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Details with Side Effects
Proper patient selection is critical to safe and effective use of SYMLIN (pramlintide acetate injection) . Before initiation of therapy, the patient's HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. SYMLIN (pramlintide acetate injection) therapy should only be considered in patients with insulin-using type 2 or type 1 diabetes 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 health care 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 (pramlintide acetate injection) therapy:
- poor compliance with current insulin regimen;
- poor compliance with prescribed self-blood glucose monitoring;
- have an HbA1c >9%;
- recurrent severe hypoglycemia requiring assistance during the past 6 months;
- presence of hypoglycemia unawareness;
- confirmed diagnosis of gastroparesis;
- require the use of drugs that stimulate gastrointestinal motility;
- pediatric patients.
Hypoglycemia. SYMLIN (pramlintide acetate injection) alone does not cause hypoglycemia. However, SYMLIN (pramlintide acetate injection) is indicated to be co-administered with insulin therapy and in this setting SYMLIN (pramlintide acetate injection) increases the risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. Severe hypoglycemia associated with SYMLIN (pramlintide acetate injection) occurs within the first 3 hours following a SYMLIN (pramlintide acetate injection) injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Therefore, when introducing SYMLIN (pramlintide acetate injection) therapy, appropriate precautions need to be taken to avoid increasing the risk for insulin-induced severe hypoglycemia. These precautions include frequent pre- and post-meal glucose monitoring combined with an initial 50% reduction in pre-meal doses of short-acting insulin (see DOSAGE AND ADMINISTRATION).
Symptoms of hypoglycemia may include hunger, headache, sweating, tremor, irritability, or difficulty concentrating. Rapid reductions in blood glucose concentrations may induce such symptoms regardless of glucose values. More severe symptoms of hypoglycemia include loss of consciousness, coma, or seizure.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes; diabetic nerve disease; use of medications such as beta-blockers, clonidine, guanethidine, or reserpine; or intensified diabetes control.
The addition of any antihyperglycemic agent such as SYMLIN (pramlintide acetate injection) to an existing regimen of one or more anti-hyperglycemic agents (e.g., insulin, sulfonylurea), or other agents that can increase the risk of hypoglycemia may necessitate further insulin dose adjustments and particularly close monitoring of blood glucose.
The following are examples of substances that may increase the blood glucose-lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, ACE inhibitors, diisopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antibiotics.
Clinical studies employing a controlled hypoglycemic challenge have demonstrated that SYMLIN (pramlintide acetate injection) does not alter the counter-regulatory hormonal response to insulin-induced hypoglycemia. Likewise, in SYMLIN (pramlintide acetate injection) -treated patients, the perception of hypoglycemic symptoms was not altered with plasma glucose concentrations as low as 45 mg/dL.
Hypoglycemia (See WARNINGS).
SYMLIN (pramlintide acetate injection) should be prescribed with caution to persons with visual or dexterity impairment.
Information for Patients
Health care providers should inform patients of the potential risks and advantages of SYMLIN (pramlintide acetate injection) therapy. Health care providers should also inform patients about self-management practices including glucose monitoring, proper injection technique, timing of dosing, and proper storage of SYMLIN (pramlintide acetate injection) . In addition, reinforce the importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Refer patients to the SYMLIN Medication Guide and Patient Instructions for Use for additional information.
Instruct patients on handling of special situations such as intercurrent conditions (illness or stress), an inadequate or omitted insulin dose, inadvertent administration of increased insulin or SYMLIN (pramlintide acetate injection) dose, inadequate food intake or missed meals.
SYMLIN (pramlintide acetate injection) and insulin should always be administered as separate injections and never be mixed.
Renal Impairment: The dosing requirements for SYMLIN (pramlintide acetate injection) are not altered in patients with moderate or severe renal impairment (ClCr >20 to ≤ 50 mL/min). No studies have been done in dialysis patients (see CLINICAL PHARMACOLOGY; Special Populations).
