Copies of letters sent to healthcare professionals in December 2013, to inform of new safety information and advice.
|
Date sent |
Medicine |
Safety information |
|---|---|---|
|
2 December 2013 |
Iclusig ▼ (ponatinib) |
Do not use ponatinib in people with a history of myocardial infarction or stroke, unless the benefit of treatment outweighs the risk. Assess cardiovascular status and manage cardiovascular risk factors (e.g. hypertension) before starting treatment with ponatinib. Continue to monitor and optimise cardiovascular status during treatment. |
|
3 December 2013 |
Efient (prasugrel) |
In order to minimise bleeding risk, the loading dose of prasugrel should only be given at the time of PCI in people with unstable angina/non-ST elevation myocardial infarction, when coronary angiography is performed within 48 hours after admission. |
|
12 December 2013 |
Temodal (temozolomide) |
Hepatic injury, including hepatic failure with fatal outcome, has been reported in patients treated with temozolomide. Liver function should be tested before and during treatment. Carefully consider the benefits of continuing treatment versus the risk of potentially severe liver injury if patients develop significant liver-function abnormalities. |
|
13 December 2013 |
Xeloda (capecitabine) |
Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine. Some cases were fatal. Capecitabine should be discontinued if these types of reactions occur, and the reaction should be treated promptly. |
|
16 December 2013 |
Arzerra (ofatumumab) |
All patients should be screened for hepatitis B virus infection before starting treatment. Patients with active infection should not be treated with ofatumumab. Those with positive hepatitis B serology should be referred to a specialist in liver disease for consultation about monitoring and initiation of antiviral treatment. If reactivation of hepatitis B virus occurs, ofatumumab and any concomitant chemotherapy should be interrupted immediately, and appropriate treatment instituted. |
|
17 December 2013 |
Increlex (mecasermin) |
Supply shortage resolved. Please limit initial prescriptions to one month to ensure an orderly return to normal supply levels. Dose should be titrated as if starting treatment for the first time while taking into account people’s clinical history with mecasermin treatment |
