Individual generic drug information

rituximab

Reference monograph

Part of registered formulation

RITUXIMAB

Reference record: Rituximab
Source: BNF 80 (2020–2021)
Printed source pages: 955, 956, 957
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Rituximab only.

Indications And Dose

Rheumatoid arthritis (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 1 g, then 1 g after 2 weeks, consult product literature for information on retreatment Non-Hodgkin’s lymphoma (specialist use only) | Chronic lymphocytic leukaemia (specialist use only) | Granulomatosis with polyangiitis and microscopic polyangiitis (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature) Non-Hodgkin’s lymphoma (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: (consult product literature) Pemphigus vulgaris (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 1 g, then 1 g after 2 weeks; maintenance 0.5 g, at months 12 and 18, and then every 6 months thereafter if needed, consult product literature for the treatment of relapse

Source page 955

Contra Indications

GENERAL CONTRA-INDICATIONS Severe infection SPECIFIC CONTRA-INDICATIONS ▶When used for granulomatosis with polyangiitis and microscopic polyangiitis, pemphigus vulgaris, or rheumatoid arthritis Severe heart failure. severe, uncontrolled heart disease CONTRA-INDICATIONS, FURTHER INFORMATION For full details on contra-indications, consult product literature.

Source page 955

Cautions

GENERAL CAUTIONS History of cardiovascular disease; exacerbation of angina, arrhythmia, and heart failure have been reported. patients receiving cardiotoxic chemotherapy; exacerbation of angina, arrhythmia, and heart failure have been reported. pre-medication recommended to minimise adverse reactions (consult product literature). predisposition to infection. transient hypotension occurs frequently during infusion (anti- hypertensives may need to be withheld for 12 hours before infusion) SPECIFIC CAUTIONS ▶When used for granulomatosis with polyangiitis and microscopic polyangiitis, or pemphigus vulgaris Pneumocystis jirovecii pneumonia—consult product literature for prophylaxis requirements CAUTIONS, FURTHER INFORMATION For full details on cautions, consult product literature or local treatment protocol. ▶Hepatitis B infection and reactivation Hepatitis B infection and reactivation (including fatal cases) have been reported in patients taking rituximab. Patients with positive hepatitis B serology should be referred to a liver specialist for monitoring and initiation of antiviral therapy before treatment initiation; treatment should not be initiated in patients with evidence of current hepatitis B infection until the infection has been adequately treated. Patients should be closely monitored for clinical and laboratory signs of active hepatitis B infection during treatment and for up to a year following the last infusion (consult product literature).

Source page 955

Prescribing And Dispensing Information

Rituximab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1.

