Apidra 100 IU/mL Solution for Injection in a Vial

APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA 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 administration instructions
• Individualize and adjust the dosage of APIDRA based on route of administration, individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
• Dosage adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns, changes in renal or hepatic function or during acute illness
• Subcutaneous Injection: Inject within 15 minutes before a meal or within 20 minutes after starting a meal into the abdomen, thigh, or upper arm
• Rotate injection sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis
• Should generally be used in regimens with an intermediate or long-acting insulin
• Continuous Subcutaneous Infusion (Insulin Pump): Refer to the insulin infusion pump user manual to see if APIDRA can be used
• Use in accordance with the insulin pump instructions for use
• Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer
• Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis
• Do not mix with other insulins or diluents in the pump
• Intravenous Administration: Administer only under medical supervision after diluting to concentrations from 0.05 to 1 unit/mL APIDRA in 0.9% sodium chloride injection, USP using polyvinyl chloride infusion bags. …

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

• The safety and effectiveness of APIDRA to improve glycemic control have been established
• In pediatric patients
• Use of APIDRA for this indication is supported by evidence from an active-controlled non-inferiority study
• In pediatric patients 4 years of age and older with type 1 diabetes mellitus treated with APIDRA (n=271) and from studies
• In adults with diabetes mellitus [see Clinical Pharmacology , and Clinical Studies ] . …

In clinical trials, APIDRA was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of geriatric patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when APIDRA is administered to geriatric patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Never Share an APIDRA SoloStar Pen or Syringe or Needle between Patients Advise patients that they must never share an APIDRA SoloStar pen with another person, even if the needle is changed
• Advise patients using APIDRA vials not to reuse or share needles or syringes with another person
• Sharing carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions ]
• Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. …

• APIDRA is contraindicated: during episodes of hypoglycemia in patients with known hypersensitivity to insulin glulisine or to any of the excipients in APIDRA; systemic allergic reactions have occurred with APIDRA [see Adverse Reactions ]
• Do not use during episodes of hypoglycemia
• Do not use in patients with hypersensitivity to insulin glulisine or any excipients in APIDRA

Table 6: Clinically Significant Drug Interactions with APIDRA 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 analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with these drugs. …

Never share an APIDRA SoloStar pen 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. Increase frequency of glucose monitoring with changes to: insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. …

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) ] Hypokalemia [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Adverse reactions commonly associated with APIDRA include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, and weight gain. ( 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 Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . …

Excess insulin may cause hypoglycemia and, particularly when given intravenously, 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 of hypoglycemia 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.

16.2 Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Do not freeze. Do not use after the expiration date (see carton and container). …

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.