Learn how Lartruvo may help with your STS

In soft tissue sarcoma:

The 1st significant advancement in initial treatment in more than 40 years.

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.

In a study, Lartruvo helped people with STS live nearly twice as long

Start with LARTRUVO:

Ask your doctor if starting LARTRUVO + doxorubicin is right for you

Have you already been prescribed LARTRUVO + doxorubicin? For tips on preparing for your first infusion, click here.

Clinical trial results |
LARTRUVO may help you live longer

LARTRUVO in combination with doxorubicin (a type of chemotherapy) helped people live significantly longer than those who took doxorubicin alone.

In a study, Lartruvo helped people with STS live nearly twice as long

Lived nearly 2 times longer

In a study, people who were treated with LARTRUVO + doxorubicin lived nearly twice as long as those who were treated with doxorubicin alone.

Half of the patients who received LARTRUVO + doxorubicin (66 people) were still alive at 26.5 months compared to 14.7 months with doxorubicin alone (67 people). This is a measure of how well a treatment works, which is called median overall survivalMedian overall survival: A way to measure how well a cancer treatment works in a clinical trial. It is the amount of time from the start of treatment until exactly half of patients are still alive.X.

Patients receiving LARTRUVO + doxorubicin (66 people) lived without their cancer getting worse for 8.2 months versus 4.4 months with doxorubicin alone

Slows the progression of disease

Patients receiving LARTRUVO + doxorubicin (66 people) lived without their cancer getting worse for 8.2 months versus 4.4 months with doxorubicin alone (67 people).

In a study, Lartruvo helped people with STS live nearly twice as long

2 times as many people experienced tumor shrinkage

Twice as many people had their tumors shrink with LARTRUVO + doxorubicin (18.2% of 66 patients) than with doxorubicin alone (7.5% of 67 patients).

LARTRUVO may not work for everyone. Individual results from treatment may vary.

STUDY DETAILS

A clinical study included 133 people with more than 20 different subtypes of soft tissue sarcoma. They received either LARTRUVO with doxorubicin or doxorubicin alone.

The study assessed overall survival, which is how long people lived after starting treatment. The trial also measured the length of time that tumors didn’t grow, spread, or worsen after starting treatment (progression-free survival) and the proportion of people whose tumors had shrunk (objective response rate).

LARTRUVO was studied in many different subtypes. Specific clinical benefits for each subtype have not been established. Talk to your healthcare team if you have questions regarding your specific subtype. Ask your doctor if LARTRUVO + doxorubicin is right for you.

In the study, people were assigned to one of 2 groups that each received a different medication regimen:

Group 1: 66 people treated with LARTRUVO + doxorubicin (a type of chemotherapy)

Group 2: 67 people treated with doxorubicin alone

People in the study were eligible to receive treatment with anthracycline, such as the chemotherapy doxorubicin. People in the study were not eligible for curative treatment with surgery or radiation.

Select Important Safety Information

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.

HOW LARTRUVO WORKS

Lartruvo works differently than a chemotherapy for STS

LARTRUVO works differently than a chemotherapy. It is a monoclonal antibody, a type of biologic therapyBiologic therapy: A type of treatment that uses substances made from living organisms to treat disease.X that works to mimic part of your body’s own immune system. LARTRUVO binds to certain substances and blocks cells from sending growth signals to cancer cells, as well as healthy cells.

POSSIBLE SIDE EFFECTS OF LARTRUVO

The most common side effects of LARTRUVO include:

  • 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
  • Headache

This is not a full list of side effects

Talk to your healthcare team if you notice side effects, including any signs of fever.

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.

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.

Your first treatment

It’s time for your first LARTRUVO + doxorubicin treatment. You’ve got this. The tips below are designed to help you get started. Remember, everyone is different, and many people will want to give you advice. But it’s important to find what works best for you—your preferences, your needs, and your comfort.

Arrange for someone to drive you to and from your Lartruvo appointment

Plan rides

There’s no way to predict exactly how your body will react to different medications, so it’s a good idea to arrange for someone to drive you to and from your infusion, at least the first time.

