Pramlintide

Pramlintide is an analog of human amylin. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake.

• SYMLIN is indicated as an adjunctive 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. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy (1) .ICD-10: E11.9

• SYMLIN is contraindicated in patients with any of the following: • serious hypersensitivity reaction to SYMLIN or to any of its product components. • hypoglycemia unawareness.contraindicated

• Upon initiation of SYMLIN, reduce mealtime insulin dose by 50%. Monitor glucoses frequently and individualize subsequent insulin dose adjustments (2.1) . • Type 1 Diabetes: Start at 15 mcg subcutaneously before major meals. Increase in 15 mcg increments to a maximum premeal dose of 30 or 60 mcg; if not tolerated, reduce to 30 mcg, as tolerated (2.2) . • Type 2 Diabetes: Start at 60 mcg subcutaneously before major meals then increase to 120 mcg before meals, as tolerated (2.2) . • Wait at least 3 days between dose titrations to minimize nausea (2.1) . 2.1 Important Considerations Pertaining to SYMLIN and Insulin Dose Adjustments SYMLIN dosage differs depending on whether the patient has type 1 or type 2 diabetes [see Dosage and Administration (2.2 , 2.3) ]. SYMLIN should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring. Insulin and SYMLIN dose adjustments should be made only as directed by a healthcare professional skilled in the use of insulin. When initiating SYMLIN, reduce mealtime insulin doses, including premixed insulins, by 50% to reduce the risk of hypoglycemia. To reduce the risk of nausea, wait at least 3 days before titrating SYMLIN to the next dose increment. Monitor blood glucoses frequently, including pre- and post-meals and at bedtime, particularly when initiating SYMLIN or increasing the SYMLIN dose.

• Severe hypoglycemia: Increased risk particularly for type 1 diabetes. Upon initiation of SYMLIN, reduce mealtime insulin dose by 50% and frequently monitor blood glucoses (5.2) . • Never share a SymlinPen between patients, even if the needle is changed (5.3) . • Do not mix SYMLIN and insulin: Mixing can alter the pharmacokinetics of both products. Administer as separate injections (5.4 , 7.1) . • Slows gastric emptying: Administer concomitant oral medications at least 1 hour before or 2 hours after SYMLIN if rapid onset or threshold concentration is critical (5.6 , 7.2) . 5.1 Patient Selection Proper patient selection is critical to the safe and effective use of SYMLIN. Before initiating SYMLIN, the patient's HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. SYMLIN therapy should only be considered in patients with type 1 diabetes or patients with type 2 diabetes using mealtime insulin who fulfill the following criteria: • have failed to achieve adequate glycemic control despite individualized insulin management. • are receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of diabetes educator(s). Patients meeting any of the following criteria should NOT be considered for SYMLIN therapy: • poor compliance with current insulin regimen. • poor compliance with prescribed self blood glucose monitoring. • have a HbA1c >9%. • recurrent severe hypoglycemia requiring assistance during the past 6 months.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. • Most common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Adverse Reactions (Excluding Hypoglycemia) 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. Table 1: Patients with Type 1 Diabetes: Common Adverse Reactions (Incidence ≥5% and Greater Incidence with SYMLIN Compared to Placebo) in 3 Pooled Placebo-Controlled Trials Long-Term, Placebo-Controlled Studies SYMLIN 30 or 60 mcg 3 Times Daily + Insulin Placebo + Insulin (N=716) % (N=538) % Nausea 48 17 Anorexia 17 2 Inflicted Injury Examples of inflicted injury included among others, abrasions, bruises, burns, fractures, lacerations, and muscle strains.

8.1 Pregnancy Risk Summary Available data from a small number of reports in the manufacturer’s safety database on SYMLIN use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy ( see Clinical Considerations ). Ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that SYMLIN has low potential to cross the maternal/fetal placental barrier. 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 ). 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. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Metabolism

Absorption The absolute bioavailability of pramlintide following a single subcutaneous dose of SYMLIN is approximately 30% to 40%. Subcutaneous administration of different doses of SYMLIN into the abdominal area or thigh of healthy individuals showed a linear, dose-dependent increase in maximum plasma concentrations (C max ) and overall exposure (AUC) (Table 5).

