Loading…
MabCampath is a brand name for Alemtuzumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B- CLL) for whom fludarabine combination chemotherapy is not appropriate.
Verbatim from this product's EMA label. Tap a section to expand.
MabCampath should be administered under the supervision of a physician experienced in the use of cancer therapy. Posology During the first week of treatment, MabCampath should be administered in escalating doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is well tolerated.
Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks. In most patients, dose escalation to 30 mg can be accomplished in 3-7 days. 4). 0 weeks for previously treated patients.
Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored. e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored.
4). 4). Dose modification guidelines There are no dose modifications recommended for severe lymphopenia given the mechanism of action of MabCampath. In the event of serious infection or severe haematological toxicity MabCampath should be interrupted until the event resolves.
It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/l or whose absolute neutrophil count (ANC) drops to < 250/l. MabCampath may be reinstituted after the infection or toxicity has resolved.
MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears. The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:Medicinal product no longer authorised 4 Haematologic values Dose modification* ANC < 250/μl and/or platelet count ≤25,000/μl For first occurrence Withhold MabCampath therapy.
Resume MabCampath at 30 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl. For second occurrence Withhold MabCampath therapy. Resume MabCampath at 10 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl. For third occurrence Discontinue MabCampath therapy.
≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μl and/or a baseline platelet count ≤ 25,000/μl For first occurrence Withhold MabCampath therapy. Resume MabCampath at 30 mg upon return to baseline value(s).
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. Medicinal product no longer authorised 8 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 Anaphylactic reaction Hypersensitivity Metabolism and nutrition disorders Weight decreased Tumour lysis syndrome Hyperglycaemia Protein total decreased Anorexia Psychiatric disorders Anxiety Nervous system disorders Syncope Dizziness Tremor Paraesthesia Hypoesthesia Headache Vertigo Eye disorders Conjunctivitis Cardiac disorders Cyanosis Bradycardia Tachycardia Sinus tachycardia Cardiac arrest Myocardial infarction Angina pectoris Atrial fibrillation Arrhythmia supraventricular Sinus bradycardia Supraventricular extrasystoles Vascular disorders Hypotension Hypertension Orthostatic hypotension Hot flush Flushing Respiratory, thoracic and mediastinal disorders Bronchospasm Dyspnoea Hypoxia Pleural effusion Dysphonia RhinorrhoeaMedicinal product no longer authorised 9 System organ class Very common Common Uncommon Gastrointestinal disorders Nausea Vomiting Abdominal pain Ileus Oral discomfort Stomach discomfort Diarrhoea Skin and subcutaneous tissue disorders Urticaria Rash Dermatitis allergic Pruritus Hyperhidrosis Erythema Rash pruritic Rash macular Rash erythematous Dermatitis Musculoskeletal and connective tissue disorders Myalgia Musculoskeletal pain Back pain Bone pain Arthralgia Musculoskeletal chest pain Muscle spasms Renal and urinary disorders Urine output decreased Dysuria General disorders and administration site conditions Fever Chills Fatigue Asthenia Mucosal inflammation Infusion site erythema Localised oedema Infusion site oedema Malaise Acute infusion reactions including fever, chills, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea have been reported.
Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/rigors, fever, shortness of breath and rashes. Additional reactions include nausea, urticaria, vomiting, fatigue, dyspnoea, headache, pruritus, diarrhoea and bronchospasm.
The frequency of infusion reactions was highest in the first week of therapy, and declined in the second or third week of treatment, in patients treated with MabCampath both as first line therapy and in previously treated patients.
If these events are moderate to severe, then dosing should continue at the same level prior to each dose escalation, with appropriate premedication, until each dose is well tolerated. If therapy is withheld for more than 7 days, MabCampath should be reinstituted with gradual dose escalation.
Transient hypotension has occurred in patients receiving MabCampath. Caution should be used in treating patients with ischaemic heart disease, angina and/or in patients receiving an antihypertensive medicinal product. Myocardial infarction and cardiac arrest have been observed in association with MabCampath infusion in this patient population.
g. echocardiography, heart rate and body weight) should be considered in patients previously treated with potentially cardiotoxic agents. It is recommended that patients be premedicated with oral or intravenous steroids 30 - 60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated.
Steroids may be discontinued as appropriate, once dose escalation has been achieved. g. g. paracetamol 500 mg, may be given. In the event that acute infusion reactions persist, the infusion time may be extended up to 8 hours from the time of reconstitution of MabCampath in solution for infusion.
