Olaratumab

What is Olaratumab?

Olaratumab (LARTRUVO) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody used in the therapy of advanced soft tissue sarcoma.

What are the uses of this medicine?

• This medicine is used in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
• This indication is approved under accelerated approval.

How does this medicine work?

• Olaratumab (oh" lar at' ue mab) is a recombinant human monoclonal IgG1 antibody to the platelet-derived growth factor receptor alpha.
• Signaling through PDGF receptors promotes cell proliferation and angiogenesis.
• Inhibition of the PDGF signaling decreases formation of new blood vessels, which plays an important role in growth and spread of cancer cells.
• When used in combination with other antineoplastic agents, olaratumab has been shown to extend recurrence-free survival in several forms of advanced cancer.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with LARTRUVO.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

• Premedicate with diphenhydramine and dexamethasone intravenously, prior to LARTRUVO on Day 1 of cycle 1.

Recommended Dosage:

• The recommended dose of LARTRUVO is 15 mg/kg administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
• For the first 8 cycles, LARTRUVO is administered with doxorubicin.

Administration

• Inspect vial contents for particulate matter and discoloration prior to dilution.
• Discard the vial if particulate matter or discolorations are identified.
• Withdraw calculated dose and further dilute with 0.9% Sodium Chloride Injection, USP to a final volume of 250 mL for intravenous infusion.
• Do not use dextrose-containing or other solutions.
• Gently invert but do not shake.
• DO NOT FREEZE the diluted solution.
• Store the diluted solution for up to 24 hours under refrigeration at 2°C to 8°C (36°F to 46°F) and for up to an additional 8 hours at room temperature (below 25°C [77°F]).
• Storage times include the duration of infusion.
• If refrigerated, allow the diluted solution to come to room temperature prior to administration.
• Discard vial with any unused portion of LARTRUVO.
• Do not administer LARTRUVO as an intravenous push or bolus.
• Do not co-infuse with electrolytes or other medications through the same intravenous line.
• Visually inspect the diluted solution for particulate matter and discoloration prior to administration.
• If particulate matter or discolorations are identified, discard the solution.
• Administer diluted solution as an intravenous infusion over 60 minutes.
• Flush the line with 0.9% Sodium Chloride Injection, USP at end of infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 500 mg/50 mL (10 mg/mL) or 190 mg/19 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• LARTRUVO

What side effects can this medication cause?

The most common side effects and laboratory abnormalities of this medicine include:

• nausea
• fatigue
• musculoskeletal pain
• mucositis
• alopecia
• vomiting
• diarrhea
• decreased appetite
• abdominal pain
• neuropathy
• headache
• lymphopenia
• neutropenia
• thrombocytopenia
• hyperglycemia
• elevated aPTT
• hypokalemia
• hypophosphatemia

What special precautions should I follow?

• Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO. Monitor for signs and symptoms during and following infusion. Discontinue LARTRUVO for Grade 3 or 4 infusion-related reactions.
• LARTRUVO Can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on LARTRUVO use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of LARTRUVO in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• olaratumab

Inactive ingredients:

• histidine
• histidine monohydrochloride
• glycine
• sodium chloride
• mannitol
• polysorbate 20
• water

Who manufactures and distributes this medicine?

• Packager: Eli Lilly and Company.

What should I know about storage and disposal of this medication?

• Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.
• Keep the vial in the outer carton to protect from light.
• DO NOT FREEZE OR SHAKE the vial.

• Dailymed label info on Olaratumab
• FDA Olaratumab

Olaratumab Resources
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