Forteo

DRUG DESCRIPTION

FORTEO (teriparatide rdna origin injection) (teriparatide [rDNA origin] injection) contains recombinant human parathyroid hormone (1-34), and is also called rhPTH (1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.

Teriparatide has a molecular weight of 4117.8 daltons and its amino acid sequence is shown below:

FORTEO (teriparatide [rDNA origin]) amino acid sequence Illustration

Teriparatide (rDNA origin) is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. FORTEO (teriparatide rdna origin injection) is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with either 3.3 mL to deliver 3 mL or 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg 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.

Each cartridge, pre-assembled into a delivery device, delivers 20 mcg of teriparatide per dose each day for up to 28 days.

What are the possible side effects of teriparatide (Forteo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using teriparatide and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed or fainting every time you inject this medicine;
  • fast or pounding heartbeats every time you inject this medicine; or
  • nausea, vomiting, constipation, and muscle weakness.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Forteo

What are the precautions when taking teriparatide (rdna origin) injection (Forteo)?

See also Warning section.

Before using teriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bone disorders (such as bone cancer), high level of calcium in the blood (hypercalcemia), kidney stones.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising...

Read All Potential Precautions of Forteo


Forteo Consumer (continued)

SIDE EFFECTS: Dizziness or fast heartbeat may occur within 4 hours after using this medication. These symptoms may persist for a few minutes to a few hours. This effect should go away after several doses as your body adjusts to the medication. It is best to lie or sit down if these symptoms occur. Muscle cramps/spasms or pain/swelling/bruising at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, constipation, unusual tiredness, mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before using teriparatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bone disorders (such as bone cancer), high level of calcium in the blood (hypercalcemia), kidney stones.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Forteo Patient Information Including Side Effects

Brand Names: Forteo

Generic Name: teriparatide (Pronunciation: ter i PAR a tide)

  • What is teriparatide (Forteo)?
  • What are the possible side effects of teriparatide (Forteo)?
  • What is the most important information I should know about teriparatide (Forteo)?
  • What should I discuss with my healthcare provider before using teriparatide (Forteo)?
  • How should I use teriparatide (Forteo)?
  • What happens if I miss a dose (Forteo)?
  • What happens if I overdose (Forteo)?
  • What should I avoid while using teriparatide (Forteo)?
  • What other drugs will affect teriparatide (Forteo)?
  • Where can I get more information?

What is teriparatide (Forteo)?

Teriparatide is a man-made form of a hormone called parathyroid that exists naturally in the body. Teriparatide increases bone density and increases bone strength to help prevent fractures.

Teriparatide is used to treat osteoporosis in men and women who have a high risk of bone fracture.

Teriparatide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of teriparatide (Forteo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using teriparatide and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed or fainting every time you inject this medicine;
  • fast or pounding heartbeats every time you inject this medicine; or
  • nausea, vomiting, constipation, and muscle weakness.

Less serious side effects may include:

  • mild dizziness;
  • pain, redness, bruising, itching, or swelling where the medicine was injected;
  • leg cramps;
  • joint pain;
  • cough, sore throat, runny nose;
  • headache or neck pain; or
  • nausea, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about teriparatide (Forteo)?

This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with teriparatide. Talk with your doctor about your individual risk.

Teriparatide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid smoking cigarettes, or try to quit smoking altogether. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking alcohol, which also may affect your bone mineral density.

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