Source page 955

National Funding Access Decisions

NICE decisions ▶Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (March 2014) NICE TA308 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab, in combination with glucocorticoids, is recommended as an option for inducing remission in adults with anti- neutrophil cytoplasmic antibody [ANCA]-associated vasculitis (severely active granulomatosis with polyangiitis [Wegener’s] and microscopic polyangiitis), only if: Immune system and malignant disease . further cyclophosphamide treatment would exceed the maximum cumulative cyclophosphamide dose, or . cyclophosphamide is contra-indicated or not tolerated, or . the patient has not completed their family, and treatment with cyclophosphamide may materially affect their fertility, or . the disease has remained active or progressed despite a course of cyclophosphamide lasting 3–6 months or . the patient has had uroepithelial malignancy. www.nice.org.uk/guidance/ta308 ▶Adalimumab, etanercept, infliximab, rituximab, and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (August 2010) NICE TA195 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab, in combination with methotrexate, is recommended as an option for the treatment of severe active rheumatoid arthritis in adults who have had an inadequate response to, or are intolerant of, other disease-modifying antirheumatic drugs (DMARDs), including at least 1 tumour necrosis factor (TNF) inhibitor. Repeat courses of rituximab should be given no more frequently than every 6 months, and should only be continued if an adequate response is achieved and maintained. www.nice.org.uk/guidance/ta195 ▶Rituximab for the first-line treatment of stage III-IV follicular lymphoma (January 2012) NICE TA243 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab, in combination with: . cyclophosphamide, vincristine and prednisolone (CVP); . cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP); . mitoxantrone, chlorambucil and prednisolone (MCP); . cyclophosphamide, doxorubicin, etoposide, prednisolone and interferon-alfa (CHVPi); or . chlorambucil is recommended as an option for the treatment of symptomatic stage III and IV follicular lymphoma in previously untreated patients. www.nice.org.uk/guidance/ta243 ▶Rituximab for the treatment of relapsed or refractory stage III or IV follicular non-Hodgkin’s lymphoma (February 2008) NICE TA137 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab, in combination with chemotherapy, is recommended as an option for the induction of remission in patients with relapsed stage III or IV follicular non-Hodgkin’s lymphoma. Rituximab monotherapy, as maintenance therapy, is recommended as an option for the treatment of patients with relapsed stage III or IV follicular non- Hodgkin’s lymphoma in remission induced with chemotherapy (with or without rituximab). Rituximab monotherapy is recommended as an option for the treatment of patients with relapsed or refractory stage III or IV follicular non-Hodgkin’s lymphoma, when all alternative treatment options have been exhausted (that is, if there is resistance to or intolerance of chemotherapy). www.nice.org.uk/guidance/ta137 ▶Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia (July 2010) NICE TA193 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab in combination with ﬂudarabine and cyclophosphamide is recommended as a treatment option for patients with relapsed or refractory chronic lymphocytic leukaemia except when the condition: . is refractory to ﬂudarabine (that is, it has not responded to ﬂudarabine, or has relapsed within 6 months of treatment), or . has previously been treated with rituximab, unless it was in the context of a clinical trial, at a dose lower than the dose currently licensed for chronic lymphocytic leukaemia or with chemotherapy other than ﬂudarabine and cyclophosphamide. Rituximab in combination with ﬂudarabine and cyclophosphamide is recommended only in the context of research for patients with relapsed or refractory chronic lymphocytic leukaemia that has previously been treated with rituximab, unless rituximab has been given as speciﬁed above. www.nice.org.uk/guidance/ta193 ▶Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma (June 2011) NICE TA226 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab maintenance therapy is recommended as an option for the treatment of patients with follicular non-Hodgkin’s lymphoma that has responded to ﬁrst-line induction therapy with rituximab in combination with chemotherapy. www.nice.org.uk/guidance/ta226 ▶Rituximab for the first-line treatment of chronic lymphocytic leukaemia (July 2009) NICE TA174 ▶With intravenous use This NICE guidance was issued for rituximab by intravenous infusion. Rituximab, in combination with ﬂudarabine and cyclophosphamide, is recommended as an option for the ﬁrst-line treatment of chronic lymphocytic leukaemia. www.nice.org.uk/guidance/ta174 ▶Idelalisib for treating chronic lymphocytic leukaemia (October 2015) NICE TA359 Rituximab, in combination with idelalisib, is recommended as an option for treatment in adults: . who have untreated chronic lymphocytic leukaemia or . who have chronic lymphocytic leukaemia when the disease has been treated but has relapsed within 24 months and . if the manufacturer provides idelalisib with the discount agreed in the simple discount agreement. Patients who are already receiving idelalisib should continue treatment until they or their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta359 ▶Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia (February 2019) NICE TA561 Venetoclax (Venclyxto ®) with rituximab is recommended, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy. It is recommended only if the manufacturer provides it according to the commercial arrangement. www.nice.org.uk/guidance/ta561 Scottish Medicines Consortium (SMC) decisions SMC No. 894/13 ▶With intravenous use The Scottish Medicines Consortium has advised (August 2013) that Rituximab (MabThera ®) is accepted for restricted use within NHS Scotland, in combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis. It is restricted to use in patients who have relapsed following treatment with cyclophosphamide or who are intolerant to or unable to receive cyclophosphamide. SMC No. 975/14 ▶With subcutaneous use The Scottish Medicines Consortium has advised (June 2014) that subcutaneous rituximab (MabThera) ® is accepted for restricted use within NHS Scotland, in accordance with UK licensing, except in the maintenance setting, where use is restricted to patients who have responded to induction therapy with rituximab plus chemotherapy.

Source pages 956, 957

Safety

Extracted information for Rituximab only.

Interactions

→Appendix 1: monoclonal antibodies

Source page 955

Side Effects

▶Common or very common Angioedema. anxiety. appetite decreased. arrhythmias. bone marrow disorders. bursitis. cancer pain. cardiac disorder. chest pain. chills. dizziness . dysphagia. dyspnoea. ear pain. electrolyte imbalance. gastrointestinal discomfort. gastrointestinal disorders. hepatitis B. hypercholesterolaemia. hyperglycaemia. hyperhidrosis. hypertension. hypotension. insomnia. Immune system and malignant disease lacrimation disorder. malaise. migraine. multi organ failure. muscle complaints. muscle tone increased. nausea. nerve disorders. oedema. oral disorders. osteoarthritis. respiratory disorders. sensation abnormal. sepsis. skin reactions. throat irritation. tinnitus. vasodilation. weight decreased ▶Uncommon Asthma. coagulation disorder. heart failure. hypoxia. ischaemic heart disease. lymphadenopathy. taste altered ▶Rare or very rare Cytokine release syndrome. facial paralysis. renal failure. Stevens-Johnson syndrome (discontinue). toxic epidermal necrolysis (discontinue). tumour lysis syndrome. vasculitis. vision disorders ▶Frequency not known Epistaxis. hearing loss. hypogammaglobulinaemia. infective thrombosis. inﬂuenza like illness. irritability. muscle weakness. nasal congestion. posterior reversible encephalopathy syndrome (PRES). psychiatric disorder. seizure. skin papilloma. tremor SIDE-EFFECTS, FURTHER INFORMATION Associated with infections, sometimes severe, including tuberculosis, septicaemia, and hepatitis B reactivation. Progressive multifocal leucoencephalopathy has been reported in association with rituximab; patients should be monitored for cognitive, neurological, or psychiatric signs and symptoms. If progressive multifocal leucoencephalopathy is suspected, suspend treatment until it has been excluded.

