Lartruvo (Intravenous)

Olaratumab injection is used together with doxorubicin to treat soft tissue sarcoma (STS) in patients who cannot be cured with radiation therapy or surgery and need treatment with an anthracycline-containing regimen. Olaratumab helps stop the growth of tumors, which are eventually destroyed by the body.

This medicine is to be given only by or under the direct supervision of your doctor.

If you will be using this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects from the medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a rare but serious type of allergic reaction called an infusion related reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty swallowing, dizziness, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the results of olaratumab injection in children. Safety and effectiveness have not been established.

Geriatric

While there have not been appropriate studies on how age affects the results of olaratumab injection in older adults, no specific problems related to older adults have been documented so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction is possible. In such cases, your doctor may want to change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Back pain
• blurred vision
• chest tightness
• chills
• confusion
• cough
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up quickly from a lying or sitting position
• fast heartbeat
• feeling of warmth
• fever
• headache
• hives, itching, or skin rash
• nausea and vomiting
• no blood pressure or pulse
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and sometimes, upper chest
• stopping of heart
• sweating
• tightness in the chest
• unconsciousness
• unusual tiredness or weakness

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also provide ways to prevent or lessen some of these side effects. Contact your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Abdominal or stomach pain
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• cracked lips
• decreased appetite
• diarrhea
• difficulty with moving
• dry eyes
• fear or nervousness
• hair loss or thinning of the hair
• muscle pain or stiffness
• pain in the joints
• sensation of pins and needles
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lartruvo

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine is usually given on Day 1 and Day 8 of a 21-day cycle treatment. For the first 8 cycles, it is given in combination with doxorubicin. Each treatment usually takes about 60 minutes.