Teriparatide

Trade Names:
Forteo
- Injection 250 mcg/mL

Pharmacology

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Regulates bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium reabsorption.

Pharmacokinetics

Absorption

Bioavailability is approximately 95% and T _max is approximately 30 min.

Distribution

Vd is approximately 0.12 L/kg (IV dose).

Metabolism

Metabolized by nonspecific enzymatic mechanisms in the liver.

Elimination

Cl is approximately 62 L/h (women) and 94 L/h (men). T _½ is 5 min (IV) and 1 h (subcutaneous). Excreted via the kidneys.

Onset

2 h (serum calcium concentrations begin to increase).

Peak

4 to 6 h (peak serum calcium concentrations).

Duration

16 to 24 h (serum calcium concentrations return to baseline).

Special Populations

In patients with severe renal function impairment (CrCl less than 30 mL/min), the AUC and t _½ increased 73% and 77%, respectively.

Systemic exposure is approximately 20% to 30% lower in men; no dosage adjustment needed.

Indications and Usage

Treatment of postmenopausal women with osteoporosis who are at high risk for fracture (eg, history of osteoporotic fracture); increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture (eg, history of osteoporotic fracture).

Contraindications

Standard considerations.

Dosage and Administration

Subcutaneous 20 mcg once daily into thigh or abdominal wall.

General Advice

• Rotate injection sites (thigh, abdominal wall). Give new injections at least 1 inch from old site and never into areas where the skin is tender, bruised, red, or hard.

Storage/Stability

Store pen in refrigerator (36° to 46°F) at all times. During the use period, minimize time out of the refrigerator; the dose can be administered immediately following removal from the refrigerator. Recap pen when not in use. Pen can be used for up to 28 days after first injection; discard pen after 28-day use period even if it still contains unused solution. Do not freeze. Discard if pen has been frozen.

Drug Interactions

Because teriparatide may increase serum calcium, which may predispose patients to digitalis toxicity, use with caution in patients receiving digoxin.

Laboratory Test Interactions

Transient increases in serum calcium, with the max effect observed at approximately 4 to 6 h postdose.

Adverse Reactions

Cardiovascular

Hypertension; syncope; angina pectoris.

CNS

Dizziness; headache; insomnia; depression; vertigo.

Dermatologic

Rash; sweating.

GI

Nausea; constipation; dyspepsia; diarrhea; vomiting; GI disorder; tooth disorder.

Respiratory

Rhinitis; increased cough; pharyngitis; pneumonia; dyspnea.

Miscellaneous

Arthralgia; leg cramp; pain; asthenia; neck pain.

Precautions

Pregnancy

Category C .

Lactation

Not established; however, since it is indicated for osteoporosis in postmenopausal women, it should not be administered to women who are breast-feeding their children.

Children

Safety and efficacy not established.

Special Risk Patients

Do not administer to patients at increased risk of osteosarcoma (ie, patients with Paget disease of the bone, children, patients with a history of radiation therapy involving the skeleton); do not use in patients with bone metastases or history of skeletal malignancies, metabolic bone diseases other than osteoporosis or preexisting hypercalcemia or underlying hypercalcemia disorder (eg, primary hyperparathyroidism).

Orthostatic hypotension

Symptomatic orthostatic hypotension may occur.

Urolithiasis

Use with caution.

Overdosage

Symptoms

Delayed hypercalcemic effect, orthostatic hypotension, nausea, vomiting, dizziness, headache.

Patient Information

• Instruct patient to read Medication Guide and pen “User Manual” before starting therapy and each time the prescription is renewed.
• Ensure that the patient understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health professional.
• Advise patient to inject prescribed dose at about the same time every day.
• Advise patient that if a dose is missed, take it as soon as remembered but to never administer more than 1 injection in the same day.
• Advise patient to administer the first few doses in an area where they can sit or lie down quickly if they get dizzy.
• Advise patient that if they feel lightheaded or have palpitations after the injection to sit or lie down until symptoms resolve. Advise patient to notify health care provider if these symptoms persist or worsen.
• Advise patient regarding other ways they can help their osteoporosis: supplemental calcium and vitamin D, weight-bearing exercises, reduction of cigarette smoking and alcohol consumption.
• Instruct patient to report the following symptoms to health care provider: persistent nausea, vomiting, constipation, tingling, lethargy, muscle weakness.

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