FORTEO Solution for injection Ref.[10817] Active ingredients: Teriparatide

Source: FDA, National Drug Code (US) Revision Year: 2020

1. Indications and Usage

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.

2. Dosage and Administration

2.1 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.

2.2 Administration Instructions

Administer FORTEO as a subcutaneous injection into the thigh or abdominal region. FORTEO is not approved for intravenous or intramuscular use.
FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions (5.4)].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (FORTEO is a clear and colorless liquid). Do not use if solid particles appear or if the solution is cloudy or colored.
Patients and/or caregivers who administer FORTEO should receive appropriate training and instruction on the proper use of the FORTEO prefilled delivery device (pen) from a qualified health professional.

2.3 Recommended Treatment Duration

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 [see Warnings and Precautions (5.1)].

10. Overdosage

In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the FORTEO prefilled delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported. Additional signs, symptoms, and complications of FORTEO overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache.

Overdose Management

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.

16.2. Storage and Handling

Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product.
Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light.
When using FORTEO, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator.
Do not freeze. Do not use FORTEO if it has been frozen.

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