MabThera SC. The wait is over. MabThera delivered in just 5 minutes Abbreviated Prescribing Information MabThera 1400 mg solution for subcutaneous (SC) injection (Rituximab) Indications: Indicated in adults for Non-Hodgkin s lymphoma (NHL): (i) Treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. (ii) Maintenance therapy for the treatment of follicular lymphoma patients responding to induction therapy. (iii) Treatment of patients with CD20 positive diffuse large B cell non-hodgkin s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Dosage and Administration: Give premedication consisting of an anti-pyretic and an antihistaminic before each administration of MabThera. Consider premedication with glucocorticoids if MabThera is not given in combination with glucocorticoid-containing chemotherapy. A full dose of MabThera intravenous (IV) infusion must be received before starting MabThera SC injection. Follicular NHL: Combination therapy 1 st cycle with MabThera IV 375mg/m 2, followed by subsequent cycles with MabThera SC injection at fixed dose 1400mg/cycle on day 1 of each cycle for up to 8 cycles. Maintenance therapy (previously untreated) - 1400mg every 2months (starting 2 months after the last dose of induction therapy) until disease progression or max. 2 years. Maintenance therapy (Relapsed/refractory) 1400mg every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or max 2 years. Diffuse large B cell NHL: in combination with CHOP chemotherapy. 1 st cycle with MabThera IV 375mg/m 2, followed by subsequent cycles with MabThera SC injection at fixed dose 1400mg/cycle on day 1 of each cycle for 8 cycles in total. No dose reductions are recommended. Method of administration: Administered as SC injection only, over approx. 5 minutes, into the abdominal wall. The hypodermic injection needle must only be attached to the syringe immediately prior to administration. Avoid areas where the skin is red, bruised, tender, hard or areas where there are moles or scars. Warnings and Precautions: All patients must always receive beforehand, a full dose of MabThera by IV infusion, using MabThera IV formulation before starting MabThera SC injections. Progressive multifocal leukoencephalopathy (PML): Monitor at regular intervals for new or worsening neurological symptoms or signs suggestive of PML. Suspend dosing if PML suspected until PML excluded. Consider further evaluation and repeat neurological assessments if needed. Permanently discontinue MabThera if PML is developed. Infusion/administration-related reaction: Including syndrome of cytokine release, tumor lysis syndrome (TLS), anaphylactic and hypersensitivity reactions. Severe infusion-related reactions with fatal outcome have been reported. Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution. Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately and should receive aggressive symptomatic treatment. Monitor closely until TLS and pulmonary infiltration have been resolved or ruled out. Anaphylactic and other hypersensitivity reactions have been reported following the IV administration of proteins to patients. Medicinal products for the treatment of hypersensitivity reactions should be available for immediate use in the event of an allergic reaction during administration of MabThera. Since hypotension may occur, consider withhold anti-hypertensive medicines 12 hours prior to giving MabThera. Observe for at least 15 minutes following MabThera SC administration. Cardiac disorders: Monitor closely patients with a history of cardiac disease and/or cardiotoxic chemotherapy. Haematological toxicities: Perform regular full blood counts during MabThera therapy. Infections: Avoid administer to patients with an active, severe infection. Caution when administer to patients with a history of recurring or chronic infections or with underlying conditions. Cases of hepatitis B reactivation have been reported in patients receiving the MabThera IV formulation. Perform hepatitis B virus screening in all patients before treatment initiation. Consult experts if hepatitis B serology is positive; monitor and managed following local medical standards to prevent hepatitis B reactivation. Immunisation: Non-live vaccines response rates may be reduced. Skin reactions: Severe skin reactions such as Lyell s Syndrome and Stevens - Johnson syndrome with fatal outcome have been reported. Discontinue treatment permanently for cases with suspected relationship to MabThera. Fertility, Pregnancy and Lactation: Women of childbearing potential must employ effective contraceptive methods during and for 12 months after treatment with MabThera. MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk. No breastfeeding while treated with MabThera and for 12 months following MabThera treatment. Contraindications and Precautions: Hypersensitivity to rituximab or to murine proteins, hyaluronidase or to any of the other excipients; Active, severe infections; Patients in a severely immunocompromised state. Interactions: Co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide and vice versa. Patients with human anti-mouse antibody or human antichimeric antibody (HAMA/HACA) titres may have allergic or hypersensitivity reactions when treated with monoclonal antibodies. Adverse Effects: Please refer to the full prescribing information for detailed information. Local cutaneous reactions were very common in patients receiving MabThera SC formulation, incidence decreased with subsequent injections. Adverse reactions: Very Common: bacterial/viral infections, bronchitis, neutropenia, leucopenia, febrile neutropenia, thrombocytopenia, infusion related reactions, angioedema, nausea, pruritis, rash, alopecia, fever, chills, asthenia, headache, decreased IgG levels. Common: sepsis, pneumonia, febrile infection, herpes zoster, respiratory tract infection, fungal infections, infections of unknown aetiology, acute bronchitis, sinusitis, hepatitis B, anaemia, pancytopenia, granulocytopenia, hypersensitivity, hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia, paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety, lacrimation disorder, conjunctivitis, tinnitus, ear pain, myocardial infarction, arrhythmia, atrial fibrillation, tachycardia, cardiac disorder, hypertension, orthostatic hypotension, hypotension, Bronchospasm, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis, vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation, urticaria, sweating, night sweats, skin disorder, hypertonia, myalgia, arthralgia, back pain, neck pain, pain, tumour pain, flushing, malaise, cold syndrome, fatigue, shivering, multi-organ failure Full prescribing information should be viewed prior to prescribing. Date of preparation: September 2016 SC= subcutaneous injection PM-HK-0050-04-2017
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