Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3440
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Humalog (Injection, Suspension)
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Humalog is
intended for subcutaneous administration, including use in select external
insulin pumps (see DOSAGE
AND ADMINISTRATION, External Insulin Pumps).
Dosage regimens of Humalog will
vary among patients and should be determined by the healthcare provider familiar with the patient's metabolic
needs, eating habits, and other lifestyle variables. Pharmacokinetic and pharmacodynamic
studies showed Humalog to
be equipotent toRegular human insulin (i.e.,
one unit of Humalog has
the same glucose���lowering effect as one unit
of Regular human insulin), but
with more rapid activity. The quicker glucose���lowering effect of Humalog is
related to the more rapid absorption rate from subcutaneous tissue. An adjustment
of dose or schedule of basal insulin may be needed when a patient changes
from other insulins to Humalog,
particularly to prevent pre���meal hyperglycemia. When used as a meal���time insulin, Humalog should
be given within 15 minutes before or immediately after a meal. Regular human insulin is
best given 30 to 60 minutes before a meal. To achieve optimal glucose control,
the amount of longer���acting insulin being given may need to be adjusted
when using Humalog. The rate of insulin absorption and consequently the onset of
activity are known to be affected
by the site of injection, exercise, and other variables. Humalog was
absorbed at a consistently faster rate than Regular human insulin in healthy male volunteers given
0.2 U/kg Regular human insulin or Humalog at
abdominal, deltoid, or femoral sites, the three sites often used by patients
with diabetes. When not mixed in the same syringe with other insulins, Humalog maintains
its rapid onset of action and has less variability in its onset of action
among injection sites compared with Regular human insulin .
After abdominal administration, Humalog concentrations
are higher than those following deltoid or thighinjections. Also, the duration
of action of Humalog is
slightly shorter following abdominal injection, compared with deltoid and
femoral injections. As with all insulin preparations, the time course of action
of Humalog may
vary considerably in different individuals or within the same individual.
Patients must be educated to use proper injection techniques. Humalog in
a vial may be diluted with STERILE DILUENT for Humalog,
Humulin N, Humulin R, Humulin 70/30,
andHumulin R U-500 to a concentration
of 1:10 (equivalent to U���10) or 1:2 (equivalent to U���50). Diluted Humalog may
remain in patient use for 28 days when stored at 5��C (41��F) and for
14 days when stored at 30��C (86��F). Do not dilute Humalog contained
in a cartridge or Humalog used
in an external insulin pump. Parenteral drug products should be inspected visually before use whenever the
solution and the container permit. If the solution is cloudy, contains particulate
matter, is thickened, or is discolored, the contents must not be injected. Humalog should
not be used after its expiration date. The cartridge containing Humalog is not designed to allow any other insulin to be mixed in the cartridge
or for the cartridge to be refilled with insulin. External
Insulin Pumps���Humalog was
tested in MiniMed'Models 506, 507, and 508
insulin pumps using MiniMed'Polyfin'infusion
sets. Humalog was
also tested in the Disetronic'H���TRONplus'
V100 insulin pump (with plastic 3.15 mL insulin reservoir)
and the Disetronic D���TRON'and D���TRON'plus
pumps (with Humalog 3 mL
cartridges) using Disetronic Rapid'infusion
sets. Humalog should
not be diluted or mixed with any other insulin when used in an external insulin
pump.
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Humalog [insulin lispro injection, USP (rDNA origin)] is a human insulin
analog that is a rapid���acting, parenteral blood glucose���lowering
agent. Chemically, it is Lys(B28), Pro(B29) human insulin analog, created
when the amino acids at positions 28 and 29 on the insulin B���chain are
reversed. Humalog is
synthesized in a special non���pathogenic laboratory strain of Escherichia coli bacteria
that has been genetically altered to produce insulin lispro. Humalog has
the following primary structure: Insulin lispro has the empirical formula CHNOSand a molecular weight of 5808, both identical to that of human
insulin. The vials, cartridges, and Pens contain a sterile solution
of Humalog for
use as an injection. Humalog injection
consists of zinc���insulin lispro crystals dissolved in a clear aqueous fluid. Each milliliter of Humalog injection
contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg
dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide
content adjusted to provide 0.0197 mg zinc ion, trace amounts
of phenol, and Water for Injection. Insulin lispro has
a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may
be added to adjust pH.
