Forteo

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Teriparatide 250 µg/mL (rhPTH(1-34));  

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Teriparatide 250 µg/mL (rhPTH(1-34))

Dosage:

250 mcg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Teriparatide 250 µg/mL (rhPTH(1-34))   Excipient: Glacial acetic acid Hydrochloric acid Mannitol Metacresol Sodium acetate Sodium hydroxide Water for injection

Units in package:

Cartridge, glass, in pen device; 1 x, 2.4 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim RCV GmbH & Co KG

Therapeutic indications:

FORTEO, in combination with calcium and vitamin D, is indicated for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture.

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, in pen device; - 2.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2001-07-12

Patient Information leaflet

________________________________________________________________________________
FORTEO
®
vA3
Page 1 of 4
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.
It is also used to treat women and men
who have developed osteoporosiss as a
result of taking corticosteroids.
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
menopause.
Osteoporosis can also occur in patients
receiving corticosteroids such as
prednisone,

Summary of Product characteristics

NEW ZEALAND DATASHEET
Forteo-ds-vA9_22May2020
SUPERSEDES: Forteo-ds-vA8_25mar19
Page 1 of 15
1.
FORTEO
®
FORTEO 250 microgram/mL, solution for injection._ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Teriparatide, 250 microgram/mL.
Teriparatide (rhPTH(1-34)) is identical to the 34 N-terminal amino
acid sequence of
endogenous human parathyroid hormone, and is manufactured using
recombinant DNA
technology.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
FORTEO 250 microgram/mL solution for injection is supplied as a 2.4 mL
cartridge contained
in a prefilled disposable delivery device (pen). FORTEO 250
microgram/mL solution is a
sterile, colourless, clear, isotonic solution intended for
subcutaneous injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FORTEO, in combination with calcium and vitamin D, is indicated for
the treatment of
osteoporosis in postmenopausal women and in men at high risk of
fracture (see 5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL EFFICACY AND SAFETY).
FORTEO is indicated for the treatment of osteoporosis associated with
sustained systemic
glucocorticoid therapy in women and men at high risk for fracture (see
5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL EFFICACY AND SAFETY)._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of teriparatide is 20 microgram administered once
daily by
subcutaneous injection in the thigh or abdomen (see 4.2 DOSE AND
METHOD OF
ADMINISTRATION - INSTRUCTIONS FOR USE).
The maximal lifetime duration of treatment should be limited to 24
months (for post
treatment efficacy, see 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL
EFFICACY AND SAFETY ).
Following cessation of teriparatide therapy, patients may be continued
on other osteoporosis
therapies.
FORTEO should be administered in conjunction with calcium and vitamin
D.
Patients must be educated to use the proper injection techniques.
Please refer to the User
Manual for instructions for the pen.
NEW ZEALAND DATASHEET
Forteo-ds-vA9_22May2020
SUPERSEDES: Forteo-ds-vA8_25ma