This is a
summary of the most important information about IPLEX. For more
information, talk to your healthcare professional.
What
Is IPLEX?
IPLEX is an injectable prescription
medicine that contains man-made insulin-like growth factor-1
(IGF-1) and insulin-like growth factor binding protein-3
(IGFBP-3). IPLEX is used to treat children with
severe primary IGF-1 deficiency. Children with severe primary
IGF-1 deficiency are very short for their age because their
bodies do not make enough IGF-1.
IPLEX should not be used in
place of growth hormone. IPLEX is not for other causes of growth
failure. IPLEX is not for children less than 3 years old or
adults with primary IGF-1 deficiency.
Who Should Not Be Treated
With IPLEX?
Your child should not take IPLEX
if your child:
-
has finished growing (bone
growth plates are closed)
-
has cancer
-
is allergic to mecasermin
rinfabate or any of the inactive ingredients in IPLEX.
-
Never inject IPLEX into a
vein.
What Are The Risks?
The
following are the major potential risks and side effects of
IPLEX therapy. However, this list is not complete.
Call
your child's healthcare professional if your child has side
effects that bother them, or do not go away.
-
Low blood sugar
(hypoglycemia). IPLEX may
lower your child’s blood sugar levels the way insulin does. Do
not give your child IPLEX if your child has signs of low blood
sugar which include dizziness, headache, tiredness,
restlessness, hunger, irritability, trouble concentrating,
sweating, nausea, or fast or irregular heartbeat.
-
Severe low
blood sugar may cause unconsciousness, convulsions, or death.
Your child should not do risky activities until the healthcare
professional has found the right dose for your child.
Before beginning
treatment with IPLEX, your child’s healthcare professional
should explain to you the symptoms of low blood sugar and how to
treat it.
-
Enlarged
tonsils.
IPLEX may
enlarge your child’s tonsils. Some signs of enlarged tonsils
are snoring, problems breathing or swallowing, earaches,
problems hearing, and breathing problems during sleep (sleep
apnea, which can also cause excessive daytime sleepiness).
Call your child’s
healthcare professional if your child gets any of these
symptoms. Your healthcare professional should do regular exams
to check your child’s tonsils.
-
Increased pressure in the
brain (intracranial hypertension).
Signs of increased pressure in
the brain include headache, nausea, vomiting, and vision
problems. Call your child’s healthcare professional if your
child has these symptoms.
-
A hip bone problem called
slipped capital femoral epiphysis.
This happens when the upper
end of the leg bone (femur) slips apart. Get medical attention
for your child right away if your child develops a limp, or
has hip or knee pain.
-
Worsened curve of the spine (scoliosis). If your child
has scoliosis, your child will need to be checked regularly for
an increase in the curve of the spine.
-
Allergic reactions. Your child may have a mild or
serious allergic reaction to IPLEX. Call your child’s
healthcare professional right away if your child gets a rash
or hives. Get medical help right away if your child has
trouble breathing or goes into shock.
-
Reactions at the injection site
including
redness, pain, increase of fat,
lumps under the skin, or slight hair growth.
What Should I Tell My Healthcare Professional?
Tell your child’s healthcare
professional about all of your child’s health conditions,
including if your child:
-
has diabetes
-
has kidney problems
-
has liver problems
-
has a curved spine (scoliosis)
-
is pregnant or breastfeeding
Can Other Medicines Or Food
Affect IPLEX?
IPLEX and
certain other medicines can interact with each other. Tell your
healthcare professional about all the medicines your child takes
including prescription and non-prescription medicines, vitamins,
and herbal supplements. Know the medicines your child takes.
Keep a list of them with you to show your child’s healthcare
professional.
t is especially important to
tell your child’s healthcare professional if your child takes
insulin or other medicine s for diabetes. A dose change may be
needed for these medicines.
How Should My Child Use
IPLEX?
-
Use IPLEX exactly as
prescribed for your child.
-
Your child’s doctor or nurse
should teach you how to inject IPLEX. Do not give your child
IPLEX unless you understand all of the instructions.
-
See the “Instructions for
Use” that come with IPLEX.
