TERIPARATIDE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Apotex Corp.

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 reactions have included angioedema and anaphylaxis [see Adverse Reactions (6.3)]. Risk Summary There are no available data on teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing teriparatide injection when pregnancy is recognized. In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data In animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2 ). At subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). When pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. In a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. Mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. There were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively. Risk Summary It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. Avoid teriparatide use in women who are breastfeeding. The safety and effectiveness of teriparatide injection have not been established in pediatric patients. Pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see Warnings and Precautions (5.1)]. Of the patients who received teriparatide injection in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. Of the patients who received teriparatide injection in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. Of the 214 patients who received teriparatide injection in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. No overall differences in safety or effectiveness of teriparatide injection have been observed between patients 65 years of age and older and younger adult patients. No studies have been performed in patients with hepatic impairment. [see Clinical Pharmacology (12.3)] . In 5 patients with severe renal impairment (CrCl<30 mL/minute), the AUC and T1/2  of teriparatide were increased by 73% and 77%, respectively. Maximum serum concentration of teriparatide was not increased. It is unknown whether teriparatide injection alters the underlying metabolic bone disease seen in chronic renal impairment  [see Clinical Pharmacology (12.3)]. Teriparatide Injection, USP User Manual Important: First read the Medication Guide that comes inside your teriparatide injection carton . Before you use your new teriparatide injection delivery device, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the teriparatide injection delivery device. Do not share your delivery device or needles because infection or disease can be spread from one person to another. The teriparatide injection delivery device contains 28 days of medicine. Throw away the teriparatide injection delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of teriparatide injection in the same day. Do not transfer teriparatide injection to a syringe. Wash your hands before every injection. Prepare the injection site as your healthcare provider instructed. For more information, or if you have any questions, turn to the back of this page. A. The yellow shaft is still showing after I push in the black injection button. How do I reset my teriparatide injection delivery device? - If you have already injected, DO NOT inject yourself a second time on the same day. - Remove the needle. - Attach a new needle, pull off the large needle cover and save it. - Pull out the black injection button until it stops. Check to make sure the red stripe shows. - Pull off the small needle protector and throw away. - Point the needle down into an empty container. Push in the black injection button until it stops. Hold it in and slowly count to five. You may see a small stream or drop of fluid. When you have finished, the black injection button should be all the way in. - If you still see the yellow shaft showing, contact Apotex Corp (see Contact Information below) or your healthcare provider. - Put the large needle cover on the needle. Unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. Pull off the covered needle and throw away as instructed by your healthcare provider. Push the white cap back on, and put your teriparatide injection delivery device in the refrigerator. - Put the large needle cover on the needle. - Use the large needle cover to unscrew the needle. - Unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. - If you still cannot get the needle off, ask someone to help you. E. What should I do if I have difficulty pulling out the black injection button? - Wipe the outside of the Teriparatide Delivery Device with a damp cloth. - Do not place the Teriparatide Delivery Device in water, or wash or clean with any liquid. Storing Your Teriparatide Delivery Device - After each use, refrigerate the Teriparatide Delivery Device right away. Read and follow the instructions in the Medication Guide section “How should I store Teriparatide Injection?”. - Do not store the Teriparatide Delivery Device with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge. - Store the Teriparatide Delivery Device with the white cap on. - Do not freeze Teriparatide Injection. If the Teriparatide Delivery Device has been frozen, throw the device away and use a new Teriparatide Delivery Device. - If the Teriparatide Delivery Device has been left out of the refrigerator, do not throw the delivery device away. Place the delivery device back in the refrigerator and call Apotex at 1-800-706-5575. - The Teriparatide Delivery Device contains 28 days of medicine. - Do not transfer Teriparatide Injection to a syringe. This may result in you taking the wrong dose of medicine. - Read and follow the instructions in the User Manual so that you use your Teriparatide Delivery Device the right way. - Check the Teriparatide Delivery Device label to make sure you have the right medicine and that it has not expired. - Do not use the Teriparatide Delivery Device if it looks damaged. Look at the Teriparatide medicine in the cartridge. If the medicine is not clear and colorless, or if it has particles, do not use it. Call Apotex if you notice any of these (see Contact Information ). - Use a new needle for each injection. - During injection, you may hear one or more clicks – this is normal. - The Teriparatide Delivery Device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device. - Keep your Teriparatide Delivery Device and needles out of the reach of children. - Before throwing away the Teriparatide Delivery Device, be sure to remove the pen needle. - Throw away your Teriparatide Delivery Device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. Contact Information

Produkt oppsummering:

Teriparatide Injection is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size:

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

TERIPARATIDE- TERIPARATIDE INJECTION, SOLUTION
Apotex Corp.
----------
Medication Guide
Teriparatide Injection, USP
(ter” i par’ a tide)
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 injection
increases your chance of getting osteosarcoma. There is little
information about the chance of getting
osteosarcoma in patients using teriparatide injection 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
whose bones are still gro

Preparatomtale

TERIPARATIDE- TERIPARATIDE INJECTION, SOLUTION
APOTEX CORP.
----------
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
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: 600 mcg/2.4 mL (250 mcg/mL) in a single-patient-use
prefilled delivery
device (pen) containing 28 daily doses of 20 mcg (3)
CONTRAINDICATIONS
Patients with hypersensitivity to teriparatide or to any of its
excipients (4)
WARNINGS AND PRECAUTIONS
Osteosarcoma: Avoid use in patients with increased risk of
osteosarcoma including patients with open
epiphyses, metabolic bone diseases including Paget’s disease, bon