HOW IS LARTRUVO GIVEN?

Your treatment will be scheduled in cycles. There are 3 weeks (21 days) in each treatment cycle. You will be given treatment on Days 1 and 8 of each 3-week (21-day) cycle.

On the 1st day of treatment, you will receive both LARTRUVO and doxorubicin.

On the 8th day, you will receive LARTRUVO only.

Lartruvo Dosing Schedule

Your doctor will start you on treatment with LARTRUVO and doxorubicin, and may adjust the medicines in your treatment plan over time.

Dosing schedule

On Day 1 of each treatment cycle, you will receive 1 hour of LARTRUVO followed by 1 hour or less of doxorubicin.

You will receive medications before your LARTRUVO infusion. This will help prepare your body for treatment with LARTRUVO.

Your treatment plan may include LARTRUVO and doxorubicin for up to 8 cycles of treatment.

After the 8th cycle, your healthcare team may decide to continue treatment with LARTRUVO alone. This will depend on the progress of your disease and how your body responds to therapy.

If your disease progresses at any point during treatment, your doctor will end treatment with LARTRUVO and discuss with you the appropriate next steps for your treatment plan.

How long will each visit take?

Lartruvo is an IV infusion and can take up to 3 hours to be given.

LARTRUVO is given by intravenous (IV) infusion in a doctor's office, hospital, or infusion center.

You may be at the infusion center for a total of 2 to 3 hours.

Your first infusion will be slightly longer than the rest.

Understanding your infusion setting

Treatment with LARTRUVO + doxorubicin is most likely to happen at an infusion center or cancer center in a hospital.

Lartruvo is given at an infusion center

Infusion center

An infusion center can have private rooms or an open floor layout, so you may be in the room with other people who are also receiving treatment. Many infusion centers with open floors have curtains for privacy.

You will be given your Lartruvo infusion in a specially designed infusion chair

Infusion chair

You will receive treatment in a specially designed infusion chair that allows the nurse to easily connect you to an IV line. Because infusions can take a few hours, the chair is designed to be comfortable, and usually reclines so you can relax.

While receiving Lartruvo you will be surrounded by your own treatment team.

Treatment team

You will encounter several people during your infusion. This includes a nurse who specializes in giving cancer treatment, the staff who are there to sign you in and assist you, and a doctor. This may be your doctor or a different doctor who works at the center.

Indication and Important Safety Information
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