Source page 955

Conception And Contraception

Effective contraception (in both sexes) required during and for 12 months after treatment.

Source page 955

Pregnancy

Avoid unless potential beneﬁt to mother outweighs risk of B-lymphocyte depletion in fetus.

Source page 955

Breast Feeding

Avoid breast-feeding during and for 12 months after treatment.

Source page 955

Monitoring Requirements

For full details on monitoring requirements consult product literature.

Source page 955

Dose and formulations

Extracted information for Rituximab only.

Directions For Administration

▶With intravenous use For intravenous infusion, give intermittently in Glucose 5% or Sodium chloride 0.9%; dilute to 1–4 mg/mL and gently invert bag to avoid foaming; for further information, consult product literature.

Source page 955

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶MabThera (Roche Products Ltd) Rituximab 119.66 mg per 1 ml MabThera 1400mg/11.7ml solution for injection vials | 1 vial P £1,344.65 (Hospital only) Solution for infusion EXCIPIENTS: May contain Polysorbates ELECTROLYTES: May contain Sodium ▶MabThera (Roche Products Ltd) Rituximab 10 mg per 1 ml MabThera 100mg/10ml concentrate for solution for infusion vials | 2 vial P £349.25 MabThera 500mg/50ml concentrate for solution for infusion vials | 1 vial P £873.15 ▶Rixathon (Sandoz Ltd) A Rituximab 10 mg per 1 ml Rixathon 100mg/10ml concentrate for solution for infusion vials | 2 vial P £314.33 (Hospital only) Rixathon 500mg/50ml concentrate for solution for infusion vials | 1 vial P £785.84 (Hospital only) | 2 vial P £1,571.67 (Hospital only) ▶Truxima (Napp Pharmaceuticals Ltd) A Rituximab 10 mg per 1 ml Truxima 100mg/10ml concentrate for solution for infusion vials | 2 vial P £314.33 (Hospital only) Truxima 500mg/50ml concentrate for solution for infusion vials | 1 vial P £785.84 (Hospital only)

Source page 957

Clinical care

Extracted information for Rituximab only.

Patient And Carer Advice

Alert card ▶When used for Granulomatosis with polyangiitis and microscopic polyangiitis or Rheumatoid arthritis or Pemphigus vulgaris Patients should be provided with a patient alert card with each infusion.

Source page 955

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

1 g, then 1 g after 2 weeks, consult product

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

(consult product literature)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

(consult product literature)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

1 g, then 1 g after 2 weeks; maintenance 0.5 g, at

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

rituximab

Reference monograph

Part of registered formulation

RITUXIMAB

Reference record: Rituximab
Source: BNF 80 (2020–2021)
Printed source pages: 955, 956, 957
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Rituximab only.

Indications And Dose

Source page 955

Contra Indications

Source page 955

Cautions

Source page 955

Prescribing And Dispensing Information

Rituximab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1.

Source page 955

National Funding Access Decisions

Source pages 956, 957

Safety

Extracted information for Rituximab only.

Interactions

→Appendix 1: monoclonal antibodies

Source page 955

Side Effects

Source page 955

Conception And Contraception

Effective contraception (in both sexes) required during and for 12 months after treatment.

Source page 955

Pregnancy

Avoid unless potential beneﬁt to mother outweighs risk of B-lymphocyte depletion in fetus.

Source page 955

Breast Feeding

Avoid breast-feeding during and for 12 months after treatment.

Source page 955

Monitoring Requirements

For full details on monitoring requirements consult product literature.

Source page 955

Dose and formulations

Extracted information for Rituximab only.

Directions For Administration

Source page 955

Medicinal Forms

Source page 957

Clinical care

Extracted information for Rituximab only.

Patient And Carer Advice

Source page 955

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

1 g, then 1 g after 2 weeks, consult product

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

(consult product literature)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

(consult product literature)

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Adults

First line only; read the complete Indications and dose section above.

1 g, then 1 g after 2 weeks; maintenance 0.5 g, at

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 955

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.