Dosing & Uses
Dosage Forms & Strengths
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 intolerant to other available osteoporosis therapy; reduces risk of vertebral and nonvertebral fractures
- Increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture, or have failed or are intolerant to other available therapy
- Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (prednisone ≥5 mg/day) at high risk for fracture, or have failed or are intolerant to other available therapy
20 mcg SC qDay
Use >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
Dosing Modifications
Renal impairment
- CrCl <30 mL/min: Dose adjustment not necessary; in clinical trial, AUC and half-life increased but maximum plasma concentration did not increase
Hepatic impairment
- No studies have been performed in patients with hepatic impairment
Dosing Considerations
Take with supplemental calcium and vitamin D if daily dietary intake is inadequate
Idiopathic Osteoporosis (Orphan)
Orphan designation for treatment of idiopathic osteoporosis
Orphan sponsor
- Biomeasure, Inc; 27 Maple St; Milford, MA 01757-3650
Hypoparathyroidism (Orphan)
Orphan designation for treatment of hypoparathyroidism
Orphan sponsor
- Entera Bio, Ltd; Kiryat Hadassah Minrav Bldg, 5th Floor, P. O. Box 12117; Jeusalem 91220, Israel
Safety and efficacy not established
Do not use in children and adolescents with open epiphyses due to increased baseline risk of osteosarcoma
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- digoxin
teriparatide increases toxicity of digoxin by Other (see comment). Use Caution/Monitor. Comment: Transient hypercalcemia may predispose to digoxin toxicity (rare case reports).
Minor (12)
- alendronate
teriparatide, alendronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- calcium acetate
teriparatide increases levels of calcium acetate by pharmacodynamic synergism. Minor/Significance Unknown.
- calcium carbonate
teriparatide increases levels of calcium carbonate by pharmacodynamic synergism. Minor/Significance Unknown.
- calcium chloride
teriparatide increases levels of calcium chloride by pharmacodynamic synergism. Minor/Significance Unknown.
- calcium citrate
teriparatide increases levels of calcium citrate by pharmacodynamic synergism. Minor/Significance Unknown.
- calcium gluconate
teriparatide increases levels of calcium gluconate by pharmacodynamic synergism. Minor/Significance Unknown.
- etidronate
teriparatide, etidronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- ibandronate
teriparatide, ibandronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- pamidronate
teriparatide, pamidronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- risedronate
teriparatide, risedronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- tiludronate
teriparatide, tiludronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
- zoledronic acid
teriparatide, zoledronic acid. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
Adverse Effects
>10%
Pain (21.3%)
Arthralgia (10.1%)
1-10%
Rhinitis (9.6%)
Asthenia (8.7%)
Nausea (8.5%)
Dizziness (8%)
Headache (7.5%)
Hypertension (7.1%)
Increased cough (6.4%)
Pharyngitis (5.5%)
Constipation (5.4%)
Dyspepsia (5.2%)
Diarrhea (5.1%)
Rash (4.9%)
Insomnia (4.3%)
Depression (4.1%)
Pneumonia (3.9%)
Vertigo (3.8%)
Dyspnea (3.6%)
Neck pain (3%)
Vomiting (3%)
Syncope (2.6%)
Leg cramps (2.6%)
Angina pectoris (2.5%)
Gastrointestinal disorder (2.3%)
Tooth disorder (2%)
Postmarketing Reports
Hypercalcemia >13 mg/dL
Allergic Reactions
Hyperuricemia
Respiratory System: Acute dyspnea, chest pain
Musculoskeletal: Muscle spasms of the leg or back
Other: Injection site reactions including injection site pain, swelling and bruising; orofacial edema
Osteosarcoma
- Cases of bone tumor and osteosarcoma reported rarely in the postmarketing period 2 osteosarcoma surveillance safety studies in US were designed to obtain data on the incidence rate of osteosarcoma among teriparatide-treated patients; osteosarcoma cases were identified among 3 of 379,283 and none of 153,316 teriparatide users
- Results suggest similar risk for osteosarcoma between teriparatide users and their comparators
- However, interpretation of the results calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders
Warnings
Contraindications
Hypersensitivity
Cautions
Transient orthostatic hypotension may occur with initial doses
May exacerbate urolithiasis; consider risk/benefit in patients with active or recent urolithiasis
Osteosarcoma risk
-
Avoid use in patients with with increased risk of osteosarcoma including those with
- Open epiphyses (children, young adults)
- Metabolic bone diseases including Paget disease, bone metastases, or history of skeletal malignancies
- Prior external beam or implant radiation therapy involving the skeleton
- Hereditary disorders predisposing to osteosarcoma
Hypercalcemia and cutaneous calcification
- Avoid in patients known to have an underlying hypercalcemic disorder
- Discontinue in patients developing worsening of previously stable cutaneous calcification
- Hypercalcemia may predispose patient to digoxin toxicity
Drug interaction overview
-
Digoxin
- A single teriparatide dose did not alter the effect of digoxin on the systolic time interval
- Owing to teriparatide may transiently increase serum calcium, use with caution in patients taking digoxin
- Consider potential onset of signs and symptoms of digitalis toxicity when used in patients receiving digoxin
