Usual Adult Dose for Diabetes Type 1

15 mcg subcutaneously, injecting immediately prior to each major meal

Comments:

• Mealtime insulin doses (including premixed insulins) should be reduced by 50%.
• Dose should be increased to next increment (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, dose should be decreased to 30 mcg.
• If the 30 mcg dose is not tolerated, discontinuation should be considered.

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

Usual Adult Dose for Diabetes Type 2

60 mcg subcutaneously, injecting immediately prior to each major meal

Comments:

• Mealtime insulin doses (including premixed insulins) should be reduced by 50%.
• Dose should be increased from 60 to 120 mcg prior to each major meal when no clinically significant nausea has occurred for at least 3 days.
• If significant nausea persists at the 120 mcg dose, dose should be decreased to 60 mcg.

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

Renal Dose Adjustments

Mild, moderate, or severe renal impairment (CrCl greater than 15 mL/min): No adjustment recommended

Liver Dose Adjustments

Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for pramlintide. It includes communication plan. For additional information: www.fda.gov/REMS

BOXED WARNING(S):

• Use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes.
• Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered subcutaneously immediately prior to each major meal (greater than or equal to 250 kcal or containing greater than or equal to 30 grams of carbohydrate).
• Each dose should be administered subcutaneously into the abdomen or thigh; administration into the arm is not recommended.
• Injection sites should be rotated so that the same site is not used repeatedly.
• Never share an insulin pen between patients, even if the needle is changed; do not reuse or share needles between patients as this presents a risk for transmission of blood-borne pathogens
• The injection site selected should be different from the site chosen for any concomitant insulin injection.
• Pramlintide and insulin should be administered as separate injections.
• This drug should not be mixed with any type of insulin.
• If a dose is missed, wait until the next scheduled dose and administer the usual amount.

Storage requirements:
For pen-injectors not in use:

• Refrigerate (2C to 8C; 36F to 46F)
• Protect from light.
• Do not freeze.
• Do not use if product has been frozen.

For pen-injectors in use:

• After first use, refrigerate or keep at a temperature not greater than 86F (30C) for 30 days.
• Use within 30 days, whether or not refrigerated.

Patient advice:

• Patients should not share a pen-injector with another person, even if the needle has been changed. Sharing of a pen may pose a risk of transmission of infection.