2.1 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 Dosage and Administration (2.2, 2.3)].

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 Dosage and Administration (2.2)].

2.2 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.

2.3 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.

2.4 Administration

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.

2.5 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.

2.6 Preparation and Handling

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

5.1 Patient Selection

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.

5.2 Hypoglycemia

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 (2.1, 2.2)].

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.

5.3 Never Share a SymlinPen Between Patients

SymlinPen must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.

5.4 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 (7.1) and Clinical Pharmacology (12.3)].

5.5 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 (7.2) and Clinical Pharmacology (12.3)].

5.6 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 (7.3)].

5.7 Allergy

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SYMLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

•

Injection site reactions

•

Pancreatitis

7.1 Insulin

The pharmacokinetic parameters of pramlintide are altered when SYMLIN is mixed in the same syringe with regular, NPH, and 70/30 premixed formulations of recombinant human insulin. SYMLIN and insulin must not be mixed and must be administered as separate injections [see Dosage and Administration (2.4), Warnings and Precautions (5.4), and Clinical Pharmacology (12.3)].

7.2 Oral Medications

SYMLIN has the potential to delay the absorption of concomitantly administered oral medications. When the rapid onset or threshold concentration of a concomitant orally administered medication is a critical determinant of effectiveness (such as with analgesics, antibiotics, and oral contraceptives), the medication should be administered at least 1 hour prior to SYMLIN injection or 2 hours after SYMLIN injection [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)].

7.3 Drugs Affecting Gastrointestinal Motility

Due to its effects on gastric emptying, SYMLIN should not be considered for patients taking medications that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) or medications that slow the intestinal absorption of nutrients (e.g., alpha-glucosidase inhibitors). Patients using these medications have not been studied in SYMLIN clinical trials [see Warnings and Precautions (5.6)].

7.4 Drugs Affecting Glucose Metabolism

The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and sulfonamide antibiotics. SYMLIN and these drugs should be coadministered with caution.

8.1 Pregnancy

8.3 Nursing Mothers

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.

8.4 Pediatric Use

Safety and effectiveness of SYMLIN in pediatric patients have not been established.

8.5 Geriatric Use

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.

8.6 Renal Impairment

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 (12.3)].

8.7 Hepatic Impairment

SYMLIN use has not been studied in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

8.8 Gender

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).

8.9 Race/Ethnicity

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.

12.1 Mechanism of Action

Pramlintide is an analog of human amylin. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1).

Figure 1: Secretion Profile of Amylin and Insulin in Healthy Adults

In patients with type 1 and type 2 diabetes, there is reduced secretion from pancreatic beta cells of both insulin and amylin in response to food.

Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms, as determined by nonclinical studies. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression of endogenous glucose output from the liver. Amylin also regulates food intake due to centrally-mediated modulation of appetite.

In human studies, pramlintide, acting as an amylin analog, slows gastric emptying, reduces the postprandial rise in plasma glucagon, and modulates satiety leading to decreased caloric intake.

12.2 Pharmacodynamics

In clinical studies in patients with type 1 diabetes and patients with type 2 diabetes using mealtime insulin, SYMLIN reduced mean postprandial glucose concentrations, reduced glucose fluctuations, and reduced food intake.

Reduction in Postprandial Glucose Concentrations

In a randomized, single-blind, placebo-controlled, crossover study, 19 subjects with type 2 diabetes using insulin lispro, 19 subjects with type 1 diabetes using regular human insulin, and 21 subjects with type 1 diabetes using insulin lispro underwent mixed-meal tests. SYMLIN administered subcutaneously immediately prior to a meal reduced plasma glucose concentrations following the meal when used with mealtime insulin (rapid-acting insulin analogs or regular human insulin) (Figure 2). When rapid-acting insulin analogs were used, plasma glucose concentrations tended to rise during the interval between 150 minutes following SYMLIN injection and the next meal [see Dosage and Administration (2)].

Figure 2: Postprandial Plasma Glucose Profiles in Patients with Type 1 Diabetes or Type 2 Diabetes Receiving SYMLIN and Insulin Compared to Those Receiving Insulin Alone

While SYMLIN reduces postprandial glucose, clinical studies employing a controlled hypoglycemic challenge have demonstrated that SYMLIN does not alter the counter-regulatory hormonal response to insulin-induced hypoglycemia. Likewise, in SYMLIN-treated patients, the perception of hypoglycemic symptoms was not altered with plasma glucose concentrations as low as 45 mg/dL. In a separate clinical trial pramlintide also reduced the 24-hour glucose fluctuations based upon 24-hour glucose monitoring.

