Pramlintide Acetate Solution for injection

What is this medicine?

PRAMLINTIDE (PRAM lin tide) is a man-made form of a hormone normally found in the body. It is used to treat type 1 and type 2 diabetes in adults. This medicine works with insulin to control blood sugar.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• HbA1c above 9

• low blood sugar episodes

• problems checking blood sugar

• problems taking diabetes medicine

• stomach problems like gastroparesis

• trouble being able to tell when blood sugar is low

• an unusual or allergic reaction to pramlintide, metacresol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Do not mix this medicine with insulin in the same syringe. Take this medicine immediately before meals. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Always check the appearance of this medicine before using it. Do not use it if it is cloudy or has solid particles in it.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Your health care professional or doctor should discuss a plan for missed doses with you. If you do miss a dose, follow their plan. Do not take double doses.

What may interact with this medicine?

• atropine

• cisapride

• erythromycin

• medicines for depression, anxiety, or psychotic disturbances

• medicines used to treat stomach problems

• narcotic medicines for pain

• other medicines for diabetes like acarbose, miglitol

• tegaserod

Many medications may cause changes in blood sugar, these include:

• alcohol containing beverages

• aspirin and aspirin-like drugs

• chloramphenicol

• chromium

• female hormones, such as estrogens or progestins, birth control pills

• heart medicines

• isoniazid

• male hormones or anabolic steroids

• medications for weight loss

• medicines for allergies, asthma, cold, or cough

• medicines for mental problems

• medicines called MAO inhibitors - Nardil, Parnate, Marplan, Eldepryl

• niacin

• NSAIDS, such as ibuprofen

• pentamidine

• phenytoin

• probenecid

• quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin

• some herbal dietary supplements

• steroid medicines such as prednisone or cortisone

• thyroid hormones

• diuretics

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)

• clonidine

• guanethidine

• reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Pramlintide pens and cartridges should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• fever, chills

• loss of appetite

• signs and symptoms of high blood sugar such as dizziness, dry mouth, dry skin, fruity breath, nausea, stomach pain, increased hunger or thirst, increased urination

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• unusual stomach pain or upset

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• decreased appetite

• dizziness

• increase or decrease in fatty tissue under the skin due to overuse of a particular injection site

• irritation at site where injected

• nausea

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store unopened vials in the refrigerator between 2 to 8 degrees C (36 to 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

Store opened vials (vials currently in use) in the refrigerator or at room temperature at or below 25 degrees C (77 degrees F). Do not freeze. Keeping this medicine at room temperature decreases the amount of pain during injection. Throw away any opened vials of this medicine 28 days after opening.