DOSAGE AND ADMINISTRATION
SYMLIN dosage differs depending on whether the patient has type 2 or type 1 diabetes (see below). When initiating therapy with SYMLIN, 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 tolerability and the effect on blood glucose, so that individualized insulin adjustments can be initiated. If SYMLIN therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is re-instituted (see below).
Initiation of SYMLIN therapy
Patients With Insulin-Using Type 2 Diabetes
In patients with insulin-using type 2 diabetes, SYMLIN 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 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 dose to 120 mcg when no clinically significant nausea has occurred for 3-7 days. SYMLIN dose adjustments should be made only as directed by the healthcare professional. If significant nausea persists at the 120 mcg dose, the SYMLIN dose should be decreased to 60 mcg;
- Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the healthcare professional;
- Contact a healthcare professional skilled in the use of insulin to review SYMLIN and insulin dose adjustments at least once a week until a target dose of SYMLIN is achieved, SYMLIN is well-tolerated, and blood glucose concentrations are stable.
Patients With Type 1 Diabetes
In patients with type 1 diabetes, SYMLIN 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 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 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 dose adjustments should be made only as directed by the healthcare professional. If significant nausea persists at the 45 or 60 mcg dose level, the SYMLIN dose should be decreased to 30 mcg. If the 30 mcg dose is not tolerated, discontinuation of SYMLIN therapy should be considered;
- Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the healthcare professional;
- Contact a healthcare professional skilled in the use of insulin to review SYMLIN and insulin dose adjustments at least once a week until a target dose of SYMLIN is achieved, SYMLIN is well-tolerated, and blood glucose concentrations are stable.
Once Target Dose of SYMLIN is Achieved in Type 2 or Type 1 Patients
After a maintenance dose of SYMLIN 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 is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by a healthcare professional;
- Contact a healthcare 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 should be administered subcutaneously immediately prior to each major meal (≥250 kcal or containing ≥30 g of carbohydrate).
SYMLIN should be at room temperature before injecting to reduce potential injection site reactions. Each SYMLIN 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 and insulin should always be administered as separate injections.
- SYMLIN should not be mixed with any type of insulin.
- If a SYMLIN dose is missed, wait until the next scheduled dose and administer the usual amount.
SymlinPen™ pen-injector
The SymlinPen™ pen-injector is available in two presentations:
- SymlinPen™ 60 pen-injector for doses of 15 mcg, 30 mcg, 45 mcg, 60 mcg.
- SymlinPen™ 120 pen-injector for doses of 60 mcg and 120 mcg.
See the accompanying Patient Instructions for Use for instructions for using the SymlinPen™ 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 from the pen-injector to a syringe. Doing so could result in a higher dose than intended, because SYMLIN in the pen-injector is a higher concentration than SYMLIN in the SYMLIN 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 vials
To administer SYMLIN 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 Dose to Insulin Unit Equivalents | Dosage Prescribed (mcg) | Increment Using a U-100 Syringe (Units) | Volume (cc or mL) |
|---|
| 15 | 2½ | 0.025 |
| 30 | 5 | 0.05 |
| 45 | 7½ | 0.075 |
| 60 | 10 | 0.1 |
| 120 | 20 | 0.2 |
Always use separate, new syringes and needles to give SYMLIN and insulin injections.
Discontinuation of Therapy
SYMLIN 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 healthcare professional contacts or recommended clinic visits.
Preparation and Handling
SYMLIN should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.
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HOW SUPPLIED
SYMLIN is supplied as a sterile injection in the following dosage forms:
- 1.5 mL disposable multidose SymlinPen™ 60 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
- 2.7 mL disposable multidose SymlinPen™ 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 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 with insulin.
SYMLIN Injection is available in the following package sizes:
- SymlinPen™ 60 pen-injector, containing 1000 mcg/mL pramlintide (as acetate)
2 X 1.5 mL disposable multidose pen-injector
(NDC 66780-115-02)
- SymlinPen™ 120 pen-injector, containing 1000 mcg/mL pramlintide (as acetate)
2 X 2.7 mL disposable multidose pen-injector
(NDC 66780-121-02)
- 5 mL vial, containing 600 mcg/mL pramlintide (as acetate), for use with an insulin syringe
(NDC 66780-110-01)
STORAGE
SYMLIN 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 (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
SYMLIN 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 | Dosage Form | Unopened (not in use)
Refrigerated | Open (in use)
Refrigerated or Temperature
Up To 86°F (30°C) |
|---|
1.5 mL pen-injector
2.7 mL pen-injector
5 mL vial | Until Expiration Date | Use Within 30 days |
The SymlinPen™ pen-injectors and SYMLIN vials are manufactured for:
Amylin Pharmaceuticals, Inc.
San Diego, CA 92121 USA
1-800-349-8919
http://www.SYMLIN.com
Rx only
The SYMLIN mark, SYMLIN design mark, and SymlinPen are trademarks of Amylin Pharmaceuticals, Inc. Copyright © 2005-2007, Amylin Pharmaceuticals, Inc. All rights reserved.
Literature Revised December 2007
812003-BB
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