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Pramlintide

Pronunciation

(PRAM lin tide)

Index Terms

  • Pramlintide Acetate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous, as acetate:

SymlinPen 60: 1500 mcg/1.5 mL (1.5 mL) [contains metacresol]

SymlinPen 120: 2700 mcg/2.7 mL (2.7 mL) [contains metacresol]

Brand Names: U.S.

  • SymlinPen 120
  • SymlinPen 60

Pharmacologic Category

  • Amylinomimetic
  • Antidiabetic Agent

Pharmacology

Synthetic analog of human amylin cosecreted with insulin by pancreatic beta cells; reduces postprandial glucose increases via the following mechanisms: 1) prolongation of gastric emptying time, 2) reduction of postprandial glucagon secretion, and 3) reduction of caloric intake through centrally-mediated appetite suppression

Metabolism

Primarily renal to des-lys1 pramlintide (active metabolite)

Excretion

Primarily urine

Time to Peak

20 minutes

Duration of Action

~ 3 hours

Half-Life Elimination

~48 minutes

Protein Binding

~60%

Use: Labeled Indications

Type 1 and type 2 diabetes: Adjunct treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

Contraindications

Serious hypersensitivity to pramlintide or any component of the formulation; confirmed diagnosis of gastroparesis; hypoglycemia unawareness

Dosing: Adult

Note: When initiating pramlintide, reduce current mealtime insulin dose (including premixed preparations) by 50% to avoid hypoglycemia. If pramlintide is discontinued for any reason, restart therapy with same initial titration protocol. If a dose is missed, wait until the next scheduled dose and administer the usual amount.

Type 1 diabetes mellitus: SubQ: Initial: 15 mcg immediately prior to major meals; titrate in 15 mcg increments every 3 days (if no significant nausea occurs) to target dose of 30 to 60 mcg prior to major meals (consider discontinuation if intolerant of 30 mcg dose)

Type 2 diabetes mellitus: SubQ: Initial: 60 mcg immediately prior to major meals; after 3 days, increase to 120 mcg prior to each major meal if no significant nausea occurs (if nausea occurs at 120 mcg dose, reduce to 60 mcg)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥15 mL/minute: No dosage adjustment necessary.

End-stage renal disease [ESRD]: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, need for adjustment not likely since undergoes minimal hepatic metabolism.

Administration

Subcutaneous: Do not mix with insulins; administer subcutaneously into abdominal or thigh areas at sites distinct from concomitant insulin injections (do not administer into arm due to variable absorption); rotate injection sites frequently. Allow solution to reach room temperature before administering; may reduce injection site reactions. For oral medications in which a rapid onset of action is desired, administer 1 hour before, or 2 hours after pramlintide, if possible.

Dietary Considerations

Dietary modification based on ADA recommendations is a part of therapy; pramlintide to be administered prior to major meals consisting of ≥250 Kcal or ≥30 g carbohydrates

Storage

Store at 2°C to 8°C (36°F to 46°F); do not freeze. After initial use, may be kept refrigerated or at room temperature ≤30°C (≤86°F); discard after 30 days. Protect from light.

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Anticholinergic Agents: Pramlintide may enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulin: Pramlintide may enhance the hypoglycemic effect of Insulin. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Consider therapy modification

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (5% to 13%)

Endocrine & metabolic: Severe hypoglycemia (type 1 diabetes ≤17%)

Gastrointestinal: Nausea (28% to 48%), anorexia (≤17%), vomiting (7% to 11%)

Miscellaneous: Accidental injury (8% to 14%)

1% to 10%:

Central nervous system: Fatigue (3% to 7%), dizziness (2% to 6%)

Endocrine & metabolic: Severe hypoglycemia (type 2 diabetes ≤8%)

Gastrointestinal: Abdominal pain (2% to 8%)

Hypersensitivity: Hypersensitivity reaction (≤6%)

Neuromuscular & skeletal: Arthralgia (2% to 7%)

Respiratory: Cough (2% to 6%), pharyngitis (3% to 5%)

Postmarketing and/or case reports (Limited to important or life-threatening): Injection site reaction, pancreatitis

ALERT: U.S. Boxed Warning

Insulin/glucose-lowering agents:

Pramlintide use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a pramlintide injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reactions: Injection site reactions, including erythema, edema, or pruritus, may occur; usually resolve in a few days to weeks.

Disease-related concerns:

• Gastroparesis: Avoid use in patients with conditions or concurrent medications likely to impair gastric motility (eg, anticholinergics); do not use in patients requiring medication(s) to stimulate gastric emptying.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Insulin/glucose-lowering agents: [U.S. Boxed Warning]: Coadministration with insulin may induce severe hypoglycemia (usually within 3 hours following administration); coadministration with insulin therapy is an approved indication, but does require an initial dosage reduction of insulin and frequent pre- and post-blood glucose monitoring to reduce risk of severe hypoglycemia. Concurrent use of other glucose-lowering agents may increase risk of hypoglycemia.

Dosage form specific issues:

• Multiple dose injection pens: According to the manufacturer and the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of transmission of blood-borne pathogens. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC, 2012).

Other warnings/precautions:

• Appropriate use: Avoid use in patients with poor compliance with their insulin regimen and/or blood glucose monitoring. Do not use in patients with HbA1c levels more than 9%, recurrent episodes of severe hypoglycemia requiring assistance during the past 6 months, or hypoglycemia unawareness; obtain detailed history of glucose control (eg, HbA1c, incidence of hypoglycemia, glucose monitoring, and medication compliance) and body weight before initiating therapy. Use caution in patients with visual or dexterity impairment. Patients should use caution when driving or operating heavy machinery until effects on blood sugar are known.

Monitoring Parameters

Prior to initiating therapy: HbA1c, hypoglycemic history, body weight. During therapy: Pre- and postprandial and bedtime serum glucose, HbA1c, signs and symptoms of hypoglycemia

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Based on in vitro data, pramlintide has a low potential to cross the placenta.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2015; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2015; Blumer 2013; Kitzmiller 2008). Prior to pregnancy, effective contraception should be used until glycemic control is achieved (Kitzmiller 2008). Other agents are currently recommended to treat diabetes in pregnant women (ACOG 2013; Blumer 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, lack of appetite, injection site irritation, abdominal pain, or loss of strength and energy. Have patient report immediately to prescriber severe nausea, vomiting, seizures, or signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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