SYMLIN SIDE EFFECTS

Generic Name: pramlintide acetate injection
Brand Name: Symlin
Drug Class: Antidiabetics, Amylinomimetics, Antidiabetics, Glucagon-like Peptide-1 Agonists

Last updated on MDtodate: 10/13/2022

SIDE EFFECTS

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.

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 mealtimeinsulin 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 (N=716) %	Placebo + Insulin (N=538) %
Nausea	48	17
Anorexia	17	2
Inflicted Injury¹	14	10
Vomiting	11	7
Arthralgia	7	5
Fatigue	7	4
Allergic Reaction	6	5
Dizziness	5	4
¹ Examples of inflicted injury included among others, abrasions, bruises, burns, fractures, lacerations, and muscle strains.

Table 2: Patients with Type 2 Diabetes on Insulin: Common Adverse Reactions (Incidence ≥5% and Greater Incidence with SYMLIN Compared to Placebo) in 2 Pooled Placebo-Controlled Trials

	Long-Term, Placebo-Controlled Studies
	SYMLIN 120 mcg 2 Times Daily + Insulin (N=292) %	Placebo + Insulin (N=284) %
Nausea	28	12
Headache	13	7
Anorexia	9	2
Vomiting	8	4
Abdominal pain	8	7
Fatigue	7	4
Dizziness	6	4
Cough	6	4
Pharyngitis	5	2

Most adverse reactions were gastrointestinal in nature. The incidence of nausea is higher at the beginning of SYMLIN treatment and decreases with time in most patients. Gradual titration of the SYMLIN dose minimizes the incidence and severity of nausea.

Severe Hypoglycemia

Coadministration of SYMLIN with mealtime insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. Two definitions of severe hypoglycemia were used in the SYMLIN clinical trials. Patient-ascertained severe hypoglycemia was defined as an episode of hypoglycemia requiring the assistance of another individual (including help administering oral carbohydrate) or requiring the administration of glucagon, intravenous glucose, or other medical intervention. Medically-assisted severe hypoglycemia was defined as an episode of hypoglycemia that was classified as a serious event by the investigator or that required glucagon, intravenous glucose, hospitalization, paramedic assistance or an emergency room visit. The incidence of severe hypoglycemia during the SYMLIN clinical development program is summarized in Table 3 and Table 4.

Table 3: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials and Dose Titration Trial in Patients with Type 1 Diabetes

Severe Hypoglycemia	Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation)				Placebo-Controlled Dose Titration Study
	SYMLIN + Insulin		Placebo + Insulin		SYMLIN + Insulin		Placebo+Insulin
	0 to 3 Months (n=716)	>3 to 6 Months (n=576)	0 to 3 Months (n=538)	>3 to 6 Months (n=470)	0 to 3 Months (n=148)	>3 to 6 Months (n=133)	0 to 3 Months (n=147)	>3 to 6 Months (n=138)
Patient- Ascertained¹
Event Rate (events/ patient-year)	1.55	0.82	1.33	1.06	0.69	0.49	0.28	0.3
Subject Incidence (%)	16.8	11.1	10.8	8.7	13.5	10.5	6.1	5.8
Medically- Assisted²
Event Rate (events/ patient-year)	0.50	0.27	0.19	0.24	0.14	0.20	0.08	0.15
Subject Incidence (%)	7.3	5.2	3.3	4.3	3.4	4.5	2.0	2.9
¹ Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. ² Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Table 4: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials in Patients with Type 2 Diabetes Using Insulin

Severe Hypoglycemia	Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation)
	SYMLIN + Insulin		Placebo + Insulin
	0 to 3 Months (n=292)	>3 to 6 Months (n=255)	0 to 3 Months (n=284)	>3 to 6 Months (n=251)
Patient-Ascertained¹
Event Rate (events/patient-year)	0.45	0.39	0.24	0.13
Subject Incidence (%)	8.2	4.7	2.1	2.4
Medically-Assisted²
Event Rate (events/patient-year)	0.09	0.02	0.06	0.07
Subject Incidence (%)	1.7	0.4	0.7	1.2
¹ Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. ² Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use 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.

Injection site reactions
Pancreatitis

SRC: NLM .

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