Olaratumab Injection

IMPORTANT NOTICE:

In a clinical study, people who received olaratumab injection in combination with doxorubicin did not live longer than those who received treatment with doxorubicin alone. As a result of the information learned in this study, the manufacturer is taking olaratumab injection off the market. If you are already receiving treatment with olaratumab injection it is important to ask your doctor if you should continue treatment. This medication will still be available directly from the manufacturer for people who have already started treatment with olaratumab, if their doctors recommend continued treatment.

WHY is this medicine prescribed?

Olaratumab injection is used along with another medication to treat certain types of soft tissue sarcoma (cancer that begins in soft tissues such as muscles, fat, tendons, nerves, and blood vessels), which cannot be treated successfully with surgery or radiation. Olaratumab injection is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Olaratumab injection comes as a solution (liquid) to be injected slowly into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected on days 1 and 8 of a 21 day cycle. The cycle may be repeated as recommended by your doctor. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Olaratumab injection may cause serious reactions during the infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: flushing, fever, chills, dizziness, feeling faint, shortness of breath, rash or hives, difficulty breathing, or swelling of the face or throat. A doctor or nurse will watch you carefully for these side effects while the medication is being infused, and for a short time after. Your doctor may need to slow down your infusion, reduce your dose, or delay or stop your treatment if you experience these or other side effects.

What SPECIAL PRECAUTIONS should I follow?

Before taking olaratumab injection,

• tell your doctor and pharmacist if you are allergic to olaratumab, any other medications, or any of the ingredients in olaratumab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment with olaratumab injection and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking olaratumab injection, call your doctor.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment with olarartumab injection and for 3 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Olaratumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• sores or swelling in mouth or throat
• hair loss
• headache
• feeling anxious
• dry eyes
• muscle, joint, or bone pain in any part of the body
• pale skin
• unusual tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• burning, tingling, numbness, pain, or weakness in arms or legs

Olaratumab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to olaratumab injection.

Ask your pharmacist any questions you have about olaratumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.