Pramlintide Acetate

Trade Names:
Symlin
- Solution for injection 0.6 mg/mL

Pharmacology

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Synthetic analog of the naturally occurring neuroendocrine hormone amylin. Amylin is colocated with insulin in pancreatic beta cells and is cosecreted with insulin in response to food intake. Amylin slows gastric emptying, suppresses glucagon secretion, and regulates food intake by centrally-mediated modulation of appetite.

Pharmacokinetics

Absorption

Absolute bioavailability following subcutaneous injection is 30% to 40%. Injection into arm showed higher exposure with more variability as compared with injection in abdominal area or thigh.

Distribution

40% of drug is unbound in plasma. Does not bind extensively to blood cells or albumin.

Metabolism

Metabolized by the kidneys to active metabolite (2-37 pramlintide). The t _½ of pramlintide and active metabolite is approximately 48 min. AUC values are relatively constant with repeated dosing.

Indications and Usage

As an adjunct treatment for type 1 diabetes in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy; as an adjunct treatment for type 2 diabetes in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without concurrent sulfonylurea and/or metformin therapy.

Contraindications

Confirmed diagnosis of gastroparesis; hypoglycemia unawareness; hypersensitivity to any component of the product.

Dosage and Administration

Subcutaneous Initiate pramlintide at dose of 15 mcg immediately prior to major meals. Reduce preprandial, rapid-acting or short-acting insulin doses, including fixed-mix insulins (eg, 70/30) 50%. Increase dose in 15 mcg increments to maintenance dose of 30 or 60 mcg. Increase pramlintide dose to next increment (eg, 30, 45, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days. If significant nausea persists at the 45 or 60 mcg dose level, decrease dose to 30 mcg. If 30 mcg dose is not tolerated, consider discontinuing therapy.

Subcutaneous Initiate pramlintide at dose of 60 mcg immediately prior to major meals. Reduce preprandial, rapid-acting, or short-acting insulin doses, including fixed-mix insulins (eg, 70/30) 50%. Increase dose to 120 mcg when no clinically significant nausea has occurred for 3 to 7 days. If significant nausea persists at 120 mcg dose, decrease pramlintide dose to 60 mcg.

General Advice

• Adjust insulin dose to optimize glycemic control once target dose of pramlintide is achieved and nausea (if experienced) has subsided.
• Administer immediately prior to each major meal (containing at least 250 kcal or 30 g of carbohydrate).
• Visually inspect solution before withdrawing dose. Do not use if particulate matter, discoloration, or cloudiness noted.
• Measure prescribed dose using 0.3 mL U-100 insulin syringe using the following guidelines: For 15 mcg dose: withdraw 0.025 mL or 2.5 units using increment line on U-100 syringe; for 30 mcg dose: withdraw 0.05 mL or 5 units using increment line on U-100 syringe; for 45 mcg dose: withdraw 0.075 mL or 7.5 units using increment line on U-100 syringe; for 60 mcg dose: withdraw 0.1 mL or 10 units using increment line on U-100 syringe; for 120 mcg dose: withdraw 0.2 mL or 20 units using increment line on U-100 syringe.
• Administer each dose into abdomen or thigh. Do not administer into arm because of variable absorption. Rotate injection sites. Make injection site distinct from the site chosen for any concomitant insulin injection.
• Always administer pramlintide and insulin as separate injections. Do not mix pramlintide with any type of insulin. Always use a new syringe and needle to give pramlintide and insulin injections.

Storage/Stability

Store unopened (not-in-use) vial in refrigerator (36° to 46°F). Protect from light and freezing. Discard if vial has been frozen or overheated. Store opened (in-use) vial in refrigerator (36° to 46°F) or at room temperature not exceeding 77° F, for up to 28 days. Discard after 28 days.

Drug Interactions

Pramlintide has the potential to delay the absorption of concomitantly administered oral drugs. When the rapid onset of the concomitantly administered oral drug is administer the drug at least 1 hr prior to or 2 hr after pramlintide injection.

Pramlintide acetate alters gastric emptying time and slows the rate at which food is released from the stomach to the small intestine. Until studied, do not consider pramlintide for use in patients taking drugs that alter GI motility or slow intestinal absorption of nutrients.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness, fatigue, headache (at least 5%).

EENT

Pharyngitis (at least 5%).

GI

Abdominal pain, anorexia, nausea, vomiting (at least 5%).

Musculoskeletal

Arthralgia (at least 5%).

Respiratory

Coughing (at least 5%).

Miscellaneous

Allergic reaction, inflicted injury (at least 5%).

Precautions

Pregnancy

Category C .

Lactation

Unknown. Use only if potential benefits outweigh potential risks to the infant.

Children

Safety and efficacy have not been established.

