Also found in: Dictionary.
Pharmacologic class: Synthetic amylin
Therapeutic class: Hypoglycemic
Pregnancy risk category C
FDA Box Warning
• Drug is used with insulin and has been linked to increased risk of insulin-induced severe hypoglycemia, especially in patients with type 1 diabetes. When severe hypoglycemia occurs, it arises within 3 hours after injection. If it occurs while patient operates a motor vehicle or heavy machinery or performs other high-risk activities, serious injuries may occur. Careful patient selection, patient instruction, and insulin dosage adjustments are crucial to reduce risk.
Mimics amylin activity to modulate gastric emptying, prevent postprandial rise in plasma glucagons, and cause feeling of satiety leading to decreased caloric intake and potential weight loss
Solution for injection: 0.6 mg/ml in 5-ml vials; 1.5-ml disposable multidose pen-injector containing 1,000 mcg/ml; 2.7-ml disposable multidose 120 pen-injector containing 1,000 mcg/ml
Indications and dosages
➣ Type 1 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy
Adults: Initially, 15 mcg subcutaneous injection immediately before major meals; after 3 days, increase in 15-mcg increments to maintenance dosage of 30 or 60 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.
➣ Type 2 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy, with or without concurrent sulfonylurea, metformin, or both
Adults: Initially, 60 mcg subcutaneous injection immediately before major meals; after 3 to 7 days, increase to 120 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.
• Hypersensitivity to drug or its components
• Confirmed gastroparesis
• Hypoglycemia unawareness
Use cautiously in:
• patients with poor compliance to insulin therapy or hemoglobin A1c levels above 9%
• patients with recurrent or severe hypoglycemia who've required treatment during past 6 months
• concurrent insulin therapy for type 1 diabetes
• concurrent use of drugs that stimulate GI motility
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Administer immediately before major meals (at least 250 kcal or 30 g carbohydrates).
• Give pramlintide and insulin as separate injections.
• Inject pramlintide and insulin more than 2" apart.
CNS: headache, dizziness, fatigue
GI: nausea, vomiting, abdominal pain, anorexia
Metabolic: severe hypoglycemia
Other: allergic reaction
Drug-drug. Angiotensin-converting enzyme inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase inhibitors, oral hypoglycemics, pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics: increased hypoglycemic effect, increased risk of hypoglycemia
Beta-adrenergic blockers, clonidine, guanethidine, reserpine: blunting of early hypoglycemia symptoms
Drugs that delay gastric emptying (such as atropine) or slow food absorption (such as acarbose): exacerbated delay in gastric emptying, slow food absorption
Insulin: severe hypoglycemia (may occur within 3 hours of insulin administration)
Oral drugs for which rapid effect is desired (such as analgesics): delayed absorption of these drugs
• Monitor premeal and postmeal blood glucose levels closely; watch for hypoglycemia.
• Instruct patient to take drug immediately before major meals.
• Teach patient how to self-administer injection; describe proper storage, handling, and disposal of drug and supplies.
• Instruct patient to inject pramlintide and insulin separately, more than 2" apart. Caution patient not to mix them together.
☞ Teach patient to recognize and immediately report hypoglycemia symptoms; tell him these may occur within 3 hours after pramlintide injection.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.
Time/action profile (effect on blood sugar*)
|Subcut||rapid||20 min||3 hr|
Adverse Reactions/Side EffectsNoted for concurrent use with insulin
Central nervous system
- nausea (most frequent)
- abdominal pain
- hypoglycemia (life-threatening)
- local allergy
- injection site reactions
- systemic allergic reactions
Drug-Drug interaction↑ likelihood of hypoglycemia with short-acting insulin ; ↓ dose of short-acting pre-meal insulin by 50%.Avoid concurrent use with other agents that ↓ GI motility, including atropine and other anticholinergics.Avoid concurrent use with other agents that ↓ GI absorption of nutrients, including α-glucosidase inhibitors including acarbose and miglitol.May delay oral absorption of concurrently administered drugs; if prompt absorption is desired, administer 1 hr before or 2 hr after pramlintide.
Insulin-using Type 2 Diabetes
Type 1 Diabetes
- Assess hemoglobin A1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight prior to initiation of therapy.
- Assess for signs and symptoms of hypoglycemia (hunger, headache, sweating, tremor, irritability, difficulty concentrating, loss of consciousness, coma, seizure), occurs within 3 hr of injection. Pramlintide alone does not cause hypoglycemia, may increase risk when administered with insulin.
- Lab Test Considerations: Monitor blood glucose frequently, including pre- and post-meals and at bedtime.
Potential Nursing DiagnosesNoncompliance (Patient/Family Teaching)
- high alert: Dose errors are a potential problem with administration of pramlintide. Pramlintide is available in a concentration of 0.6 mg/mL, dosing is in mcg, and insulin syringe for administration is in units. Carefully review dosing and conversion table prior to administration.
- Administer pramlintide and insulin as separate injections; do not mix.
- Adjust insulin doses to optimize glycemic control once target dose of pramlintide is achieved and nausea has subsided.
- Subcutaneous: Administer immediately prior to major meals ≥250 kcal or containing ≥30 g of carbohydrate. Reduce preprandial rapid-acting, short-acting, and fixed-mix insulin doses by 50%. Use a U-100 syringe (preferably a 0.3 mL size) for optimal accuracy. Administer into abdomen or thigh, rotating injection sites. Do not administer solutions that are cloudy. Store unopened vials in refrigerator. Opened vials may be refrigerated or kept at room temperature for up to 28 days.
- Instruct patient in proper use of pramlintide (injection technique, timing of doses, storage, and disposal of equipment). Make sure patient understands dosing and preparation of correct dose. Emphasize importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Advise patient to read the Medication Guide before use and with each refill for new information.
- Review with patient how to handle illness or stress, inadequate or omitted insulin dose, inadvertent administration of increased dose of insulin or pramlintide, inadequate food intake or missed meals. If a dose is missed, wait until the next meal and take usual dose; do not give an additional injection.
- Instruct patient to contact health care professional at least once a week until target dose of pramlintide is achieved, pramlintide is well-tolerated, and blood glucose concentrations are stable.
- May cause difficulty concentrating. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Inform patient that signs of local allergy (redness, swelling, itching at site of injection) usually resolve within a few days to a few weeks; may be related to pramlintide, irritants in skin cleansing agent or improper injection technique.
- Advise patient to contact health care professional if recurrent nausea or hypoglycemia occur; may lead to increased risk of severe hypoglycemia. Discontinue pramlintide therapy if recurrent unexplained hypoglycemia requiring medical assistance, persistent clinically significant nausea, or noncompliance with self-monitoring of blood glucose concentrations, insulin dose adjustments, or scheduled health care professional contacts or recommended clinic visits occur.
- Advise patient to contact health care professional before taking other Rx, OTC, vitamins, or herbal products with pramlintide and to avoid concurrent alcohol use.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Reduction in postprandial glucose concentrations.