RituxiRel Rituximab 500mg

[Drug Name] Rituximab Injection

[Generic Name] Rituximab Injection

[Composition] In addition to the active ingredient, this product contains the following inactive ingredients: sodium citrate, polysorbate 80, sodium chloride, and water for injection.

[Indications] Indicated for patients with relapsed or chemotherapy-refractory B-cell non-Hodgkin's lymphoma.

[Packaging Specifications] 100 mg/50 mL

[Dosage and Administration] Adults: As monotherapy for adult patients, the recommended dose is 375 mg/m² of body surface area, administered intravenously once weekly for a total of four doses; suitable for outpatient use. Analgesics (e.g., acetaminophen) and antihistamines (e.g., diphenhydramine hydrochloride) may be administered 60 minutes prior to the infusion of this product. The recommended initial infusion rate is 50 mg/h; this rate may be increased by 50 mg/h every 30 minutes thereafter, up to a maximum of 400 mg/h. If an allergic reaction or an infusion-related reaction occurs, the infusion rate should be temporarily slowed or the infusion stopped. If the patient's symptoms improve, the infusion rate may be increased by half. For subsequent infusions, the initial rate may be 100 mg/h, increasing by 100 mg/h every 30 minutes, up to a maximum of 400 mg/h. The prepared infusion solution should not be administered as an intravenous bolus or rapid infusion. Pediatrics: The safety and efficacy of this product in pediatric patients have not been established.

[Adverse Reactions] The following adverse reactions were observed in clinical trials. Most of these patients had received multiple prior therapies and had a poor prognosis; therefore, the adverse reactions listed herein are not necessarily attributable to treatment with this product. Infusion-related symptoms typically manifest initially as fever and chills, occurring predominantly during the first infusion, usually within 2 hours. Other subsequent symptoms include nausea, urticaria/rash, fatigue, headache, pruritus, bronchospasm/dyspnea, angioedema (edema of the tongue or larynx), rhinitis, vomiting, transient hypotension, flushing, arrhythmia, and tumor pain. The second most common adverse events involve the exacerbation of pre-existing cardiac conditions, such as angina pectoris and congestive heart failure. Adverse reactions to the medication tend to diminish as the infusion continues. A small number of patients experience hemorrhagic side effects, which are typically mild and reversible. The incidence of severe thrombocytopenia and neutropenia is 1.8%, while the incidence of severe anemia is 1.4%. Although this medication can induce B-lymphocyte depletion and is associated with a reduction in serum immunoglobulins, the incidence of infection in patients is no higher than expected; furthermore, the occurrence of severe infections is significantly lower than that observed with conventional chemotherapy. During the treatment period and within one year following treatment, the incidence of infection among patients was 17% and 12%, respectively; these infections were generally common, non-opportunistic, and mild in nature. As a monotherapy, this medication did not induce clinically significant hepatotoxicity or nephrotoxicity; only mild, transient elevations in liver function parameters were observed. Adverse reactions occurring in more than 1% of patients are listed below: General Disorders: abdominal pain, back pain, chest pain, neck pain, malaise, abdominal distension, pain at the infusion site. Cardiovascular System: hypertension, bradycardia, tachycardia, orthostatic hypotension, vasodilation. Gastrointestinal System: diarrhea, dyspepsia, anorexia. Hematologic and Lymphatic Systems: leukopenia, lymphadenopathy. Metabolic and Nutritional Disorders: hyperglycemia, peripheral edema, elevated LDH, generalized edema, weight loss, facial edema, hypocalcemia, hyperuricemia. Musculoskeletal System: arthralgia, myalgia, bone pain, hypertonia. Nervous System: dizziness, anxiety, depression, paresthesia, agitation, insomnia, nervousness, somnolence, neuritis. Respiratory System: cough, asthma, laryngospasm. Skin and Appendages: night sweats, diaphoresis, dry skin. Special Senses: lacrimal gland disorders, ear pain, dysgeusia. Genitourinary System: dysuria, hematuria. Other serious adverse reactions occurring in less than 1% of patients include: coagulation disorders; elevated creatine phosphokinase, hypercalcemia; spontaneous fractures; and recurrence of skin tumors. [Contraindications] Contraindicated in patients with known hypersensitivity to any component of this product or to murine proteins. Contraindicated in nursing women and children.

