FORTEO teriparatide (rbe) 250 microgram solution for injection cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Teriparatide, Quantity: 250 microgram

Available from:

Eli Lilly Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glacial acetic acid; sodium acetate; hydrochloric acid; mannitol; sodium hydroxide; water for injections; metacresol

Administration route:

Subcutaneous

Units in package:

1 x 2.4mL in a 3mL prefilled cartridge [pen]

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FORTEO is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. FORTEO is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Product summary:

Visual Identification: Clear colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2003-05-22

Patient Information leaflet

FORTEO
®
_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 you more
likely to break bones, especially in
your spine, hips and wrists and may
cause back pain, loss of height and a
curved back.
This medicine is

Summary of Product characteristics

forteo-pi-vA8.0-May22
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
FORTEO

(TERIPARATIDE (RBE)) SOLUTION FOR INJECTION
1 NAME OF THE MEDICINE
Teriparatide (rbe)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FORTEO contains 250

g teriparatide.
Teriparatide (rbe) injection [recombinant human parathyroid hormone
(1-34), rhPTH
(1-34)] is the first in a new class of bone formation agents.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Solution for injection.
FORTEO is a sterile, colourless, clear, isotonic solution in prefilled
pens.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FORTEO is indicated for the treatment of osteoporosis in
postmenopausal women and the
treatment of primary osteoporosis in men when other agents are
considered unsuitable and
when there is a high risk of fractures.
FORTEO is indicated for the treatment of osteoporosis associated with
sustained systemic
glucocorticoid therapy in women and men at high risk for fracture.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of FORTEO is 20

g administered once daily by subcutaneous
injection in the thigh or abdomen.
Based on clinical experience, treatment with FORTEO is recommended for
a lifetime
duration of 24 months treatment (for post-treatment efficacy
,
see Section 5.1
PHARMACODYNAMIC PROPERTIES / Clinical trials ). FORTEO should be
prescribed
to patients with a full explanation and their informed consent on the
lifetime duration of 24
months treatment.
Calcium and vitamin D supplements are advised in patients with a low
dietary intake of
these nutrients.
_ _
forteo-pi-vA8.0-May22
Page 2 of 25
USE IN MALES
– Primary or secondary hypogonadism should first be excluded and, if
relevant, be treated (see Section 5.1 PHARMACODYNAMIC PROPERTIES /
Clinical
trials )
INSTRUCTIONS FOR USE/HANDLING
To prevent the possible transmission of disease, each pen must be used
by one patient only,
even if the needle is changed.
Following cessation of FORTEO therapy, patients may be continued on
other