Libtayo TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: cemiplimab
Pack: Libtayo 350 mg/7 mL injection, 7 mL vial
Brand name
(ARTG)
: LIBTAYO cemiplimab 350 mg concentrate for solution for infusionDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
Cutaneous Squamous Cell Carcinoma,LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.Non-Small Cell Lung Cancer,LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 tumour proportion score (TPS) greater than and equal to 50% as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have:, locally advanced NSCLC and who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.,LIBTAYO in combination with platinum-based chemotherapy is indicated for the first-line treatment of patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and is:, locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or, metastatic.Basal Cell Carcinoma,LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, intravenous infusion
- Intravenous Infusion
- Clear to slightly opalescent, colourless to pale yellow solution. May contain trace amounts of translucent to white particles in a single-use vial
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- Refrigerate
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 1 vial pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on November, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient cemiplimab
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
