Forteo

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Teriparatide

Հասանելի է:

Eli Lilly Australia Pty Ltd

Դաս:

Medicine Registered

Տեղեկատվական թերթիկ

FORTEO(R)
1
FORTEO(R)
_Teriparatide (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FORTEO.  It does
not contain all the available
information and does not take the
place of talking to your doctor or
health care professional. 
All medicines have risks and
benefits.  Your doctor has weighed
the risks of you using FORTEO
against the benefits they expect it
will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR HEALTH CARE PROFESSIONAL. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT IS THE MOST
IMPORTANT INFORMATION I
SHOULD KNOW ABOUT
FORTEO? 
IN RATS THAT WERE TREATED WITH
FORTEO FOR MORE THAN A QUARTER
OF THEIR LIFETIME, TERIPARATIDE
CAUSED SOME RATS TO DEVELOP
OSTEOSARCOMA, A BONE CANCER.  THE
POTENTIAL TO CAUSE OSTEOSARCOMA IN
RATS WAS INCREASED WITH HIGHER
DOSES AND LONGER PERIODS OF
TREATMENT. 
Osteosarcoma in humans is a serious
but very rare cancer.  Osteosarcoma
occurs in about 4 out of every
million people each year. 
THERE IS ONE REPORT OF
OSTEOSARCOMA IN A PATIENT
ADMINISTERED FORTEO FOR 14
MONTHS.  DUE TO THE COMPLEX 
MEDICAL HISTORY, CAUSE AND EFFECT
BETWEEN FORTEO AND
OSTEOSARCOMA COULD NOT BE
ESTABLISHED.  AT PRESENT, IT IS NOT
KNOWN WHETHER HUMANS TREATED
WITH FORTEO WOULD HAVE AN
INCREASED CHANCE OF GETTING
OSTEOSARCOMA. 
You should discuss any safety
concerns you have about the use of
FORTEO with your doctor. 
WHAT FORTEO IS USED
FOR
FORTEO is used to treat
osteoporosis in women after
menopause and in men. 
Osteoporosis is a disease which
causes bones to become less dense,
gradually making them weaker, more
brittle and likely to break.  This
disease is especially common in
women after the menopause.
Osteoporosis is also common in
patients receiving corticosteroids
such as prednisone, cortisone. 
Although it may have no symptoms
at first, osteoporosis makes y

Ապրանքի հատկությունները

 
FORTEO


Teriparatide (rbe) Injection 

WARNING 
In male and female rats, teriparatide caused an increase in
the incidence of osteosarcoma 
that was dependent on dose and treatment duration.  The effect was
observed at systemic 
exposures to teriparatide ranging from 3 to 60 times the
exposure in humans given a 20-µg 
dose and occurred after treatment durations ranging from 6 to 24
months.  Effects were 
dependent on dose and duration of treatment, but a no-effect
dose was not determined.  The 
relevance of the rat osteosarcoma findings to humans has not yet
been established (see 
PRECAUTIONS, Carcinogenesis and ADVERSE REACTIONS – Spontaneous
data). 

1B1B
NAME OF THE MEDICINE 

FORTEO

, teriparatide (rbe) injection [recombinant human parathyroid
hormone(1-34), 
rhPTH(1-34)] is the first in a new class of bone formation
agents.  Once-daily 
administration of FORTEO activates osteoblasts and stimulates the
formation of new bone. 

Teriparatide has a molecular weight of 4117.8 daltons and is
identical in sequence to the 34 
N-terminal amino acids of the natural human parathyroid hormone. 

The amino acid sequence of teriparatide is shown below: 

FORTEO is manufactured by Eli Lilly and
Company using recombinant DNA technology.  
The CAS number for teriparatide is 52232-67-4. 

2B2B
DESCRIPTION 

FORTEO is supplied as a sterile, colourless, clear, isotonic
solution for subcutaneous 
injection.  Each mL of solution contains 250 

g teriparatide, 410 

g acetic acid – glacial, 
100 

g sodium acetate, 45.4 mg mannitol, 3.0 mg meta-cresol and water
for injections.  In 
addition, hydrochloric acid solution 10% and/or sodium hydroxide
solution 10% may have 
been added to adjust product pH. 

FORTEO is supplied in a 2.4 mL cartridge contained in a prefilled,
disposable delivery 
device (pen).  The pen delivers 20 

g per dose and contains dosing