دواعي استعمال ريكساثون 100مجم/10مل 2 فيال وريد

معلومات من نشرات دوائية ومراجع موثقة، مع مصدر كل معلومة. السعر الحالي: 6,321ج.م.

دواعي الاستعمال

Non-Hodgkin's lymphoma: previously untreated stage III-IV follicular lymphoma with chemotherapy; maintenance in follicular lymphoma responding to induction; monotherapy for chemoresistant or relapsed stage III-IV follicular lymphoma; CD20-positive diffuse large B-cell lymphoma with CHOP.الفئة: Adultselectronic medicines compendium (emc)
Previously untreated advanced CD20-positive DLBCL, Burkitt lymphoma/leukaemia or Burkitt-like lymphoma in combination with chemotherapy.الفئة: Paediatric patients aged 6 months to under 18 yearselectronic medicines compendium (emc)
Chronic lymphocytic leukaemia, previously untreated or relapsed/refractory, in combination with chemotherapy.الفئة: Adultselectronic medicines compendium (emc)
Severe active rheumatoid arthritis with inadequate response or intolerance to other DMARDs including one or more TNF inhibitors, in combination with methotrexate.الفئة: Adultselectronic medicines compendium (emc)
Severe active granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis, induction of remission with glucocorticoids.الفئة: Adults and paediatric patients 2 years and olderelectronic medicines compendium (emc)
Moderate to severe pemphigus vulgaris.الفئة: Adultselectronic medicines compendium (emc)

الآثار الجانبية

Very common adverse reactions include infusion-related reactions, bacterial and viral infections, neutropenia, leukopenia, nausea, pruritus, rash, alopecia, fever, chills, asthenia, headache and decreased IgG levels.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

موانع الاستعمال

Hypersensitivity to the active substance, to murine proteins or to any excipient.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Active, severe infections; patients in a severely immunocompromised state.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Rheumatoid arthritis, GPA, MPA and pemphigus vulgaris: severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

تحذيرات واحتياطات

Progressive multifocal leukoencephalopathy (PML), including fatal cases, has been reported; monitor for new or worsening neurological symptoms.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Infusion-related reactions, including cytokine release syndrome, can be severe or fatal, particularly with the first infusion; patients with high tumour burden or high circulating malignant cell counts are at higher risk.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Hepatitis B virus screening should be performed in all patients before starting treatment; HBV reactivation, including fatal cases, has been reported.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Cardiac disorders (angina, arrhythmias, heart failure, myocardial infarction) reported; monitor patients with a history of cardiac disease closely. Live viral vaccines are not recommended during treatment or while B-cell depleted.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

التداخلات الدوائية

Live vaccinesVaccination with live virus vaccines is not recommended during treatment or while peripherally B-cell depleted.electronic medicines compendium (emc)

الحمل والرضاعة

IgG crosses the placenta and B-cell depletion has been detected in infants exposed in utero; do not administer to pregnant women unless the possible benefit outweighs the potential risk.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Women of childbearing potential must use effective contraception during and for 12 months after treatment.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
Women should not breast-feed while being treated and for 6 months after rituximab treatment.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

كيف يعمل الدواء

Chimeric mouse/human monoclonal antibody that binds specifically to the transmembrane antigen CD20 on pre-B and mature B lymphocytes, mediating B-cell lysis via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and induction of apoptosis (Rixathon SmPC section 5.1).

المصادر