TECVAYLI 90 mg/mL solution for injection
*Company:
Janssen Sciences IrelandStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 August 2024
File name
EN-Tecvayli-20240711-PIL-clean-approved_EDMS-RIM-378075_44.0.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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
Updated on 21 August 2024
File name
EN-Tecvayli-20240711-SPC-clean-approved_EDMS-RIM-378075_44.0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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.
Updated on 27 June 2024
File name
Tecvayli SmPC - NI and IE - MajesTEC1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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. "
Updated on 27 June 2024
File name
Tecvayli PIL - NI and IE - MajesTEC1.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
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)
Updated on 06 June 2024
File name
EN-Tecvayli-20240528-IE PIL-IB-013-clean-approved_EDMS-RIM-378075_40.0.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
EMA/H/C/5864/IB/013G: Addition of Beerse as a batch release site.
Updated on 06 June 2024
File name
EN-Tecvayli-20240528-IE-SmPC-IB-013-clean-approved_EDMS-RIM-378075_40.0.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMA/H/C/5864/IB/013G:
6.3 Shelf life
Unopened vial
18 months2 years
File name
Tecvayli Patient Card_EM-148252_Feb 2024.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Updated to inform and explain to patients the risks of CRS and nervous system toxicity, including ICANS.
File name
Tecvayli Patient Card_EM-148252_Feb 2024.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Updated to inform and explain to patients the risks of CRS and nervous system toxicity, including ICANS.
Updated on 19 December 2023
File name
EN-Tecvayli-20231207-ICANs Update -clean-approved_SmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
ICANs Update
Updated on 19 December 2023
File name
EN-Tecvayli-20231207-ICANs Update -clean-approved_PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
ICANs Update
Updated on 21 August 2023
File name
IE and NI - EN-Tecvayli-Patient Information Leaflet - Biweekly Dosing.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Free text change information supplied by the pharmaceutical company
Tecvayli Posology update Q2W dosing.
Updated on 21 August 2023
File name
IE and NI - EN-Tecvayli-SmPC - Biweekly Dosing.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Tecvayli Posology update Q2W dosing.
File name
Tecvayli Patient Card_EM-128613_April 2023.pdf
Reasons for updating
- Add New Doc
Updated on 28 July 2023
File name
Tecvayli IE SPC_22.06.2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2023
File name
Tecvayl_IE PIL_22 June 2023.pdf
Reasons for updating
- New PIL for new product