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Antidiabetic
Activity: The primary activity of insulin, including Humalog,
is the regulation of glucose metabolism. In addition, all insulins have several
anabolic and anti���catabolic actions on many tissues in the body. In
muscle and other tissues (except the brain), insulin causes rapid transport
of glucose and amino acids intracellularly, promotes anabolism, and inhibits
protein catabolism. In the liver, insulin promotes the uptake and storage
of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes
the conversion of excess glucose into fat. Humalog has
been shown to be equipotent to human insulin on a molar basis. One unit of Humalog has
the same glucose���lowering effect as one unit of Regular human insulin, but its effect is more rapid
and of shorter duration. The glucose���lowering activity of Humalog and Regular human insulin is
comparable when administered to nondiabetic
subjects by the intravenous route.<br/>Pharmacokinetics:<br/>Absorption and Bioavailability: Humalog is
as bioavailable as Regular human insulin, with
absolute bioavailability ranging between 55% to 77% with doses between 0.1
to 0.2 U/kg, inclusive. Studies in nondiabetic subjects and patients
with type 1 (insulin���dependent) diabetes demonstrated that Humalog is
absorbed faster than Regular human insulin (U���100)
(see Figure 1).
In nondiabetic subjects given subcutaneous
doses of Humalog ranging
from 0.1 to 0.4 U/kg, peak serum concentrations were observed 30
to 90 minutes after dosing. When nondiabetic subjects received
equivalent doses of Regular human insulin, peak
insulin concentrations occurred
between 50 to 120 minutes after dosing. Similar results were seen in patients
with type 1 diabetes. The pharmacokinetic profiles of Humalog and Regular human insulin are
comparable to one another when administered to nondiabetic subjects by the intravenous route. Humalog was
absorbed at a consistently faster rate than Regular human insulin in healthy male volunteers given
0.2 U/kg Regular human insulin or Humalog at
abdominal, deltoid, or femoral subcutaneous sites, the three sites often used
by patients with diabetes. After abdominal administration of Humalog,
serum drug levels are higher and the duration of action is slightly shorter
than after deltoid orthigh administration (see DOSAGE AND
ADMINISTRATION). Humalog has
less intra���and inter���patient variability compared with Regular human insulin.<br/>Distribution: The volume of
distribution following injection of Humalog is
identical to that of Regular human insulin, with
a range of 0.26 to 0.36 L/kg.<br/>Metabolism: Human metabolism
studies have not been conducted. However, animal studies indicate that the
metabolism of Humalog is
identical to that of Regular human insulin.<br/>Elimination: When Humalog is
given subcutaneously, its tis shorter than that
of Regular human insulin (1 versus 1.5 hours, respectively). When given
intravenously, Humalog and Regular human insulin show
identical dose���dependent elimination, with a tof
26 and 52 minutes at 0.1 U/kg and 0.2 U/kg,
respectively.<br/>Pharmacodynamics: Studies in nondiabetic subjects and patients with diabetes demonstrated
that Humalog has
a more rapid onset of glucose���lowering activity, an earlier peak for
glucose���lowering, and a shorter duration of glucose���lowering activity
than Regular human insulin (see Figure 2).
The earlier onset of activity of Humalog is
directly related to its more rapid rate of absorption. The time course of
action of insulin and insulin analogs, such as Humalog,
may vary considerably in different individuals or within the same individual.
