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Redditux 100mg / 10ml injection

Ferron Par Pharmaceuticals

Ingredients in every 10 ml

Rituximab 100 mg

Each package contains

1 vial of 10 ml

Dosage form

injection

Dosage formInjection

Flavour

None

W.H.O. classification

L01X
L01X

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01X

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01X

A.T.C. Level 3

Pharmacological subgroup

L01X - Other Antineoplastic Agents in ATC

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

Non-Hodgkin's Lymphoma
Redditux is indicated for the treatment of patients with relapsed or chemoresistant low grade or follicular, CD20 positive B-cell Non-Hodgkin's Lymphoma. Redditux is indicated for the treatment of patients with stage III – IV follicular lymphoma in combination with CVP chemotherapy. Redditux is indicated for patients with follicular lymphoma as maintenance treatment, after response to induction therapy. Redditux is indicated for the treatment of patients with CD20 positive diffuse large B-cell Non-Hodgkin's Lymphoma in combination with CHOP therapy.
Chronic Lymphocytic Leukemia
Redditux in combination with Fludarabine and Cyclophosphamide is indicated for the treatment of patients with previously untreated and relapsed/refractory Chronic Lymphocytic Leukemia.

Dosage

18 YEARS OLD AND ABOVE
• Follicular non-Hodgkin's lymphoma
Combination therapy
The recommended dose of rituximab in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m² body surface area per cycle, for up to 8 cycles. Rituximab should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.

Maintenance therapy
— Previously untreated follicular lymphoma:
The recommended dose of rituximab used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is: 375 mg/m² body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.
— Relapsed/refractory follicular lymphoma:
The recommended dose of rituximab used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m² body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.

Monotherapy
— Relapsed/refractory follicular lymphoma
The recommended dose of rituximab monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m² body surface area, administered as an intravenous infusion once weekly for four weeks.

— For retreatment with rituximab monotherapy for patients who have responded to previous treatment with rituximab monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m² body surface area, administered as an intravenous infusion once weekly for four weeks.


• Diffuse large B cell non-Hodgkin's lymphoma
Rituximab should be used in combination with CHOP chemotherapy. The recommended dosage is 375 mg/m² body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP. Safety and efficacy of rituximab have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.

Dose adjustments during treatment
No dose reductions of rituximab are recommended. When rituximabis given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.


• Chronic lymphocytic leukaemia
Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome. For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with rituximab to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.

The recommended dosage of rituximab in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m² body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m² body surface area administered on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after rituximab infusion.

Rituximab should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available.
Premedication with glucocorticoids should be considered if rituximab is not given in combination with glucocorticoids-containing chemotherapy for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
Premedication consisting of an antipyretic and an antihistamine, e.g. paracetamol and diphenhydramine, should always be given before each administration of rituximab.

65 YEARS OLD AND ABOVE
No dose adjustment is required in elderly patients

Rituximab should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available.
Premedication with glucocorticoids should be considered if rituximab is not given in combination with glucocorticoids-containing chemotherapy for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
Premedication consisting of an antipyretic and an antihistamine, e.g. paracetamol and diphenhydramine, should always be given before each administration of rituximab.