Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Round shaped (5.8 mm diameter) white to off-white tablet, debossed with I on one side and with 4.5 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Round shaped (5.8 mm diameter) white to off-white tablet, debossed with I on one side and with 4.5 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Oval shaped (10 mm by 5 mm) white to off-white tablet, debossed with I on one side and with 9 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Oval shaped (10 mm by 5 mm) white to off-white tablet, debossed with I on one side and with 9 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Round shaped (8.5 mm diameter) white to off-white tablet, debossed with I on one side and with 13.5 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
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 48 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
Round shaped (8.5 mm diameter) white to off-white tablet, debossed with I on one side and with 13.5 on the other side.
Do I need a prescription?
This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.
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.
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.
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