2: Adjunct treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Anticholinergic Agents: Pramlintide may enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Etilefrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Insulins: Pramlintide may enhance the hypoglycemic effect of Insulins. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Risk D: Consider therapy modification

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Pregnancy Considerations

Based on in vitro data, pramlintide has a low potential to cross the placenta (Hiles 2003).

Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major malformations, stillbirth, and macrosomia (ACOG 201 2018). To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2021; Blumer 2013).

Agents other than pramlintide are currently recommended to treat diabetes mellitus in pregnancy (ADA 2021).

Breastfeeding Considerations

It is not known if pramlintide is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Dietary Considerations

Dietary modification based on ADA recommendations is a part of therapy; pramlintide to be administered prior to major meals consisting of ≥250 Kcal or ≥30 g carbohydrates

Monitoring Parameters

Prior to initiating therapy: Signs and symptoms of hypoglycemia.

HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2021; KDIGO 2020).

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults with diabetes (AACE [Samson 2023]; ADA 2023):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Older adults (≥65 years of age) (ADA 2023):

Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (LeRoith 2019).

HbA1c: <7% to 7.5% (healthy); <8% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).

Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).

Classification of hypoglycemia (ADA 2023):

Level 1: 54 to 70 mg/dL (SI: ≥3 to ≤3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.

Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.

Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.

Mechanism of Action

Synthetic analog of human amylin cosecreted with insulin by pancreatic beta cells; reduces postprandial glucose increases via the following mechanisms: 1) prolongation of gastric emptying time, 2) reduction of postprandial glucagon secretion, and 3) reduction of caloric intake through centrally-mediated appetite suppression

Pharmacokinetics (Adult Data Unless Noted)

Duration: ~3 hours

Protein binding: ~60%

Metabolism: Primarily renal to des-lys1 pramlintide (active metabolite)

Bioavailability: ~30% to 40%

Half-life elimination: ~48 minutes

Time to peak, plasma: 20 minutes

Excretion: Primarily urine

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Symlinpen
  1. American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 201: pregestational diabetes mellitus. Obstet Gynecol. 2018;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960. [PubMed 30461693]
  2. American Diabetes Association (ADA). Standards of care in diabetes–2023. Diabetes Care. 2023;46(suppl 1):S1-S291. https://diabetesjournals.org/care/issue/46/Supplement_1. Accessed January 4, 2023.
  3. American Diabetes Association (ADA). Standards of medical care in diabetes–2020. Diabetes Care. 2020;43(suppl 1):S1-S212. https://care.diabetesjournals.org/content/43/Supplement_1. Accessed January 22, 2020.
  4. American Diabetes Association (ADA). Standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S1-S232. https://care.diabetesjournals.org/content/44/Supplement_1. Accessed January 13, 2021.
  5. Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249. [PubMed 24194617]
  6. Centers for Disease Control and Prevention (CDC). CDC clinical reminder: insulin pens must never be used for more than one person. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed January 9, 2012.
  7. Hiles RA, Bawdon RE, and Petrella EM, "Ex vivo Human Placental Transfer of the Peptides Pramlintide and Exenatide (Synthetic Exendin-4)," Hum Exp Toxicol, 2003, 22(12):623-8. [PubMed 14992323]
  8. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2020;98(suppl 4):S1-S115. doi:10.1016/j.kint.2020.06.019 [PubMed 32998798]
  9. Korner J, Inabnet W, Febres G, et al. Prospective study of gut hormone and metabolic changes after adjustable gastric banding and Roux-en-Y gastric bypass. Int J Obes (Lond). 2009;33(7):786-795. doi: 10.1038/ijo.2009.79. [PubMed 19417773]
  10. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of diabetes in older adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574. doi: 10.1210/jc.2019-00198. [PubMed 30903688]
  11. Mingrone G, Cummings DE. Changes of insulin sensitivity and secretion after bariatric/metabolic surgery. Surg Obes Relat Dis. 2016;12(6):1199-1205. doi: 10.1016/j.soard.2016.05.013. [PubMed 27568471]
  12. Peterli R, Steinert RE, Woelnerhanssen B, et al. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012;22(5):740-748. doi: 10.1007/s11695-012-0622-3. [PubMed 22354457]
  13. Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology consensus statement: comprehensive type 2 diabetes management algorithm – 2023 update. Endocr Pract. 2023;29(5):305-340. doi:10.1016/j.eprac.2023.02.001 [PubMed 37150579]
  14. Symlin (pramlintide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2019.
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