a pregnant woman.
Males and females of childbearing capacity should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see section 5.3).
Lactation
It is not known whether MabCampath is excreted in human milk. If treatment is needed, breast-feeding should be discontinued during treatment and for at least 4 weeks following MabCampath therapy.
Fertility
There are no definitive studies of MabCampath which assess its impact on fertility. It is not known if MabCampath can affect human reproductive capacity (see section 5.3).
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, caution should be exercised as confusion and somnolence have been reported.
4.8 Undesirable effects
The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs). The frequencies are based on clinical trial data.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
The frequencies are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to <1/1,000); very rare (<1/10,000). No information is available for events that occur at lower frequency, due to the size of the population studied; n=147 for first line treated patients and n=149 for previously treated patients.
The most frequent adverse reactions with MabCampath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnoea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anaemia), infections (CMV viraemia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most frequent serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.
Undesirable effects in first line patients
Safety data in first-line B-CLL patients are based on adverse reactions that occurred on study in 147 patients enrolled in a randomized, controlled study of MabCampath as a single agent administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks, inclusive of dose escalation period. Approximately 97% of first-line patients experienced adverse reactions; the most commonly reported reactions in first line patients usually occurred in the first week of therapy.
Within each frequency grouping, undesirable effects observed during treatment or within 30 days following the completion of treatment with MabCampath are presented in order of decreasing seriousness.
System organ class
Very common
Common
Uncommon
Infections and infestations
Cytomegalovirus viraemia
Cytomegalovirus infection
Pneumonia
Bronchitis
Pharyngitis
Oral candidiasis
Sepsis
Staphylococcal bacteraemia
Tuberculosis
Bronchopneumonia
Herpes ophthalmicus
Beta haemolytic streptococcal infection
Candidiasis
Genital candidiasis
Urinary tract infection
Cystitis
Body tinea
Nasopharyngitis
Rhinitis
Blood and lymphatic system disorder
Febrile neutropenia
Neutropenia
Leukopenia
Thrombocytopenia
Anaemia
Agranulocytosis
Lymphopenia
Lymphadenopathy
Epistaxis
Immune system disorders
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