TERIPARATIDE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TERIPARATIDE (UNII: 10T9CSU89I) (TERIPARATIDE - UNII:10T9CSU89I)

Tilgjengelig fra:

Alvogen, Inc.

Administreringsrute:

SUBCUTANEOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Teriparatide injection is indicated: - For the treatment of postmenopausal women with osteoporosis 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 to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures. - To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. - For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. Teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactio

Produkt oppsummering:

Teriparatide injection is a colorless solution, available as single-patient-use pens in the following package size:

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Alvogen, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 11/2023
Medication Guide
Teriparatide (ter i par a tide) Injection
for subcutaneous use
Read this Medication Guide before you start using teriparatide
injection and each time you get a refill.
There may be new information. Also, read the User Manual that comes
with the teriparatide injection
delivery device (pen) for information on how to use the device to
inject your medicine the right way.
This Medication Guide does not take the place of talking with your
healthcare provider about your
medical condition or your treatment.
What is the most important information I should know about
teriparatide injection?
Possible bone cancer. During drug testing, the medicine in
teriparatide injection caused some rats to
develop a bone cancer called osteosarcoma. Studies in people have not
shown that teriparatide increases
your chance of getting osteosarcoma. There is little information about
the chance of getting osteosarcoma
in patients using teriparatide beyond 2 years.
What is teriparatide injection?
Teriparatide injection is a prescription medicine used to:
•
treat postmenopausal women who have osteoporosis who are at high risk
for having broken bones
(fractures) or who cannot use other osteoporosis treatments.
Teriparatide injection can lessen the
chance of broken bones (fractures) in the spine and other bones in
postmenopausal women with
osteoporosis.
•
increase the bone mass in men with primary or hypogonadal osteoporosis
who are at high risk for
having broken bones (fractures) or who cannot use other osteoporosis
treatments.
•
treat both men and women with osteoporosis due to use of
glucocorticoid medicines, such as
prednisone, for several months, who are at high risk for having broken
bones (fractures) or who
cannot use other osteoporosis treatments.
It is not known if teriparatide injection is safe and effective in
children.
Teriparatide injection should not be used in children and young adults
whos

Preparatomtale

TERIPARATIDE- TERIPARATIDE INJECTION, SOLUTION
ALVOGEN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERIPARATIDE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TERIPARATIDE INJECTION.
TERIPARATIDE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Osteosarcoma Boxed Warning, Removed
11/2023
Dosage and Administration: Treatment Duration (2.3)
11/2023
Warnings and Precautions, Osteosarcoma (5.1)
11/2023
Warnings and Precautions, Hypercalcemia and Cutaneous Calcification
(5.2)
11/2023
INDICATIONS AND USAGE
Teriparatide injection is a parathyroid hormone analog, (PTH 1-34),
indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for
fracture or patients who have
failed or are intolerant to other available osteoporosis therapy (1)
Increase of bone mass in men with primary or hypogonadal osteoporosis
at high risk for fracture or
patients who have failed or are intolerant to other available
osteoporosis therapy (1)
Treatment of men and women with osteoporosis associated with sustained
systemic glucocorticoid
therapy at high risk for fracture or patients who have failed or are
intolerant to other available
osteoporosis therapy (1)
DOSAGE AND ADMINISTRATION
Recommended dosage is 20 mcg subcutaneously once a day (2.1)
Consider supplemental calcium and Vitamin D based on individual
patient needs (2.1)
Administer as a subcutaneous injection into the thigh or abdominal
region (2.2)
Administer initially under circumstances in which the patient can sit
or lie down if symptoms of
orthostatic hypotension occur (2.2)
Use of teriparatide for more than 2 years during a patient's lifetime
should only be considered if a
patient remains at or has returned to having a high risk for fracture
(2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 620 mcg/2.48 mL (250 mcg/mL) in single-patient-use pen
containing 28 daily doses of 20 mcg
(3)
CONTRAINDICATIONS
Patients with hypersensitivity to teripar