EMA makes new recommendations for Imbruvica, medicines with terlipressin over respiratory and cardiovascular risks
The EMA is handing out a new recommendation surrounding J&J and AbbVie’s cancer drug Imbruvica and some medicines containing terlipressin.
On Friday, the EMA’s safety committee (PRAC) stated that it has taken new measures to reduce the risk of respiratory failure and sepsis when medicines containing terlipressin that are used to treat people with hepatorenal syndrome (HRS-1), particularly for patients with advanced acute-on-chronic liver disease or advanced kidney failure.
Healthcare officials should consider giving medicines containing terlipressin on a drip as it may reduce any side effects as well as monitoring any patients for signs of reparatory failure, according to the committee.
This move stems from the safety committees’ review of a clinical trial involving patients with HRS-1 which showed that those treated with these medicines were more likely to experience and possibly die from reparatory disorders within 90 days than those with a placebo. However, limitations were noted in the data including differences in how terlipressin was used in the trials compared to the actual clinical space. But combining this with data on hand convinced the PRAC to take new measures.
The medicines are available in most EU member states under several names including glypressin, terlipressin acetate and variquel.
However, that is not the only medicine that the EMA is raising concerns about. It is also letting healthcare providers know of an increased risk of serious and deadly cardiac arrhythmias and cardiac failure with the use of Imbruvica.
While the drug from J&J and AbbVie is meant to treat people with blood cancers, the EMA said that patients with “advanced age” may be at a greater risk of cardiac events that may be fatal.
The PRAC is advising that an evaluation of cardiac history should be conducted before starting treatment. Patients that are at risk should be assessed before treatment starts and possible alternatives may be considered and should not be given to anyone with onset or worsening of grade two cardiac failure or grade three cardiac arrhythmias.
Brian Kenney, the global therapeutic area and cross-sector oncology communication leader at Janssen R&D, said in an email to Endpoints News the company had recently updated the Imbruvica SmPC to provide further information for healthcare professionals about monitoring and managing patients with cardiac risks along with specific guidance related to dose modifications for patients.
“We continually monitor patient safety and, working closely with the EMA, update our label guidance accordingly as additional clinical trial data and real-world experience is accumulated. We are confident in the benefit/risk profile of Imbruvica, which has been used to treat more than 250,000 patients worldwide with complex B-cell blood cancers,” Kenney said in the email.
Imbruvica is a major drug for J&J and AbbVie, when data on the BTK inhibitor was revealed at ASCO in June, it kept a rare and aggressive form of cancer back, in combination with two other drugs, for more than six years, however, investigators did not see a significant difference in overall survival. Last month, it also won approval in a pediatric population as it netted approval as a second-line treatment for chronic graft versus host disease (cGVHD) in children one year and older.