FORTEO- teriparatide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eli Lilly and Company

INN (International Name):

Teriparatide

Composition:

Teriparatide 250 ug in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FORTEO 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, FORTEO 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. FORTEO 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 FORTEO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing FORTEO 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 FORTEO use in women who are breastfeeding. The safety and effectiveness of FORTEO 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 FORTEO 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 FORTEO 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 FORTEO 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 FORTEO 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 FORTEO alters the underlying metabolic bone disease seen in chronic renal impairment [see Clinical Pharmacology (12.3)] . FORTEO® (for-TAY-o) teriparatide injection User Manual Important: First read the Medication Guide that comes inside your FORTEO carton. Before you use your new FORTEO delivery device, please read the entire front and back of this User Manual completely. Follow the directions carefully when using the FORTEO delivery device. Do not share your delivery device or needles because infection or disease can be spread from one person to another. The FORTEO delivery device contains 28 days of medicine. Throw away the FORTEO delivery device after 28 days, even if it is not completely empty. Do not inject more than one dose of FORTEO in the same day. Do not transfer FORTEO 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. FORTEO® (for-TAY-o) teriparatide injection A. The yellow shaft is still showing after I push in the black injection button. How do I reset my FORTEO 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 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 FORTEO 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 FORTEO delivery device with a damp cloth. - Do not place the FORTEO delivery device in water, or wash or clean it with any liquid. Storing Your FORTEO Delivery Device - After each use, refrigerate the FORTEO delivery device right away. Read and follow the instructions in the Medication Guide section “How should I store FORTEO?”. - Do not store the FORTEO delivery device with a needle attached. Doing this may cause air bubbles to form in the medicine cartridge. - Store the FORTEO delivery device with the white cap on. - Do not freeze FORTEO. If the FORTEO delivery device has been frozen, throw the device away and use a new FORTEO delivery device. - If the FORTEO 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 1-866-4FORTEO (1-866-436-7836). - The FORTEO delivery device contains 28 days of medicine. - Do not transfer FORTEO 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 FORTEO delivery device the right way. - Check the FORTEO delivery device label to make sure you have the right medicine and that it has not expired. - Do not use the FORTEO delivery device if it looks damaged. Look at the FORTEO 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 FORTEO 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 FORTEO delivery device and needles out of the reach of children. - Before throwing away the FORTEO delivery device, be sure to remove the pen needle. - Throw away your FORTEO delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. Contact Information Literature revised October 3, 2019 FOR-0002-IFU-20191003

Product summary:

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

Authorization status:

New Drug Application

Patient Information leaflet

Eli Lilly and Company
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 11/2020
MEDICATION GUIDE
FORTEO® (for-TAY-o)
teriparatide injection
for subcutaneous use
Read this Medication Guide before you start using FORTEO and each time
you get a refill. There may be
new information. Also, read the User Manual that comes with the FORTEO
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 FORTEO?
Possible bone cancer. During drug testing, the medicine in FORTEO
caused some rats to develop a bone
cancer called osteosarcoma. Studies in people have not shown that
FORTEO increases your chance of
getting osteosarcoma. There is little information about the chance of
getting osteosarcoma in patients
using FORTEO beyond 2 years.
What is FORTEO?
FORTEO 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. FORTEO
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 FORTEO is safe and effective in children.
FORTEO should not be used in children and young adults whose bones are
still growing.
Who should not use FORTEO?
Do not use FORTEO if you:
•
are allergic to any of the ingredients in FORTEO. See the end

Summary of Product characteristics

FORTEO- TERIPARATIDE INJECTION, SOLUTION
ELI LILLY AND COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FORTEO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FORTEO.
FORTEO (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
FORTEO 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 FORTEO 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 an