The parameters of Humalog activity
(time of onset, peak time, and duration) as presented in Figure 2 should
be considered only as general guidelines. The rate of insulin absorption and
consequently the onset of activity is known to be affected by the site of
injection, exercise, and other variables .<br/>Special
Populations:<br/>Age and Gender: Information on
the effect of age and gender on the pharmacokinetics of Humalog is
unavailable. However, in large clinical trials, sub-group analysis based on age and gender did
not indicate any difference in postprandial glucose parameters between Humalog and Regular human insulin.<br/>Smoking: The effect of
smoking on the pharmacokinetics and pharmacodynamics of Humalog has
not been studied.<br/>Pregnancy: The effect of
pregnancy on the pharmacokinetics and pharmacodynamics of Humalog has
not been studied.<br/>Obesity: The effect of
obesity and/or subcutaneous fat thickness on the pharmacokinetics and pharmacodynamics
of Humalog has
not been studied. In large clinical trials, which included patients with Body
Mass Index up to and including 35 kg/m,
no consistent differences were observed between Humalog and
Humulin R with respect to postprandial glucose
parameters.<br/>Renal Impairment: Some studies
with human insulin have shown increased circulating levels of insulin in patients
with renal failure. In a study of 25 patients with type 2 diabetes and a wide
range of renal function, the pharmacokinetic differences between Humalog and Regular human insulin were
generally maintained. However, the sensitivity of the patients to insulin
did change, with an increased response to insulin as the renal function declined.
Careful glucose monitoring and dose reductions of insulin, including Humalog,
may be necessary in patients with renal dysfunction.<br/>Hepatic Impairment: Some studies
with human insulin have shown increased circulating levels of insulin in patients
with hepatic failure. In a study of 22 patients with type 2 diabetes, impaired
hepatic function did not affect the subcutaneous absorption or general disposition
of Humalog when
compared with patients with
no history of hepatic dysfunction. In that study, Humalog maintained
its more rapid absorption and elimination when compared with Regular human insulin. Careful glucose monitoring and
dose adjustments of insulin, including Humalog, may be necessary in patients with hepatic dysfunction.
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Humalog is
contraindicated during episodes of hypoglycemia and in patients sensitive
to Humalog or any of its excipients.
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Humalog [insulin lispro injection,
USP (rDNA origin)] is available in the following package sizes:
each presentation containing 100 units insulin lispro per
mL (U-100). ____________ Storage���Unopened Humalog should
be stored in a refrigerator [2��to 8��C (36��to 46��F)],
but not in the freezer. Do not use Humalog if
it has been frozen. Unrefrigerated [below 30��C (86��F)] vials,
cartridges, Pens, and KwikPens must be used within 28 days or be discarded,
even if they still contain Humalog.
Protect from direct heat and light. See table below: Use in an
External Insulin Pump���A Humalog 3 mL
cartridge used in the D���TRON'or D���TRON'plus
should be discarded after 7 days, even if it still contains Humalog.
Infusion sets, D���TRON'and D���TRON'plus
cartridge adapters, and Humalog in
the external insulin pump reservoir should be discarded every 48 hours or
less.
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General: Hypoglycemia and hypokalemia are among the potential clinical adverse
effects associated with the use of all insulins. Because of differences in
the action of Humalog and
other insulins, care should be taken in patients in whom such potential sideeffects might be clinically relevant (e.g., patients who are fasting, have
autonomic neuropathy, or are using potassium���lowering drugs or patients
taking drugs sensitive to serum potassium level). Lipodystrophy and hypersensitivity
are among other potential clinical adverse effects associated with the use
of all insulins. As with all insulin preparations, the time course of Humalog action
may vary in different individuals or at different times in the same individual
and is dependent on site of injection, blood supply, temperature, and physical
activity. Adjustment of dosage of any insulin may be necessary if patients change
their physical activity or their usual meal plan. Insulin requirements may
be altered during illness, emotional disturbances, or other stress. Hypoglycemia���As with all insulin preparations, hypoglycemic reactions may be associated
with the administration of Humalog.
