For the use only of an Oncologist or a Rheumatologist or a Hospital or a Laboratory

TM

(Rituximab Injection)
TM

100
100 mg

TM

500
500 mg

Each 10 mL vial contains Rituximab (r DNA origin)

Each 50 mL vial contains Rituximab (r DNA origin)

TM

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Body system Adverse event Any adverse event Body as a whole Fever Chills Asthenia Headache Throat irritation Abdominal pain Cardiovascular system Hypotension Digestive system Nausea Vomiting Blood and lymphatic system Leucopenia Neutropenia Thrombocytopenia Metabolic and nutritional disorders Angioedema Hyperglycaemia Musculoskeletal system Myalgia Arthralgia Nervous system Dizziness Respiratory system Bronchospasm Rhinitis Increased cough Skin and appendages Pruritus Rash Urticaria

All grades % 91.0

Grade 3 and 4 % 17.7

48.3 31.7 18.0 12.6 7.6 7.0

0.6 2.2 0.3 0.6 0.6

9.8

0.8

17.1 6.7

0.3 0.3

12.4 11.2 9.6

2.8 4.2 1.7

10.7 5.3

0.3 0.3

8.1 5.9

0.3 0.6

7.3

7.9 7.3 5.1

1.4 0.3 0.3

12.4 11.2 7.3

0.3 0.3 0.8

Others reported <5% were:- bodypain (4.2%), flushing (4.2%), chest pain (2.2%), malaise (2.0%), tumour pain (1.7%), cold syndrome (1.4%), neck pain (1.1%), hypertension(4.5%), tachycardia (1.4%), arrhythmia (1.4%), orthostatic hypotension (1.1%), diarrhoea (4.2%), dyspepsia (2.8%), anorexia (2.8%), dysphagia (1.4%), stomatitis (1.4%), constipation (1.1%), anaemia (3.7%), peripheral oedema (4.8%), LDH increase (2.2%), hypocalcaemia (2.2%), facial oedema (1.1%), weight decrease (1.1%), hypertonia (1.4%), pain (musculoskeletal) (1.1%), insomnia (2.2%), vasodilatation (1.7%), hypoaesthesia (1.4%), agitation (1.4%), dyspnoea (2.2%), chest pain (1.1%), respiratory disease (1.1%), night sweats (2.8%), sweating (2.8%), lacrimation disorder (3.1%), conjunctivitis (1.4%), ear pain (1.1%), tinnitus (1.1%). The following adverse events were reported in < 1 %: coagulation disorders, asthma, lung disorder, bronchiolitis obliterans, hypoxia, abdominal enlargement, pain at the infusion site, bradycardia, lymphadenopathy, nervousness, depression, dysgeusia.
TM

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System Organ Class Adverse event CHOP Any adverse event Gastrointestinal disorders Nausea Vomiting Diarrhoea Abdominal pain
TM

Incidence N (%) R-CHOP 185 (79)

152 (67)

9 (4) 8 (4) 5 (2) 6 (3)

13 (6) 7 (3) 6 (3) 4 (2)

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