Profound lymphocyte depletion, an expected pharmacological effect of MabCampath, inevitably occurs and may be prolonged. CD4 and CD8 T-cell counts begin to rise from weeks 8-12 during treatment and continue to recover for several months following the discontinuation of treatment.
Hypersensitivity to alemtuzumab, to murine proteins or to any of the excipients. - Active systemic infections. - HIV. - Active second malignancies. Medicinal product no longer authorised 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alemtuzumab in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
For second occurrence Withhold MabCampath therapy. Resume MabCampath at 10 mg upon return to baseline value(s). For third occurrence Discontinue MabCampath therapy. *If the delay between dosing is 7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg and then to 30 mg as tolerated Special populations Elderly (over 65 years of age) Recommendations are as stated above for adults.
4). Patients with renal or hepatic impairment No studies have been conducted. Paediatric population The safety and efficacy of MabCampath in children aged less than 17 years of age have not been established. No data are available. 6. All doses should be administered by intravenous infusion over approximately 2 hours.
The majority of these reactions are mild to moderate in severity. Acute infusion reactions usually occur during the first week of therapy and substantially decline thereafter. Grade 3 or 4 infusion reactions are uncommon after the first week of therapy.
Undesirable effects in previously treated patients Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3). More than 80% of previously treated patients may be expected to experience adverse reactions; the most commonly reported reactions usually occur during the first week of therapy.
Medicinal product no longer authorised 10 System organ class Very common Common Uncommon Infections and infestations Sepsis Pneumonia Herpes simplex Cytomegalovirus infection Pneumocystis jiroveci infection Pneumonitis Fungal infection Candidiasis Herpes zoster Abscess Urinary tract infection Sinusitis Bronchitis Upper respiratory tract infection Pharyngitis Infection Bacterial infection Viral infection Fungal dermatitis Laryngitis Rhinitis Onychomycosis Neoplasms, benign, malignant and unspecified (incl.
cysts and polyps) Lymphoma – like disorder Blood and lymphatic system disorder Granulocytopenia Thrombocytopenia Anaemia Febrile neutropenia Pancytopenia Leukopenia Lymphopenia Purpura Aplasia bone marrow Disseminated intravascular coagulation Haemolytic anaemia, Decreased haptoglobin Bone marrow depression Epistaxis Gingival bleeding Haematology test abnormal Immune system disorders Allergic reaction Severe anaphylactic and other hypersensitivity reactions Metabolism and nutrition disorders Anorexia Hyponatraemia Hypocalcaemia Weight decrease Dehydration Thirst Hypokalaemia Diabetes mellitus aggravated Psychiatric disorders Confusion […]
In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥200 cells/μl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/l. In previously treated patients receiving MabCampath, the median time to reach a level of 200 cells/l is 2 months following last infusion with MabCampath but may take more than 12 months to approximate pretreatment levels.
This may predispose patients to opportunistic infections. g. trimethoprim/sulfamethoxazole 1 tablet twice daily, 3 times weekly, or other prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and an effective oral anti-herpes agent, such as famciclovir, 250 mg twice daily) should be initiated while on therapy and for a minimum of 2 months following completion of treatment with MabCampath or until the CD4+ count has recovered to 200 cells/l or greater, whichever is the later.
The potential for an increased risk of infection-related complications may exist following treatment with multiple chemotherapeutic or biological agents. Because of the potential for Transfusion Associated Graft Versus Host Disease (TAGVHD) it is recommended that patients who have been treated with MabCampath receive irradiated blood products.
Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy. Ongoing clinical assessment should be performed for symptomatic CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
Transient grade 3 or 4 neutropenia occurs very commonly by weeks 5-8 following initiation of treatment. Transient grade 3 or 4 thrombocytopenia occurs very commonly during the first 2 weeks of therapy and then begins to improve in most patients.
Therefore, haematological monitoring of patientsMedicinal product no longer authorised 6 is indicated. If a severe haematological toxicity develops, MabCampath treatment should be interrupted until the event resolves. 2). MabCampath should be permanently discontinued if autoimmune anaemia or autoimmune thrombocytopenia appears.
Complete blood counts and platelet counts should be obtained at regular intervals during MabCampath therapy and more frequently in patients who develop cytopenias. It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice.
However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression. In data available from first line patients treated with MabCampath, loss of CD52 expression was not observed around the time of disease progression or death.
Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric monoclonal antibodies. 2). 3). No studies have been conducted which specifically address the effect of age on MabCampath disposition and toxicity.
In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals. 2). In the studies in first line and previously […]