Olaratumab

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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?

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:

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.

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.

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