Finished product reference
Olaratumab
Injection · Parenteral · 10 mg/1mL · 50 mL
- List code
- 51027
- Pharmacologic class
- Antineoplastic; anti-PDGFR-alpha monoclonal antibody
What it is and how it works
Olaratumab is a human IgG1 monoclonal antibody that binds platelet-derived growth factor receptor alpha (PDGFR-α), blocking ligand binding and receptor activation involved in tumour growth and the tumour stroma.
Indications
Previously authorised in combination with doxorubicin for advanced soft tissue sarcoma not amenable to surgery or radiotherapy; marketing authorisations were withdrawn in 2019 after the confirmatory phase III trial failed to show a survival benefit.
Dosage and administration (summary)
Dosing was individualised by the oncologist: intravenous infusion on days 1 and 8 of each 21-day cycle according to body weight and protocol.
Contraindications
Hypersensitivity to olaratumab.
Warnings and precautions
Infusion-related reactions, including severe reactions mostly with the first infusion, require premedication and monitoring. Neutropenia and musculoskeletal pain are common with doxorubicin combination therapy. Because efficacy was not confirmed, use outside clinical trials or specific access programmes is not recommended.
Pregnancy
Avoid; PDGFR-α signalling is involved in fetal development, and contraception is advised.
Storage and supply
Store at 2–8 °C in a refrigerator; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.