Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
INOTUZUMAB OZOGAMICIN
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XC26
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
INOTUZUMAB OZOGAMICIN 1 MG/VIAL
I.V
Required
PHARMACIA & UPJOHN COMPANY , USA
INOTUZUMAB OZOGAMICIN
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
2023-08-31
pfizer pharmaceuticals Israel | office:09-9700500 | fax:09-9700501 | www.pfizer.co.il PP-INO-ISR-0010 ® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION This card contains select safety information that is important for you to know before and during treatment with BESPONSA. This card does not contain information about all of the side effects that you could experience during treatment with BESPONSA. Besponsa Patient Information Card Additional safety information that requires special attention The use of BESPONSA is linked to several additional side effects. You should contact your physician immediately if you have signs and symptoms of any of the following serious side effects: ● Suppressed immune system: Signs and symptoms include infection, fever, tendency to bruise easily or regular nose bleeds. A suppressed immune system condition may be expressed by a low number of blood cells known as neutrophils (occasionally accompanied by a fever), red blood cells, white blood cells, lymphocytes or blood components known as platelets. ● Infusion-related reactions: Signs and symptoms include fever and chills or breathing difficulties during or shortly after the BESPONSA infusion. ● Tumor lysis syndrome: This effect may be related to a wide range of symptoms in the stomach and intestines (for example: nausea, vomiting, diarrhea), the heart (for example: changes in regularity of the heart rate), the kidneys (for example: decreased urine output, blood in urine), and nerves and muscles (for example: spasms, cramps or muscle weakness). ● QT interval prolongation: Signs and symptoms include dizziness or fainting. Not all patients will respond to BESPONSA in the same way. Some people might experience more side effects than others and some not. Certain side effects may be mild and appear for a short time and others may be more severe and require medical care. Please speak to your medical team if you suffer from any side effects during treatment with BESPONSA, including side effects not specified on this card. For full in Soma hati kamili
Besponsa LPD, WC Israel, 25 Apr 2022 2021-0073929 1 1. NAME OF THE MEDICINAL PRODUCT BESPONSA powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg inotuzumab ozogamicin. After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin. Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to off-white, lyophilised cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph + ) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. When considering the use of BESPONSA as a treatment for relapsed or refractory B cell ALL, baseline CD22 positivity of > 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1). For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count ≤ 10,000/mm 3 is recommended prior to the first dose. PATIENT SAFETY INFORMATION CARD The marketing of Besponsa is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety inf Soma hati kamili