The percentage of men treated with teriparatide whose serum calcium was above the upper limit of normal on consecutive measurements was 1.3% (2 men) compared with none of the men treated with placebo. Of the patients receiving teriparatide in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and over and 23% were 75 years of age and over. Teriparatide can cause you to feel dizzy or light-headed. For injection dosage form (prefilled pen): For osteoporosis: Adults20 micrograms (mcg) injected under the skin once a day. Maximum serum concentration of teriparatide was not increased. It is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breast fed infant. This survey is being conducted by the WebMD marketing sciences department. In the placebo group, this concentration was unchanged in women and increased by 1% in men. Properly discard this product when it is expired or no longer needed. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. A special MedGuide will be given to you by the pharmacist with each prescription and refill. This list is not complete. This medicine helps prevent bone fractures. Call your doctor for medical advice about side effects. privacy practices. hydrochlorothiazide, alendronate, Prolia, Fosamax, calcium carbonate, Tymlos. Be sure that you understand how to use the medicine. Teriparatide also caused a dose-related increase in osteoblastoma and osteoma in both sexes. Keep all medical and lab appointments. Advertising revenue supports our not-for-profit mission. Applies to the following strengths: 600 mcg/2.4 mL; 750 mcg/3 mL; 620 mcg/2.48 mL, 20 mcg subcutaneously once a day into the thigh or abdominal wall. Always store the device in the refrigerator with the white cap on. It's for people who are at very high fracture risk or people who've already tried other osteoporosis medications. (, In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. Teriparatide is not expected to accumulate in bone or other tissues. For these reasons, comparison of the incidence of antibodies to teriparatide in the study described below with the incidence of antibodies in other studies or to other teriparatide products may be misleading. Teriparatide injection is available as single-patient-use pens in the following package size: Advise the patient to read the FDA-approved patient labeling (Medication Guide and User Manual). The results did not demonstrate a difference in susceptibility to bone tumor formation, associated with teriparatide treatment, between mature and immature rats. Serum Calcium Concentrations When teriparatide 20 mcg is administered once daily, the serum calcium concentration increases transiently, beginning approximately 2 hours after dosing and reaching a maximum concentration between 4 and 6 hours (median increase, 0.4 mg/dL). information submitted for this request. Teriparatide may cause serious side effects. Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. Hepatic Impairment No studies have been performed in patients with hepatic impairment [see Use in Specific Populations (8.6)]. prefilled injectable pen 250mcg/mL (2.4 mL [Forteo, Bonsity]) Osteoporosis Indications Treatment of postmenopausal women with osteoporosis at high risk for fracture who have failed or are. teriparatide 20 mcg/dose (620 mcg/2.48 mL) subcutaneous pen injector, This medicine is a colorless, clear, injection, Select a condition to view a list of medication options. Other drugs may affect teriparatide, including prescription and over-the-counter medicines, vitamins, and herbal products. TERIPARATIDE injection . Solution, Subcutaneous: Forteo: 600 mcg/2.4 mL (2.4 mL) [contains metacresol] Pharmacology Mechanism of Action Teriparatide is a recombinant formulation of endogenous parathyroid hormone (PTH), containing a 34-amino-acid sequence which is identical to the N-terminal portion of this hormone. Call your pharmacist for new medicine. You might not use all of the medicine in each prefilled pen. Forteo. Do not use if solid particles appear or if the solution is cloudy or colored. For the treatment of postmenopausal women with osteoporosis, To increase bone mass in men with primary or hypogonadal osteoporosis, For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid (equivalent to prednisone 5 mg/day or greater), Hypersensitivity to the active ingredient or any product ingredients; hypersensitivity reactions have included angioedema and anaphylaxis, For subcutaneous administration only; not for IM or IV use, Administer subcutaneously once a day into thigh or abdominal region, Patients should be instructed on proper administration technique, Initial doses of this drug should be administered in settings where patient can sit or lie down if symptoms of orthostatic hypotension occur, Store under refrigeration 2 to 8 degrees C (36 to 46 degrees F) at all times except when administering product; limit time out of refrigerator, Once opened, can be used for up to 28 days; discard after 