(Additions and/or
revisions are underlined)
Changes
in an insulin regimen (e.g., insulin strength, manufacturer, type, injection
site or method of administration) may affect glycemic control and
predispose to hypoglycemia or hyperglycemia. Repeated insulin injections
into areas of lipodystrophy or localized cutaneous amyloidosis have been
reported to result in hyperglycemia; and a sudden change in the injection site
(to an unaffected area) has been reported to result in hypoglycemia.
Make
any
changes to a patient’s insulin regimen under close medical supervision with
increased frequency of blood glucose monitoring. Advise patients who have
repeatedly injected into areas of lipodystrophy or localized cutaneous
amyloidosis to change the injection site to unaffected areas and closely
monitor for hypoglycemia. For patients with type 2 diabetes, dosage
adjustments of concomitant anti-diabetic products may be needed.
(Additions and/or
revisions are underlined)
The
following adverse reactions are also discussed elsewhere in the labeling:
Adverse
Reactions from Clinical Studies or Postmarketing Reports
The
following additional adverse reactions have been identified during clinical
studies or from postmarketing reports with use of NOVOLIN 70/30. Because some
of these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or to
establish a causal relationship to drug exposure.
Adverse reactions
associated with insulin initiation and glucose control intensification
Intensification
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. Over the long-term, improved glycemic
control decreases the risk of diabetic retinopathy and neuropathy.
Hypersensitivity
reactions
Severe,
life-threatening, generalized allergy, including anaphylaxis.
Hypoglycemia
Hypoglycemia
is the most commonly observed adverse reaction in NOVOLIN 70/30.
Hypokalemia
NOVOLIN
70/30 can cause a shift in potassium from the extracellular to intracellular
space, possibly leading to hypokalemia.
Injection site
reactions
NOVOLIN
70/30 can cause local injection site reactions including redness, swelling, or
itching at the site of injection. These
reactions usually resolve in a few days to a few weeks, but in some occasions,
may require discontinuation. Localized reactions and generalized myalgias have
been reported with the use of metacresol, which is an excipient in NOVOLIN
70/30.
Lipodystrophy
Administration
of insulin subcutaneously, including NOVOLIN 70/30, has resulted in lipoatrophy
(depression in the skin) or lipohypertrophy (enlargement or thickening of
tissue) in some patients.
Localized
Cutaneous Amyloidosis
Localized
cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has
been reported with repeated insulin injections into areas of localized cutaneous
amyloidosis; hypoglycemia has been reported with a sudden change to an
unaffected injection site.
Medication Errors
Medication
errors in which other insulins have been accidentally substituted for NOVOLIN
70/30 have been identified during postapproval use.
Peripheral edema
Insulins,
including NOVOLIN 70/30, may cause sodium retention and edema, particularly if
previously poor metabolic control is improved by intensified insulin therapy.
Weight gain
Weight
gain can occur with insulin therapies, including NOVOLIN 70/30, and has been
attributed to the anabolic effects of insulin and the decrease in glucosuria.
Immunogenicity
As
with all therapeutic peptides, insulin administration may cause anti-insulin
antibodies to form. The incidence of antibody formation with NOVOLIN 70/30 is
unknown.
(Additions and/or
revisions are underlined)
Advise the patient
to read the FDA-approved patient labeling (Patient Information and Instructions
for Use).
Never
Share a NOVOLIN 70/30 FlexPen or Syringe between Patients
Advise
patients using NOVOLIN 70/30 vials or NOVOLIN 70/30 FlexPen not to share
needles, syringes, or FlexPen with another person. Sharing poses a risk for
transmission of blood-borne pathogens.
Hyperglycemia
or
Hypoglycemia
Inform
patients that hypoglycemia is the most common adverse reaction with insulin.
Instruct patients on self-management procedures including glucose monitoring,
proper injection technique, and management of hypoglycemia and hyperglycemia,
especially at initiation of NOVOLIN 70/30 therapy. Instruct patients on
handling of special situations such as intercurrent conditions (illness,
stress, or emotional disturbances), an inadequate or skipped insulin dose,
inadvertent administration of an increased insulin dose, inadequate food intake,
and skipped meals. Instruct patients on the management of hypoglycemia.
Inform
patients that their ability to concentrate and react may be impaired as a
result of hypoglycemia. Advise patients who have frequent hypoglycemia or
reduced or absent warning signs of hypoglycemia to use caution when driving or
operating machinery.
Advise
patients that changes in insulin regimen can predispose to hyperglycemia or
hypoglycemia and that changes in insulin regimen should be made under close
medical supervision.
Hypoglycemia
due to Medication Errors
Instruct
patients to always check the insulin label before each injection to avoid
mix-ups between insulin products.
Hypersensitivity
Reactions
Advise
patients that hypersensitivity reactions have occurred with NOVOLIN 70/30.
Inform patients on the symptoms of hypersensitivity reactions and to seek
medical attention if they occur.
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