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Mavenclad is a brand name for Cladribine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MAVENCLAD is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated and supervised by a physician experienced in the treatment of MS. 75 mg/kg per year. Each treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year.
g. for recovery of lymphocytes), the treatment course in year 2 can be delayed for up to 6 months. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight.
For details, see Tables 1 and 2 below. 1). Re-initiation of therapy after year 4 has not been studied. Criteria for initiating and continuing therapy Lymphocyte counts must be • normal before initiating treatment in year 1, • at least 800 cells/mm³ before initiating treatment in year 2.
If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes. If this recovery takes more than 6 months, the patient should not receive cladribine tablets anymore. 3 Distribution of dose The distribution of the total dose over the 2 years of treatment is provided in Table 1.
For some weight ranges the number of tablets may vary from one treatment week to the next. Use of oral cladribine in patients weighing less than 40 kg has not been investigated. Table 1 Dose of cladribine per treatment week by patient weight in each treatment year Weight range Dose in mg (number of tablets) per treatment week kg Treatment week 1 Treatment week 2 40 to < 50 40 mg (4 tablets) 40 mg (4 tablets) 50 to < 60 50 mg (5 tablets) 50 mg (5 tablets) 60 to < 70 60 mg (6 tablets) 60 mg (6 tablets) 70 to < 80 70 mg (7 tablets) 70 mg (7 tablets) 80 to < 90 80 mg (8 tablets) 70 mg (7 tablets) 90 to < 100 90 mg (9 tablets) 80 mg (8 tablets) 100 to < 110 100 mg (10 tablets) 90 mg (9 tablets) 110 and above 100 mg (10 tablets) 100 mg (10 tablets) Table 2 shows how the total number of tablets per treatment week is distributed over the individual days.
It is recommended that the daily cladribine doses in each treatment week be taken at intervals of 24 hours at approximately the same time each day. If a daily dose consists of two tablets, both tablets are taken together as a single dose.
Table 2 Number of tablets per week day Total number of tablets per week Day 1 Day 2 Day 3 Day 4 Day 5 4 1 1 1 1 0 5 1 1 1 1 1 6 2 1 1 1 1 7 2 2 1 1 1 8 2 2 2 1 1 9 2 2 2 2 1 10 2 2 2 2 2 A missed dose must be taken as soon as remembered on the same day according to the treatment schedule.
0%). 4). 5 mg/kg. The safety database from these studies comprises 923 patients. Adverse reactions identified during post- marketing surveillance are indicated by an asterisk [*]. The following definitions apply to the frequency terminology used hereafter: 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) and frequency not known (cannot be estimated from the available data).
Infections and infestations Common:
Oral herpes, dermatomal herpes zoster. 4).
Blood and lymphatic system disorders Very common:
Lymphopenia.
Common:
Decrease in neutrophil count.
Immune system disorders Common:
Hypersensitivity* including pruritus, urticaria, rash and rare cases of angio-oedema.
Hepatobiliary disorders Uncommon:
Liver Injury*. 10 Skin and subcutaneous tissue disorders Common: Rash, alopecia. 5 mg/kg over 2 years as monotherapy developed transient grade 3 or 4 lymphopenia. Grade 4 lymphopenia was seen in less than 1% of the patients. 4% of patients with grade 4 lymphopenia in year 1 and year 2).
It is expected that most patients recover to either normal lymphocyte counts or grade 1 lymphopenia within 9 months. 2). 4). 4%). 3% of cladribine-treated patients and in no patients who received placebo. 3% patients who received placebo.
Liver Injury During post-marketing experience, uncommon events of liver injury, including serious cases and cases leading to discontinuation of treatment, were reported in temporal association with MAVENCLAD. Transient elevations of serum transaminases were usually greater than 5-fold the upper limit of normal (ULN).
Haematological monitoring Cladribine's mode of action is closely linked to a reduction in lymphocyte count. The effect on lymphocyte count is dose-dependent. Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have also been observed in clinical studies, although these parameters usually remain within normal limits.
5). Lymphocyte counts must be determined • before initiating treatment in year 1, • before initiating treatment in year 2, • 2 and 6 months after start of treatment in each treatment year. If the lymphocyte count is below 500 cells/mm³, it should be actively monitored until values increase again.