28 days, Do not freeze; do not use if it has been frozen, Store with cap on to protect from physical damage and light. Following the 18-month treatment period, the monkeys were removed from teriparatide treatment and were observed for an additional 3 years. Teriparatide may also be used for purposes not listed in this medication guide. During injection, you may hear one or more clicks - this is normal. You will be taught how to prepare and give this medicine. Before injecting each dose, clean the injection site with rubbing alcohol. Distribution Systemic clearance of teriparatide (approximately 62 L/hr in women and 94 L/hr in men) exceeds the rate of normal liver plasma flow, consistent with both hepatic and extra-hepatic clearance. In these women, calcium supplements and/or teriparatide doses were reduced. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Coadministration of intravenous furosemide (20 to 100mg) with teriparatide 40mcg in healthy people and patients with mild, moderate, or severe renal impairment (CrCl 13 to 72mL/min) resulted in small increases in the serum calcium (2%) and 24-hour urine calcium (37%) responses to teriparatide that did not appear to be clinically important [see Clinical Pharmacology (12.2)]. Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. If you take too much teriparatide injection, you may have nausea, vomiting, weakness, or dizziness. stomach upset. Patients and caregivers who administer teriparatide injection should be instructed on how to properly use the delivery device (refer to User Manual), properly dispose of needles, and be advised not to share their delivery device with other patients. After the 28-day use period, discard the teriparatide injection delivery device, even if it still contains some unused solution. Forteo (teriparatide) is a brand-name prescription drug used to treat osteoporosis in certain adults. Side-effects of teriparatide include headache (8%), nausea (8%), dizziness and reactions at the site of the injections. If you notice other effects not listed above, contact your doctor or pharmacist. Forteo (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). To provide you with the most relevant and helpful information, and understand which The peak serum calcium remained below 2.76 mmol/L (11.0 mg/dL) in >99% of women at each visit. Patients need to understand and follow the instructions in the teriparatide injection delivery device User Manual. Copyright 1996-2023 Cerner Multum, Inc. Teriparatide Injection (also referred to as PF708 and Bonsity) is a prescription medicine approved for several uses, including in postmenopausal women with osteoporosis who are at high risk. Teriparatide injection is indicated 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, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.3)]. wish to switch from a morning to evening shot. Renal Function No clinically important adverse renal effects were observed in clinical studies. In single-dose rodent studies using subcutaneous injection of teriparatide, no mortality was seen in rats given doses of 1000mcg/kg (540times the human dose based on surface area, mcg/m2) or in mice given 10,000mcg/kg (2700times the human dose based on surface area, mcg/m2). Get Label RSS Feed, Use 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 as there is limited data assessing the risk of osteosarcoma beyond 2 years of use. Transient events reported have included nausea, weakness/lethargy and hypotension. Some items may interact with your medicine. How useful is Terifrac injection 20mg and what are it's side effects? We comply with the HONcode standard for trustworthy health information. DO NOT dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Forteo (teriparatide) is used to treat osteoporosis (bone loss or weakening). Do not take double or extra doses. The number of patients treated with teriparatide whose transient hypercalcemia was verified on consecutive measurements was 3% of women and 1% of men. The black injection button should be all the way in to show that the full dose of medicine has been injected from the teriparatide injection delivery device. Teriparatide injection is a clear and colorless liquid. Special care may be needed. Teriparatide injection is a prescription medicine that is like a hormone made by the body called parathyroid hormone or PTH. Do not freeze the teriparatide injection delivery device. The increases in formation markers were accompanied by secondary increases in the markers of bone resorption: urinary N-telopeptide (NTX) and urinary deoxypyridinoline (DPD), consistent with the physiological coupling of bone formation and resorption in skeletal remodeling. Serious side effects of Teriparatide include: bone pain; new or unusual swelling or lumps under the skin; a light-headed feeling (may occur within 4 hours after injection); pounding heartbeats or fluttering in the chest after using an injection; or. However, because teriparatide may transiently increase serum calcium, teriparatide injection should be used with caution in patients taking digoxin [see Warnings and Precaution (5.8) and Clinical Pharmacology (12.2)]. Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days. Report Adverse Do not use teriparatide injection if it has been frozen. The bone tumors in rats occurred in association with a large increase in bone mass and focal osteoblast hyperplasia. Teriparatide is available in a multi-dose pen device with 28 doses [20 g each] for daily administration under the trade name Forteo. In 5 patients with severe renal impairment (CrCl <30 mL/min), the AUC and T1/2 of teriparatide were increased by 73% and 77%, respectively. Usually these symptoms go away within a few minutes to a few hours. Events, (What Impairment of Fertility No effects on fertility were observed in male and female rats given subcutaneous teriparatide doses of 30, 100, or 300 mcg/kg/day prior to mating and in females continuing through gestation Day 6 (16 to 160 times the human dose of 20 mcg based on surface area, mcg/m2). Changes in BSAP, NTX, and DPD were lower in men than in women, possibly because of lower systemic exposure to teriparatide in men. Teriparatide injection is used to treat osteoporosis in postmenopausal women who are at high risk for bone fracture. Follow state or local laws about how to dispose of this container. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Bone tumors were observed when immature 2-month old rats were treated with 30 mcg/kg/day for 24 months or with 5 or 30 mcg/kg/day for 6 months. The absolute reduction in risk was 2.9% and the relative reduction was 53%. Overdose symptoms may include nausea, vomiting, dizziness, headache, feeling light-headed, or fainting. All patients received 1000 mg of calcium plus 800 IU of vitamin D supplementation per day. Teriparatide injection is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.2)]. Urinary Calcium Excretion In a clinical study of postmenopausal women with osteoporosis who received 1000 mg of supplemental calcium and at least 400 IU of vitamin D, daily teriparatide increased urinary calcium excretion. In patients with glucocorticoid-induced osteoporosis, teriparatide increased lumbar spine BMD compared with baseline at 3 months through 18 months of treatment. If you miss a dose, take it as soon as you can. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Consult your pharmacist or local waste disposal company. Ask your doctor if you have any questions. Limit alcoholic beverages. After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away. The immunogenicity profile of teriparatide injection was evaluated in a 24-week randomized trial comparing the effects of teriparatide injection 20 mcg daily with another teriparatide product 20 mcg daily. Ninetypercent of the women in the study had 1or more radiographically diagnosed vertebral fractures at baseline. During the use period, time out of the refrigerator should be minimized; the dose may be delivered immediately following removal from the refrigerator. The effects of teriparatide on bone histology were evaluated in iliac crest biopsies of 35postmenopausal women treated for 12to 24months with calcium and vitaminD and teriparatide 20or 40mcg/day. Talk to a healthcare provider about how to rotate injection sites. Do not transfer the medicine to a syringe or other injection device or you could get an overdose. ), 5 Presence in Breast Milk, Medline Plus, NOTE: This medicine is only for you. However, sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. In Canada - Call your doctor for medical advice about side effects. These doses resulted in systemic exposures that were, respectively, 3, 20, and 60 times higher than the systemic exposure observed in humans following a subcutaneous dose of 20 mcg (based on AUC comparison). You should not use teriparatide if you are allergic to it. Assessments included creatinine clearance; measurements of blood urea nitrogen (BUN), creatinine, and electrolytes in serum; urine specific gravity and pH; and examination of urine sediment. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. Postmenopausal women with osteoporosis who were treated with teriparatide had statistically significant increases in BMD from baseline to endpoint at the lumbar spine, femoral neck, total hip, and total body (see Table 4). Check Device, Device Label and Medication, count to 5 slowly. 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. Do not share this medication with others. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Teriparatide increased lumbar spine BMD in postmenopausal women with osteoporosis. Get an overview of FORTEO (teriparatide injection, solution), including warnings and precautions, directions, and the names of other drugs and products that include the same medication. Written by Cerner Multum. The recommended dose is 20 mcg subcutaneously once a day. The rates of absorption and elimination are rapid. Read and follow the instructions in the. What is the most important information I should know about teriparatide injection? Sign up for free and stay up to date on research advancements, health tips, current health topics, and expertise on managing health. Before throwing away the teriparatide injection delivery device, be sure to remove the pen needle. Drug class: parathyroid hormone and analogs. Teriparatide injection is used in 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). Teriparatide Injection prescription and dosage sizes information for physicians and healthcare professionals. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. (, Teriparatide injection should not be prescribed for patients at increased baseline risk for osteosarcoma (e.g., those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton). The maximum increases of BSAP were 45% above baseline in women and 23% in men. Teriparatide injection should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton) [see Warnings and Precautions (5.1), Adverse Reactions (6.2), and Nonclinical Toxicology (13.1)]. WARNING: POTENTIAL RISK OF OSTEOSARCOMA In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. This medicine comes with a Medication Guide and the User Manual. Follow all directions on your prescription label and read all medication guides or instruction sheets. No studies have been performed in patients undergoing dialysis for chronic renal failure [see Use in Specific Populations (8.7)]. The incidence of serious adverse events was 21% in teriparatide patients and 18% in active control patients, and included pneumonia (3% teriparatide, 1% active control). Do not flush medications down the toilet or pour them into a drain unless instructed to do so. It is best to lie or sit down if these symptoms occur. Files, All Mapping Treatment of Osteoporosis in Men and Postmenopausal Women. 6.b) If any blood samples are taken from a patient, this should be done at Ask your pharmacist for directions on how to use this drug. a Intent-to-treat analysis, last observation carried forward. Before using teriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Talk to your doctor about your risk of cancer. The new bone formed with teriparatide was of normal quality (as evidenced by the absence of woven bone and marrow fibrosis). The recommended dose regimen is 20 g subcutaneously once daily. Put your used needles in a FDA-cleared sharps disposal container right away after use. DESCRIPTION. The drug product is a pH 4.0 solution. Low blood pressure: Teriparatide can cause a temporary drop in blood pressure within 4 hours of taking this medication. The incidence of all cause mortality was 1% in the teriparatide group and 1% in the placebo group. information is beneficial, we may combine your email and website usage information with In the teriparatide group, the baseline median glucocorticoid dose was 7.5 mg/day and the median duration of glucocorticoid use was 1.5 years. Each single-patient-use pen will deliver 28 subcutaneous doses. Each prefilled injection pen contains enough teriparatide for 28 separate injections. These symptoms may last for a few minutes to a few hours. Mayo Clinic does not endorse companies or products. This Medication Guide has been approved by the U.S. Food and Drug Administration. Canada residents can call a provincial poison control center. Abdominal pain, constipation, depression, dyspepsia, headache, nausea, vomiting, and weight loss are some of the common side effects. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. The median peak serum calcium concentration measured 4 to 6 hours after dosing with teriparatide was 2.35 mmol/L (9.44 mg/dL) at 12 months. Dosage adjustment based on age is not required (see section 5.2). being able to get an erection, but not having it last long enough for sex. Serum calcium measured at least 16hours post-dose was not different from pretreatment levels. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This reduces the risk of dizzy or fainting spells. Do not freeze. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. The safety and efficacy of teriparatide have not been evaluated beyond 2years of treatment. The recommended dose is 20 mcg subcutaneously once a day. Volume of distribution, following intravenous injection, is approximately 0.12 L/kg. ; *Tmax = median (minimum, maximum). Use your next dose at the regular time and stay on your once-daily schedule. In a long-term study, skeletally mature ovariectomized female monkeys (N=30 per treatment group) were given either daily subcutaneous teriparatide injections of 5 mcg/kg or vehicle. Medically reviewed by Drugs.com. 20 mcg per dose (given once daily subcutaneously) Each single-patient-use prefilled pen will deliver 28 subcutaneous doses. Supplemental calcium and vitamin D should be taken if daily dietary intake is inadequate. When pregnant rats received