Rapid changes in serum glucose concentrations may
induce symptoms of hypoglycemia in persons with diabetes, regardless of the
glucose value. Early warning symptoms of hypoglycemia may be differentor
less pronounced under certain conditions, such as long duration of diabetes,
diabetic nerve disease, use of medications such as beta���blockers, or
intensified diabetes control. Renal Impairment���The requirements for insulin may be reduced in patients with renal impairment. Hepatic Impairment���Although impaired hepatic function does not affect the absorption or disposition
of Humalog,
careful glucose monitoring and dose adjustments of insulin, including Humalog,
may be necessary. Allergy���Local Allergy���As with any insulin therapy, patients may experience redness, swelling, or
itching at the site of injection. These minor reactions usually resolve in
a few days to a few weeks. In some instances, these reactions may be related
to factors other than insulin, such as irritants in the skin
cleansing agent or poor injection technique. Systemic
Allergy���Less common, but potentially more serious, is generalized
allergy to insulin, which may cause rash (including pruritus) over the whole
body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse,
or sweating. Severe cases of generalized allergy, including anaphylactic reaction,
may be life threatening. In controlled clinical trials, pruritus (with or
without rash) was seen in 17 patients receiving Humulin R (N=2969) and 30
patients receiving Humalog (N=2944)
(p=0.053). Localized reactions and generalized myalgias have been reported
with the use of cresol as an injectable excipient. Antibody
Production���In large clinical trials, antibodies that cross���react
with human insulin and insulin lispro were observed in both Humulin R���and Humalog���treatment
groups. As expected, the largest increase in the antibody levels during the
12���month clinical trials was observed with patients new to insulin therapy. Usage in External
Insulin Pumps���The infusion set (reservoir syringe, tubing, and catheter),
Disetronic' D���TRON'or D���TRON'plus
cartridge adapter, and Humalog in
the external insulin pump reservoir should be replaced and a new infusion
site selected every 48 hours or less. Humalog in the external insulin pump should not be exposed to temperatures above
37��C (98.6��F). In the D���TRON'or D���TRON'plus
pump, Humalog 3 mL
cartridges may be used for up to 7 days. However, as with other external insulin
pumps, the infusion set should be replaced and a new infusion site should
be selected every 48 hours or less. When used in an external insulin pump, Humalog should
not be diluted or mixed with any other insulin (see INDICATIONS
AND USAGE, WARNINGS, PRECAUTIONS, For Patients Using External
Insulin Pumps, Mixing of Insulins, DOSAGE AND ADMINISTRATION, and Storage).<br/>Information
for Patients: Patients should be informed of the potential risks and advantages of Humalog and
alternative therapies. Patients should also be informed about the importance
of proper insulin storage, injection technique, timing of dosage, adherence
to meal planning, regular physical activity, regular blood glucose monitoring,
periodic hemoglobin Atesting,
recognition and management of hypo���and hyperglycemia, and periodic
assessment for diabetes complications. Patients should be advised to inform their physician if they are pregnant
or intend to become pregnant. Refer patients to the Patient Information leaflet for timing of Humalog dosing
(���15 minutes before or immediately after a meal), storing insulin, and
common adverse effects. For
Patients Using Insulin Pen Delivery Devices: Before starting therapy,
patients should read the Patient Information leaflet that accompanies the drug product and
the User Manual that accompanies the delivery device and re-read them each
time the prescription is renewed. Patients should be instructed on how to
properly use the delivery device, prime the Pen, and properly dispose of needles.
Patients should be advised not to share their Pens with others. For
Patients Using External Insulin Pumps: Patients using an external
infusion pump should be trained in intensive insulin therapy and in the function
of their external insulin pump and pump accessories. Humalog was
tested in the MiniMed'Models 506, 507, and
508 insulin pumps using MiniMed'Polyfin'infusion
sets. Humalog was
also tested in Disetronic'H���TRONplus'
V100 insulin pump (with plastic 3.15 mL insulin reservoir),
and the Disetronic D���TRON'and D���TRON'plus
insulin pumps (with Humalog 3 mL cartridges) using Disetronic Rapid'infusion
sets. The infusion
set (reservoir syringe, tubing, catheter), D���TRON'or
D���TRON'plus cartridge adapter, and Humalog in
the external insulin pump reservoir should be replaced, and a new infusion
site selected every 48 hours or less. Humalog in the external pump should not be exposed to temperatures above 37��C
(98.6��F). A Humalog 3 mL cartridge used in the D���TRON'or
D���TRON'plus pump should be discarded
after 7 days, even if it still contains Humalog. Infusion sites that are erythematous, pruritic, or thickened should be
reported to medical personnel, and a new site selected. Humalog should
not be diluted or mixed with any other insulin when used in an external insulin
pump.<br/>Laboratory
Tests: As with all insulins, the therapeutic response to Humalog should
be monitored by periodic blood glucose tests. Periodic measurement of hemoglobin Ais
recommended for the monitoring of long���term glycemic control.<br/>Drug
Interactions: Insulin requirements may be increased by medications with hyperglycemic
activity such as corticosteroids, isoniazid, certain lipid���lowering
drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, and
thyroid replacement therapy . Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic
activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics,
certain antidepressants (monoamine oxidase inhibitors), angiotensin���converting���enzyme
inhibitors, angiotensin II receptor blocking agents, beta���adrenergic
blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol.
