PRAM-lin-tide

Therapeutic Classification: antidiabetics

Pharmacologic Classification: hormones

• Used with mealtime insulin in the management of type 1 or type 2 diabetes in patients whose blood sugar cannot be controlled by optimal insulin therapy; can be used with other agents (sulfonylureas, metformin).

• 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.

• Improved control of postprandial hyperglycemia.

Absorption: 30–40% absorbed following SUBQ administration.

Distribution: Does not appear to significantly cross the placenta.

Metabolism/Excretion: Metabolized by the kidneys; major metabolite has pharmacologic properties similar to the parent compound.

Half-life: 48 min.

(effect on blood sugar*)

*Blood level.

Contraindicated in:

• Hypersensitivity
• 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
• OB: Insulin is the drug of choice for blood glucose control during pregnancy.

Use Cautiously in:

• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness in children not established.

Noted for concurrent use with insulin

Derm: local allergy.

Endo: HYPOGLYCEMIA.

GI: nausea, abdominal pain, anorexia, vomiting.

MS: arthralgia.

Neuro: dizziness, fatigue, headache.

Resp: cough.

Misc: injection site reactions, systemic allergic reactions.

Drug-Drug:

• ↑ 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 -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

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

Type 1 Diabetes

• SC (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.

• Solution for injection (pen-injector): 1000 mcg/mL;

• 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.

• Monitor blood glucose frequently, including pre- and post-meals and at bedtime.

• 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.
• SC: 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%. Administer into abdomen or thigh, rotating injection sites. Do not administer solutions that are cloudy. Pen-injector is stable for 30 days at controlled room temperature.

• Instruct patient in proper use of pramlintide (Pen-injector, injection technique, timing of doses, storage, and disposal of equipment). Make sure patient understands dosing and preparation of correct dose. Use a new needle with each injection. Follow manufacturer's instructions for use of Symlin Pen . 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.
• Caution patient not to share pen device with another person, even if needle is changed; may risk transmission of blood-borne pathogens.
• 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 wk 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 breastfeeding.

• Reduction in postprandial glucose concentrations.

Symlin

NDC Code^*

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6615- SymlinPen
    • 0310-6615-02- 2 CARTRIDGE in 1 CARTON (0310-6615-02) > 1.5 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6627- SymlinPen
    • 0310-6627-02- 2 CARTRIDGE in 1 CARTON (0310-6627-02) > 2.7 mL in 1 CARTRIDGE