FORTEO INJECTION 20 mcg80mcL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TERIPARATIDE (rDNA ORIGIN)

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

H05AA02

Dosage:

750 mcg/3 ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

TERIPARATIDE (rDNA ORIGIN) 750 mcg/3 ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

LILLY FRANCE

Authorization status:

ACTIVE

Authorization date:

2004-09-27

Patient Information leaflet

 FORTEO
®

TERIPARATIDE (RDNA ORIGIN) INJECTION 
20 MICROGRAMS/80 MICROLITERS 

WARNING 

IN MALE AND FEMALE RATS, TERIPARATIDE CAUSED AN INCREASE IN THE
INCIDENCE OF OSTEOSARCOMA (A 
MALIGNANT BONE TUMOR) 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-
MCG DOSE. BECAUSE OF THE UNCERTAIN RELEVANCE OF THE
RAT OSTEOSARCOMA FINDING TO HUMANS, TERIPARATIDE 
SHOULD BE PRESCRIBED ONLY TO PATIENTS FOR WHOM THE POTENTIAL
BENEFITS ARE CONSIDERED TO OUTWEIGH THE 
POTENTIAL RISK. TERIPARATIDE SHOULD NOT
BE PRESCRIBED FOR PATIENTS WHO ARE AT INCREASED BASELINE RISK 
FOR OSTEOSARCOMA (INCLUDING THOSE WITH PAGET’S
DISEASE OF BONE OR UNEXPLAINED ELEVATIONS OF ALKALINE 
PHOSPHATASE, OPEN EPIPHYSES, OR PRIOR EXTERNAL BEAM OR IMPLANT
RADIATION THERAPY INVOLVING THE 
SKELETON) (_SEE _WARNINGS _AND _PRECAUTIONS, CARCINOGENESIS). 

DESCRIPTION 
    FORTEO
®
 [teriparatide (rDNA origin) injection] contains
recombinant human parathyroid hormone (1-
34), [rhPTH (1-34)], which has an identical sequence
to the 34 N-terminal amino acids (the biologically 
active region) of the 84-amino acid human parathyroid hormone. 
    Teriparatide has a molecular weight of 4117.8 daltons and
its amino acid sequence is shown below: 

    Teriparatide (rDNA origin) is manufactured by Eli Lilly
and Company using a strain of _Escherichia coli _
modified by recombinant DNA technology. FORTEO is supplied as
a sterile, colorless, clear, isotonic 
solution in a glass cartridge which is pre-assembled
into a disposable pen device for subcutaneous 
injection. Each mL contains 250 mcg teriparatide (corrected for
acetate, chloride, and water content), 0.41 
mg glacial acetic acid, 0.10 mg sodium acetate (anhydrous), 45.4
mg mannitol, 3.0 mg Metacresol,

Summary of Product characteristics

FORTEO
® INJECTION 20MCG/80MCL
(TERIPARATIDE)
1
INDICATIONS AND USAGE
Forteo is indicated:
•
For the treatment of postmenopausal women with osteoporosis who are at
high risk
for fracture (defined herein as having a history of osteoporotic
fracture or multiple risk
factors for fracture) or who have failed or are intolerant of previous
osteoporosis
therapy,
based
upon
physician
assessment.
In
postmenopausal
women
with
osteoporosis, Forteo increases BMD and reduces the risk of vertebral
and nonvertebral
fractures.
•
To increase bone mass in men with primary or hypogonadal osteoporosis
who are at
high risk for fracture. These include men with a history of
osteoporotic fracture, or who
have multiple risk factors for fracture, or who have failed or are
intolerant to previous
osteoporosis therapy, based upon physician assessment. In men with
primary or
hypogonadal osteoporosis, Forteo increases BMD. The effects of Forteo
on risk for
fracture in men have not been studied.
•
For the treatment of men and women with glucocorticoid-induced
osteoporosis at high
risk for fracture. See CLINICAL STUDIES (12.3).
.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSAGE
The recommended dosage is 20 mcg given subcutaneously once a day.
2.2
ADMINISTRATION INSTRUCTIONS
•
Administer Forteo as a subcutaneous injection into the thigh or
abdominal region.
Forteo is not approved for intravenous or intramuscular use.
•
Forteo should be administered initially under circumstances in which
the patient can
sit or lie down if symptoms of orthostatic hypotension occur [see
WARNINGS
and
PRECAUTIONS (4.4)].
•
Parenteral drug products should be inspected visually for particulate
matter and
discolouration prior to administration. Forteo is a clear and
colorless liquid. Do not use
if solid particles appear or if the solution is cloudy or colored.
Patients and/or
caregivers who administer Forteo should receive appropriate training
and instruction
on the proper use of the Forteo prefilled delivery device (pen) from a
qualified health
profession