Pronunciation:

oh-lar-AT-ue-mab

Brand Names:

• Lartruvo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of olaratumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of olaratumab injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 keep from getting pregnant 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 an 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 cough, difficulty with 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 suddenly 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 occasionally, upper chest

stopping of heart

sweating

tightness in the chest

unconsciousness

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with 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, check with 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.