What it is used for

Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or who have no satisfactory alternative therapy. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

• Store below 25 degrees Celsius
• Shelf lifetime is 36 Months.

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.

Visual appearance

White opaque hard gelatin capsule, size 2, with blue printing of BAYER cross and 25 mg on body of capsule

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine. open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on April 1, 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient larotrectinib

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.

What it is used for

Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or who have no satisfactory alternative therapy. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

• Store at 2 to 8 degrees Celsius
• Refrigerate
• Do not Freeze
• Shelf lifetime is 24 Months.

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.

Visual appearance

100 mL clear yellow to orange liquid solution

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine. open tool tip to find out more

Pregnant or planning a pregnancy?

For the active ingredient larotrectinib

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.

What it is used for

Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or who have no satisfactory alternative therapy. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

• Store at 2 to 8 degrees Celsius
• Refrigerate
• Do not Freeze
• Shelf lifetime is 24 Months.

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.

Visual appearance

Colourless to yellow or orange or red or brownish liquid solution

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine. open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on April 1, 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient larotrectinib

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.

What it is used for

Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or who have no satisfactory alternative therapy. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

• Store at 2 to 8 degrees Celsius
• Refrigerate
• Do not Freeze
• Shelf lifetime is 24 Months.

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.

Visual appearance

Colourless to yellow or orange or red or brownish liquid solution

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine. open tool tip to find out more

Pregnant or planning a pregnancy?

For the active ingredient larotrectinib

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.