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.

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.

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.

• 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. 

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.

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.

Pramlintide can cause low blood sugar (hypoglycemia) especially with other medications for diabetes. Know the signs and symptoms of low blood sugar. 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. If nausea continues or bothers you, call your doctor right away.

Do not use pramlintide if you plan to eat a meal with less than 250 calories or 30 grams of carbohydrate. Pramlintide should only be given if you eat a major meal must have at least 250 calories or 30 grams of carbohydrate.