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Symlin

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Symlin

Side Effects
Interactions

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 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
(N=716) %
Placebo + Insulin
(N=538) %
Nausea 48 17
Anorexia 17 2
* Inflicted Injury 14 10
Vomiting 11 7
Arthralgia 7 5
Fatigue 7 4
Allergic Reaction 6 5
Dizziness 5 4

* 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 [see DOSAGE AND ADMINISTRATION].

Severe Hypoglycemia

Coadministration of SYMLIN with mealtime insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

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-Ascertained*
  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-Assisted†
  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
* 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.
† 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-Ascertained*
  Event Rate (events/patient-year) 0.45 0.39 0.24 0.13
  Subject Incidence (%) 8.2 4.7 2.1 2.4
Medically-Assisted†
  Event Rate events/patient-year) 0.09 0.02 0.06 0.07
  Subject Incidence (%) 1.7 0.4 0.7 1.2
* 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.
† 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.

Read the Symlin (pramlintide acetate injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Insulin

The pharmacokinetic parameters of pramlintide are altered when SYMLIN is mixed in the same syringe with regular, NPH, and 70/30 premixed formulations of recombinant human insulin. SYMLIN and insulin must not be mixed and must be administered as separate injections [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Oral Medications

SYMLIN has the potential to delay the absorption of concomitantly administered oral medications. When the rapid onset or threshold concentration of a concomitant orally administered medication is a critical determinant of effectiveness (such as with analgesics, antibiotics, and oral contraceptives), the medication should be administered at least 1 hour prior to SYMLIN injection or 2 hours after SYMLIN injection [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Drugs Affecting Gastrointestinal Motility

Due to its effects on gastric emptying, SYMLIN should not be considered for patients taking medications that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) or medications that slow the intestinal absorption of nutrients (e.g., alpha-glucosidase inhibitors). Patients using these medications have not been studied in SYMLIN clinical trials [see WARNINGS AND PRECAUTIONS].

Drugs Affecting Glucose Metabolism

The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and sulfonamide antibiotics. SYMLIN and these drugs should be coadministered with caution.

Read the Symlin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/14/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Symlin - User Reviews

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