LARTRUVO + DOXORUBICIN FOR SOFT TISSUE SARCOMA

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INDICATION AND IMPORTANT SAFETY INFORMATION

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WHO IS LARTRUVO FOR?

LARTRUVO (olaratumab) is a prescription medicine used with a type of chemotherapy called doxorubicin to treat adult patients with soft tissue sarcoma (STS) for whom doxorubicin is appropriate and who cannot be cured with radiation or surgery.

There is an ongoing study to confirm how LARTRUVO works in combination with doxorubicin.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO

What is the most important information I should know about LARTRUVO?

  • Infusion reactions related to injecting LARTRUVO have occurred. Most of these reactions happened during or after the first or second LARTRUVO infusion. Signs and symptoms of infusion reactions include flushing, shortness of breath, severe trouble breathing, or fever/chills. In severe cases, severe low blood pressure, anaphylactic shock (a severe, potentially life-threatening allergic reaction), or cardiac arrest (abrupt loss of heart function) may occur. Tell your doctor if you have any of these symptoms. Your healthcare team will monitor you for these side effects. In the case of a severe infusion reaction, your LARTRUVO treatment will have to be immediately and permanently stopped.

  • LARTRUVO can harm your unborn baby. You should avoid getting pregnant, and use effective birth control while receiving LARTRUVO and for at least 3 months after stopping LARTRUVO.

What are the most common side effects of LARTRUVO?

  • The most common side effects reported in patients treated with LARTRUVO when given in combination with doxorubicin were nausea; tiredness or weakness; pain in the muscles, joints, and bones; sores and swelling of the mouth and digestive tract; hair loss; vomiting; diarrhea; decreased appetite; stomach pain; weakness, numbness, or pain in the hands and feet; and headache.

  • The most common changes to blood tests were low white blood cell count, low platelet count, high blood sugar, increased blood clotting time, low blood potassium level, and low blood phosphate level.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before receiving treatment with LARTRUVO?

Before you receive LARTRUVO, tell your doctor if you:

  • Are pregnant or may be pregnant. If you become pregnant during treatment, discuss this with your doctor.

  • Are breastfeeding: your doctor will tell you not to breastfeed during LARTRUVO treatment and for at least 3 months after stopping LARTRUVO.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications.

LARTRUVO is available by prescription only.

Please see full Prescribing Information for additional information about LARTRUVO.

OR CON ISI 12JAN2017

WHO IS LARTRUVO FOR?

LARTRUVO (olaratumab) is a prescription medicine used with a type of chemotherapy called doxorubicin to treat adult patients with soft tissue sarcoma (STS) for whom doxorubicin is appropriate and who cannot be cured with radiation or surgery.

There is an ongoing study to confirm how LARTRUVO works in combination with doxorubicin.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO

What is the most important information I should know about LARTRUVO?

  • Infusion reactions related to injecting LARTRUVO have occurred. Most of these reactions happened during or after the first or second LARTRUVO infusion. Signs and symptoms of infusion reactions include flushing, shortness of breath, severe trouble breathing, or fever/chills. In severe cases, severe low blood pressure, anaphylactic shock (a severe, potentially life-threatening allergic reaction), or cardiac arrest (abrupt loss of heart function) may occur. Tell your doctor if you have any of these symptoms. Your healthcare team will monitor you for these side effects. In the case of a severe infusion reaction, your LARTRUVO treatment will have to be immediately and permanently stopped.

  • LARTRUVO can harm your unborn baby. You should avoid getting pregnant, and use effective birth control while receiving LARTRUVO and for at least 3 months after stopping LARTRUVO.

What are the most common side effects of LARTRUVO?

  • The most common side effects reported in patients treated with LARTRUVO when given in combination with doxorubicin were nausea; tiredness or weakness; pain in the muscles, joints, and bones; sores and swelling of the mouth and digestive tract; hair loss; vomiting; diarrhea; decreased appetite; stomach pain; weakness, numbness, or pain in the hands and feet; and headache.

  • The most common changes to blood tests were low white blood cell count, low platelet count, high blood sugar, increased blood clotting time, low blood potassium level, and low blood phosphate level.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before receiving treatment with LARTRUVO?

Before you receive LARTRUVO, tell your doctor if you:

  • Are pregnant or may be pregnant. If you become pregnant during treatment, discuss this with your doctor.

  • Are breastfeeding: your doctor will tell you not to breastfeed during LARTRUVO treatment and for at least 3 months after stopping LARTRUVO.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications.

LARTRUVO is available by prescription only.

Please see full Prescribing Information for additional information about LARTRUVO.

OR CON ISI 12JAN2017

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