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; consider discontinuing drug when pregnancy is recognized
Animal data
- In animal reproduction studies, drug increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times 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
Lactation
Not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on breastfed infant; because of potential for osteosarcoma shown in animal studies, advise patients that breastfeeding is not recommended during therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant human parathyroid hormone; stimulates osteoblast function, increases calcium absorption, and increases renal tubular reabsorption of calcium; these effects lead to increased bond mineral density, bone mass, and strength
Absorption
Bioavailability: 95%
Onset: 3 months
Peak serum time: 30 min
Peak plasma concentration: 109.5 pg/mL
AUC: 149.8 pg⋅hr/mL
Concentration: Calcium, 9.68 mg/dL
Distribution
Vd: 0.12 L/kg
Metabolism
No metabolism or excretion studies have been performed
Mechanisms of metabolism and elimination of PTH(1-34) and intact PTH have been extensively described in published literature
Peripheral metabolism of PTH is believed to occur by non-specific enzymatic mechanisms in the liver followed by excretion via the kidneys
Elimination
Half-life: 0.79 hr (Bonsity 20-mcg); 0.083 hr (Forteo IV); ~1 hr (Forteo SC)
Total body clearance: Women, 62 L/hr; men, 94 L/hr
Excretion: Urine
Administration
SC Administration
SC administration only
During use period, minimize time out of the refrigerator; deliver the dose immediately following removal from refrigerator
Administer into the thigh or abdominal wall
No data available on the safety or efficacy of IV/IM injection
Administer under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur
Visually inspect for particulate matter and discoloration before administration, whenever solution and container permit; appears clear and colorless liquid
Do not use if solid particles appear or if the solution is cloudy or colored
Patients and caregivers administering medication should receive appropriate training and instruction on the proper use
Storage
Refrigerate at 2-8ºC (36-46ºF)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| teriparatide subcutaneous - | 20 mcg/dose (620mcg/2.48mL) injection |  | |
| Forteo subcutaneous - | 20 mcg/dose (600mcg/2.4mL) injection |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
teriparatide subcutaneous
TERIPARATIDE - INJECTION
(TER-i-PAR-a-tide)
COMMON BRAND NAME(S): Forteo
USES: Teriparatide is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. It is similar to a natural hormone in your body (parathyroid hormone). It works by increasing bone mass and strength. This effect helps to decrease the risk of getting a fracture.This medication is not recommended for use in children or young adults whose bones are still growing.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using teriparatide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.A health care professional should instruct you on the proper usage of this medication. Also, learn all preparation and usage instructions in the user manual. If any of the information is unclear, consult your doctor or pharmacist.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Inject this medication under the skin as directed by your doctor, usually once daily into the thigh or abdomen. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
SIDE EFFECTS: Dizziness or fast heartbeat may occur within 4 hours after using this medication. These symptoms may last for a few minutes to a few hours. This effect should go away after several doses as your body adjusts to the medication. It is best to lie or sit down if these symptoms occur. Muscle cramps/spasms, nausea, or pain/swelling/bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fainting, constipation, unusual tiredness, mental/mood changes (such as confusion), purplish spots on the skin, skin ulcers/lesions.Teriparatide has been shown to increase bone cancer (osteosarcoma) in rats. It is unknown if this medication can cause bone cancer in humans. Tell your doctor right away if you have any symptoms of bone cancer, including: bone pain, unusual growths/lumps.A very serious allergic reaction to this drug is rare. 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.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using teriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bone disorders (such as Paget's disease), personal/family history of bone cancer, radiation treatment, high level of calcium in the blood (hypercalcemia), kidney stones.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, severe dizziness, unusual tiredness.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as calcium levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.
MISSED DOSE: If you miss a dose and remember on the same day, use it as soon as you remember. If you remember on the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store in the refrigerator away from light. Do not freeze. Do not use this medication if it has been frozen. This medication should be used immediately after removing from the refrigerator and then returned to refrigerator after use. This product may be used for up to 28 days. Mark the day when you start using the product. Discard the product after 28 days, even if there is still medication in the product. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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