SYMLIN (pramlintide acetate injection) is given at mealtimes and is indicated for:

• Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
• Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.

SYMLIN (pramlintide acetate injection) dosage differs depending on whether the patient has type 2 or type 1 diabetes (see below). When initiating therapy with SYMLIN (pramlintide acetate injection) , initial insulin dose reduction is required in all patients (both type 2 and type 1) to reduce the risk of insulin-induced hypoglycemia. As this reduction in insulin can lead to glucose elevations, patients should be monitored at regular intervals to assess SYMLIN (pramlintide acetate injection) tolerability and the effect on blood glucose, so that individualized insulin adjustments can be initiated. If SYMLIN (pramlintide acetate injection) therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN (pramlintide acetate injection) therapy is re-instituted (see below).

Initiation of SYMLIN (pramlintide acetate injection) therapy

Patients With Insulin-using Type 2 Diabetes

In patients with insulin-using type 2 diabetes, SYMLIN (pramlintide acetate injection) should be initiated at a dose of 60 mcg and increased to a dose of 120 mcg as tolerated.

Patients should be instructed to:

• Initiate SYMLIN (pramlintide acetate injection) at 60 mcg subcutaneously, immediately prior to major meals;
• Reduce preprandial, rapid-acting or short-acting insulin dosages, including fixed-mix insulins (70/30) by 50%;
• Monitor blood glucose frequently, including pre- and post-meals and at bedtime;
• Increase the SYMLIN (pramlintide acetate injection) dose to 120 mcg when no clinically significant nausea has occurred for 3-7 days. SYMLIN (pramlintide acetate injection) dose adjustments should be made only as directed by the health care professional. If significant nausea persists at the 120 mcg dose, the SYMLIN (pramlintide acetate injection) dose should be decreased to 60 mcg;
• Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the health care professional;
• Contact a health care professional skilled in the use of insulin to review SYMLIN (pramlintide acetate injection) and insulin dose adjustments at least once a week until a target dose of SYMLIN (pramlintide acetate injection) is achieved, SYMLIN (pramlintide acetate injection) is well-tolerated, and blood glucose concentrations are stable.

Patients With Type 1 Diabetes

In patients with type 1 diabetes, SYMLIN (pramlintide acetate injection) should be initiated at a dose of 15 mcg and titrated at 15-mcg increments to a maintenance dose of 30 mcg or 60 mcg as tolerated.

Patients should be instructed to:

• Initiate SYMLIN (pramlintide acetate injection) at a starting dose of 15 mcg subcutaneously, immediately prior to major meals;
• Reduce preprandial, rapid-acting or short-acting insulin dosages, including fixed-mix insulins (e.g., 70/30) by 50%;
• Monitor blood glucose frequently, including pre- and post-meals and at bedtime;
• Increase the SYMLIN (pramlintide acetate injection) dose to the next increment (30 mcg, 45 mcg, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days. SYMLIN (pramlintide acetate injection) dose adjustments should be made only as directed by the health care professional. If significant nausea persists at the 45- or 60-mcg dose level, the SYMLIN (pramlintide acetate injection) dose should be decreased to 30 mcg. If the 30-mcg dose is not tolerated, discontinuation of SYMLIN (pramlintide acetate injection) therapy should be considered;
• Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the health care professional;
• Contact a health care professional skilled in the use of insulin to review SYMLIN (pramlintide acetate injection) and insulin dose adjustments at least once a week until a target dose of SYMLIN (pramlintide acetate injection) is achieved, SYMLIN (pramlintide acetate injection) is well-tolerated, and blood glucose concentrations are stable.

Once Target Dose of SYMLIN (pramlintide acetate injection) Is Achieved in Type 2 or Type 1 Patients

After a maintenance dose of SYMLIN (pramlintide acetate injection) is achieved, both insulin-using patients with type 2 diabetes and patients with type 1 diabetes should be instructed to:

• Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by a health care professional;
• Contact a health care professional in the event of recurrent nausea or hypoglycemia. An increased frequency of mild to moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.

Administration

SYMLIN (pramlintide acetate injection) should be administered subcutaneously immediately prior to each major meal ( ≥ 250 kcal or containing ≥ 30 g of carbohydrate).

SYMLIN (pramlintide acetate injection) should be at room temperature before injecting to reduce potential injection site reactions. Each SYMLIN (pramlintide acetate injection) dose should be administered subcutaneously into the abdomen or thigh (administration into the arm is not recommended because of variable absorption). Injection sites should be rotated so that the same site is not used repeatedly. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection.

