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Winglore 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: ipilimumab

Brand name

(ARTG)

: WINGLORE ipilimumab (rch) 50mg in 10mL (5mg/mL) concentrate solution for IV infusion vial

What this medicine is used for

(ARTG)

Melanoma,WINGLORE, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma. WINGLORE, in combination with nivolumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,Renal Cell Carcinoma (RCC),WINGLORE, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,Non-Small Cell Lung Cancer (NSCLC),WINGLORE, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.,Malignant Pleural Mesothelioma (MPM),WINGLORE, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,Oesophageal Squamous Cell Carcinoma (OSCC),WINGLORE in combination with nivolumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression equal to or greater than 1% as determined by a validated test.,Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) Colorectal Cancer (CRC),WINGLORE in combination with nivolumab is indicated for the treatment of adult patients with unresectable or metastatic colorectal cancer (CRC) that is MSI-H or dMMR as determined by a validated test.,Hepatocellular Carcinoma (HCC),WINGLORE, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, concentrated
  • Intravenous
  • Clear to slightly opalescent, colourless to pale yellow aqueous solution. May contain particles.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Shelf lifetime is 3 Years.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • One 10mL glass vial containing 50mg ipilimumab pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient ipilimumab

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

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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