Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Teriparatide (UNII: 10T9CSU89I) (Teriparatide - UNII:10T9CSU89I)
Prasco Laboratories
SUBCUTANEOUS
PRESCRIPTION DRUG
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 Injection 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 [ter-i-par-a-tide] Injection User Manual Important: First read the Medication Guide that comes inside your teriparatide carton. Before you use your new teriparatide delivery device, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the teriparatide delivery device. Do not share your delivery device or needles because infection or disease can be spread from one person to another. The teriparatide delivery device contains 28 days of medicine. Throw away the teriparatide delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of teriparatide in the same day. Do not transfer teriparatide 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. - 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 Eli Lilly and Company (see Contact Information below) or your healthcare provider. - Put the large needle cover on 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 delivery device in the refrigerator. - 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 it with any liquid. - 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?”. - 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. 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 Eli Lilly and Company at 1-866-436-7836. - The teriparatide delivery device contains 28 days of medicine. - Do not transfer teriparatide 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 Eli Lilly and Company 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. Literature revised October 3, 2019 TER-0002-IFU-20191003
Teriparatide Injection is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size:
New Drug Application Authorized Generic
Prasco Laboratories ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2020 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 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 chi read_full_document
TERIPARATIDE- TERIPARATIDE INJECTION, SOLUTION PRASCO LABORATORIES ---------- 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 11/2020 Dosage and Administration: Treatment Duration (2.3) 11/2020 Warnings and Precautions, Osteosarcoma (5.1) 11/2020 Warnings and Precautions, Hypercalcemia and Cutaneous Calcification (5.2) 11/2020 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 Injection 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) CONTRAINDICATI read_full_document