Symlin (Amylin Pharmaceuticals)

Symlin (Amylin Pharmaceuticals) - General Information

Symlin (Amylin Pharmaceuticals) is a relatively new adjunct treatment for diabetes (both type 1 and 2), developed by Amylin Pharmaceuticals. It is derived from amylin, a hormone that is released into the bloodstream, in a similar pattern as insulin, after a meal. Like insulin, amylin is deficient in individuals with diabetes.

 

Pharmacology of Symlin (Amylin Pharmaceuticals)

Symlin (Amylin Pharmaceuticals) is a relatively new adjunct treatment for diabetes (both type 1 and 2), developed by Amylin Pharmaceuticals. It is derived from amylin, a hormone that is released into the bloodstream, in a similar pattern as insulin, after a meal. Like insulin, amylin is deficient in individuals with diabetes. It is provided as an acetate salt.

 

Symlin (Amylin Pharmaceuticals) for patients

Medication Guide

SYMLIN^®

(pramlintide acetate) Injection

Read the Medication Guide that comes with 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 doctor about your medical condition or treatment.

What is the most important information I should know about SYMLIN?

· SYMLIN is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.

· SYMLIN is given at mealtimes. The use of SYMLIN does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.

· 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 low blood sugar (severe hypoglycemia) happens, it is seen within 3 hours after a SYMLIN injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.

· SYMLIN should only be used by people with type 1 and type 2 diabetes who:

· already use their insulin as prescribed, but still need better blood sugar control.

· will follow their doctor's instructions exactly.

· will follow up with their doctor often.

· will test their blood sugar levels before and after every meal, and at bedtime.

· understand how to adjust SYMLIN and insulin doses.

What is SYMLIN?

SYMLIN is an injectable medicine for adults with type 1 and type 2 diabetes to control blood sugar. SYMLIN slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. SYMLIN is always used with insulin to help lower blood sugar during the 3 hours after meals.

Who should not use SYMLIN?

Do not use SYMLIN if you:

· cannot tell when your blood sugar is low (hypoglycemia unawareness).

· have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.

· are allergic to SYMLIN or any ingredients in SYMLIN. See the end of this Medication Guide for a complete list of ingredients.

SYMLIN has not been studied in children.

What should I tell my doctor before starting SYMLIN?

Tell your doctor about all of your medical conditions including if you:

· are pregnant or planning to become pregnant. It is not known if SYMLIN can harm your unborn baby. You and your doctor will decide how to best control your blood sugar levels during pregnancy.

· are breastfeeding. It is not known if SYMLIN passes into your milk and if it can harm your baby. You and your doctor will decide the best way to feed your baby if you are using SYMLIN.

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

SYMLIN can slow down how other medicines pass through your stomach and may affect how much of them get into your body. Therefore, you may have to change the times you take certain medicines.

How should I use SYMLIN?

· You must use SYMLIN exactly as prescribed. The amount of SYMLIN you use will depend on whether you have type 1 or type 2 diabetes. You and your doctor will decide if you can use SYMLIN.

· Never mix SYMLIN and insulin. You must use different syringes for SYMLIN and insulin because insulin can affect SYMLIN when the two are mixed together.

· Injecting SYMLIN is similar to injecting insulin. Inject SYMLIN under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN at a site that is more than 2 inches away from your insulin injection. Allow SYMLIN to warm to room temperature before injecting. Use a U-100 insulin syringe (best to use 0.3 mL [0.3 cc] size) to draw-up and inject SYMLIN. Always use a new syringe and needle for each SYMLIN injection.

· The dose of SYMLIN that your doctor prescribes should be one in the table below. Use this table to match your SYMLIN dose to insulin syringe units:

Find Your Dose in micrograms (µg)	Draw Up This Amount in U-100 Insulin Syringe (units)
15	2.5
30	5.0
45	7.5
60	10.0
120	20.0

· Do not use SYMLIN if the liquid in the vial looks cloudy.

· If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.

· If you miss or forget a dose of SYMLIN, wait until the next meal and take your usual dose of SYMLIN at that meal. Do not take more than your usual dose of SYMLIN.