Single 10 mg doses of SYMLIN (83 times the maximum recommended dose of 120 mcg for patients with type 2 diabetes) were administered to 3 healthy volunteers. All 3 individuals reported severe nausea associated with vomiting, diarrhea, vasodilatation, and dizziness. No hypoglycemia was reported. Pramlintide has a short half-life (approximately 48 minutes in healthy individuals). Initiate supportive measures in the case of overdose.

• Mar 16, 2005NDANDA021332Astrazeneca Ab

1. 1Blood Glucose Increased1515%
2. 2Acute Kidney Injury1111%
3. 3Chronic Kidney Disease1111%
4. 4Nausea98.8%
5. 5Dyspnoea87.8%
6. 6Fatigue87.8%
7. 7Hypertension76.9%
8. 8Renal Failure76.9%
9. 9Weight Decreased76.9%
10. 10Chest Pain65.9%
11. 11Diarrhoea65.9%
12. 12Drug Ineffective65.9%
13. 13Osteoarthritis65.9%
14. 14Weight Increased65.9%
15. 15Back Pain54.9%

The 10 most recently updated of 63 ClinicalTrials.gov registrations naming Pramlintide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
  Completed · Interventional · 33 enrolled · Oregon Health and Science University
  NCT06422325updated 2026-06-09
• Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease
  Active not recruiting · Early phase 1 · Interventional · 57 enrolled · Boston University
  NCT03560960updated 2026-05-28
• Tailoring Obesity Treatment Trial
  Withdrawn · Phase 2 · Phase 3 · Interventional · 0 enrolled · Esbjerg Hospital - University Hospital of Southern Denmark
  NCT06619015updated 2026-04-17
• Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
  Recruiting · Interventional · 18 enrolled · University Hospital, Gentofte, Copenhagen
  NCT07506369updated 2026-04-01
• Hypersensitivity to Amylin in Post-Traumatic Headache
  Not yet recruiting · Interventional · 21 enrolled · Danish Headache Center
  NCT07340775updated 2026-01-14
• Amylin-Induced Migraine Attacks Without Aura
  Not yet recruiting · Interventional · 21 enrolled · Danish Headache Center
  NCT07340788updated 2026-01-14
• A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
  Unknown · Phase 2 · Phase 3 · Interventional · 30 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT06046417updated 2024-04-18
• Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
  Completed · Phase 2 · Interventional · 18 enrolled · Xeris Pharmaceuticals
  NCT04074317updated 2024-03-27
• The Role of Amylin in Bone Metabolism
  Unknown · Interventional · 20 enrolled · Filip Krag Knop
  NCT06186063updated 2024-02-21
• A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
  Completed · Interventional · 12 enrolled · McGill University Health Centre/Research Institute of the McGill University Health Centre
  NCT05199714updated 2023-10-25

Frequently asked questions

How does Pramlintide work?

Pramlintide is an analog of human amylin. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake.

What is Pramlintide used for?

According to FDA labeling, Pramlintide carries indications including: SYMLIN is indicated as an adjunctive 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. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy (1) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pramlintide?

Pramlintide is classified as Other blood glucose lowering drugs, excl. insulins, Amylin Analog, Amylin Agonists, Appetite Suppression, Decreased Gastric Motility, Decreased Glucagon Secretion.

What are the brand names for Pramlintide?

Pramlintide is marketed under brand names including Symlin.

What are the contraindications for Pramlintide?

Pramlintide labeling lists contraindications including: SYMLIN is contraindicated in patients with any of the following: • serious hypersensitivity reaction to SYMLIN or to any of its product components. • hypoglycemia unawareness.. Always consult the full prescribing information and a clinician.