12.3 Pharmacokinetics

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14.1 Type 1 Diabetes

The efficacy and safety of SYMLIN were evaluated in 3 (26-52-week), randomized, double-blind, placebo-controlled trials in patients with type 1 diabetes. In these studies, insulin adjustments were minimized in order to isolate the SYMLIN effect with insulin adjustments allowed, at the investigator's discretion, when excessive hypoglycemia was encountered. Patients participating in these 3 trials had a mean age of 40 years, a mean duration of diabetes of 17 years, and a mean body mass index of 25.9 kg/m2.

Table 6 summarizes the 6-month results for those patients assigned to the 30 or 60 mcg dose of SYMLIN or placebo.

In the three studies, from a mean baseline body weight of 75.3 kg, 73.3 kg, and 76.6 kg, respectively, after randomization there were corresponding mean reductions of –0.8 kg, –1.6 kg, and –1.3 kg (60 mcg TID) and –0.8 kg (60 mcg QID) in the SYMLIN treatment group compared to mean increases of +0.8 kg, +0.4 kg, and +0.7 kg in the placebo treatment group.

14.2 Type 2 Diabetes

The efficacy and safety of SYMLIN were evaluated in 2 (a 26-week and a 52-week) randomized, double-blind, placebo-controlled trials in patients with type 2 diabetes. These trials enrolled patients with inadequate glycemic control (HbA1c >8%) on fixed dose insulin. In both trials, SYMLIN or placebo was added to existing insulin therapies. Concomitant use of a sulfonylurea and/or metformin was permitted. Insulin doses were to be kept as stable as possible throughout the treatment period to isolate the SYMLIN effect.

Patients participating in these 2 trials had a mean age of 57 years and a mean duration of diabetes of 13 years. Mean body mass index was 32.9 kg/m2 for SYMLIN and 32.2 kg/m2 for placebo.

Table 8 summarizes the 6-month results for each trial for those patients assigned to the 120 mcg dose of SYMLIN and placebo.

In both studies, from a mean baseline body weight of 96.7 kg, and 85.6 kg, respectively, after randomization there were corresponding mean reductions of –1.4 kg, and –1.6 kg in the SYMLIN treatment group compared to mean increases of +0.3 kg, and +0.1 kg in the placebo treatment group.

16.1 How Supplied

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)

16.2 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.

17.1 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.

17.2 Never Share a SymlinPen Between Patients

Advise patients that they must never share a SymlinPen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens.

17.3 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.

17.4 Instructions

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.

Distributed by:

AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850

SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies.

SymlinPen® (SĬM-lĭnPεn) 120

(pramlintide acetate)
Pen-Injector

Read the Medication Guide and these Instructions for Use before you start using SYMLIN and each time you get a refill. There may be new information.

Do not share your SymlinPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Important:

•

Ask your healthcare provider about your dose of SYMLIN and how to inject SYMLIN the right way before you inject it for the first time.

•

Use a new needle for each SYMLIN injection. Do not reuse or share your needles with other people.You may give other people a serious infection, or get a serious infection from them.

•

This SymlinPen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of this SymlinPen.

•

Check SYMLIN before you use it. SYMLIN should be clear and colorless. Do not use SYMLIN if the liquid looks cloudy or colored or has lumps or particles in it.

•

Your SymlinPen may look empty because SYMLIN is a clear and colorless liquid.

•

Small bubbles will not hurt you or affect your dose of SYMLIN.

•

Do not transfer SYMLIN from your SymlinPen into a syringe.

•

Do not inject your dose of SYMLIN if you:

∘

have low blood sugar (hypoglycemia)

∘

do not plan to eat. Do not inject SYMLIN if you skip a meal. Wait until the next meal and take your usual dose of SYMLIN at that meal.

∘

plan to eat a meal with less than 250 calories or 30 grams of carbohydrate

∘

are sick and cannot eat your usual meal

∘

are having surgery or a medical test where you cannot eat

•

If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and may not be able to eat the amount of food you usually eat. If you take more SYMLIN than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your healthcare provider for guidance.

Supplies you will need to give each injection of SYMLIN:

•

SymlinPen® 120 Pen-Injector (Pen) (See Figure A)

•

a new SymlinPen compatible needle (See Figure B). Pen needles are not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your healthcare provider which needle gauge and length is best for you.

