"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Proper patient selection is critical to the safe and effective use of SYMLIN. Before initiating SYMLIN, the patient's HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. SYMLIN therapy should only be considered in patients with type 1 diabetes or patients with type 2 diabetes using mealtime insulin 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 healthcare 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 therapy:
- poor compliance with current insulin regimen.
- poor compliance with prescribed self blood glucose monitoring.
- have a 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.
SYMLIN should be prescribed with caution to persons with visual or dexterity impairment.
SYMLIN alone does not cause hypoglycemia. However, SYMLIN is indicated to be coadministered with mealtime insulin therapy, and in this setting there is an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes. If severe hypoglycemia associated with SYMLIN occurs, it is usually seen within the first 2 to 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries or death may occur.
Therefore, when introducing SYMLIN therapy, appropriate precautions need to be taken to avoid increasing the risk for severe hypoglycemia. These precautions include frequent monitoring of pre-and post-meal glucose combined with an initial 50% reduction in doses of mealtime insulin [see DOSAGE AND ADMINISTRATION].
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes; diabetic neuropathy; use of medications such as beta-blockers, clonidine, guanethidine, or reserpine; or intensified glycemic control.
The addition of any anti-diabetic medication, such as SYMLIN, to an existing regimen of one or more anti-diabetic medications (e.g., sulfonylurea), or other medications that can increase the risk of hypoglycemia may necessitate further insulin dose adjustments and particularly close monitoring of blood glucose.
Never Mix SYMLIN And Insulin
Mixing SYMLIN and insulin can alter the pharmacokinetics of both products which may result in inadequate glucose control or hypoglycemia. Therefore, SYMLIN and insulin must always be administered as separate injections and should never be mixed [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Concomitantly Administered Oral Medications
SYMLIN slows gastric emptying, which may delay the absorption of concomitantly administered oral medications. Administer the concomitant oral medication at least 1 hour prior to SYMLIN injection or 2 hours after SYMLIN injection if the rapid onset or threshold concentration of the concomitant medication is a critical determinant of its effectiveness (such as with analgesics, antibiotics, and oral contraceptives) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY )].
Medications That Affect Gastrointestinal Motility
SYMLIN slows gastric emptying. SYMLIN is not recommended for patients taking other medications that alter gastrointestinal motility [see DRUG INTERACTIONS].
Patients may experience erythema, edema, or pruritus 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, such as irritants in a skin cleansing agent or improper injection technique.
Patient Counseling Information
See FDA-approved Medication Guide.
Risk Of Hypoglycemia
Discuss the risk and consequences of hypoglycemia and approaches to minimize its occurrence. Inform patients about the importance of self-management practices including glucose monitoring and timing of dosing. In addition, reinforce the importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications.
Never Mix SYMLIN and Insulin
Inform patients that SYMLIN and insulin should always be administered as separate injections and never be mixed.
Show patients how to administer SYMLIN using the pen-injector. Advise patients to use a new needle for each injection.
Never Share A SYMLIN Pen Between Patients
Inform patients never to share a SYMLIN pen-injector with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection.
Inform patients of the potential risks and advantages of SYMLIN therapy. Advise women with diabetes to inform their healthcare professional if they are pregnant or contemplating pregnancy. Instruct patients on the proper injection technique and proper storage of SYMLIN. 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 dose, inadequate food intake or missed meals. Refer patients to the SYMLIN Medication Guide and Patient Instructions for Use for additional information.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
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 (32, 67, and 159 times the exposure resulting from the human dose of 360 mcg/day 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 (3, 9, and 25 times the exposure resulting from the human dose of 360 mcg/day based on AUC, respectively). No drug-induced tumors were observed in any organ.
SYMLIN was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. SYMLIN 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 (8, 17, and 82 times the exposure resulting from the human dose of 360 mcg/day of mcg 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.
Use In Specific Populations
Pregnancy Category C
No adequate and well-controlled studies have been conducted in pregnant women. Studies in perfused human placenta indicate that SYMLIN has low potential to cross the maternal/fetal placental barrier. Embryofetal toxicity studies with SYMLIN 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 human dose of 360 mcg/day based on area under the plasma concentration curve [AUC], respectively). Administration of doses up to 0.3 mg/kg/day SYMLIN (9 times the human dose of 360 mcg/day based on AUC) to pregnant rabbits had no adverse effects in embryo fetal development; however, animal reproduction studies are not always predictive of human response. SYMLIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is unknown whether SYMLIN is excreted in human milk. Many drugs, including peptides, are excreted in human milk. Therefore, SYMLIN should be administered to nursing women only if it is determined by the healthcare professional that the potential benefit outweighs the potential risk to the infant.
Safety and effectiveness of SYMLIN in pediatric patients have not been established.
SYMLIN has been studied in patients ranging in age from 15 to 84 years of age, including 769 patients ≥ 65 to 75 years of age and 87 patients ≥ 75 years of age. No consistent differences in the efficacy and safety of SYMLIN have been observed in older patients, but greater sensitivity in some older individuals cannot be ruled out. As is recommended for all patients, SYMLIN and insulin regimens should be carefully managed to minimize the risk of severe hypoglycemia.
The dosing requirements for SYMLIN are not altered in patients with mild (creatinine clearance [ClCr] 60-89 mL/min), moderate (ClCr 30-59 mL/min) or severe renal impairment (ClCr 15-29 mL/min). SYMLIN has not been studied in patients with end-stage renal disease [see CLINICAL PHARMACOLOGY].
SYMLIN use has not been studied in patients with hepatic impairment [see CLINICAL PHARMACOLOGY].
No consistent differences in the efficacy and safety of SYMLIN have been observed between men and women in SYMLIN clinical trials (n=2799 for male and n=2085 for female).
No consistent differences in the efficacy and safety of SYMLIN have been observed among patients of differing race/ethnicity in SYMLIN clinical trials (n=4257 for Caucasian, n=229 for black, n=337 for Hispanic or Latino, and n=61 for Asian and one or more races) although the smaller sample sizes for non-Caucasians, particularly Asians, limit conclusions.
Last reviewed on RxList: 7/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Symlin Information
Symlin - User Reviews
Symlin User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Find out what women really need.