Hepatic Impairment: Studies have not been performed in patients with hepatic impairment. However, hepatic dysfunction is not expected to affect blood concentrations of SYMLIN (see CLINICAL PHARMACOLOGY; Special Populations).
Allergy: Local allergy. Patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than SYMLIN (pramlintide acetate injection) , such as irritants in a skin cleansing agent or improper injection technique.
Systemic Allergy. In controlled clinical trials up to 12 months, potential systemic allergic reactions were reported in 65 (5%) of type 2 patients and 59 (5%) of type 1 SYMLIN (pramlintide acetate injection) -treated patients. Similar reactions were reported by 18 (4%) and 28 (5%) of placebo-treated type 2 and type 1 patients, respectively. No patient receiving SYMLIN (pramlintide acetate injection) was withdrawn from a trial due to a potential systemic allergic reaction.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis. A two-year carcinogenicity study was conducted in CD-1 mice with doses of 0.2, 0.5, and 1.2 mg/kg/day of SYMLIN (pramlintide acetate injection) (32, 67, and 159 times the exposure resulting from the maximum recommended human dose based on area under the plasma concentration curve or AUC, respectively). No drug-induced tumors were observed. A two-year carcinogenicity study was conducted in Sprague-Dawley rats with doses of 0.04, 0.2, and 0.5 mg/kg/day of SYMLIN (pramlintide acetate injection) (3, 9, and 25 times the exposure resulting from the maximum recommended human dose based on AUC, respectively). No drug-induced tumors were observed in any organ.
Mutagenesis. SYMLIN (pramlintide acetate injection) was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. SYMLIN (pramlintide acetate injection) was not clastogenic in the in vivo mouse micronucleus test or in the chromosomal aberration assay utilizing Chinese hamster ovary cells.
Impairment of Fertility. Administration of 0.3, 1, or 3 mg/kg/day of SYMLIN (pramlintide acetate injection) (8, 17, and 82 times the exposure resulting from the maximum recommended human dose based on body surface area) had no significant effects on fertility in male or female rats. The highest dose of 3 mg/kg/day resulted in dystocia in 8/12 female rats secondary to significant decreases in serum calcium levels.
Teratogenic Effects: Pregnancy Category C. No adequate and well-controlled studies have been conducted in pregnant women. Studies in perfused human placenta indicate that SYMLIN (pramlintide acetate injection) has low potential to cross the maternal/fetal placental barrier. Embryofetal toxicity studies with SYMLIN (pramlintide acetate injection) have been performed in rats and rabbits. Increases in congenital abnormalities (neural tube defect, cleft palate, exencephaly) were observed in fetuses of rats treated during organogenesis with 0.3 and 1.0 mg/kg/day (10 and 47 times the exposure resulting from the maximum recommended human dose based on AUC, respectively). Administration of doses up to 0.3 mg/kg/day SYMLIN (pramlintide acetate injection) (9 times maximum recommended dose based on AUC) to pregnant rabbits had no adverse effects in embryofetal development; however, animal reproduction studies are not always predictive of human response. SYMLIN (pramlintide acetate injection) should be used during pregnancy only if it is determined by the healthcare professional that the potential benefit justifies the potential risk to the fetus.
It is unknown whether SYMLIN (pramlintide acetate injection) is excreted in human milk. Many drugs, including peptide drugs, are excreted in human milk. Therefore, SYMLIN (pramlintide acetate injection) should be administered to nursing women only if it is determined by the health care professional that the potential benefit outweighs the potential risk to the infant.
Safety and effectiveness of SYMLIN (pramlintide acetate injection) in pediatric patients have not been established.
SYMLIN (pramlintide acetate injection) has been studied in patients ranging in age from 15 to 84 years of age, including 539 patients 65 years of age or older. The change in HbA1c values and hypoglycemia frequencies did not differ by age, but greater sensitivity in some older individuals cannot be ruled out. Thus, both SYMLIN (pramlintide acetate injection) and insulin regimens should be carefully managed to obviate an increased risk of severe hypoglycemia.
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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