•

alcohol swab

•

1 sharps container for throwing away used SymlinPens and needles. See “Disposing of used SymlinPens and needles” at the end of these Instructions for Use.

(Figure A)

(Figure B)

Preparing your SymlinPen:

•

Wash your hands with soap and water.

•

Check the SymlinPen label before each use to make sure you have the right SymlinPen.

•

Check the expiration date (EXP) on the SymlinPen label (See Figure A). Do not use the SymlinPen past the expiration date printed on the label.

•

Check the liquid in your SymlinPen to make sure you have enough SYMLIN left in your SymlinPen to load your correct dose.

∘

The lines on the cartridge show about how much SYMLIN is left in your SymlinPen. When the top of the plunger is at the thickest line on the cartridge, your SymlinPen is almost empty (See Figure C).

(Figure C)

Attaching a Needle:

Step 1: • Pull the pen cap straight off the SymlinPen and wipe the rubber seal with an alcohol swab.	Figure D
Step 2: • Get a new needle. • Peel off the paper tab and throw it away.	Figure E
Step 3: • Push the capped needle straight onto the end of the SymlinPen and twist the needle clockwise until it is tight.	Figure F
Step 4: • Pull off the outer needle cover. Do not throw it away. • Pull off the inner needle cover and throw it away.	Figure G

New Pen Setup - Priming your SymlinPen:

Note:

•

Steps 5 through 7 are only required if you are using your SymlinPen for the first time. Do not repeat Step 1 through 4 before each dose.

∘

If you have already primed your SymlinPen, go to Step 8 for instructions about giving your scheduled dose.

Step 5: • Turn the dial to select 60 mcg. ∘ You should see the number 60 in the window.	Figure H
Step 6: • Pull the knob straight out as far as it will go. You should hear a “clicking” sound while you are pulling the knob out.	Figure I
Step 7: • Hold your SymlinPen with the needle pointing up. Push the knob all the way in until it stops. You should hear a “clicking” sound while you are pushing the knob in. ∘ A stream of liquid should be seen from the needle. ▪ If you do not see a stream of liquid, repeat Step 6 and Step 7 (you may repeat up to 3 times). ▪ If you still do not see a stream of liquid after 3 attempts, change the needle and repeat Step 6 and Step 7. If you still do not see a stream of liquid, call Information Support.	Figure J

Selecting your routine dose:

Step 8: • Turn the dial to select the correct dose you need to inject.	Figure K
Step 9: • Pull the knob straight out as far as it will go. You should hear a “clicking” sound while you are pulling the knob out.	Figure L
Step 10: • Turn the knob forward or backward until you see the correct dose you need to inject. • Check that you see the line to make sure you have loaded your full dose. You should see a line, arrow, and the number of your dose. ∘ If you do not see a line, arrow, and the number of your dose, do not inject the dose. Point the needle away from you, push the knob all the way in until it stops, then repeat Step 8 to Step 10. ∘ Once the knob has been pulled out, the dial will not move and you cannot reset your dose. If correct dose was not selected, push in the knob to discard the dose and repeat the instructions. If the knob is pushed in all the way, and you cannot turn the dial, call Information Support.	Figure M Figure N

Giving your SYMLIN injection:

•

Inject your SYMLIN exactly as your doctor has shown you.

•

Change (rotate) injection sites for SYMLIN. Inject SYMLIN at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN and insulin in the same site.

•

To help reduce the chances of getting a reaction at the injection site, let SYMLIN come to room temperature before you inject it.

Step 11: • Choose your injection site. • SYMLIN is injected under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). • Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.	Figure O
Step 12: • Insert the needle into your skin.	Figure P
Step 13: • Put your thumb on the knob and push the knob all the way in until it stops. You should hear the “clicking” as you push and hold the knob in and slowly count to 10 to give your full dose.	Figure Q
Step 14: • Pull the needle out of your skin. • If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area. ∘ A drop or 2 of liquid on the needle tip is normal. It will not affect your dose. ∘ If you see more than 2 drops, you may not have received your full dose. Do not inject another dose. Talk to your doctor for help.	Figure R
Step 15: • Carefully replace the outer needle cover by pushing straight onto the end of the SymlinPen.	Figure S
Step 16: • Unscrew the capped needle counterclockwise with the outer needle cover on it and throw it away. • Do not store the SymlinPen with the needle attached or with the knob pulled out to prevent air bubbles.	Figure T
Step 17: • Replace the pen cap.	Figure U

After your injection:

•

Put your used needles and SymlinPen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

∘

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

▪

made of a heavy-duty plastic,

▪

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

▪

upright and stable during use,

▪

leak-resistant, and

▪

properly labeled to warn of hazardous waste inside the container.