[Precautions] Transient hypotension and bronchospasm have been observed in association with treatment using this medication. The risk of bronchospasm may be increased in patients with a history of pulmonary disease. In such cases, the infusion of this medication should be temporarily discontinued, and analgesics, anti-allergic agents, or—if necessary—intravenous saline or bronchodilators should be administered; these measures typically alleviate the symptoms. Since transient hypotension may occur during the infusion of this medication, consideration should be given to withholding antihypertensive therapy for 12 hours prior to, and during, the infusion; patients with a history of cardiac disease (e.g., angina pectoris, arrhythmia, or heart failure) should be closely monitored. Patients receiving intravenous protein-based therapies may experience anaphylactoid or hypersensitivity reactions. If an allergic reaction occurs during the use of this medication, appropriate anti-allergic treatment—such as epinephrine, antihistamines, and corticosteroids—should be administered. Caution should be exercised when administering this medication to patients with a neutrophil count of less than 1.5 x 10^9/L and/or a platelet count of less than 7.5 x 10^10/L, as clinical experience with this medication in such patient populations is limited. During treatment with this medication, it is advisable to periodically monitor complete blood cell counts, including platelet counts. Effects on Ability to Drive and Operate Machinery: It is currently unknown whether rituximab affects the ability to drive or operate machinery; however, reports regarding its pharmacological effects and adverse reactions to date do not suggest such an impact.

[Drug Interactions] To date, there have been no reports of interactions between this medication and other drugs. In patients with detectable titers of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA), the subsequent administration of other diagnostic or therapeutic monoclonal antibodies may precipitate allergic or hypersensitivity reactions.

[Pharmacological Action] Rituximab is a chimeric murine/human monoclonal antibody that specifically binds to the transmembrane CD20 antigen. This antigen is located on pre-B and mature B lymphocytes but is absent from hematopoietic stem cells, post-B cells, normal plasma cells, or other normal tissues. The antigen is expressed in over 95% of B-lymphocyte-type non-Hodgkin's lymphomas. Upon binding with an antibody, CD20 is neither internalized nor shed from the cell membrane. CD20 does not circulate in the plasma as a free antigen; therefore, it does not compete with the antibody for binding sites. Rituximab binds to CD20 on B lymphocytes and triggers an immune response resulting in B-cell lysis. Possible mechanisms of cell lysis include complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC). Furthermore, in vitro studies have demonstrated that rituximab can sensitize drug-resistant human lymphocytes to the cytotoxic effects of certain chemotherapeutic agents.

Product Specifications

Product Name: Rituximab Injection (MabThera) 100 mg/50 mL | RituxiRel Rituximab

Common Name: MabThera

Composition: In addition to the active ingredient, this medication contains the following inactive ingredients: sodium citrate, polysorbate 80, sodium chloride, and water for injection.

Dosage Form: Injection Solution

Specification: 100 mg/50 mL

Manufacturer: Reliance Life Sciences

Indications: Indicated for patients with relapsed or chemotherapy-resistant B-lymphocyte-type non-Hodgkin's lymphoma.

Dosage and Administration: For adult patients receiving this medication as monotherapy, the recommended dose is 375 mg per square meter of body surface area, administered intravenously once weekly for a total of four doses; this regimen is suitable for outpatient use. Analgesics (e.g., acetaminophen) and antihistamines (e.g., diphenhydramine hydrochloride) may be administered 60 minutes prior to the infusion of this medication. The recommended initial infusion rate is 50 mg/hr; this rate may subsequently be increased by 50 mg/hr every 30 minutes, up to a maximum rate of 400 mg/hr. If hypersensitivity reactions or infusion-related reactions occur, the infusion rate should be temporarily slowed down or the infusion should be discontinued. If the patient's symptoms improve, the infusion rate may be increased by 50%. Subsequent infusion rates may be initiated at 100 mg/hr, increased by 100 mg/hr every 30 minutes, up to a maximum of 400 mg/hr. The prepared infusion solution should not be administered via IV push or rapid infusion. Pediatrics: The safety and efficacy of this medication in children have not been established.