A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Apidra Side Effects, and Drug Interactions - Insulin glulisine
Apidra Side Effects, and Drug Interactions - Insulin glulisine
SIDE EFFECTS
Overall, clinical studies comparing APIDRA with short-acting
insulins did not demonstrate a difference in frequency of adverse events.
Adverse events commonly associated with human insulin therapy
include the following:
Body as a whole: allergic reactions. (See PRECAUTIONS.)
Skin and appendages: injection site reaction, lipodystrophy,
pruritus, rash. (See PRECAUTIONS.)
Other: hypoglycemia. (See WARNINGS
and PRECAUTIONS.)
The rates and incidence of severe symptomatic hypoglycemia,
defined as hypoglycemia requiring intervention from a third party, were comparable
for all treatment regimens (see Table 4).
|
Table 4: Severe Symptomatic Hypoglycemia
|
|
|
Type 1 Diabetes Mellitus – Adult 12 weeks in combination
with Lantus *
|
Type 1 Diabetes Mellitus – Adult 26 weeks in combination
with Lantus **
|
Type 2 Diabetes Mellitus – Adult 26 weeks in combination
with NPH human insulin**
|
|
|
Apidra Pre-meal
|
Apidra Post-meal
|
Regular Human Insulin
|
APIDRA
|
Insulin Lispro
|
APIDRA
|
Regular Human Insulin
|
|
Severe symptomatic Hypoglycemia(events/month/patient)
|
0.05
|
0.05
|
0.13
|
0.02
|
0.02
|
0.00
|
0.00
|
|
Severe symptomatic
|
8.4%
|
8.4%
|
10.1%
|
4.8%
|
4.0%
|
1.4%
|
1.2%
|
|
hypoglycemia Percent of patients(n/total
N)
|
(24/286)
|
(25/296)
|
(28/278)
|
(16/335)
|
(13/326)
|
(6/416)
|
(5/420)
|
|
*Entire treatment phase (3 months) has been included.
|
|
**Last three months of treatment have been considered.
|
Continuous Subcutaneous Insulin Infusion (CSII) (Type 1
Diabetes): The rates of catheter occlusions and infusion site reactions
were similar for APIDRA and insulin aspart (see Table 5).
|
Table 5: Catheter Occlusions and Infusion Site Reactions.
|
| |
Apidra
|
Insulin aspart
|
|
Catheter occlusions/month
|
0.08
|
0.15
|
|
Infusion site reactions
|
10.3% (3/29)
|
13.3% (4/30)
|
DRUG INTERACTIONS
A number of substances affect glucose metabolism and may require
insulin dose adjustment and particularly close monitoring.
The following are examples of substances that may reduce the
blood-glucose-lowering effect of insulin: corticosteroids, danazol, diazoxide,
diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline),
glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones,
estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors,
and atypical antipsychotic medications (e.g., olanzepine and clozapine).
The following are examples of substances that may increase
the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic
products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors,
pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics.
Beta-blockers, clonidine, lithium salts, and alcohol may either
potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine
may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
In addition, under the influence of sympatholytic medicinal
products such as beta-blockers, clonidine, guanethidine, and reserpine, the
signs of hypoglycemia may be reduced or absent.
Mixing of Insulins
In a clinical study in healthy volunteers (n=32) the total
insulin glulisine bioavailability was similar after subcutaneous injection of
insulin glulisine and NPH insulin (premixed in the syringe) and following separate
simultaneous subcutaneous injections. There was some attenuation (27%) of the
maximum concentration (Cmax) after premixing, however the time to
maximum concentration (Tmax) was not affected.
If APIDRA is mixed with NPH human insulin, APIDRA should be
drawn into the syringe first. Injection should be made immediately after mixing.
No data are available on mixing APIDRA with insulin preparations
other than NPH. (See CLINICAL STUDIES.) APIDRA should not be mixed with insulin
preparations other than NPH.
Mixtures should not be administered intravenously.
The effects of mixing APIDRA with diluents or other insulins
when used in external subcutaneous infusion pumps for insulin have not been
studied. Therefore, APIDRA should not be mixed in these instances.
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