TERIPARATIDE- teriparatide injection, solution 
Alvogen, Inc.

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Medication Guide
Teriparatide [ter i par a tide]
Injection
Read this Medication Guide before you start taking teriparatide injection and each time you get a refill. There may be new information. Also, read the User Manual that comes with the teriparatide injection device (pen) for information on how to use the device to inject your medicine the right way. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about teriparatide injection?
  • Possible bone cancer. During drug testing, the medicine in teriparatide injection caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who have taken teriparatide injection. It is not known if people who take teriparatide injection have a higher chance of getting osteosarcoma.
  • You should not take teriparatide injection for more than 2 years over your lifetime.
What is teriparatide injection?
  • Teriparatide injection is a prescription medicine that is like a hormone made by the body called parathyroid hormone or PTH.
  • Teriparatide injection may help to form new bone, increase bone mineral density and bone strength.
  • Teriparatide injection can lessen the number of fractures of the spine and other bones in postmenopausal women with osteoporosis.
  • The effect on fractures has not been studied in men.
  • Teriparatide injection is used in both men and postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide injection can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who can not use other osteoporosis treatments.
  • Teriparatide injection is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones, who have several risk factors for fracture, or who can not use other osteoporosis treatments.
It is not known if teriparatide injection is safe and effective in children.
Teriparatide injection should not be used in children and young adults whose bones are still growing.
Who should not use teriparatide injection?
Do not use teriparatide injection if you are allergic to any of the ingredients in teriparatide injection. See the end of this Medication Guide for a complete list of the ingredients in teriparatide injection.
Before you take teriparatide injection, tell your healthcare provider if you:
  • have the condition listed in the section “Who should not use teriparatide injection?”
  • have Paget's disease or other bone disease
  • have cancer in your bones
  • have trouble injecting yourself and do not have someone who can help you
  • are a child or young adult whose bones are still growing
  • have or have had kidney stones
  • have had radiation therapy
  • have or had too much calcium in your blood
  • have any other medical conditions
  • are pregnant or thinking about becoming pregnant. It is not known if teriparatide injection will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. You should not breast-feed while taking teriparatide injection.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking teriparatide injection with other medicines that may harm you.

Especially tell your doctor if you take medicines that contain digoxin (Digoxin, Lanoxicaps, Lanoxin).
How should I use teriparatide injection?
  • Inject teriparatide injection one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites.
  • Before you try to inject teriparatide injection yourself, a healthcare provider should teach you how to use the teriparatide injection delivery device to give your injection the right way.
  • Read the detailed User Manual.
  • You can take teriparatide injection with or without food or drink.
  • The teriparatide injection delivery device has enough medicine for 28 days. It is set to give a 20 microgram dose of medicine each day. Do not inject all the medicine in the teriparatide injection delivery device at any one time.
  • Do not transfer the medicine from the teriparatide injection delivery device to a syringe. This can result in taking the wrong dose of teriparatide injection. If you do not have pen needles to use with your teriparatide injection delivery device, talk with your healthcare provider.
  • Teriparatide injection should look clear and colorless. Do not use teriparatide injection if it has particles in it, or if it is cloudy or colored.
  • Inject teriparatide injection right away after you take the delivery device out of the refrigerator.
  • After each use, safely remove the needle, recap the delivery device, and put it back in the refrigerator right away.
  • You can take teriparatide injection at any time of the day. To help you remember to take teriparatide injection, take it at about the same time each day.
  • If you forget or cannot take teriparatide injection at your usual time, take it as soon as you can on that day. Do not take more than one injection in the same day.
  • If you take more teriparatide injection than prescribed, call your healthcare provider. If you take too much teriparatide injection, you may have nausea, vomiting, weakness, or dizziness.
  • Follow your healthcare provider's instructions about other ways you can help your osteoporosis, such as exercise, diet, and reducing or stopping your use of tobacco and alcohol. If your healthcare provider recommends calcium and vitamin D supplements, you can take them at the same time you take teriparatide injection.
What are the possible side effects of teriparatide injection?
Teriparatide injection can cause serious side effects, including:
  • See “What is the most important information I should know about teriparatide injection?”
  • Decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking teriparatide injection and goes away within a few hours. For the first few doses, take your injections of teriparatide injection in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking teriparatide injection and call your healthcare provider.
  • Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs that there is too much calcium in your blood.
Common side effects of teriparatide injection include:
  • nausea
  • joint aches
  • pain
Your healthcare provider may take samples of blood and urine during treatment to check your response to teriparatide injection. Also, your healthcare provider may ask you to have follow-up tests of bone mineral density.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of teriparatide injection. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store teriparatide injection?
  • Keep your teriparatide injection delivery device in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze the teriparatide injection delivery device. Do not use teriparatide injection if it has been frozen.
  • Do not use teriparatide injection after the expiration date printed on the delivery device and packaging.
  • Throw away the teriparatide injection delivery device after 28 days even if it has medicine in it (see the User Manual).
Keep teriparatide injection and all medicines out of the reach of children.
General information about teriparatide injection
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use teriparatide injection for a condition for which it was not prescribed. Do not give teriparatide injection to other people, even if they have the same condition you have.

This Medication Guide summarizes the most important information about teriparatide injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about teriparatide injection that is written for healthcare professionals. For more information, call Alvogen, Inc. at 1-866-770-3024.
What are the ingredients in teriparatide injection?

Active ingredient: teriparatide
Inactive ingredients: glacial acetic acid, sodium acetate, mannitol, metacresol, and water for injection.
What is Osteoporosis?
Osteoporosis is a disease in which the bones become thin and weak, increasing the chance of having a broken bone. Osteoporosis usually causes no symptoms until a fracture happens. The most common fractures are in the spine (backbone). They can shorten height, even without causing pain. Over time, the spine can become curved or deformed and the body bent over. Fractures from osteoporosis can also happen in almost any bone in the body, for example, the wrist, rib, or hip. Once you have had a fracture, the chance for more fractures greatly increases.

The following risk factors increase your chance of getting fractures from osteoporosis:
  • past broken bones from osteoporosis
  • very low bone mineral density (BMD)
  • frequent falls
  • limited movement, such as using a wheelchair
  • medical conditions likely to cause bone loss, such as some kinds of arthritis
  • taking steroid medicines called glucocorticoids, such as prednisone
  • other medicines that may cause bone loss, for example: seizure medicines (such as phenytoin), blood thinners (such as heparin), and high doses of vitamin A
*The brands listed are trademarks of their respective owners and are not trademarks of Alvogen, Inc.

Distributed by:
Alvogen, Inc.
Morristown, NJ 07960 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: November 2019

PL652-04

Revised: 11/2019
Alvogen, Inc.