"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
DOSAGE AND ADMINISTRATION
Important Considerations Pertaining To SYMLIN And Insulin Dose Adjustments
SYMLIN dosage differs depending on whether the patient has type 1 or type 2 diabetes [see Patients with Type 2 Diabetes Using Mealtime Insulin and Patients with Type 1 Diabetes below].
SYMLIN should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring.
Insulin and SYMLIN dose adjustments should be made only as directed by a healthcare professional skilled in the use of insulin.
When initiating SYMLIN, reduce mealtime insulin doses, including premixed insulins, by 50% to reduce the risk of hypoglycemia.
To reduce the risk of nausea, wait at least 3 days before titrating SYMLIN to the next dose increment.
Monitor blood glucoses frequently, including pre-and post-meals and at bedtime, particularly when initiating SYMLIN or increasing the SYMLIN dose. After the initial 50% reduction in mealtime insulin dose, individualize insulin dose adjustments based on glycemic control and tolerability (e.g., if nausea occurs it may affect the dose of insulin required). An increased frequency of mild-to-moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.
If SYMLIN therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is reinstituted [see Patients with Type 2 Diabetes Using Mealtime Insulin below].
Patients With Type 2 Diabetes Using Mealtime Insulin
Reduce mealtime insulin doses (including premixed insulins) by 50%, then initiate SYMLIN at 60 mcg subcutaneously, injecting immediately prior to each major meal.
Increase the SYMLIN dose from 60 to 120 mcg prior to each major meal when no clinically significant nausea has occurred for at least 3 days.
If significant nausea persists at the 120 mcg dose, the SYMLIN dose should be decreased to 60 mcg.
Patients With Type 1 Diabetes
Reduce mealtime insulin doses by 50%, then initiate SYMLIN at 15 mcg subcutaneously, injecting immediately prior to each major meal.
Increase the SYMLIN dose to the next increment (30, 45, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days.
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.
SYMLIN should be administered subcutaneously immediately prior to each major meal ( ≥ 250 kcal or containing ≥ 30 grams 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.
Discontinuation Of Therapy
SYMLIN therapy should be discontinued if there is:
- 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 provider 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.
Dosage Forms And Strengths
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).
SYMLIN Injection is available in the following package sizes:
SymlinPen® 60 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) Two 1.5 mL disposable multidose pen-injectors (NDC 0310-6615-02)
SymlinPen® 120 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) Two 2.7 mL disposable multidose pen-injectors (NDC 0310-6627-02)
Storage And Handling
SYMLIN pen-injectors not in use: Refrigerate (2°C to 8°C; 36°F to 46°F), 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 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||Until Expiration Date||Use Within 30 Days|
Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Revised: Feb 2015.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2015
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