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Teriparatide (Subcutaneous route)

Pronunciation:

ter-i-PAR-a-tide

Brand Names:

  • Forteo

Dosage Forms:

  • Solution

Warnings:

Subcutaneous route(Solution)

In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma that was dependent on dose and treatment duration. Teriparatide should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton) .

Classifications:

Therapeutic—

Calcium Regulator

Pharmacologic—

Parathyroid

Uses of This Medicine:

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This product, for use as a test to help diagnose problems of the parathyroid gland, was withdrawn from the U.S. market in January 1997.

Before Using This Medicine:

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.

Children—

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 .

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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
Abdominal pain
confusion
constipation
depression
dry mouth
headache
incoherent speech
increased urination
loss of appetite
metallic taste
muscle weakness
nausea
thirst
unusual tiredness
vomiting
weight loss
Less common
Arm, back, or jaw pain
chest pain or discomfort
chest tightness or heaviness
cough
difficult or labored breathing
fainting
fast or irregular heartbeat
fever or chills
nausea
shortness of breath
sneezing
sore throat
sweating
tightness in the chest
wheezing
Incidence not known
Hives or welts
itching
redness of the skin
skin rash
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
Acid or sour stomach
belching
blurred vision
body aches or pain
congestion
diarrhea
difficulty having a bowel movement (stool)
difficulty with moving
dizziness
heartburn
hoarseness
indigestion
lack or loss of strength
muscle pain or stiffness
muscle spasm
nervousness
pain in the joints
pounding in the ears
runny nose
tender, swollen glands in the neck
trouble with swallowing
voice changes
Less common
Abdominal or stomach cramps
back pain
discomfort
discouragement
feeling of constant movement of self or surroundings
feeling sad or empty
indigestion
irritability
lack of appetite
leg cramps
loss of interest or pleasure
neck pain
rash
sensation of spinning
sleeplessness
swollen mouth and tongue
tiredness
tooth disorder
trouble concentrating
trouble sleeping
unpleasant taste
urge to have bowel movement
Rare
Pain at the place of injection during or following the injection
tingling feeling in the hands and feet
urge for bowel movement
Incidence not known
Bruising at the injection site
flushing
minor bleeding at the injection site
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.


Last Updated: 11/4/2014

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