• SYMLIN (pramlintide acetate injection) and insulin should always be administered as separate injections.
• SYMLIN (pramlintide acetate injection) should not be mixed with any type of insulin.
• If a SYMLIN (pramlintide acetate injection) dose is missed, wait until the next scheduled dose and administer the usual amount.

Symlin (pramlintide acetate injection) Pen™ pen-injector

The Symlin (pramlintide acetate injection) Pen™ pen-injector is available in two presentations:

• Symlin (pramlintide acetate injection) Pen™ 60 pen-injector for doses of 15 mcg, 30 mcg, 45 mcg and 60 mcg
• Symlin (pramlintide acetate injection) Pen™ 120 pen-injector for doses of 60 mcg and 120 mcg

See the accompanying Patient Instructions for Use for instructions for using the Symlin (pramlintide acetate injection) Pen™ pen-injector.

The patient should be advised:

• to confirm they are using the correct pen-injector that will deliver their prescribed dose
• on proper use of the pen-injector, emphasizing how and when to set up a new pen-injector
• not to transfer SYMLIN (pramlintide acetate injection) from the pen-injector to a syringe. Doing so could result in a higher dose than intended, because SYMLIN (pramlintide acetate injection) in the pen-injector is a higher concentration than SYMLIN (pramlintide acetate injection) in the SYMLIN (pramlintide acetate injection) vial
• not to share the pen-injector and needles with others
• that needles are not included with the pen-injector and must be purchased separately
• which needle length and gauge should be used
• to use a new needle for each injection.

SYMLIN (pramlintide acetate injection) vials

To administer SYMLIN (pramlintide acetate injection) from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size) for optimal accuracy. If using a syringe calibrated for use with U-100 insulin, use the chart below (Table 8) to measure the microgram dosage in unit increments.

Table 8: Conversion of SYMLIN (pramlintide acetate injection) Dose to Insulin Unit Equivalents

Always use separate, new syringes and needles to give SYMLIN (pramlintide acetate injection) and insulin injections.

Discontinuation of Therapy

SYMLIN (pramlintide acetate injection) therapy should be discontinued if any of the following occur:

• Recurrent unexplained hypoglycemia that requires medical assistance;
• Persistent clinically significant nausea;
• Noncompliance with self-monitoring of blood glucose concentrations;
• Noncompliance with insulin dose adjustments;
• Noncompliance with scheduled health care professional contacts or recommended clinic visits.

Preparation and Handling

SYMLIN (pramlintide acetate injection) should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.

SYMLIN (pramlintide acetate injection) is supplied as a sterile injection in the following dosage forms:

• 1.5 mL disposable multidose Symlin (pramlintide acetate injection) Pen™ 60 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
• 2.7 mL disposable multidose Symlin (pramlintide acetate injection) Pen™ 120 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
• 5 mL vial, containing 600 mcg/mL pramlintide (as acetate), for use with an insulin syringe.

To administer SYMLIN (pramlintide acetate injection) from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size). If using a syringe calibrated for use with U-100 insulin, use the chart (Table 8) in the DOSAGE AND ADMINISTRATION section to measure the microgram dosage in unit increments.

Do not mix SYMLIN (pramlintide acetate injection) with insulin.

SYMLIN (pramlintide acetate injection) Injection is available in the following package sizes:

Symlin (pramlintide acetate injection) Pen™ 60 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) 2 X 1.5 mL disposable multidose pen-injector...............................(NDC 66780-111-08)

Symlin (pramlintide acetate injection) Pen™ 120 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) 2 X 2.7 mL disposable multidose pen-injector...............................(NDC 66780-111-09)

5 mL vial, containing 600 mcg/mL pramlintide (as acetate), for use with an insulin syringe...............................(NDC 66780-110-01)

Storage

SYMLIN (pramlintide acetate injection) pen-injectors and vials not in use: Refrigerate (36°F to 46°F; 2°C to 8°C), and protect from light. Do not freeze. Do not use if product has been frozen. Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.

SYMLIN (pramlintide acetate injection) pen-injectors and vials in use: After first use, refrigerate or keep at a temperature not greater than 86°F (30°C) for 30 days. Use within 30 days, whether or not refrigerated.

Storage conditions are summarized in Table 9:

Table 9: Storage Conditions

The Symlin (pramlintide acetate injection) Pen™ pen-injectors and SYMLIN (pramlintide acetate injection) vials are manufactured for: Amylin Pharmaceuticals, Inc. San Diego, CA 92121 USA http://www.SYMLIN (pramlintide acetate injection) .com. FDA rev date: 9/25/2007

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