Discontinuation of therapy

Discontinue pramlintide therapy if any of the following occur: recurrent unexplained hypoglycemia requiring medical assistance; persistent clinically significant nausea; noncompliance with self-monitoring of blood glucose concentrations; noncompliance with insulin dose adjustments; noncompliance with scheduled health care provider contacts or recommended follow-up.

Hypoglycemia

Pramlintide alone does not cause hypoglycemia but does increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes. Severe hypoglycemia occurs within the first 3 hr following pramlintide administration. Take precautions (eg, frequent pre- and post-meal glucose monitoring combined with an initial 50% reduction in pre-meal dose of short-acting insulin) to reduce the risk of insulin-induced severe hypoglycemia.

Missed dose

If pramlintide dose is missed, do not administer an additional injection.

Patient selection

Pramlintide therapy should only be considered in patients with insulin-using type 2 or type 1 diabetes who have failed to achieve adequate glycemic control despite individualized insulin management and are receiving ongoing care under the guidance of a health care professional skilled in the use of insulin and supported by the services of diabetes educator(s). Pramlintide should not be used if the patient has any of the following: poor compliance with current insulin regimen; poor compliance with prescribed self- blood glucose monitoring; HBA1c greater than 9%; recurrent severe hypoglycemia requiring assistance during the past 6 mo; presence of hypoglycemia unawareness; confirmed diagnosis of gastroparesis; require use of drugs that stimulate gastrointestinal motility.

Reinstituting pramlintide therapy

If pramlintide therapy is discontinued for any reason (eg, surgery or illness), follow the same initiation protocol when pramlintide therapy is re-instituted.

Overdosage

Symptoms

Severe nausea, vomiting, diarrhea, vasodilation, dizziness.

Patient Information

• Explain name, dose, action, potential side effects of pramlintide, and the need for frequent blood sugar monitoring, and follow-up visits for dosage adjustment of pramlintide and insulin.
• Ensure that patient or caregiver understands that pramlintide does not replace daily insulin but may lower the amount of insulin needed, especially before meals.
• Advise patient that pramlintide will be started at a low dose and then increased, as tolerated, to a dose that will provide maximum benefit.
• Advise patient that insulin dose will be reduced when pramlintide is started but the insulin dose will be periodically readjusted to achieve maximum blood sugar control.
• Advise patient or caregiver to read Patient Information leaflet before using the first time and with each refill.
• Ensure that patient or caregiver understands how to store, prepare, and administer the pramlintide and insulin doses, and dispose of used equipment and supplies.
• Ensure that patient or caregiver understands that pramlintide and insulin must be administered as separate injections at separate injection sites and that pramlintide cannot be mixed with any insulin product.
• Advise patient to continuously rotate pramlintide and insulin injection sites (abdomen and thigh). Caution patient not to inject pramlintide into arm because of variable absorption and effectiveness.
• Instruct patient to administer prescribed dose of pramlintide immediately before each major meal.
• Advise patient that if a pramlintide dose is missed, to skip it and take the next dose immediately before the next major meal. Caution patient not to double the dose to catch up.
• Educate patient or caregiver regarding diabetes and its management, including target ranges for blood sugar control. Instruct patient that pramlintide and insulin are not a substitute for diet and exercise and to follow prescribed regimens.
• Educate patient or caregiver regarding potential long-term complications of diabetes and need for regular general physical and eye examinations.
• Ensure that patient or caregiver understands how to use home glucose monitoring system and understands the need for frequent (eg, pre- and post meals and bedtime) monitoring and recording of blood sugar measurements. Advise patient to take blood sugar log to each visit with health care provider.
• Advise patient that dose(s) of insulin will be adjusted based on the results of home glucose monitoring.
• Ensure that patient with type 1 diabetes understands how to monitor for ketones and knows what to do if ketones are detected.
• Educate patient regarding value of periodic A _1c testing to confirm level of glucose control.
• Review symptoms of hypoglycemia and hyperglycemia and what to do if either occurs.
• Advise patient to discuss with health care provider a plan for managing each of the following situations: pramlintide and insulin dosing during intercurrent conditions (eg, vomiting, infection, trauma, stress, sick days); accidental administration of too little or too much pramlintide or insulin; missing insulin dose; inadequate food intake or a skipped meal; travel across time zones; change in physical activity.
• Advise patient to carry medical identification (eg, card bracelet) indicating diabetes.
• Instruct patient to notify health care provider if experiencing severe, continuous, or frequent hypoglycemic episodes, recurrent nausea, hypoglycemic episodes with few or no warning symptoms, continuous or severe hyperglycemia, or injection site reactions that do not go away or continue to recur.
• Caution patient that pramlintide may cause hypoglycemia during the first 3 hr following a dose and to use caution while driving or performing other high risk activities during that time.

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