Symlin

Symlin is a prescription medication used in the treatment of type 1 and type 2 diabetes in certain people who require additional blood glucose control despite optimal insulin therapy.

Symlin belongs to a group of drugs called amylin analogs. These work to lower blood sugar levels by slowing the movement of food from the stomach into the small intestine which keeps blood sugar levels from rising quickly. 

This medication is available in an injectable form to be given directly under the skin and is typically given prior to major meals.

Common side effects of Symlin include nausea and loss of appetite. 

Symlin can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Symlin affects you.

Symlin is a prescription medication used in the treatment of both type 1 and type 2 diabetes in certain people who require additional blood glucose control despite optimal insulin therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Amylin Pharmaceuticals, LLC

Serious side effects have been reported with Symlin. See the “Symlin Precautions” section.

Common side effects of Symlin include the following:

• nausea. Mild nausea is more likely during the first weeks after starting this medication and usually does not last long. 
• loss of appetite
• vomiting
• headache
• fatigue
• dizziness
• cough
• sore throat
• stomach pain
• indigestion
• injection site reactions such as redness and swelling

This is not a complete list of Symlin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

• medications to lower blood sugar
• medications that affect the time it takes to empty the stomach 
• medications that affect the way glucose is metabolized such as oral antidiabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and sulfonamide antibiotic

This is not a complete list of Symlin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symlin including the following:

Severe Low Blood Sugar (Hypoglycemia). When used in combination with insulin therapy, Symlin can raise your risk for developing severe hypoglycemia, especially if you have type I diabetes. Severe hypoglycemia typically occurs within two or three hours following a dose of Symlin and can be dangerous if it occurs while you are operating a motor vehicle, heavy machinery, or engaged in any other high-risk activities. Symptoms of severe low blood sugar and low blood sugar include:

• lightheadedness
• dizziness
• shakiness
• sweating
• hunger
• fast heartbeat
• trouble concentrating or confusion
• change in vision
• headache
• irritability
• drowsiness

Certain things can affect your blood sugar. With this being said, your chance for having low sugar is higher in the following situations:

• changing your insulin dose without checking your blood sugar.
• eating 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. Alcohol may increase the risk of low blood sugar. 

Consult with your physician about your risk for developing severe hypoglycemia, to learn about the early warning signs of hypoglycemia, and for information about how to correct hypoglycemia when it occurs. Your pharmacist can also advise you on how to treat and prevent hypoglycemia. 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.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Symlin, there are no specific foods that you must exclude from your diet when receiving this medication.

Symlin is administered before a major meal. A major meal must have at least 250 calories or 30 grams of carbohydrate.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Symlin falls into category C. There are no well-controlled studies in pregnant women. It is not known if Symlin will harm your unborn baby. Symlin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding. 

It is not known if Symlin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, 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.

Administer Symlin exactly as prescribed.

Symlin comes in an injectable form to be given just under the skin and is typically injected just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

Do not inject Symlin until you have been instructed and trained properly by your healthcare provider.

Always follow your healthcare provider's instructions on administration of Symlin exactly. You may refer to the following section for additional information on proper use of Symlin.

• Your healthcare provider will tell you how much Symlin to use and when to use it.
• Your healthcare provider may change your dose if needed.
• If you stop taking Symlin for any reason, such as surgery or illness, talk to your healthcare provider about how to restart Symlin.
• To reduce the risk of hypoglycemia, it is important that you plan your meals and physical activity every day while you use Symlin. Plan for what you will eat and when you will eat your meals. 
• The amount of Symlin you use will depend on whether you have type 1 or type 2 diabetes.

Important notes about Symlin use:

• To reduce the risk of having a painful injection-site reaction, allow Symlin to come to room temperature before injecting
• Use a new needle for each Symlin injection
• Never mix Symlin and insulin and do not inject Symlin and insulin in the same site. Insulin can affect Symlin when they are mixed together.
• Do not use Symlin if the liquid looks cloudy
• Do not share your Symlin with another person, even if the needle is changed; you may give another person an infection or get an infection from them   
• Do not use Symlin if you 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.
• 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.

Selecting your dose:

1. Turn the dose dial to select the correct dose you need to inject
2. Pull the dose knob straight out as far as it will go; you should hear a “clicking” sound while you are pulling the dose knob out
3. Turn the dose knob forward or backward until you see the correct dose you need to inject
4. Check the dose 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 dose knob all the way in until it stops, then repeat step 1 to step 4 to get the accurate dose. 
• once the Knob has been pulled out, the dial will not move and you cannot reset your dose; if the correct dose was not selected, push in the knob to discard the dose and repeat the instructions

Administering Symlin:

1. Inject your Symlin exactly as your doctor has shown you
2. Choose your injection site; Symlin is injected 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. Do not inject SYMLIN and insulin in the same site.
3. Wipe the skin with an alcohol swab and let the injection site dry before you inject your dose
4. Insert the needle into your skin
5. Put your thumb on the dose knob and push the dose knob all the way in until it stops; hold the dose knob in and slowly count to 10
6. 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
7. If you see 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 of liquid on the needle tip, you may not have received your full dose; do not inject another dose; talk to your doctor for help if this happens
8. Carefully replace the outer needle cover
9. Unscrew the capped needle with the outer needle cover on it and safely throw it away as instructed; do not store the Symlin pen with the needle attached or with the dose knob pulled out to prevent air bubbles
10. Replace the pen cap

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended starting dose of Symlin for the treatment of type 1 diabetes is 15 mcg injected under the skin (subcutaneously) prior to major meals. The doctor will increase the dose in 15 mcg increments to a maximum premeal dose of 30 or 60 mcg. 

The recommended starting dose of Symlin for the treatment of type 2 diabetes is 60 mcg injected under the skin (subcutaneously) before major meals. The docto can then increase the dose to 120 mcg before meals. 

If you take too much Symlin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Unopened Symlin:

• Store 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 Symlin. Do not use Symlin if it has been frozen.
• Keep unopened Symlin out of the light

Opened Symlin:

• Keep Symlin in the refrigerator or at room temperature up to 86°F (30°C) for 30 days; do not leave above 86°F (30°C)
• Any Symlin in use should be thrown away after 30 days, even if it still has medicine in it

Unused Symlin (opened or unopened) should not be used after the expiration date printed on the carton and the label

Keep Symlin and all medicines out of the reach of children

Symlin is typically used along with insulin therapy and has been associated with an increased risk of insulin-induced severe hypoglycemia (low blood sugar), particularly in patients with type 1 diabetes. When severe hypoglycemia associated with Symlin use occurs, it is generally seen within 3 hours following a Symlin injection. If severe hypoglycemia occurs while you are operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.