INCRELEX
zhion@zhion.com December 06, 2005
INCRELEX - BASIC INFORMATION

Tercica'  Increlex (mecasermin [rDNA origin] injection), or recombinant human
Insulin-like Growth Factor-1 (rhIGF-1), was approved by the U.S. FDA to treat
a hormone deficiency that causes short stature and other health problems.
This synthetic 70 amino acid peptide is licensed from Genentech. TercicÂ’s
recombinant human IGF-1, or rhIGF-1 is is identical to the natural hormone,
human Insulin-like Growth Factor-1 (hIGF-1) that must be present in tissues
for normal growth and metabolism in humans

In February 2005, Tercica submitted a New Drug Application (NDA) to the FDA
for approval to market Increlex for the long-term treatment of children with
growth failure caused by a severe form of Primary IGF-1 deficiency (Primary
IGFD). Primary IGF-1 deficiency (Primary IGFD) is an underlying cause of short
stature characterized by lack of IGF-1 production in the presence of normal
or elevated levels of endogenous growth hormone. Primary IGF-1 deficiency
(Primary IGFD) also is associated with serious metabolic conditions such as
obesity, diabetes and cardiovascular disease.

Their NDA for Increlex is based upon the results of a Phase III clinical trial of
rhIGF-1 for the treatment of short stature caused by Severe Primary IGF-1
deficiency (Primary IGFD). Data from the study, presented in June 2004 at
the 86th Annual Meeting of The Endocrine Society, demonstrated a
statistically significant increase (p<0.001) in growth rate over an eight-year
period in response to therapy. The most common adverse events were
hypoglycemia, lipohypertrophy and tonsillar hypertrophy. No patients
withdrew from the study due to side effects. [1]

INCRELEX - SUMMARIZED INFORMATION FOR USERS 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 Side Effects?
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:
Low blood sugar (hypoglycemia). Increlex may lower blood sugar levels like insulin. It is
important to only give your child Increlex within 20 minutes right before or within 20
minutes right after a snack or meal to reduce the chances of low blood sugar. Do not give
your child Increlex if your child is sick or cannot eat. Signs of low blood sugar are:
dizziness tiredness restlessness hunger irritability trouble concentrating sweating
nausea and fast or irregular heartbeat .

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&#8217;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.

Slipped capital Fermoral epiphysis ( a bone problem). 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.

Reactions at injection site. Increlex can cause reactions at the injection site including:
loss of fat, increase of fat, pain and redness or bruising

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
has liver problems
has a curved spine (scoliosis)
is pregnant or breast-feeding

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.

SOURCES
Tercica Press Release, August 31, 2005.
Patient Information Sheet, FDA Online Publication, December 06, 2005
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