Insulin lispro

ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

• See Full Prescribing Information for important preparation and administration instructions
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis
• Subcutaneous injection : Administer ADMELOG by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis
• Continuous subcutaneous infusion (Insulin Pump) : Refer to the insulin infusion pump user manual to see if ADMELOG can be used
• Use in accordance with the insulin pump instructions for use
• Administer ADMELOG by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer
• Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis
• Do not mix with other insulins or diluents in the pump
• Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY after dilution and under medical supervision
• The dosage of ADMELOG must be individualized based on the route of administration and the patient's metabolic needs, blood glucose monitoring results and glycemic control goal
• Important Preparation and Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ]
• Inspect ADMELOG visually before use
• It should appear clear and colorless

Injection: 100 units/mL (U-100) is a clear and colorless solution available as: 10 mL multiple-dose vials 3 mL multiple-dose vials 3 mL single-patient-use SoloStar prefilled pens Injection: 100 units/mL (U-100) is available as: ( 3 ) 10 mL multiple-dose vials 3 mL multiple-dose vials 3 mL single-patient-use SoloStar ® prefilled pens

• The safety and effectiveness of ADMELOG to improve glycemic control have been established
• In pediatric patients with diabetes mellitus
• Use of ADMELOG for this indication is supported by evidence from an adequate and well-controlled study with another insulin lispro product, 100 units/ml, in 60
• Pediatric patients 3 years of age and older with type 1 diabetes mellitus and studies in adult patients with diabetes mellitus [see Clinical Studies ]

Of the total number of patients (n=2,834) in eight clinical studies of another insulin lispro product, 100 units/mL, 12% (n=338) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Of the total number of patients (n=1,011) in clinical studies of ADMELOG or another insulin lispro product, 100 units/mL, 26.5% (n=268) were 65 years of age or over. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Never Share an ADMELOG SoloStar Prefilled Pen or Syringe Between Patients Advise patients that they must never share an ADMELOG SoloStar pen with another person, even if the needle is changed
• Advise patients using ADMELOG vials not to share needles or syringes with another person
• Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ] . …

• ADMELOG is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ] . in patients who are hypersensitive to insulin lispro or to any of the excipients in ADMELOG [see Warnings and Precautions ]
• Do not use during episodes of hypoglycemia
• Do not use in patients with hypersensitivity to insulin lispro or any of the excipients in ADMELOG

Table 2 presents clinically significant drug interactions with ADMELOG. Table 2: Clinically Significant Drug Interactions with ADMELOG Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when ADMELOG is concomitantly administered with these drugs. …

Never share an ADMELOG SoloStar disposable prefilled pen or syringe between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. …

The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . …

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Dispense in the original sealed carton with the enclosed Instructions for Use. Store ADMELOG according to the table below. Do not freeze and do not use ADMELOG if it has been frozen. Protect from direct heat and light. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.