Pramlintide (Subcutaneous route)
Severe hypoglycemia has occurred within 3 hours of pramlintide injection when used concomitantly with insulin, especially in patients with type 1 diabetes. Serious injuries may happen if hypoglycemia occurs during high-risk activities, and appropriate patient selection, instruction, and insulin dose reduction are critical for reducing this risk .
Uses of This Medicine:
Pramlintide injection is used to treat high blood sugar in patients with type 1 and type 2 diabetes who are also using mealtime insulin and have failed to control blood sugar levels.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of pramlintide injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramlintide injection in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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 (eg, physical or emotional)—May increase the amount of pramlintide that is needed.
Proper Use of This Medicine:
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.
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.
This medicine should come with a Medication Guide. 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 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.
When you first start using this medicine, you will need to adjust your insulin dose. Do not change the timing or amount of any of your medicines without your doctor's advice. It is very important that you follow your doctor's instructions about all medicines you use to control your diabetes.
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.
Allow the medicine to warm at room temperature before you inject it. If the medicine in the 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.
Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.
Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Take oral medications (such as antibiotics, pain medicines, or birth control pills) 1 hour prior to or 2 hours after you use pramlintide. Tell your doctor about any medications you are taking.
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—Dose is based on your blood sugar and how well your body adjusts to the medicine, and this must be determined by your doctor. The starting dose is 15 micrograms (mcg) injected under the skin right before each major meal. 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—Dose is based on your blood sugar and how well your body adjusts to the medicine, and this must be determined by your doctor. The starting dose is 60 micrograms (mcg) injected under the skin right before each major meal. 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 1 diabetes:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 pen-injector in the refrigerator until you are ready to use it. Protect it from bright light.
An opened pen-injector 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 This Medicine:
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 hypoglycemia (low blood sugar), especially in patients with type 1 diabetes. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.
If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
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.
Side Effects of This Medicine:
- More common
- blurred vision
- cold sweats
- cool pale skin
- difficulty with swallowing
- fast heartbeat
- hives, itching, or skin rash
- increased hunger
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slurred speech
- tightness in the chest
- unusual tiredness or weakness
- More common
- Difficulty with moving
- inflicted injury
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- stomach pain
- weight loss
- Less common
- Body aches or pain
- dryness or soreness of the throat
- runny nose
- tender, swollen glands in the neck
- voice changes
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:
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:
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.
Last Updated: 11/4/2014