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Symlin

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Symlin

Symlin

SIDE EFFECTS

Adverse events (excluding hypoglycemia, discussed below) commonly associated with SYMLIN (pramlintide acetate injection) when co-administered with a fixed dose of insulin in the long-term, placebo-controlled trials in insulin-using type 2 patients and type 1 patients are presented in Table 4 and Table 5, respectively. The same adverse events were also shown in the open-label clinical practice study, which employed flexible insulin dosing.

Table 4: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence With SYMLIN (pramlintide acetate injection) Compared With Placebo in Long-Term, Placebo-Controlled Trials. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Insulin-Using Type 2 Diabetes, 120 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=284)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=292)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=166)
Nausea 34 (12) 81 (28) 53 (30)
Headache 19 (7) 39 (13) 8 (5)
Anorexia 5 (2) 27 (9) 1 (<1)
Vomiting 12 (4) 24 (8) 13 (7)
Abdominal Pain 19 (7) 23 (8) 3 (2)
Fatigue 11 (4) 20 (7) 5 (3)
Dizziness 11 (4) 17 (6) 3 (2)
Coughing 12 (4) 18 (6) 4 (2)
Pharyngitis 7 (2) 15 (5) 6 (3)

Table 5: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence with SYMLIN (pramlintide acetate injection) Compared to Placebo in Long-Term, Placebo-Controlled Studies. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Type 1 Diabetes, 30 or 60 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=538)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=716)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=265)
Nausea 92 (17) 342 (48) 98 (37)
Anorexia 12 (2) 122 (17) 0 (0)
Inflicted Injury 55 (10) 97 (14) 20 (8)
Vomiting 36 (7) 82 (11) 18 (7)
Arthralgia 27 (5) 51 (7) 6 (2)
Fatigue 22 (4) 51 (7) 12 (4.5)
Allergic Reaction 28 (5) 41 (6) 1 (<1)
Dizziness 21 (4) 34 (5) 5 (2)

Most adverse events were gastrointestinal in nature. In patients with type 2 or type 1 diabetes, the incidence of nausea was higher at the beginning of SYMLIN (pramlintide acetate injection) treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN (pramlintide acetate injection) is gradually titrated to the recommended doses (see DOSAGE AND ADMINISTRATION).

Severe Hypoglycemia

SYMLIN (pramlintide acetate injection) alone (without the concomitant administration of insulin) does not cause hypoglycemia. However, SYMLIN (pramlintide acetate injection) is indicated as an adjunct treatment in patients who use mealtime insulin therapy and co-administration of SYMLIN (pramlintide acetate injection) with insulin can increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes (see BOXED WARNING). The incidence of severe hypoglycemia during the SYMLIN (pramlintide acetate injection) clinical development program is summarized in Table 6 and Table 7.

Table 6: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Insulin-Using Type 2 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label, Clinical Practice Study (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLIN + Insulin
Severe Hypoglycemia 0-3 Months
(n=284)
>3-6 Months
(n=251)
0-3 Months
(n=292)
>3-6 Months
(n=255)
0-3 Months
(n=166)
>3-6 Months
(n=150)
Patient-Ascertained*
  Event Rate (event rate/patient year) 0.24 0.13 0.45 0.39 0.05 0.03
  Incidence (%) 2.1 2.4 8.2 4.7 0.6 0.7
Medically Assisted**
  Event Rate (event rate/patient year) 0.06 0.07 0.09 0.02 0.05 0.03
  Incidence (%) 0.7 1.2 1.7 0.4 0.6 0.7
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

Table 7: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Type 1 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label,Clinical PracticeStudy (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLI N + Insulin
Severe Hypoglycemia 0-3 Months
(n=538)
>3-6 Months
(n=470)
0-3 Months
(n=716)
>3-6 Months
(n=576)
0-3 Months
(n=265)
>3-6 Months
(n=213)
Patient-Ascertained*
  Event Rate (event rate/patient year) 1.33 1.06 1.55 0.82 0.29 0.16
  Incidence (%) 10.8 8.7 16.8 11.1 5.7 3.8
Medically Assisted**
  Event Rate (event rate/patient year) 0.19 0.24 0.50 0.27 0.10 0.04
  Incidence (%) 3.3 4.3 7.3 5.2 2.3 0.9
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

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

DRUG INTERACTIONS

Due to its effects on gastric emptying, SYMLIN (pramlintide acetate injection) therapy should not be considered for patients taking drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) and agents that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors). Patients using these drugs have not been studied in clinical trials.

SYMLIN (pramlintide acetate injection) has the potential to delay the absorption of concomitantly administered oral medications. When the rapid onset of a concomitant orally administered agent is a critical determinant of effectiveness (such as analgesics), the agent should be administered at least 1 hour prior to or 2 hours after SYMLIN (pramlintide acetate injection) injection.

In clinical trials, the concomitant use of sulfonylureas or biguanides did not alter the adverse event profile of SYMLIN (pramlintide acetate injection) . No formal interaction studies have been performed to assess the effect of SYMLIN (pramlintide acetate injection) on the kinetics of oral antidiabetic agents.

Mixing SYMLIN (pramlintide acetate injection) and Insulin

The pharmacokinetic parameters of SYMLIN (pramlintide acetate injection) were altered when mixed with regular, NPH, and 70/30 premixed formulations of recombinant human insulin immediately prior to injection. Thus, SYMLIN (pramlintide acetate injection) and insulin should not be mixed and must be administered separately.

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

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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