Teriparatide

What is Teriparatide?

• Teriparatide (FORTEO) is a parathyroid hormone analog, (PTH 1-34) used in the treatment of some forms of osteoporosis.

Teriparatide structure

Treprostinil2

What are the uses of this medicine?

Teriparatide (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.

How does this medicine work?

• Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
• Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption.
• The biological actions of PTH and teriparatide are mediated through binding to specific high-affinity cell-surface receptors.
• Teriparatide and the 34 N-terminal amino acids of PTH bind to these receptors with the same affinity and have the same physiological actions on bone and kidney.
• Teriparatide is not expected to accumulate in bone or other tissues.
• Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with hypersensitivity to teriparatide or to any of its excipients.

What drug interactions can this medicine cause?

• Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin.

Is this medicine FDA approved?

• Initial U.S. Approval: 1987

How should this medicine be used?

Recommended dosage:

• The recommended dosage is 20 mcg given subcutaneously once a day.
• Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.
• 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.

Administration:

• Use FORTEO exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much FORTEO to use and when to use it.
• Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO delivery device to give your injection the right way.
• Inject FORTEO 1 time each day in your thigh or abdomen (lower stomach area). Do not inject into a vein or a muscle. Talk to a healthcare provider about how to rotate injection sites.
• The FORTEO delivery device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Do not inject all the medicine in the FORTEO delivery device at any one time.
• Do not transfer the medicine from the FORTEO delivery device to a syringe. This can result in taking the wrong dose of FORTEO. If you do not have pen needles to use with your FORTEO delivery device, talk with your healthcare provider.
• FORTEO should look clear and colorless. Do not use FORTEO if it has particles in it, or if it is cloudy or colored.
• Inject FORTEO right away after you take the delivery device out of the refrigerator.
• After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away.
• When you inject the first few doses of FORTEO, make sure you are in a place where you can sit or lie down right away in case you feel dizzy or have an abnormal heartbeat after the injection.
• Do not take more than 1 injection in the same day.
• Do not share your FORTEO delivery device with other people.
• If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.
• You should not use FORTEO for more than 2 years over your lifetime unless your healthcare provider finds that you need longer treatment because you have a high chance of breaking your bones.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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

This medicine is available in fallowing brand namesː

• FORTEO

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain
• nausea
• joint aches

FORTEO may cause serious side effects including:

• osteosarcoma
• Increased calcium in your blood
• Worsening of your kidney stones
• Decrease in blood pressure when you change positions

What special precautions should I follow?

• Osteosarcoma has been reported in patients treated with FORTEO. Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma.
• FORTEO has not been studied in patients with pre-existing hypercalcemia, cutaneous calcification. Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification.
• Consider the risk/benefit in patients with active or recent urolithiasis because of risk of exacerbation. The frequency of urolithiasis was similar in patients treated with FORTEO.
• Transient orthostatic hypotension may occur with initial doses of FORTEO. FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
• Consider the potential onset of signs and symptoms of digitalis toxicity when FORTEO is used in patients receiving digoxin.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• weakness/lethargy
• hypotension
• hypercalcemic effect
• vomiting
• dizziness
• headache

Management of overdosage:

• There is no specific antidote for a FORTEO overdosage.
• Treatment of suspected overdosage should include discontinuation of FORTEO, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.

Can this medicine be used in pregnancy?

• 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
• Consider discontinuing FORTEO when pregnancy is recognized.

Can this medicine be used in children?

• The safety and effectiveness of FORTEO have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: teriparatide
• Inactive ingredients: glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.

Who manufactures and distributes this medicine?

Marketed by: Lilly USA, LLC Indianapolis, IN, USA

What should I know about storage and disposal of this medication?

• Store FORTEO in the refrigerator between 36°F to 46°F (2°C to 8°C) until ready to use. Use FORTEO right away after you remove it from the refrigerator.
• Do not freeze FORTEO. Do not use FORTEO if it has been frozen.
• Throw away the FORTEO delivery device after 28 days even if it has medicine in it (see the User Manual).
• Do not use FORTEO after the expiration date printed on the delivery device and packaging.
• Recap FORTEO when not in use to protect it from physical damage and light.

• Dailymed label info on Teriparatide
• FDA Teriparatide

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