Using SYMLIN and insulin with Type 2 Diabetes

1. Start SYMLIN at 60 µg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

2. Reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use.

3. You must check your blood sugar before and after every meal and at bedtime.

4. Increase your dose of SYMLIN to 120 µg on your doctors instructions if you have not had any nausea for 3 days or more.

5. Tell your doctor right away if you have nausea with the 120 µg dose. Your doctor will tell you how to adjust your dose of SYMLIN.

6. Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 µg dose of SYMLIN. All insulin changes should be directed by your doctor.

Using SYMLIN and insulin with Type 1 Diabetes

1. Start SYMLIN at 15 µg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

2. When starting SYMLIN, reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use. All insulin changes should be directed by your doctor.

3. You must check your blood sugar before and after every meal and at bedtime.

4. Increase your dose of SYMLIN to 30 µg on your doctors instructions if you have not had any nausea for 3 days or more. If you have nausea with SYMLIN at 30 µg, call your doctor right away. Your doctor may decide that you should stop SYMLIN.

5. Increase your dose of SYMLIN to 45 µg on your doctors instructions if you have not had any nausea for 3 days or more while using the 30 µg dose.

6. Increase your dose of SYMLIN to 60 µg on your doctors instructions if you have not had any nausea for 3 days or more while using the 45 µg dose.

7. Call your doctor right away if you are bothered with nausea on the 45 µg or 60 µg dose. Your doctor may decide that you should reduce SYMLIN to the 30 µg dose.

8. Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of SYMLIN that is right for you. All insulin changes should be directed by your doctor.

Staying on SYMLIN

· Once you reach your recommended dose of SYMLIN, talk to your doctor about changing your insulin doses to better control your blood sugar. You may have to increase your long-acting insulin to prevent high blood sugar (hyperglycemia) between meals. Insulin changes should be directed by your doctor based on blood sugar testing.

· Call your doctor if nausea or low blood sugar continues while on your recommended dose of SYMLIN. Low blood sugar that happens often is a warning sign of possible severe low blood sugar, especially if you have type 1 diabetes.

· If you stop taking SYMLIN for any reason, such as surgery or illness, call your doctor. SYMLIN should be restarted as described above in "How should I use SYMLIN?"

When should I not use SYMLIN?

Do not use SYMLIN if:

· Your blood sugar is too low.

· You do not plan to eat. Do not inject SYMLIN if you skip a meal.

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

· You are sick and cant eat your usual meal.

· You are having surgery or a medical test where you cannot eat.

· You are pregnant or breastfeeding and have not talked to your doctor.

Talk to your doctor if you have any of these conditions.

What should I avoid while taking SYMLIN?

· Do not drive or operate dangerous machinery until you know how SYMLIN affects your blood sugar. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others. Discuss with your doctor what activities you should avoid.

· Alcohol may increase the risk of low blood sugar.

· Your doctor will tell you which medicines you can take while using SYMLIN. Do not take other medicines that slow stomach emptying.

Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.

What are the possible side effects of SYMLIN?

Low blood sugar (hypoglycemia)

· SYMLIN is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes. See "What is the most important information I should know about SYMLIN?"

· When starting SYMLIN, reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor 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 with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.

Your chance for low blood sugar is higher if you:

· do not reduce your insulin dose before meals at the beginning of SYMLIN treatment, as directed by your doctor.

· use more SYMLIN or insulin than prescribed by your doctor.

· change your insulin dose without checking your blood sugar.

· eat less food than your usual meal.

· are sick and cannot eat.

· are more active than usual.

· have a low blood sugar level before eating.

· drink alcohol.

Nausea

Nausea is the most common side effect with SYMLIN. Mild nausea is more likely during the first weeks after starting SYMLIN and usually does not last long. It is very important to start SYMLIN at a low dose and increase it as directed by your doctor. See "How should I use SYMLIN?" If nausea continues or bothers you, call your doctor right away.

Other Side Effects

SYMLIN also may cause the following side effects: decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion.

SYMLIN also can cause reactions at the injection site including redness, minor bruising, or pain. Follow the directions under "How should I use SYMLIN?" to reduce the chance of an injection site reaction.