If you can, familiarize yourself with the location of your infusion site, where to park, and where to sign in upon arrival.

Wear a comfortable outfit to your Lartruvo appointment

Plan a comfortable outfit

Dress comfortably in soft, loose clothes. For extra comfort, bring your favorite pair of socks and slippers.

Be sure to eat and be hydrated to help with your treatment.

Plan meals

It is important to maintain proper nutrition and to stay hydrated. It is also important to minimize stress on your infusion days—planning healthy meals in advance can help both causes.

TIP: Don’t eat 1 to 2 hours before treatment. Avoid eating favorite foods when feeling nauseated as this may diminish your enjoyment of these foods later. A bad experience could turn your most favorites into your least favorites!

It’s treatment day. Bring your 4 B’s!

Bring a Buddy or family member to help provide emotional support through your Lartruvo treatment

A Buddy

A loved one can make all the difference

A family member or friend can be a great distraction and can provide emotional support. They can also help take notes and organize information, such as post-treatment instructions.

Confirm in advance that your treatment location allows visitors to stay with you during treatment.

Compile all of your paperwork into one binder.

A Binder

On the day of your first infusion, the last thing you want to do is go searching for paperwork.

Put all your important documents in one travel binder, with backup copies at home, just in case you need them:

  • Insurance information
  • Paperwork from your doctor such as lab results or prescriptions
  • Contact information for your extended healthcare team and caregivers
  • Appointment schedule
Pack a bag to bring snack & entertainment that will distract you during your treatment.

A Bag

Snacks

  • Choose snacks that are high in nutritional value, don’t have a strong smell, and are somewhat bland in taste. For example, nuts, whole grain crackers, hard cheese, hummus, granola bars, and fruit.

Hard candy

  • During treatment, some people like to suck on hard candy, like mints, lemon drops, or citrus candies. This is to help in case you experience a slight bitter or metallic taste in your mouth during treatment with doxorubicin.

Lip balm, lotion, and ice

  • Keep your lips and skin hydrated with scent-free lip balm and hand lotion.
  • You can also ask your nurse for ice packs or cooling caps during treatment. Placing them on your head may help reduce hair loss.

Entertainment

  • To help pass the time:
    • Get lost in a great book
    • Relax and listen to music or watch a movie on your tablet or phone
    • Are you the crafting type? Bring it along!
Stay cozy and bring a blanket!

A Blanket

  • Bring a blanket. Treatment areas tend to be cold, so if you don’t have a travel-size blanket, treat yourself to an extra cozy one. You deserve it.
  • Keep in mind, you’ll be connected to your IV, which makes removing and adding layers of clothes difficult. So a blanket is best.

The first 24 hours after your infusion

Going home

You may feel hopeful, relieved, overwhelmed, or just tired. You may experience a range of emotions, but you won’t know until you get there.

One thing is for sure: You got up. You did it. You just got a round of treatment under your belt. Be proud. Pat yourself on the back. Today was a major accomplishment.

Here are a few things to keep in mind during your first 24 hours after treatment:

Talk to your doctor if you develop any side effects.

Reflect on your first infusion

Reflect on what worked in your first appointment. What went well? What could be improved the next time?

Speak up!

Your doctor is there to help, so don’t hesitate to call. If you develop any side effects, call your doctor.

Keep a journal to track side effects and how long they last so that you can communicate those with your doctor.

Keep a journal

A journal can be useful to keep track of side effects, including their severity and how long they last. It can also be helpful as an emotional outlet. You can also keep track of memorable moments and experiences, or note down questions for your doctor so they can remain fresh in your mind.

Be sure to follow any instructions after your Lartruvo Infusion.

Follow instructions

Once you’re home, it is important to follow any instructions you received. Take your medication on time, rest, hydrate, and eat.

You can ask your family member or friend to help make sure you’ve picked up any medication you’ll need before returning home.

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