Pramlintide

Pramlintide is a prescription medication used to treat the symptoms of Type 1 and Type 2 Diabetes. 

• Pramlintide is available under the following different brand names: Symlin, SymlinPen 120, SymlinPen 60

• Common side effects of Pramlintide include:
• nausea,
• vomiting,
• loss of appetite, and
• headache

Serious side effects of Pramlintide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe ongoing nausea,
• headache,
• dizziness,
• drowsiness,
• vision problems,
• hunger,
• weakness,
• sweating,
• confusion,
• irritability,
• fast heart rate, and
• feeling jittery

Rare side effects of Pramlintide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 0.6 mg/mL

Pen-injector

• 15 mcg/dose
• 30 mcg/dose
• 45 mcg/dose
• 60 mcg/dose
• 120 mcg/dose

Type 1 Diabetes

Adult dosage

• Initial: 15 mcg Subcutaneous immediately before major meals
• Increase by 15 mcg every 3 days (if no significant nausea occurs)
• Reduce postprandial short-acting insulin dose by 50%
• Maintenance: 30-60 mcg Subcutaneous

Type 2 Diabetes

Adult dosage

• Initial: 60 mcg Subcutaneous immediately before major meals
• After 3-7 days increase to 120 mcg before meals (if not significant nausea occurs)
• Reduce postprandial short-acting insulin dose by 50%
• Maintenance: 60-120 mcg Subcutaneous

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pramlintide has severe interactions with the following drugs
  • insulin aspart
  • insulin detemir
  • insulin glargine
  • insulin glulisine
  • insulin lispro
  • insulin NPH
  • insulin regular human
• Pramlintide has serious interactions with at least 42 other drugs
• Pramlintide has moderate interactions with at least 28 other drugs
• Pramlintide has severe interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Gastroparesis
• Hypoglycemia unawareness

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pramlintide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pramlintide?”

Cautions

• Risk of severe insulin-induced hypoglycemia; pramlintide alone does not cause hypoglycemia; however, since it is indicated to be coadministered with mealtime insulin therapy, and in this setting, there is an increased risk of severe hypoglycemia
• Do not mix with insulin - administer the two separately
• Slows gastric emptying, which may delay the absorption of concomitantly administered oral medications; administer the concomitant oral medication at least 1 hour prior or 2 hours after pramlintide
• Slows gastric emptying; not recommended if taking other medications that alter gastrointestinal motility
• Never share a pen between patients even if the needle is changed
• Erythema, edema, or pruritus at the site of injection reported; may be related to other factors, such as irritants in a skin cleansing agent or improper injection technique
• Proper patient selection
  • Proper patient selection is essential to safe and effective use
  • For use only in patients with type 1 or type 2 diabetes using mealtime insulin who fulfill the following criteria:
  • Failed to achieve adequate glycaemic control despite individualized insulin management
  • Receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of a diabetes educator
  • Not for use in patients with ANY of the following criteria:
  • Poor compliance with a current insulin regimen
  • Poor compliance with prescribed self-blood glucose monitoring
  • Have an hba1c above 9%
  • Recurrent severe hypoglycemia requiring assistance during the past 6 months
  • Presence of hypoglycemia unawareness
  • Confirmed diagnosis of gastroparesis
  • Require the use of drugs that stimulate gastrointestinal motility
  • Pediatric patients

Pregnancy and Lactation

• Available data from a small number of reports in the manufacturer’s safety database on use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
• Ex-vivo studies using the term perfused human, rabbit, and rat placentas indicate that the drug has a low potential to cross the maternal/fetal placental barrier
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
• Lactation
  • There is no data on the presence of human milk, effects on the breastfed infant or milk production; developmental and health benefits of breastfeeding should be considered along with the mother her’s a clinical need for drugs and any potential adverse effects on the breastfed child from the drug or underlying maternal condition