Beta���adrenergic blockers may mask the symptoms of hypoglycemia in some
patients. Mixing
of Insulins���Care should be taken when mixing all insulins
as a change in peak action may occur. The American Diabetes Association warns
in its Position Statement on Insulin Administration,���On mixing, physiochemical
changes in the mixture may occur (either immediately or over time). As a result,
the physiological response to the insulin mixture may differ from that of
the injection of the insulins separately.���Mixing Humalog with
Humulin N or Humulin U does not decrease the
absorption rate or the total bioavailability of Humalog.
Given alone or mixed with Humulin N, Humalog results in a more rapid absorption and glucose���lowering effect compared
with Regular human insulin. The effects of mixing Humalog with
insulins of animal source or insulin preparations produced by other manufacturers
have not been studied . If Humalog is
mixed with a longer���acting insulin, such as Humulin N or Humulin U, Humalog should
be drawn into the syringe first to prevent clouding of the Humalog by
the longer���acting insulin. Injection should be made immediately after
mixing. Mixtures should not be administered intravenously. The cartridge containing Humalog is
not designed to allow any other insulin to be mixed in the cartridge, for
the Humalog in
the cartridge to be diluted or for the cartridge to be refilled with insulin. Humalog should
not be diluted or mixed with any other insulin when used in an external insulin
pump.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility: Long���term studies in animals have not been performed to evaluate
the carcinogenic potential of Humalog, Humalog Mix75/25,
or Humalog Mix50/50. Insulin lispro was not mutagenic
in a battery of in
vitro and in
vivo genetic toxicity assays (bacterial mutation tests, unscheduled
DNA synthesis, mouse lymphoma assay, chromosomal aberration tests, and a micronucleus
test). There is no evidence from animal studies of impairment of fertility inducedby insulin lispro.<br/>Pregnancy:<br/>Teratogenic Effects���Pregnancy Category
B: Reproduction studies have been performed in pregnant rats and rabbits
at parenteral doses up to 4 and 0.3 times, respectively, the average human
dose (40 units/day) based on body surface area. The results have revealed
no evidence of impaired fertility or harm to the fetus due to Humalog.
