Symlin

1. Symlin
2. SymlinPen

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Before taking Symlin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Symlin or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have gastroparesis
• have a difficulty telling when your blood sugar is too low
• drink alcohol. Alcohol may increase the risk of low blood sugar. 
• have an A1c of over 9%

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Absorption

Bioavailability

Absolute bioavailability is 30–40%.1

Distribution

Extent

Does not extensively bind to blood cells.1

Not known whether distributed into human milk.1

Plasma Protein Binding

Approximately 60%; does not extensively bind to albumin.1

Elimination

Metabolism

Metabolized principally by the kidneys primarily to the active metabolite des-lys1 pramlintide (2-37 pramlintide).1

Half-life

Approximately 48 minutes.1

• An amylinomimetic agent that has physiologic actions equivalent to those of human amylin (glucoregulatory hormone synthesized by pancreatic β-cells and released with insulin in response to a meal).1 3

• Inhibits inappropriately high glucagon secretion during episodes of hyperglycemia (e.g., after a meal) in patients with type 1 or type 2 diabetes mellitus;1 2 does not impair normal glucagon response to hypoglycemia.3

• Slows gastric emptying and reduces the rate of glucose absorption from a meal without altering the net absorption of ingested carbohydrate and other nutrients.1 3

• Prevents the initial postprandial glucose excursions usually observed with insulin therapy alone.1 3

• Reduces food intake and increases satiety, possibly resulting in weight loss.1 3

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)].

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.

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.

Discontinuation of Therapy

Symlin therapy should be discontinued if there is:

Preparation and Handling

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause diarrhea, vomiting, dizziness, cold sweats, warmth or tingly feeling.

Get emergency medical help if you have any signs of an allergic reaction to Symlin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe ongoing nausea; or

• severe hypoglycemia - headache, dizziness, drowsiness, vision problems, hunger, weakness, sweating, confusion, irritability, fast heart rate, feeling jittery.

Common Symlin side effects may include:

• nausea, vomiting, loss of appetite; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with pramlintide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to pramlintide: subcutaneous solution

Along with its needed effects, pramlintide (the active ingredient contained in Symlin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pramlintide:

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool pale skin
• cough
• depression
• difficulty with swallowing
• dizziness
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased hunger
• nausea
• nightmares
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• slurred speech
• tightness in the chest
• unusual tiredness or weakness

Some side effects of pramlintide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• inflicted injury
• loss of appetite
• muscle pain or stiffness
• pain in the joints
• stomach pain
• vomiting
• weight loss

• Body aches or pain
• congestion
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• voice changes