Symlinpen 120 (pramlintide acetate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Pramlintide, a synthetic analog of human amylin, is an antidiabetic agent.
Pramlintide is a synthetic analog of amylin, a glucoregulatory hormone synthesized by pancreatic beta-cells and released with insulin in response to a meal. Pramlintide, a 37-amino acid polypeptide, differs structurally from human amylin by the replacement of alanine, serine, and serine at positions 25, 28, and 29, respectively, with proline. In patients with type 1 or 2 diabetes mellitus who require insulin therapy, secretion of amylin from pancreatic beta-cells in response to a meal is reduced.
Pramlintide is an amylinomimetic agent that has physiologic actions equivalent to those of human amylin. Pramlintide inhibits inappropriately high glucagon secretion during episodes of hyperglycemia (e.g., after a meal) in patients with type 1 or 2 diabetes mellitus but does not impair the normal glucagon response to hypoglycemia. In addition, pramlintide slows gastric emptying and reduces the rate of glucose absorption from a meal without altering the net absorption of ingested carbohydrates and other nutrients.
Use of pramlintide in combination with insulin in patients with type 1 or 2 diabetes mellitus prevents the initial postprandial glucose excursions usually observed with insulin therapy alone. Pramlintide reduces food intake and increases satiety, possibly resulting in weight loss.
Following subcutaneous administration into the abdomen or thigh, pramlintide maximum plasma concentration (Cmax) and AUC increase in a linear, dose-dependent manner. Compared to the abdomen or thigh, injection of pramlintide into the arm results in higher overall exposure (20--36%) and greater variability in patients with type 1 or type 2 diabetes mellitus that are obese. The absolute bioavailability of pramlintide is approximately 30--40%.
Pramlintide is not extensively bound to red blood cells or albumin (approximately 60% is bound). The half-life of pramlintide is approximately 48 minutes. Pramlintide is metabolized in the kidneys principally by lysis of the terminal lysine group to form a pharmacologically active, 36-amino acid, polypeptide fragment.
The relative bioavailability of pramlintide is not substantially different in patients with obesity based on body mass index (BMI) or skin fold thickness. The impact of hepatic impairment, age, sex, and race/ethnicity on the pharmacokinetics of pramlintide is not known.
USES: Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.
Proper control of diabetes may also lessen your risk of a heart attack or stroke. Pramlintide acts like a certain natural substance called amylin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach.
It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need. This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (such as children).
Generic name: pramlintide acetate
Pronunciation: (PRAM-lin-tide)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Symlinpen 120
Indications
The following indications are listed for Symlinpen 120:
- Type 1 Diabetes Mellitus Treatment Adjunct
- Type 2 Diabetes Mellitus Treatment Adjunct
Dosing
Dosage of pramlintide acetate is expressed in terms of pramlintide.
Pramlintide acetate is administered subcutaneously into the abdominal wall or thigh immediately before each major meal (i.e., a meal providing at least 250 kcal or containing at least 30 g of carbohydrate); administration into the arm is not recommended because of variable absorption. Injection sites should be rotated and distinct (i.e., more than 2 inches away) from the site chosen for concomitant insulin injection.
Pramlintide and insulin should be administered as separate injections. Mixing pramlintide and insulin in the same syringe has resulted in alterations in the pharmacokinetics of pramlintide in some studies ; the manufacturer states that pramlintide injection should not be mixed with any type of insulin.
Instruct patients to place used pens and needles in an approved sharps disposal container immediately after use; instruct patients not to dispose of pens and needles in the household trash. Additional information about sharps disposal can be found at https://www.fda.gov/safesharpsdisposal.
If a dose of pramlintide is missed, the dose should be omitted, and the next dose should be taken at the regularly scheduled time. A dose of pramlintide should be omitted if a meal is skipped or if the meal provides less than 250 kcal or contains less than 30 g of carbohydrate.
Store unopened injection pens of pramlintide protected from light at 2--8degreesC until the expiration date. Pramlintide should not be frozen and should not be used if frozen. Opened (in-use) injection pens of pramlintide can be stored refrigerated or at room temperature (up to 30degreesC) for up to 30 days.
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No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to pramlintide acetate or any ingredient in the formulation.
*Documented diagnosis of gastroparesis.
*Hypoglycemic unawareness.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects of pramlintide reported in at least 5% of patients and at a higher incidence than placebo include nausea, vomiting, anorexia, and headache.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy not established in children younger than 17 years of age. Pediatric patients should not be considered for pramlintide therapy.
There is insufficient evidence with pramlintide in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies in animals, congenital abnormalities were observed in fetuses of pregnant rats but not in pregnant rabbits exposed during organogenesis at 10 times the clinical dosage of 360 mcg/day, based on exposure. In pregnant rats, an increase in congenital abnormalities (neural tube defect, cleft palate, exencephaly) was observed at dosages of 0.3 mg/kg and 1 mg/kg per day (10 times and 47 times the human dosage of 360 mcg/day) but not at 3 mg/kg per day. In pregnant rabbits, maternal toxicity was observed, but no increase in fetal malformations was noted at dosages up to 0.3 mg/kg per day (9 times the human dosage of 360 mcg/day based on AUC).
Poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
There are no data on the presence of pramlintide in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for pramlintide and any potential adverse effects on the breast-fed child from pramlintide or from the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for pramlintide for geriatric patients. Geriatric patients should be managed carefully to minimize the risk of severe hypoglycemia.
In clinical trials of pramlintide, 769 patients were >=65--75 years of age and 87 patients were >=75 years of age. No substantial differences in safety and efficacy relative to younger adults was observed, but increased sensitivity cannot be ruled out. Pharmacokinetic studies have not been conducted in geriatric patients. No consistent age-related differences in the activity of pramlintide have been observed in geriatric patients. Both pramlintide and insulin regimens should be carefully managed to obviate an increased risk of hypoglycemia. Pramlintide should only be used in patients known to fully understand and adhere to proper insulin adjustments and glucose monitoring.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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