TECVAYLI 90 mg/mL solution for injection

Section 2 - has been updated as follows:

Warnings and precautions

Talk to your doctor or nurse before you are given TECVAYLI if you 

• have had a stroke or seizure within the past 6 months.

• have ever had or might now have a hepatitis B infection. This is because TECVAYLI could cause hepatitis B virus to become active again. Your doctor will check you for signs of this infection before, during and for some time after treatment with TECVAYLI. Tell your doctor or nurse if you get worsening tiredness, or yellowing of your skin or white part of your eyes.

At any time during or after your treatment, tell your doctor or nurse immediately if you

• notice any new or worsening symptoms of Progressive Multifocal Leukoencephalopathy (PML). PML is a serious and potentially fatal brain infection. Symptoms may include, but are not limited to, blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.

Section 4. Possible Side Effects, sub section 'Serious side effects' has been updated as follows:

Uncommon (may affect up to 1 in 100 people):

• a serious and potentially fatal brain infection called Progressive Multifocal Leukoencephalopathy (PML). Some of the symptoms are:

o blurred, loss of or double vision

o difficulty speaking

o weakness in an arm or a leg

o a change in the way you walk or problems with your balance

o persistent numbness

o decreased sensation or loss of sensation

o memory loss or confusion

Section 4.4 has been updated as follows:

Infections

Severe, life-threatening, or fatal infections have been reported in patients receiving TECVAYLI (see section 4.8). New or reactivated viral infections occurred during therapy with TECVAYLI. Progressive multifocal leukoencephalopathy (PML) has also occurred during therapy with TECVAYLI.

Patients should be monitored for signs and symptoms of infection prior to and during treatment with TECVAYLI and treated appropriately. Prophylactic antimicrobials should be administered according to local institutional guidelines.

TECVAYLI step-up dosing schedule should not be administered in patients with active infection. For subsequent doses, TECVAYLI should be withheld as indicated in Table 3 (see section 4.2).

Progressive Multifocal Leukoencephalopathy (PML), which can be fatal, has also been reported in patients receiving TECVAYLI. Patients should be monitored for any new onset of or changes in pre existing neurological signs or symptoms. If PML is suspected, treatment with TECVAYLI should be withheld and appropriate diagnostic testing initiated. If PML is confirmed, TECVAYLI must be discontinued.

Section 4.8

Table 6 has been updated to add Progressive Multifocal Leukoencephalopathy, with frequency uncommon.

Change to section 4.2 - Posology and method of administration

Refer to Tables 9, 10 and 11 to determine the dosage based on predetermined weight ranges (see section 6.6).

Update Table 2

Change to section 4.8 - Undesirable effects

Addition of very common and common side effects

Change to section 5.1 - Pharmacodynamic properties

Addition of following information: "Results of an updated efficacy analysis after a median follow-up of 30.6 months among responders (n=104) showed a higher proportion of patients with CR (7.3%) and sCR (38.8%) compared with the primary analysis. MRD negativity rates also increased in all treated patients (29.1%) and in patients achieving CR or sCR (51.3%). The median DOR was 24.0 (17.0, NE) months. "

Addition of following side effects:

Very common:

•  urinary tract infection,
• stomach pain (abdominal pain),  
• muscle spasms,
• low blood pressure (hypotension) ·             

Common:

•   low level of sugar in the blood (hypoglycaemia)

EMA/H/C/5864/IB/013G: Addition of Beerse as a batch release site.

EMA/H/C/5864/IB/013G:

6.3 Shelf life 

 Unopened vial 

 18 months2 years 

Updated to inform and explain to patients the risks of CRS and nervous system toxicity, including ICANS.

Updated to inform and explain to patients the risks of CRS and nervous system toxicity, including ICANS.

ICANs Update

ICANs Update

Tecvayli Posology update Q2W dosing.

Tecvayli Posology update Q2W dosing.