Pramlintide

Pramlintide is a prescription medication used with meal time insulin to treat type 1 and type 2 diabetes. Pramlintide is an amylin analog drug which works by slowing movement of food from the stomach, which keeps blood sugar from rising too fast. It also works by lowering the amount of sugar produced by the liver.

This medication comes in an injectable form to be given just under the skin. Inject pramlintide just before meals.

Common side effects of pramlintide include nausea, decreased appetite, and vomiting.

Pramlintide is a prescription medicine used along with insulin to treat type 1 or type 2 diabetes.

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

Pramlintide may be found in some form under the following brand names:

• Symlin

Low blood sugar (hypoglycemia):

• Pramlintide is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes.
• When starting pramlintide, 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 pramlintide treatment, as directed by your doctor.
  • use more pramlintide 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.

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

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

Pramlintide also may cause the following side effects:

• decreased appetite
• vomiting
• stomach pain
• tiredness
• dizziness
• indigestion
• redness, bruising, pain at injection site

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 pramlintide. Ask your doctor or pharmacist for more information.

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:

• Angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, Lotensin HCT), captopril (Capoten, Capozide), and enalapril (Vasotec, Vaseretic)

• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• clonidine (Catapres)
• disopyramide (Norpace)
• fenofibrate (Lofibra, Tricor)
• fluoxetine (Prozac, Sarafem)
• gemfibrozil (Lopid)
• guanethidine (Ismelin)
• other medications for diabetes
• monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate)
• pentoxifylline (Trental)
• reserpine (Serpalan, Serpasil)
• salicylate pain relievers such as aspirin
• sulfonamide antibiotics such as trimethoprim/sulfamethoxazole (Bactrim, Septra)

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

• Pramlintide is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
• Pramlintide is given at mealtimes. The use of pramlintide does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
• Even when pramlintide 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 pramlintide 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.
• Pramlintide should only be used by people with type 2 and type 1 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 pramlintide and insulin doses.

Do not drive or operate dangerous machinery until you know how pramlintide 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 pramlintide. Do not take other medicines that slow stomach emptying.

Do not use pramlintide 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 pramlintide or any ingredients in pramlintide. 

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 pramlintide, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are pregnant or planning to become pregnant. It is not known if pramlintide 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 pramlintide 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 pramlintide.

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.

Pramlintide falls into category C. There are no well-controlled studies in pregnant women. Pramlintide 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 pramlintide 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 pramlintide.

• You must use pramlintide exactly as prescribed. The amount of pramlintide you use will depend on whether you have type 2 or type 1 diabetes. You and your doctor will decide if you can use pramlintide.
• Pramlintide is available in vials and two pramlintide pen-injectors. Your doctor will prescribe the type of pramlintide that is right for you.

The way you inject pramlintide is similar to the way you inject insulin. Inject pramlintide under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Do not inject pramlintide and insulin in the same site.

• To help reduce the chances of getting a reaction at the injection site, allow pramlintide to come to room temperature before injecting.
• Use a new needle for each pramlintide injection.
• Never mix pramlintide and insulin. Insulin can affect pramlintide when the two are mixed together.
• Do not use pramlintide if the liquid looks cloudy.
• If you take more than your prescribed dose of pramlintide, you may get nauseated or vomit, and you may not be able to eat the amount of food you usually eat. If you take more pramlintide 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 doctor for guidance.
• If you miss or forget a dose of pramlintide, wait until the next meal and take your usual dose of pramlintide at that meal. Do not take more than your usual dose of pramlintide.

Using pramlintide and insulin with Type 2 Diabetes

1. Start pramlintide at 60 mcg 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, including fixed-mix insulin such as 70/30, used before meals by 50 percent. 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 pramlintide to 120 mcg on your doctor's 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 mcg dose. Your doctor will tell you how to adjust your dose of pramlintide.
6. Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of pramlintide. All insulin changes should be directed by your doctor.

Using pramlintide and insulin with Type 1 Diabetes

1. Start pramlintide at 15 mcg 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 pramlintide, reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. 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 pramlintide to 30 mcg on your doctor's instructions if you have not had any nausea for 3 days or more. If you have nausea with pramlintide at 30 mcg, call your doctor right away. Your doctor may decide that you should stop pramlintide.
5. Increase your dose of pramlintide to 45 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 30 mcg dose.
6. Increase your dose of pramlintide to 60 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 45 mcg dose.
7. Call your doctor right away if you are bothered with nausea on the 45 mcg or 60 mcg dose. Your doctor may decide that you should reduce pramlintide to the 30 mcg dose.
8. Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of pramlintide that is right for you. All insulin changes should be directed by your doctor.

Staying on pramlintide:

• Once you reach your recommended dose of pramlintide, 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 always 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 pramlintide. 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 pramlintide for any reason, such as surgery or illness, talk to your doctor about how to re-start pramlintide.

Do not use pramlintide if:

• your blood sugar is too low.
• you do not plan to eat. Do not inject pramlintide 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 can't 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.

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
• how you tolerate this medication

The recommended dose range of pramlintide for the treatment of patients with insulin-using type 2 diabetes is 60 mcg-120 mcg .

The recommended dose range of pramlintide for the treatment of dose of patients with type 1 diabetes is 30 mcg-60 mcg.

If you take more than your prescribed dose of pramlintide, you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. If you take more pramlintide 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 doctor for guidance or seek emergency medical attention.

• Store pramlintide that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect pramlintide from light.
• After a vial or pen-injector has been used for the first time, it can be refrigerated or kept at a temperature up to 86°F (30°C) for 30 days. Do not leave above 86°F (30°C). Any vial or pen-injector in use should be thrown away after 30 days, even if it still has medicine in it.
• Unused pramlintide (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
• Do not freeze pramlintide. Do not use pramlintide if it has been frozen.

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

WARNING

Pramlintide is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with pramlintide use occurs, it is seen within 3 hours following a pramlintide injection. If severe hypoglycemia occurs while 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.