Symlin

Generic Name: pramlintide (Subcutaneous route)

PRAM-lin-tide

Commonly used brand name(s):

In the U.S.

• Symlin
• SymlinPen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Uses For Symlin

Pramlintide is used to treat high blood sugar in patients with type 1 and type 2 diabetes. This medicine will decrease the time it takes for food to move through the stomach. It also works to prevent the liver from making sugar. Pramlintide is always used together with insulin to lower the high blood sugar that occurs after meals.

This medicine is available only with your doctor's prescription.

Before Using Symlin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pramlintide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramlintide in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Gastroparesis (stomach does not empty food normally) or
• High HbA1c level, greater than 9% (lab test used for diabetics) or
• Hypoglycemia (severe), occurs often and required doctor's help in the past 6 months or
• Hypoglycemia unawareness (not able to recognize low blood sugar symptoms)—Should not be used in patients with these conditions.

• Hypoglycemia from insulin, history of—May increase risk of severe hypoglycemia occurring again.

• Infection or
• Stress (e.g., physical or emotional)—May increase the amount of pramlintide that is needed.

Proper Use of pramlintide

This section provides information on the proper use of a number of products that contain pramlintide. It may not be specific to Symlin. Please read with care.

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be using pramlintide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected. Tell your doctor if you have dexterity (skill in using the hands) or vision problems.

This medicine is available in 2 forms. You may use a vial or a SymlinPen™ pen-injector. Your doctor will tell you which dosage form is right for you.

You should never mix your insulin and pramlintide injections together. These injections are always given separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.

This medicine is given as a shot under the skin of your stomach or upper thigh. Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Never inject insulin and pramlintide in the same site.

Allow the medicine to warm at room temperature before you inject it. If the medicine in the vial or pen-injector has changed color, looks cloudy, or if you see particles in it, do not use it.

Use a new needle and syringe each time you inject your medicine.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary for the medicine to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For Type 1 diabetes:
    • Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 15 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For Type 2 diabetes:
    • Adults—The dose is based on your blood sugar and how well your body adjusts to the medicine. This must be determined by your doctor. The starting dose is 60 micrograms (mcg) injected under the skin right before major meals. A major meal has at least 250 calories or 30 grams of carbohydrates. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store the unopened vial or pen-injector in the refrigerator until you are ready to use it. Protect the vial or pen-injector from bright light.

A vial or pen-injector that has been used may be kept in the refrigerator or at room temperature for up to 30 days. Throw away any medicine that has not been used after 30 days.

Precautions While Using Symlin

It is very important that your doctor check your progress at regular visits, especially during the first few weeks you receive this medicine. Blood tests may be needed to see how well you have adjusted to the medicine.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes, especially teenagers, may need special counseling about pramlintide dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in women with diabetes who become pregnant.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times, and store pramlintide properly.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and lists all of your medicines.
• Keep an extra supply of insulin and syringes with needles on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

When used together with insulin, pramlintide may cause low blood sugar (also called hypoglycemia or insulin reaction), especially in patients with type 1 diabetes. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn what symptoms of low blood sugar you usually have so that you can treat it quickly.

• Symptoms of low blood sugar can include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.
• The symptoms of low blood sugar may develop quickly and result from:
  • delaying or missing a scheduled meal or snack.
  • exercising more than usual.
  • drinking a significant amount of alcohol.
  • taking certain medicines.
  • using too much insulin.
  • sickness (especially with vomiting or diarrhea).
• Know what to do if symptoms of low blood sugar occur. Eating some form of quick-acting sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse. Good sources of sugar include:
  • Glucose tablets or gel, fruit juice or nondiet soft drink (4 to 6 ounces [one-half cup]), corn syrup or honey (1 tablespoon), sugar cubes (six one-half inch size), or table sugar (dissolved in water).
    • If a snack is not scheduled for an hour or more you should also eat a light snack, such as cheese and crackers, half a sandwich, or drink an 8-ounce glass of milk.
    • Do not use chocolate because the fat slows down the sugar getting into the blood.
  • Glucagon is used in emergency situations such as unconsciousness. Have a glucagon kit available and know how to prepare and use it. Members of your household also should know how and when to use it.

High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. If you have any symptoms of high blood sugar, contact your health care team right away. If high blood sugar is not treated, severe hyperglycemia can occur, leading to ketoacidosis (diabetic coma) and death.

• The symptoms of mild high blood sugar appear more slowly than those of low blood sugar. Symptoms can include: blurred vision; drowsiness; dry mouth; flushed and dry skin; fruit-like breath odor; increased urination (frequency and volume); loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); and unusual thirst.
• Symptoms of severe high blood sugar (called ketoacidosis or diabetic coma) that need immediate hospitalization include: flushed and dry skin, fruit-like breath odor, ketones in urine, passing out, and troubled breathing (rapid and deep).
• High blood sugar symptoms may occur if you:
  • have diarrhea, a fever, or an infection.
  • do not take enough insulin or skip a dose of insulin.
  • do not exercise as much as usual.
  • overeat or do not follow your meal plan.
• Know what to do if high blood sugar occurs. Your doctor may recommend changes in your pramlintide and/or insulin dose or meal plan to avoid high blood sugar. Symptoms of high blood sugar must be corrected before they progress to more serious conditions. Check with your doctor often to make sure you are controlling your blood sugar. Your doctor might discuss the following with you:
  • Increasing your insulin dose when you plan to eat an unusually large dinner, such as on holidays. This type of increase is called an anticipatory dose.
  • Decreasing your dose for a short time for special needs, such as when you cannot exercise as you normally do. Changing only one type of insulin dose (usually the first dose) and anticipating how the change may affect other doses during the day. Contacting your doctor if you need a permanent change in dose.
  • Delaying a meal if your blood glucose is over 200 mg/dL to allow time for your blood sugar to go down. An extra insulin dose may be needed if your blood sugar does not come down shortly.
  • Not exercising if your blood glucose is over 240 mg/dL and reporting this to your doctor immediately.
  • Being hospitalized if ketoacidosis or diabetic coma occurs.

You may have some skin redness, swelling, or itching at the injection site. If this irritation is severe or does not go away, call your doctor.

Symlin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool pale skin
• cough
• depression
• difficulty swallowing
• dizziness
• fast heartbeat
• headache
• hives
• increased hunger
• itching
• nausea
• nervousness
• nightmares
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• shortness of breath
• skin rash
• slurred speech
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• inflicted injury
• loss of appetite
• muscle pain or stiffness
• pain in the joints
• stomach pain
• vomiting
• weight loss

• Body aches or pain
• congestion
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• trouble in swallowing
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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