Olaratumab

Contraindications

None

Cautions

Infusion-related reactions

• May cause infusion-related reactions; premedicate before first dose (see Administration)
• Infusion-related reactions may require permanent discontinuation or interruption of infusion (see Dosage Modifications)
• Monitor during and following infusions for reactions
• Administer in a setting with available resuscitation equipment

Embryo-fetal toxicity

• Based on animal data and its mechanism of action, can cause fetal harm when administered to a pregnant woman
• Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose
• Advise women to inform their healthcare provider of known or suspected pregnancy
• Also see Pregnancy

Call your doctor for instructions if you miss an appointment for your olaratumab injection.

• Tell all of your health care providers that you take olaratumab. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• This medicine may affect being able to father a child. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine and for 3 months after care ends.
• If you get pregnant while taking olaratumab or within 3 months after your last dose, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad and sometimes deadly infusion reactions have happened with this medicine. Call your doctor right away if you have chest pain, flushing, shortness of breath, very bad dizziness, or you pass out.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store olaratumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

There are no contraindications listed in the manufacturer’s labeling.

Soft tissue sarcoma: IV: 15 mg/kg on days 1 and 8 every 3 weeks (in combination with doxorubicin) for 8 cycles; after 8 cycles are completed, continue olaratumab (as a single agent) until disease progression or unacceptable toxicity (Tap 2016).

Premedications: On day 1 of cycle 1, premedicate with diphenhydramine (25 to 50 mg IV) and dexamethasone (10 to 20 mg IV) prior to olaratumab.

Note: Dexrazoxane was allowed on day 1 of cycles 5 to 8 to reduce the potential for doxorubicin-related cardiotoxicity (Tap 2016).

Withdraw calculated dose volume and dilute in NS to a total volume of 250 mL. Gently invert to mix (do not shake). Do not freeze the diluted solution. Dilute with NS only; do not use dextrose-containing or other solutions.

Infuse over 60 minutes. Do not infuse as an IV push or bolus. Flush the IV line with normal saline at the end of infusion. Do not coadminister electrolytes or other medications through the same IV line.

If refrigerated, allow infusion solution to reach room temperature prior to administration. Infusion must be completed within 28 hours of dilution (when stored appropriately; see Storage/Stability).

Data not available