SYMLINPEN- pramlintide acetate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pramlintide acetate (UNII: 726I6TE06G) (pramlintide - UNII:D3FM8FA78T)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

pramlintide acetate

Composition:

pramlintide 1000 ug in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is contraindicated in patients with any of the following: Risk Summary Available data from a small number of reports in the manufacturer’s safety database on SYMLIN use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that SYMLIN has low potential to cross the maternal/fetal placental barrier. In animal reproduction studies, congenital abnormalities were observed in fetuses of pregnant rats but not in fetuses of pregnant rabbits exposed during organogenesis to pramlintide at 10 times the c

Product summary:

SYMLIN Injection is available in the following package sizes: 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. 1.5 mL pen-injector Until Expiration Date Use Within 30 Days 2.7 mL pen-injector

Authorization status:

New Drug Application

Patient Information leaflet

SYMLINPEN- PRAMLINTIDE ACETATE INJECTION
AstraZeneca Pharmaceuticals LP
----------
MEDICATION GUIDE
SYMLIN® (SĬM-lĭn)
(pramlintide acetate)
injection for subcutaneous use
Read this Medication Guide and Instructions for Use that come with
your SYMLIN before you start using
it and each time you get a refill. There may be new information. This
Medication Guide does not take the
place of talking to your healthcare provider about your medical
condition or treatment.
What is the most important information I should know about SYMLIN?
SYMLIN can cause serious side effects, including:
•
severe low blood sugar (hypoglycemia). Even when SYMLIN is carefully
added to your mealtime
insulin therapy, your blood sugar may drop too low, especially if you
have type 1 diabetes. If this
severe low blood sugar (hypoglycemia) happens, it is seen within 3
hours after a SYMLIN
injection. Symptoms of severe low blood sugar and low blood sugar
include:
o
lightheadedness
o
dizziness
o
shakiness
o
sweating
o
hunger
o
fast heartbeat
o
trouble concentrating or confusion
o
change in vision
o
headache
o
irritability
o
drowsiness
People who have severely low blood sugar have had injuries while
driving their car, operating heavy
machinery or doing other dangerous activities. You and your healthcare
provider should talk about a plan
to treat low blood sugar. You should have fast-acting sugar (such as
hard candy, glucose tablets, juice) or
glucagon for injection with you at all times. Call your healthcare
provider if you have severe low blood
sugar or if you have low blood sugar more often than normal.
You have a higher chance of getting severe low blood sugar if you:
o
do not follow your healthcare provider’s instructions to reduce your
insulin use before meals
o
use more SYMLIN or insulin than prescribed by your healthcare provider
o
change your insulin dose without checking your blood sugar
o
eat less food than your usual meal
o
are sick and cannot eat
o
are more active than usual
o
have a low blood sugar level before eating
o
drink alcoho

Summary of Product characteristics

SYMLINPEN- PRAMLINTIDE ACETATE INJECTION
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYMLIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SYMLIN.
SYMLIN (PRAMLINTIDE ACETATE) INJECTION FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
WARNING: SEVERE HYPOGLYCEMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
SYMLIN is an amylin analog indicated for patients with type 1 or type
2 diabetes who use mealtime insulin and have failed
to achieve desired glycemic control despite optimal insulin therapy
(1).
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA AT 1-800-FDA-
®
SYMLIN USE WITH INSULIN HAS BEEN ASSOCIATED WITH AN INCREASED RISK OF
SEVERE HYPOGLYCEMIA,
PARTICULARLY IN PATIENTS WITH TYPE 1 DIABETES.
HYPOGLYCEMIA RISK MAY BE REDUCED BY APPROPRIATE PATIENT SELECTION,
CAREFUL PATIENT INSTRUCTION, AND
INSULIN DOSE REDUCTION (5.1, 5.2).
Upon initiation of SYMLIN, reduce mealtime insulin dose by 50%.
Monitor glucoses frequently and individualize
subsequent insulin dose adjustments (2.1).
Type 1 Diabetes: Start at 15 mcg subcutaneously before major meals.
Increase in 15 mcg increments to a maximum
premeal dose of 30 or 60 mcg; if not tolerated, reduce to 30 mcg, as
tolerated (2.2).
Type 2 Diabetes: Start at 60 mcg subcutaneously before major meals
then increase to 120 mcg before meals, as
tolerated (2.2).
Wait at least 3 days between dose titrations to minimize nausea (2.1).
1.5 mL SymlinPen
60 disposable multidose pen-injector, (1000 mcg/mL) for 15, 30, 45,
and 60 mcg doses (3).
®
2.7 mL SymlinPen
120 disposable multidose pen-injector, (1000 mcg/mL) for 60 and 120
mcg doses (3).
®
Prior serious hypersensitivity reaction to SYMLIN or its ingredients
(4)
Hyp