There are, however, no adequate and well���controlled studies with Humalog, Humalog Mix75/25,
or Humalog Mix50/50 in
pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
needed. Although there are limited clinical studies of the use of Humalog in
pregnancy, published studies with human insulins suggest that optimizing overall
glycemic control, including postprandial control, before conception and during
pregnancy improves fetal outcome. Although the fetal complications of maternal
hyperglycemia have been well documented, fetal toxicity also has been reported
with maternal hypoglycemia. Insulin requirements usually fall during the first
trimester and increase during the second and third trimesters. Careful monitoring
of the patient is required throughout pregnancy. During the perinatal period,
careful monitoring of infants born to mothers with diabetes is warranted.<br/>Nursing
Mothers: It is unknown whether Humalog is
excreted in significant amounts in human milk. Many drugs, including human
insulin, are excreted in human milk. For this reason, caution should be exercised
when Humalog is
administered to a nursing woman. Patients with diabetes who are lactating
may require adjustments in Humalog dose,
meal plan, or both.<br/>Pediatric
Use: In a 9���month, cross���over study of pre���pubescent children
(n=60), aged 3 to 11 years, comparable glycemic control as measured by HbAwas
achieved regardless of treatment group: Regular human insulin 30 minutes before meals 8.4%, Humalog immediately
before meals 8.4%, and Humalog immediately
after meals 8.5%. In an 8���month, cross���over study of adolescents
(n=463), aged 9 to 19 years, comparable glycemic control as measured by HbAwas
achieved regardless of treatment group: Regular human insulin 30
to 45 minutes before meals 8.7% and Humalog immediately
before meals 8.7%. The incidence of hypoglycemia was similar for all three
treatment regimens. Adjustment of basal insulin may be required. To improve
accuracy in dosing in pediatric patients, a diluent may be used. If the diluent
is added directly to the Humalog vial,
the shelf���life may be reduced (see DOSAGE AND
ADMINISTRATION).<br/>Geriatric
Use: Of the total number of subjects (n=2834) in eight clinical studies of Humalog,
twelve percent (n=338) were 65 years of age or over. The majority of these
were patients with type
2 diabetes. HbAvalues
and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic
studies to assess the effect of age on the onset of Humalog action
have not been performed.
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Hypoglycemia may occur as a result of an excess of insulin
relative to food intake, energy expenditure, or both. 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 intramuscular/subcutaneous glucagon
or concentrated intravenous glucose. Sustained carbohydrate intake and observation
may be necessary because hypoglycemia may recur after apparent clinical recovery.
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Insulin lispro
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Humalog (Injection, Suspension)
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Clinical studies comparing Humalog with Regular human insulin did
not demonstrate a difference in frequency of adverse events between the two
treatments. Adverse events commonly associated with human
insulin therapy include the following: Body
as a Whole���allergic reactions . Skin
and Appendages���injection site reaction, lipodystrophy,
pruritus, rash. Other���hypoglycemia .
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| dailymed-instance:warning |
This human insulin
analog differs from Regular human insulin by
its rapid onset of action as well as a shorter duration of activity. When
used as a meal-time
insulin, the dose of Humalog should
be given within 15 minutes before or immediately after the meal. Because of
the short duration of action of Humalog,
patients with type 1 diabetes also require a longer���acting insulin to
maintain glucose control (except when using an external insulin pump). Glucose
monitoring is recommended for all patients with diabetes and is particularly
important for patients using an external insulin pump. Hypoglycemia
is the most common adverse effect associated with insulins, including Humalog.
As with all insulins, the timing of hypoglycemia may differ among various
insulin formulations. Glucose monitoring is recommended for all patients with
diabetes. Any change of
insulin should be made cautiously and only under medical supervision. Changes
in insulin strength, manufacturer, type (e.g., Regular,
NPH, analog), species, or
method of manufacture may result in the need for a
change in dosage. External Insulin
Pumps: When used in an external insulin pump, Humalog should
not be diluted or mixed with any other insulin. Patients should carefully
read and follow the external insulin pump manufacturer's instructions
and the Patient Information leaflet before using Humalog. Physicians should carefully evaluate information on external insulin
pump use in this Humalog physician
package insert and in the external insulin pump manufacturer's instructions.
If unexplained hyperglycemia or ketosis occurs during external insulin pump
use, prompt identification and correction of the cause is necessary. The patient
may require interim therapy with subcutaneous insulin injections (see PRECAUTIONS, For Patients Using External
Insulin Pumps, and DOSAGE AND
ADMINISTRATION).
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| dailymed-instance:indicatio... |
Humalog is
an insulin analog that is indicated in the treatment of patients with diabetes
mellitus for the control of hyperglycemia. Humalog has
a more rapid onset and a shorter duration of action than Regular human insulin. Therefore, in patients with type
1 diabetes, Humalog should
be used in regimens that include a longer���acting insulin. However, in
patients with type 2 diabetes, Humalog may
be used without a longer���acting insulin when used in combination therapy
with sulfonylurea agents. Humalog may
be used in an external insulin pump, but should not be diluted or mixed with
any other insulin when used in the pump.
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Humalog
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