Home' The Source : Fourth Quarter 2011 Contents Humalog
(insulin lispro injection [rDNA origin])
Brief Summary: Consult the package insert for complete prescribing
INDICATIONS AND USAGE
HUMALOG is an insulin analog indicated to improve glycemic control in adults and
children with diabetes mellitus.
HUMALOG is contraindicated:
• during episodes of hypoglycemia
• in patients who are hypersensitive to HUMALOG or to any of its excipients.
WARNINGS AND PRECAUTIONS
Dose Adjustment and Monitoring²Glucose monitoring is essential for patients
receiving insulin therapy. Changes to an insulin regimen should be made cautiously
and only under medical supervision. Changes in insulin strength, manufacturer, type, or
method of administration may result in the need for a change in insulin dose. Concomitant
oral antidiabetic treatment may need to be adjusted.
As with all insulin preparations, the time course of action for HUMALOG may vary in
different individuals or at different times in the same individual and is dependent on many
conditions, including the site of injection, local blood supply, or local temperature. Patients
who change their level of physical activity or meal plan may require adjustment of insulin
Hypoglycemia²Hypoglycemia is the most common adverse effect associated with
insulins, including HUMALOG. The risk of hypoglycemia increases with tighter glycemic
control. Patients must be educated to recognize and manage hypoglycemia. Hypoglycemia
can happen suddenly and symptoms may be different for each person and may change
from time to time. Severe hypoglycemia can cause seizures and may be life-threatening
or cause death.
The timing of hypoglycemia usually re ects the time-action pro le of the administered
insulin formulations. Other factors such as changes in food intake (e.g., amount of food or
timing of meals), injection site, exercise, and concomitant medications may also alter the
risk of hypoglycemia [see Drug Interactions].
As with all insulins, use caution in patients with hypoglycemia unawareness and in
patients who may be predisposed to hypoglycemia (e.g., the pediatric population and
patients who fast or have erratic food intake). The patient's ability to concentrate and react
may be impaired as a result of hypoglycemia. This may present a risk in situations where
these abilities are especially important, such as driving or operating other machinery.
Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia
in persons with diabetes, regardless of the glucose value. Early warning symptoms of
hypoglycemia may be different or less pronounced under certain conditions, such
as longstanding diabetes, diabetic nerve disease, use of medications such as beta-
blockers [see Drug Interactions], or intensi ed diabetes control. These situations may
result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's
awareness of hypoglycemia.
Hypersensitivity and Allergic Reactions²Severe, life-threatening, generalized
allergy, including anaphylaxis, can occur with insulin products, including HUMALOG [see
Hypokalemia²All insulin products, including HUMALOG, cause a shift in potassium
from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated
hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use
caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-
lowering medications, patients taking medications sensitive to serum potassium
Renal or Hepatic Impairment²Frequent glucose monitoring and insulin dose
reduction may be required in patients with renal or hepatic impairment.
Mixing of Insulins²HUMALOG for subcutaneous injection should not be mixed
with insulin preparations other than NPH insulin. If HUMALOG is mixed with NPH insulin,
HUMALOG should be drawn into the syringe rst. Injection should occur immediately after
Do not mix HUMALOG with other insulins for use in an external subcutaneous
Subcutaneous Insulin Infusion Pumps²When used in an external insulin pump for
subcutaneous infusion, HUMALOG should not be diluted or mixed with any other insulin.
Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and
the infusion set insertion site at least every 3 days. HUMALOG should not be exposed to
temperatures greater than 98.6°F (37°C).
Malfunction of the insulin pump or infusion set or insulin degradation can rapidly
lead to hyperglycemia and ketosis. Prompt identi cation and correction of the cause of
hyperglycemia or ketosis is necessary. Interim subcutaneous injections with HUMALOG
may be required. Patients using continuous subcutaneous insulin infusion pump therapy
must be trained to administer insulin by injection and have alternate insulin therapy
available in case of pump failure [see Dosage and Administration and How Supplied/
Storage and Handling].
Drug Interactions²Some medications may alter insulin requirements and the risk
for hypoglycemia or hyperglycemia [see Drug Interactions].
The following adverse reactions are discussed elsewhere:
• Hypoglycemia [see Warnings and Precautions].
• Hypokalemia [see Warnings and Precautions].
Clinical Trial Experience²Because clinical trials are conducted under widely varying
designs, the adverse reaction rates reported in one clinical trial may not be easily
compared with those rates reported in another clinical trial, and may not re ect the rates
actually observed in clinical practice.
The frequencies of Treatment-Emergent Adverse Events during HUMALOG clinical trials
in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the
Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes
Mellitus (adverse events with frequency ≥5%)
Events, n (%)
(n=81) Regular human
Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes
Mellitus (adverse events with frequency ≥5%)
Events, n (%)
(n=714) Regular human
Insulin initiation and intensi cation of glucose control
Intensi cation or rapid improvement in glucose control has been associated with a
transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy,
and acute painful peripheral neuropathy. However, long-term glycemic control decreases
the risk of diabetic retinopathy and neuropathy.
Long-term use of insulin, including HUMALOG, can cause lipodystrophy at the site of
repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening
of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin
absorption. Rotate insulin injection or infusion sites within the same region to reduce the
risk of lipodystrophy [see Dosage and Administration].
Weight gain can occur with insulin therapy, including HUMALOG, and has been
attributed to the anabolic effects of insulin and the decrease in glucosuria.
Insulin, including HUMALOG, may cause sodium retention and edema, particularly if
previously poor metabolic control is improved by intensi ed insulin therapy.
Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
In a 12-week, randomized, crossover study in adult patients with type 1 diabetes
(n=39), the rates of catheter occlusions and infusion site reactions were similar for
HUMALOG and regular human insulin treated patients (see Table 3).
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