Patient Information Sheet
Mecasermin [rDNA origin] (marketed as Increlex)
PDF Print Version
This is a
summary of the most important information about Increlex. For more
information, talk to your child’s healthcare professional.
What Is Increlex?
Increlex is an injectable
prescription medicine used to treat children who are very short
for their age because their bodies do not make enough insulin-like
growth factor-1 (IGF-1). IGF-1 should not be used instead of
growth hormone.
Increlex has not been studied in
children under 2 years of age.
Who Should Not Be Treated With
Increlex?
Your
child should not be treated with Increlex if your child:
-
has
finished growing (the bone growth plates are closed)
-
has
cancer
-
has
other causes of growth failure
-
is
allergic to mecasermin or any of the inactive ingredients in
Increlex.
Your child should never receive
Increlex through a vein.
What Are The Risks?
The
following are the major potential risks and side effects of
Increlex therapy. However, this list is not complete.
Increlex may cause the following
side effects, which can be serious:
Severe low blood sugar may cause
unconsciousness, seizures or death. Your child should avoid
participating in high risk activities (such as driving) within 2
to 3 hours after Increlex injection, especially at the beginning
of Increlex treatment.
Before beginning treatment with
Increlex, your child’s healthcare professional should
explain to you the symptoms of low blood sugar and how to treat
it.
-
Enlarged Tonsils.
Increlex may enlarge your
child’s tonsils. Some signs of tonsils that have increased in
size include: snoring, difficulty breathing or swallowing, sleep
apnea (a condition where breathing stops briefly during sleep),
or fluid in the middle-ear. Your child’s healthcare professional
should do regular exams to check your child’s tonsils.
-
Increased pressure in the brain
(intracranial hypertension).
Increlex, like growth hormone, can sometimes cause a temporary
increase in pressure within the brain. The symptoms of
intracranial hypertension can include headache and nausea with
vomiting. Tell your child’s healthcare provider if your child
has a headache with vomiting.
-
A bone problem called slipped
capital femoral epiphysis.
This happens when the top of the
upper leg (femur) slips apart. Get medical attention for your
child right away if your child develops a limp or has hip or
knee pain.
-
Worsened scoliosis
(caused by rapid growth). If your child has scoliosis, your
child will need to be checked often for an increase in the curve
of the spine.
-
Allergic reactions.
Your child may have a mild or serious allergic reaction with
Increlex. Call your child’s healthcare professional right away
if your child gets a rash or hives. Get medical help immediately
if your child has trouble breathing or goes into shock.
Increlex can cause reactions at
the injection site including:
What Should I Tell My Child’s Healthcare Professional?
Before
your child starts taking Increlex, tell your child’s healthcare
professional if your child:
-
has
diabetes
-
has
kidney problems
Can Other Medicines Or Food Affect
Increlex?
Tell
your child’s healthcare professional about all the medicines your
child takes including prescription and non-prescription medicines,
vitamins, and herbal supplements.
Especially tell your child’s
healthcare professional if your child takes insulin or other
anti-diabetes medicines.
How Should My Child Use Increlex?
-
Use Increlex exactly as prescribed for
your child.
-
Your child’s healthcare professional
should teach you how to inject Increlex. Do not give Increlex
unless you understand all of the instructions.
-
See the “Instructions for Use”
that come with Increlex.
Link to
Increlex’s Approved Labeling and Patient Information
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Date Approved: August 2005
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Date created: November
21, 2005
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