∘

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and SymlinPen. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

∘

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store my SymlinPen?

Unused SymlinPens:

•

Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C to 8°C), until you are ready to use it.

•

Do not freeze. Do not use SYMLIN if it has been frozen.

•

Keep unopened SYMLIN out of the light.

Used SymlinPens:

•

Store SymlinPens in the refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C) for up to 30 days.

•

Throw away used SymlinPens after 30 days of use, even if a used SymlinPen still has medicine in it.

•

Do not use SymlinPens (opened or unopened) after the expiration (EXP) date printed on the carton and the label.

General information about the safe and effective use of SymlinPens.

•

If you drop your SymlinPen, you should prime it before you use it to make sure your SymlinPen works.

•

Do not use your SymlinPen if any part looks broken or damaged.

•

Keep SYMLIN and all medicines out of the reach of children.

•

It is not known if SYMLIN is safe and effective in children.

If you are having problems using your SymlinPen, go to www.SYMLIN.com or call Information Support at 1-800-236-9933.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies.

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

Revised: March 2015

SymlinPen® (SĬM-lĭnPεn 60)

(pramlinitide acetate)
Pen-Injector

Read the Medication Guide and these Instructions for Use before you start using SYMLIN and each time you get a refill. There may be new information.

Do not share your SymlinPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Important:

•

Ask your healthcare provider about your dose of SYMLIN and how to inject SYMLIN the right way before you inject it for the first time.

•

Use a new needle for each SYMLIN injection. Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.

•

This SymlinPen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of this SymlinPen.

•

Check SYMLIN before you use it. SYMLIN should be clear and colorless. Do not use SYMLIN if the liquid looks cloudy or colored or has lumps or particles in it.

•

Your SymlinPen may look empty because SYMLIN is a clear and colorless liquid.

•

Small bubbles will not hurt you or affect your dose of SYMLIN.

•

Do not transfer SYMLIN from your SymlinPen into a syringe.

•

Do not inject your dose of SYMLIN if you:

∘

have low blood sugar (hypoglycemia)

∘

do not plan to eat. Do not inject SYMLIN if you skip a meal. Wait until the next meal and take your usual dose of SYMLIN at that meal.

∘

plan to eat a meal with less than 250 calories or 30 grams of carbohydrate

∘

are sick and cannot eat your usual meal

∘

are having surgery or a medical test where you cannot eat

•

If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and may not be able to eat the amount of food you usually eat. If you take more SYMLIN than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your healthcare provider for guidance.

Supplies you will need to give each injection of SYMLIN:

•

SymlinPen® 60 Pen-Injector (Pen) (See Figure A)

•

a new SymlinPen compatible needle (See Figure B). Pen needles are not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your healthcare provider which needle gauge and length is best for you.

•

alcohol swab

•

1 sharps container for throwing away used SymlinPens and needles. See “Disposing of used SymlinPens and needles” at the end of these Instructions for Use.

(Figure A)

(Figure B)

Preparing your SymlinPen:

•

Wash your hands with soap and water.

•

Check the SymlinPen label before each use to make sure you have the right SymlinPen.

•

Check the expiration date (EXP) on the SymlinPen label (See Figure A). Do not use the SymlinPen past the expiration date printed on the label.

•

Check the liquid in your SymlinPen to make sure you have enough SYMLIN left in your SymlinPen to load your correct dose.

∘

The lines on the cartridge show about how much SYMLIN is left in your SymlinPen. When the top of the plunger is at the thickest line on the cartridge, your SymlinPen is almost empty (See Figure C).

(Figure C)

Attaching a Needle:

Step 1: • Pull the pen cap straight off the SymlinPen and wipe the rubber seal with an alcohol swab.	Figure D
Step 2: • Get a new needle • Peel off the paper tab and throw it away.	Figure E
Step 3: • Push the capped needle straight onto the end of the SymlinPen and twist the needle clockwise until it is tight.	Figure F
Step 4: • Pull off the outer needle cover. Do not throw it away. • Pull off the inner needle cover and throw it away.	Figure G

New Pen Setup - Priming your SymlinPen:

Note:

•

Steps 5 through 7 are only required if you are using your SymlinPen for the first time. Do not repeat Step 1 through 4before each dose.

