Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Forteo

Descriptions


Teriparatide is a synthetic form of the natural human parathyroid hormone and is used by injection to treat osteoporosis. Teriparatide forms new bone, increases bone mineral density and bone strength, and as a result reduces the chance of getting a fracture (broken bone). Teriparatide can be used by men or postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide can be used by people who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture, or who cannot use other osteoporosis treatments.

Teriparatide has been used by injection into a vein as a test to help diagnose problems of the parathyroid gland. This test determines whether you have hypoparathyroidism or a type of pseudohypoparathyroidism.

This product, for use as a test to help diagnose problems of the parathyroid gland, was withdrawn from the U.S. market in January 1997.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of teriparatide in the pediatric population. Safety and efficacy have not been established. Use in children or young adults is not recommended due to possible effects on growing bones .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of teriparatide in the elderly .

Pregnancy

Information about this teriparatide-subcutaneous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alkaline phosphatase (an enzyme in the blood), elevated levels or
  • Bone cancer, or history of or
  • Hypercalcemia (high calcium in the blood) or
  • Metabolic bone disease or
  • Paget's disease (bone disease) or
  • Radiation therapy of bones, history of—Should not use in these conditions.
  • Urolithiasis (kidney stone), active or recent—May make this condition worse.

Proper Use

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Special patient instructions will come with the medicine. Read the directions carefully before using the medicine. Make sure you understand:

  • Where to give the injection.
  • How to give the injection.
  • How long the injection is stable.

If you have any questions, check with your health care professional.

Do not use the medicine if you see solid particles in the liquid.

Do not use the medicine beyond the expiration date on the package.

For the first few doses, inject the medicine where you can sit or lie down right away in case you get dizzy.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For subcutaneous injection dosage form:
    • For osteoporosis:
      • Adults—20 micrograms (mcg) once daily, injected under the skin on the thigh or abdominal (gut) wall.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Throw away the teriparatide pen at 28 days after the first injection, even if there is still medicine in it. Do not use the medicine if it has been frozen.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not inject this medicine into a vein or muscle.

This medicine may cause lightheadedness or fast heartbeats. If this happens, sit or lie down until you feel better. If you do not feel better, call your health care provider before continuing treatment.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as bone cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Abdominal pain
  2. confusion
  3. constipation
  4. depression
  5. dry mouth
  6. headache
  7. incoherent speech
  8. increased urination
  9. loss of appetite
  10. metallic taste
  11. muscle weakness
  12. nausea
  13. thirst
  14. unusual tiredness
  15. vomiting
  16. weight loss

Less common

  1. Arm, back, or jaw pain
  2. chest pain or discomfort
  3. chest tightness or heaviness
  4. cough
  5. difficult or labored breathing
  6. fainting
  7. fast or irregular heartbeat
  8. fever or chills
  9. nausea
  10. shortness of breath
  11. sneezing
  12. sore throat
  13. sweating
  14. tightness in the chest
  15. wheezing

Incidence not known

  1. Hives or welts
  2. itching
  3. redness of the skin
  4. skin rash
  5. swelling or puffiness of the mouth and face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Acid or sour stomach
  2. belching
  3. blurred vision
  4. body aches or pain
  5. congestion
  6. diarrhea
  7. difficulty having a bowel movement (stool)
  8. difficulty with moving
  9. dizziness
  10. heartburn
  11. hoarseness
  12. indigestion
  13. lack or loss of strength
  14. muscle pain or stiffness
  15. muscle spasm
  16. nervousness
  17. pain in the joints
  18. pounding in the ears
  19. runny nose
  20. tender, swollen glands in the neck
  21. trouble with swallowing
  22. voice changes

Less common

  1. Abdominal or stomach cramps
  2. back pain
  3. discomfort
  4. discouragement
  5. feeling of constant movement of self or surroundings
  6. feeling sad or empty
  7. indigestion
  8. irritability
  9. lack of appetite
  10. leg cramps
  11. loss of interest or pleasure
  12. neck pain
  13. rash
  14. sensation of spinning
  15. sleeplessness
  16. swollen mouth and tongue
  17. tiredness
  18. tooth disorder
  19. trouble concentrating
  20. trouble sleeping
  21. unpleasant taste
  22. urge to have bowel movement

Rare

  1. Pain at the place of injection during or following the injection
  2. tingling feeling in the hands and feet
  3. urge for bowel movement

Incidence not known

  1. Bruising at the injection site
  2. flushing
  3. minor bleeding at the injection site
  4. unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.