Symlin


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pramlintide acetate

Symlin

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.

Action

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

Availability

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%.

Contraindications

• Hypersensitivity to drug or its components

• Confirmed gastroparesis

• Hypoglycemia unawareness

Precautions

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).

Administration

• 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.

Adverse reactions

CNS: headache, dizziness, fatigue

EENT: pharyngitis

GI: nausea, vomiting, abdominal pain, anorexia

Metabolic: severe hypoglycemia

Musculoskeletal: arthralgia

Respiratory: cough

Other: allergic reaction

Interactions

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

Patient monitoring

• Monitor premeal and postmeal blood glucose levels closely; watch for hypoglycemia.

Patient teaching

• 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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

pramlintide

(pram-lin-tide) ,

Symlin

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: hormones
Pregnancy Category: C

Indications

Used with mealtime insulin in the management of diabetics whose blood sugar cannot be controlled by optimal insulin therapy; can be used with other agents (sulfonylureas, metformin).

Action

Acts as a synthetic analogue of amylin, an endogenous pancreatic hormone that helps to control postprandial hyperglycemia; effects include slowed gastric emptying, suppression of glucagon secretion and regulation of food intake.

Therapeutic effects

Improved control of postprandial hyperglycemia.

Pharmacokinetics

Absorption: 30–40% absorbed following subcutaneous administration.
Distribution: Does not appear to significantly cross the placenta.
Metabolism and Excretion: Metabolized by the kidneys; major metabolite has pharmacologic properties similar to the parent compound.
Half-life: 48 min.

Time/action profile (effect on blood sugar*)

ROUTEONSETPEAKDURATION
Subcutrapid20 min3 hr
*Blood level

Contraindications/Precautions

Contraindicated in: Hypersensitivty;Inability to identify hypoglycemia;Gastroparesis or need for medications to stimulate gastric motility;Poor compliance with current insulin regimen or self-monitoring;HbA1c >9%;Recurring severe hypoglycemia within the last 6 mo, requiring treatment; Obstetric: Insulin is the drug of choice for blood glucose control during pregnancy; Pediatric: Safety not established.
Use Cautiously in: Lactation: Lactation.

Adverse Reactions/Side Effects

Noted for concurrent use with insulin

Central nervous system

  • dizziness
  • fatigue
  • headache

Respiratory

  • cough

Gastrointestinal

  • nausea (most frequent)
  • abdominal pain
  • anorexia
  • vomiting

Endocrinologic

  • hypoglycemia (life-threatening)

Dermatologic

  • local allergy

Musculoskeletal

  • arthralgia

Miscellaneous

  • injection site reactions
  • systemic allergic reactions

Interactions

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.

Route/Dosage

Insulin-using Type 2 Diabetes

Subcutaneous (Adults) 60 mcg, immediately prior to major meals initially, if no significant nausea occurs, dose may be ↑ to 120 mcg.

Type 1 Diabetes

Subcutaneous (Adults) 15 mcg, immediately prior to major meals initially, if no significant nausea occurs, dose may be ↑ by 15 mcg every 3 days up to 60 mcg.

Availability

Pen-injector: 1000 mcg/mL
Solution for injection: 600 mcg/mL

Nursing implications

Nursing assessment

  • 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 Diagnoses

Noncompliance (Patient/Family Teaching)

Implementation

  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Reduction in postprandial glucose concentrations.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
Sales of the twice-daily injectable diabetes treatment Byetta fell 20% to $140.7 million while sales of diabetes medication Symlin accounted for $21.8 million in revenue.
Pramlintide (Symlin), a daily injectable, decreases the speed at which sugar enters the blood after a meal by slowing digestion.
In March 2005, for example, the RiskMAP that accompanied the FDA's approval of a diabetes drug called Symlin prohibited the company from conducting any direct-to-consumer advertising or journal advertising for one year following approval, and also restricted promotion primarily to physicians who specialize in diabetes management and who are supported by certified diabetes educators.
The morning after the company's diabetes drug, Symlin, was finally approved by the federal government after 18 years of research and development, she arrived in the office in a Sleeping Beauty costume and handed out copies of the fairy tale.
In July 2012, BMS and AZ worked together to acquire Amylin and its injectable diabetes treatments, Byetta, By-dureon and Symlin, for $5.3 billion.
This agreement will see the company sell its global diabetes business that was part of its collaboration with AstraZeneca, which includes Onglyza (saxagliptin), Kombiglyze XR/Komboglyze (saxagliptin and metformin HCl extended release), dapagliflozin (marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended release for injectable suspension), Symlin (pramlintide acetate) and metreleptin.
Sales of Byetta edged higher and Symlin revenue slipped, but a change in accounting cut its revenue by $27.7 million.
Some drugs in these classes already have been approved, most notably the incretin mimetic exenatide (Byetta), an inhaled insulin (Exubera), and the amylin analogue pramlintide (Symlin).
Most recently the agency approved Amylin Pharmaceuticals' injectable diabetes drug Symlin on the condition that it not be advertised directly to consumers or in medical journals for a year.
21 June 2011 - US-based biopharmaceutical company Amylin Pharmaceuticals Inc (NASDAQ: AMLN) said yesterday that it will present data for its two first-in-class diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidates BYDUREON and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, 24-28 June.
Pramlintide (Symlin) is an injectable synthetic analogue of human amylin, a peptide hormone that is naturally cosecreted with insulin in response to meals.