•

If you have already primed your SymlinPen, go to Step 8 for instructions about giving your scheduled dose.

Step 5: • Turn the dial to select 15 mcg. ∘ You should see the number 15 in the window.	Figure H
Step 6: • Pull the knob straight out as far as it will go. You should hear a “clicking” sound while you are pulling the knob out.	Figure I
Step 7: • Hold your SymlinPen with the needle pointing up. Push the knob all the way in until it stops. You should hear a “clicking” sound while you are pushing the knob in. ∘ A stream of liquid should be seen from the needle. ▪ If you do not see a stream of liquid, repeat Step 6 and Step 7 (you may repeat up to 6 times). ▪ If you still do not see a stream of liquid after 6 attempts, change the needle and repeat Step 6 and Step 7. If you still do not see a stream of liquid, call Information Support.	Figure J

Selecting your routine dose:

Step 8: • Turn the dial to select the correct dose you need to inject.	Figure K
Step 9: • Pull the knob straight out as far as it will go. You should hear a “clicking” sound while you are pulling the knob out.	Figure L
Step 10: • Turn the knob forward or backward until you see the correct dose you need to inject. • Check that you see the line to make sure you have loaded your full dose. You should see a line, arrow, and the number of your dose. ∘ If you do not see a line, arrow, and the number of your dose, do not inject the dose. Point the needle away from you, push the knob all the way in until it stops, then repeat Step 8 to Step 10. ∘ Once the knob has been pulled out, the dial will not move and you cannot reset your dose. If correct dose was not selected, push in the knob to discard the dose and repeat the instructions. If the knob is pushed in all the way, and you cannot turn the dial, call Information Support.	Figure M Figure N

Giving your SYMLIN injection:

•

Inject your SYMLIN exactly as your doctor has shown you.

•

Change (rotate) injection sites for SYMLIN. Inject SYMLIN at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN and insulin in the same site.

•

To help reduce the chances of getting a reaction at the injection site, let SYMLIN come to room temperature before you inject it.

Step 11: • Choose your injection site. • SYMLIN is injected under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). • Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.	Figure O
Step 12: • Insert the needle into your skin.	Figure P
Step 13: • Put your thumb on the knob and push the knob all the way in until it stops. You should hear the “clicking” as you push and hold the knob in and slowly count to 10 to give your full dose.	Figure Q
Step 14: • Pull the needle out of your skin. • If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area. ∘ A drop or 2 of liquid on the needle tip is normal. It will not affect your dose. ∘ If you see more than 2 drops, you may not have received your full dose. Do not inject another dose. Talk to your doctor for help.	Figure R
Step 15: • Carefully replace the outer needle cover by pushing straight onto the end of the SymlinPen.	Figure S
Step 16: • Unscrew the capped needle counterclockwise with the outer needle cover on it and throw it away. • Do not store the SymlinPen with the needle attached or with the knob pulled out to prevent air bubbles.	Figure T
Step 17: • Replace the pen cap.	Figure U

After your injection:

•

Put your used needles and SymlinPen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

∘

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

▪

made of a heavy-duty plastic,

▪

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

▪

upright and stable during use,

▪

leak-resistant, and

▪

properly labeled to warn of hazardous waste inside the container.

∘

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and SymlinPen. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

∘

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store my SymlinPen?

Unused SymlinPens:

•

Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C to 8°C), until you are ready to use it.

•

Do not freeze. Do not use SYMLIN if it has been frozen.

•

Keep unopened SYMLIN out of the light.

Used SymlinPens:

•

Store SymlinPens in the refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C) for up to 30 days.

•

Throw away used SymlinPens after 30 days of use, even if a used SymlinPen still has medicine in it.

•

Do not use SymlinPens (opened or unopened) after the expiration (EXP) date printed on the carton and the label.

General information about the safe and effective use of SymlinPens.

•

If you drop your SymlinPen, you should prime it before you use it to make sure your SymlinPen works.

•

Do not use your SymlinPen if any part looks broken or damaged.

•

Keep SYMLIN and all medicines out of the reach of children.

•

It is not known if SYMLIN is safe and effective in children.

 

If you are having problems using your SymlinPen, go to www.SYMLIN.com or call Information Support at 1-800-236-9933.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies.

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

Revised: March 2015