SYMLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SYMLIN (SYMLIN).

How it works

Amylin analog that slows gastric emptying, suppresses glucagon secretion, and increases satiety via central nervous system actions.

What the body does with it

Metabolism	Primarily metabolized by the kidneys
Excretion	Primarily metabolized via proteolytic degradation; renal elimination of metabolites is minor. Less than 5% excreted unchanged in urine.
Half-life	Approximately 1.6 hours (range 1.2–2.4 hours) after subcutaneous administration. Clinically, duration of action is 3–5 hours.
Protein binding	Approximately 60% bound to plasma proteins.
Volume of Distribution	Approximately 1.0 L/kg, indicating distribution into total body water.
Bioavailability	30–40% after subcutaneous administration.
Onset of Action	15 minutes after subcutaneous injection.
Duration of Action	3–5 hours post-dose; effect may be prolonged in patients with gastroparesis.

Classification & Brands

Dosing & administration

Initial: 60 mcg subcutaneously immediately before each major meal; titrate to 120 mcg if tolerated and needed after 3-7 days. Maximum single dose: 120 mcg.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment provided for renal impairment; use with caution in severe renal impairment (CrCl <20 mL/min) due to increased risk of hypoglycemia.
Liver impairment	No specific dose adjustment recommended for hepatic impairment.
Pediatric use	Safety and efficacy in pediatric patients (<18 years) have not been established; not recommended.
Geriatric use	No specific dose adjustment; initiate at 60 mcg and titrate cautiously due to potential for increased hypoglycemia risk in elderly patients.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SYMLIN (SYMLIN).

Breastfeeding	It is unknown whether pramlintide is excreted in human milk. Caution should be exercised when administered to a nursing woman. No M/P ratio available.
Teratogenic Risk	Pramlintide (SYMLIN) is classified as Pregnancy Category C. Animal reproduction studies have not been conducted; potential fetal risk is unknown. Use during pregnancy only if clearly needed. No adequate and well-controlled studies in pregnant women.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Pramlintide increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to pramlintide or any component","Gastroparesis","Hypoglycemia unawareness","Current use of drugs that slow gastrointestinal motility"]

Clinical Precautions

Precautions

["Severe hypoglycemia, especially in type 1 diabetes","Need for reduction of mealtime insulin dose to avoid hypoglycemia","Nausea","Allergic reactions","Impaired gastric emptying (contraindicated in gastroparesis)"]

Clinical Tips & Counseling

Drug interactions

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SYMLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SYMLIN (SYMLIN).

How it works

Amylin analog that slows gastric emptying, suppresses glucagon secretion, and increases satiety via central nervous system actions.

What the body does with it

Metabolism	Primarily metabolized by the kidneys
Excretion	Primarily metabolized via proteolytic degradation; renal elimination of metabolites is minor. Less than 5% excreted unchanged in urine.
Half-life	Approximately 1.6 hours (range 1.2–2.4 hours) after subcutaneous administration. Clinically, duration of action is 3–5 hours.
Protein binding	Approximately 60% bound to plasma proteins.
Volume of Distribution	Approximately 1.0 L/kg, indicating distribution into total body water.
Bioavailability	30–40% after subcutaneous administration.
Onset of Action	15 minutes after subcutaneous injection.
Duration of Action	3–5 hours post-dose; effect may be prolonged in patients with gastroparesis.

Classification & Brands

Dosing & administration

Initial: 60 mcg subcutaneously immediately before each major meal; titrate to 120 mcg if tolerated and needed after 3-7 days. Maximum single dose: 120 mcg.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment provided for renal impairment; use with caution in severe renal impairment (CrCl <20 mL/min) due to increased risk of hypoglycemia.
Liver impairment	No specific dose adjustment recommended for hepatic impairment.
Pediatric use	Safety and efficacy in pediatric patients (<18 years) have not been established; not recommended.
Geriatric use	No specific dose adjustment; initiate at 60 mcg and titrate cautiously due to potential for increased hypoglycemia risk in elderly patients.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SYMLIN (SYMLIN).

Breastfeeding	It is unknown whether pramlintide is excreted in human milk. Caution should be exercised when administered to a nursing woman. No M/P ratio available.
Teratogenic Risk	Pramlintide (SYMLIN) is classified as Pregnancy Category C. Animal reproduction studies have not been conducted; potential fetal risk is unknown. Use during pregnancy only if clearly needed. No adequate and well-controlled studies in pregnant women.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Pramlintide increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to pramlintide or any component","Gastroparesis","Hypoglycemia unawareness","Current use of drugs that slow gastrointestinal motility"]