MabCampath 30 mg/ml concentrate for solution for infusionAle - Ireland[爱尔兰药品]

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MabCampath 30 mg/ml concentrate for solution for infusionAle

2014-02-16 17:19:19 来源: 作者: 【大中小】浏览:826次评论:0条

Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

MabCampath 30 mg/ml concentrate for solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains 30 mg of alemtuzumab.

Each vial contains 30 mg of alemtuzumab.

Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Concentrate for solution for infusion.

Colourless to slightly yellow concentrate.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.

4.2 Posology and method of administration

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. However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).

Median duration of treatment was 11.7 weeks for first-line patients and 9.0 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. If a patient improves (i.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. Therapy should be discontinued if there is evidence of disease progression.

Concomitant medicinal products

Premedications

Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).

Prophylactic antibiotics

Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see section 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/μl or whose absolute neutrophil count (ANC) drops to < 250/μl. 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:

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).
For second occurrence	Withhold MabCampath therapy. Resume MabCampath at 10 mg upon return to baseline value(s).
For third occurrence	Discontinue MabCampath therapy.