Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
TECLISTAMAB
J-C HEALTH CARE LTD
SOLUTION FOR INJECTION
TECLISTAMAB 10 MG / 1 ML
S.C
Required
JANSSEN BIOLOGICS B.V, THE NETHERLAND
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.
2023-06-29
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 Leggi il documento completo
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 Leggi il documento completo