subcutaneous teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. The efficacy of teriparatide for treating glucocorticoid-induced osteoporosis was assessed in a randomized, double-blind, active-controlled trial of 428 patients (19% men, 81% women) aged 22 to 89 years (mean 57 years) treated with 5 mg/day prednisone or equivalent for a minimum of 3 months. After use, remove the needle, recap the pen, and return it to the refrigerator. We comply with the HONcode standard for trustworthy health information. Otherwise, call a poison control center right away. This content does not have an Arabic version. Do not double the dose to catch up. Consider discontinuing teriparatide injection when pregnancy is recognized. You should receive the first several injections of this medicine while sitting or lying down if needed, until you know how this medicine affects you. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Talk to your pharmacist or health care provider if you have questions. In postmenopausal women with osteoporosis, this drug has been shown to reduce the risk of vertebral and nonvertebral fractures. Teriparatide Teva 20 micrograms/80 microlitres Solution for Injection in Pre-filled Pen - Summary of Product Characteristics (SmPC) - (emc) Teriparatide Teva 20 micrograms/80 microlitres Solution for Injection in Pre-filled Pen Active Ingredient: teriparatide Company: Teva UK Limited See contact details ATC code: H05AA02 About Medicine How useful is Terifrac injection 20mg and what are it's side effects? Each pen is filled to deliver 2.48 mL. View NDC Code(s)NEW! The causality to teriparatide use is unclear. The safety and efficacy of teriparatide have not been established in any pediatric population. Because teriparatide may transiently increase serum calcium, teriparatide injection should be used with caution in patients taking digoxin [see Drug Interactions (7.1)]. The mean (SD) baseline lumbar spine BMD was 0.85 0.13 g/cm2 and lumbar spine BMD T-score was 2.5 1 (number of standard deviations below the mean BMD value for healthy adults). Date of first use ___/___/___ Discard unused portion 28 days after first use. How can I tell if my teriparatide injection delivery device works? Heavy drinking can also cause bone loss. Pharmacokinetic data from another brand of injection (20-mcg dose) results in a Cmax of 109.5 +/- 62.8 pg/mL (mean +/- SD) at a median Tmax of 0.25 hours (0.12 minimum, 1.08 maximum). The following adverse reactions have been identified during post-approval use of teriparatide. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day. Paget's disease or a bone disease other than osteoporosis; a genetic condition that increases your risk of bone cancer; a painful skin condition caused by too much calcium; an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis. The primary efficacy endpoint was change in lumbar spine BMD. Seventy-two percent of patients treated with teriparatide achieved at least a 5% increase in spine BMD, and 44% gained 10% or more. teriparatide is for use when you have a high risk of bone fracture due to osteoporosis. Osteosarcomas were observed at all doses and the incidence reached 40% to 50% in the high-dose groups. The incidence of all cause mortality was 4% in the teriparatide group and 6% in the active control group. Patients should be instructed to notify their healthcare provider if they develop persistent symptoms of hypercalcemia. The safety and efficacy of once-daily teriparatide, median exposure of 19 months, were examined in a double-blind, multicenter, placebo-controlled clinical study of 1637 postmenopausal women with osteoporosis (teriparatide 20 mcg, n=541). Routine calcium monitoring during therapy is not required. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. A healthcare provider will teach you how to give yourself this injection. The teriparatide injection 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. Do not double doses. If you have questions, need help or for more information with your teriparatide injection delivery device, contact Alvogen, Inc. at 1-866-770-3024 or your healthcare provider. Wipe the outside of the teriparatide injection delivery device with a damp cloth. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. The percentage of women treated with teriparatide whose serum calcium was above the upper limit of normal on consecutive 4- to 6-hour post-dose measurements was 3.0% compared with 0.2% of women treated with placebo. In the first study, male and female rats were given daily subcutaneous teriparatide injections of 5, 30, or 75 mcg/kg/day for 24 months from 2 months of age. Teriparatide is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. this version. Figure 1. This drug is indicated for men and women as described below who are at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. 2005 - 2023 WebMD LLC, an Internet Brands company. 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