TECVAYLI 90 MGML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TECLISTAMAB

متاح من:

J-C HEALTH CARE LTD

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

TECLISTAMAB 90 MG / 1 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JANSSEN BIOLOGICS B.V, THE NETHERLAND

الخصائص العلاجية:

TECVAYLI is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

تاريخ الترخيص:

2023-06-29

نشرة المعلومات

TECVAYLI
(TECLISTAMAB)
PATIENT CARD
Please carry this card with you regularly.
SHOW THIS CARD to any healthcare professional
involved in your care, and upon arrival at the hospital
TECVAYLI can cause side effects that could be severe and
life-threatening, such as cytokine release syndrome (CRS),
a severe immune response that can be triggered by various
factors and a variety of medicines. In addition, TECVAYLI can
affect the nervous system, leading to immune effector cell-
associated neurotoxicity syndrome (ICANS).
PATIENT’S NAME:
___________________________________________
IMPORTANT SAFETY INFORMATION FOR PATIENTS
SEEK IMMEDIATE MEDICAL HELP IF YOU EXPERIENCE ANY OF THE FOLLOWING:
•
Confusion
•
Sensation of altered alertness
•
Difficulty speaking and writing (including
changes in handwriting)
•
Muscle weakness, slow movements,
difficulty walking
•
Seizures
•
Memory impairment
•
Fever (38°C or higher)
•
Chills
•
Fast heartbeat
•
Difficulty breathing
•
Nausea
•
Headache
•
Feeling dizzy
_These are some of the possible effects on _
_the nervous system; some of them may be _
_signs and symptoms of (ICANS)_
_These may be signs and _
_symptoms of a serious _
_immune reaction (CRS)_
If you have ANY of the symptoms listed on this card, call your
doctor or seek emergency medical attention right away! These
are not all the possible side effects of TECVAYLI. Tell your doctor
if you have any side effect that bothers you or does not go away.
IMPORTANT TO REMEMBER: STAY CLOSE TO A TREATMENT
CENTER FOR TWO DAYS AFTER RECEIVING THE FIRST THREE DOSES OF
TECVAYLI (USUALLY TWO DOSES OF STEP-UP DOSING AND ONE
MAINTENANCE DOSE).Your doctor may instruct you to stay near
the treatment center for additional periods of time.
TREATING PHYSICIAN
TREATING PHYSICIAN’S
PHONE NUMBER:
____________________
TREATING PHYSICIAN’S
NAME:
____________________
PHONE NUMBER:
____________________
HOSPITAL NAME AND
ADDRESS:
____________________
INFORMATION FOR HEALTHCARE TEAM TO FILL IN
Please give this card to your healthc

خصائص المنتج

1
Tecvayli-10mg_ml_90mg_ml_solution for injection_PI_12_2023
1.
NAME OF THE MEDICINAL PRODUCT
TECVAYLI 10 mg/mL
TECVAYLI 90 mg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TECVAYLI 10 mg/mL solution for injection
One 3 mL vial contains 30 mg of teclistamab (10 mg/mL).
TECVAYLI 90 mg/mL solution for injection
One 1.7 mL vial contains 153 mg of teclistamab (90 mg/mL).
Teclistamab is a humanised immunoglobulin G4-proline, alanine, alanine
(IgG4-PAA) bispecific
antibody directed against the B cell maturation antigen (BCMA) and CD3
receptors, produced in a
mammalian cell line (Chinese hamster ovary [CHO]) using recombinant
DNA technology.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is colourless to light yellow, with a pH of 5.2 and
osmolarity of approximately
296 mOsm/L (10 mg/mL solution for injection), and approximately 357
mOsm/L (90 mg/mL solution
for injection).
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
TECVAYLI is indicated as monotherapy for the treatment of adult
patients with relapsed and
refractory multiple myeloma, who have received at least three prior
therapies, including an
immunomodulatory agent, a proteasome inhibitor, and an anti-CD38
antibody and have demonstrated
disease progression on the last therapy.
4.2
Posology and method of administration
Treatment with TECVAYLI should be initiated and supervised by
physicians experienced in the
treatment of multiple myeloma.
Patient safety information card
The marketing of TECVAYLI is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment.
Please explain to the patient the need to review the card before
starting treatment.
2
Tecvayli-10mg_ml_90mg_ml_solution for injection_PI_12_2023
TECVAYLI should be administered by a healthcare professional with
adequately trained medical
personnel and approp