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the side effects with SYMLIN. Ask your doctor or pharmacist for more information.

How should I store SYMLIN?

· Store SYMLIN vials in the refrigerator until you open them.

· Opened vials can be refrigerated or kept at room temperature for up to 28 days. Any opened vial should be thrown away after 28 days, even if it still has medicine in it.

· Throw away any vial that is out-of-date, has been frozen, heated above room temperature (77°F/25°C) or left at room temperature for more than 28 days.

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

General information about the safe and effective use of SYMLIN

Medicines are sometimes prescribed for conditions other than those described in a Medication Guide. Do not use SYMLIN for a condition for which it was not prescribed. Do not give SYMLIN to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SYMLIN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about SYMLIN that is written for health professionals.

More information on SYMLIN can be found at https://www.symlin.com.

SYMLIN Customer Service is available 24 hours a day at 1-800-349-8919.

What are the ingredients in SYMLIN?

Active ingredient: pramlintide acetate

Inactive ingredients: metacresol, D-mannitol, acetic acid, and sodium acetate.

This draft Medication Guide is pending approval by the U.S. Food and Drug Administration.

 

Symlin (Amylin Pharmaceuticals) Interactions

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

SYMLIN has the potential to delay the absorption of concomitantly administered oral medications. When the rapid onset of a concomitant orally administered agent is a critical determinant of effectiveness (such as analgesics), the agent should be administered at least 1 hour prior to or 2 hours after SYMLIN injection.

In clinical trials, the concomitant use of sulfonylureas or biguanides did not alter the adverse event profile of SYMLIN. No formal interaction studies have been performed to assess the effect of SYMLIN on the kinetics of oral antidiabetic agents.

Mixing SYMLIN and Insulin

The pharmacokinetic parameters of SYMLIN were altered when mixed with regular, NPH, and 70/30 premixed formulations of recombinant human insulin immediately prior to injection. Thus, SYMLIN and insulin should not be mixed and must be administered separately.

 

Symlin (Amylin Pharmaceuticals) Contraindications

SYMLIN is contraindicated in patients with any of the following:

• a known hypersensitivity to SYMLIN or any of its components, including metacresol
• a confirmed diagnosis of gastroparesis
• hypoglycemia unawareness

 

Additional information about Symlin (Amylin Pharmaceuticals)

Symlin (Amylin Pharmaceuticals) Indication: For the mealtime treatment of Type I and Type II diabetes in combination with standard insulin therapy, in patients who have failed to achieve adequate glucose control on insulin monotherapy.
Mechanism Of Action: Symlin (Amylin Pharmaceuticals) is an amlyinomimetic, a functional analog of the naturally occurring pancreatic hormone amylin. Amylin has activity in a number of gastrointestinal and glucodynamic systems, and by mimicking its activity, Symlin (Amylin Pharmaceuticals) acts to improve glycemic control through modulation of the rate of gastric emptying, prevention of post-prandial rise in glucagon levels, and by increasing sensations of satiety, thereby reducing caloric intake and potentiating weight loss. There appears to be at least three distinct receptor complexes that bind with high affinity to amylin. All three complexes contain the calcitonin receptor at the core, plus one of three Receptor activity-modifying proteins, RAMP1, RAMP2, or RAMP3.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Pramlintide
Synonyms: Pramlintide acetate
Drug Category: Not Available
Drug Type: Biotech; Approved

Other Brand Names containing Pramlintide: Symlin (Amylin Pharmaceuticals);
Absorption: The absolute bioavailability of a single subcutaneous dose of pramlintide is approximately 30 to 40%.
Toxicity (Overdose): Not Available
Protein Binding: Pramlintide does not extensively bind to blood cells or albumin (approximately 40% of the drug is unbound in plasma).
Biotransformation: Metabolized primarily by the kidneys.
Half Life: Approximately 48 minutes
Dosage Forms of Symlin (Amylin Pharmaceuticals): Solution Subcutaneous
Chemical IUPAC Name: Not Available
Chemical Formula: C171H267N51O53S2
Pramlintide on Wikipedia: https://en.wikipedia.org/wiki/Pramlintide
Organisms Affected: Humans and other mammals