2 and subsection 'Infections' below. Infections Cladribine can reduce the body's immune defence and may increase the likelihood of infections. Serious, severe, and opportunistic infections - including events with fatal outcome - have been observed with MAVENCLAD treatment.
3). Latent infections may be activated, including tuberculosis or hepatitis. Therefore, screening for latent infections, in particular tuberculosis and hepatitis B and C, must be performed prior to initiation of therapy in year 1 and year 2.
Initiation of MAVENCLAD should be delayed until the infection has been adequately treated. A delay in initiation of cladribine should also be considered in patients with an acute infection until the infection is fully controlled. Particular attention is recommended for patients who have no history of exposure to varicella zoster virus.
Vaccination of antibody-negative patients is recommended prior to initiation of cladribine therapy. Initiation of treatment with MAVENCLAD should be postponed for 4 to 6 weeks to allow for the full effect of vaccination to occur. The incidence of herpes zoster was increased in patients on cladribine.
8). Patients with lymphocyte counts below 500 cells/mm³ should be actively monitored for signs and symptoms suggestive of infections, in particular herpes zoster. If such signs and symptoms occur, anti- infective treatment should be initiated as clinically indicated.
1. Infection with human immunodeficiency virus (HIV). Active chronic infection (tuberculosis or hepatitis). 5). Active malignancy. 2). 6). 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cladribine in European Union.
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A missed dose must not be taken together with the next scheduled dose on the following day. In the case of a missed dose, the patient must take the missed dose on the following day, and extend the number of days in that treatment week.
If two consecutive doses are missed, the same rule applies, and the number of days in the treatment week is extended by two days. 5). Special populations Renal impairment No dedicated studies have been conducted in patients with renal impairment.
2). Safety and efficacy in patients with moderate or severe renal impairment have not been established. 3). Hepatic impairment No studies have been conducted in patients with hepatic impairment. 2). In absence of data, the use of cladribine is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6).
Elderly Caution is recommended when cladribine is used in elderly patients, taking into account the potential greater frequency of decreased hepatic or renal function, concomitant diseases and other medicinal therapies. Paediatric population The safety and efficacy of MAVENCLAD in children below the age of 18 years have not been established.
No data are available. Method of administration MAVENCLAD is for oral use. The tablets must be taken with water, and swallowed without chewing. The tablets can be taken independent of food intake. As the tablets are uncoated, they must be swallowed immediately once removed from the blister and not be left exposed on surfaces or handled for any period of time longer than that required for dosing.
If a tablet is left on a surface, or if a broken or fragmented tablet is released from the blister, the area must be thoroughly washed. The patient's hands must be dry when handling the tablets and washed thoroughly afterwards.
Isolated cases of transient serum transaminase elevations up to 40-fold the ULN and / or symptomatic hepatitis with transient elevation of bilirubin and jaundice have been observed. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 11
Interruption or delay of MAVENCLAD may be considered until proper resolution of the infection. Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.
Although no case of PML has been reported with cladribine tablets, a baseline magnetic resonance imaging (MRI) should be performed before initiating cladribine tablets treatment (usually within 3 months). 8). 3). An individual benefit-risk evaluation should be performed before initiating treatment in patients with prior malignancy.
Patients treated with cladribine should be advised to follow standard cancer screening guidelines. Liver function Liver injury, including serious cases, has been reported uncommonly in patients treated with MAVENCLAD. Before initiating MAVENCLAD a comprehensive patient history regarding previous episodes of liver injury with other drugs or underlying liver disorders should be taken.
Patients should have their serum aminotransferase, alkaline phosphatase, and total bilirubin levels assessed prior to initiation of therapy in year 1 and year 2. During treatment, liver enzyme and bilirubin monitoring should be obtained based on clinical signs and symptoms.
, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), serum transaminases and total bilirubin should be measured promptly. Treatment with MAVENCLAD should be interrupted or discontinued, as appropriate.
6). 5). Male patients must take precautions to prevent pregnancy of their female partner during cladribine treatment and for at least 3 months after the last dose. Blood transfusions In patients who require blood transfusion, irradiation of cellular blood components is recommended prior to administration to prevent transfusion-related graft-versus-host disease.
Consultation with a haematologist is advised. Switching to and from cladribine treatment In patients who have previously been treated with immunomodulatory or immunosuppressive medicinal products the mode of action and duration of effect of the other medicinal product should be considered prior to initiation of treatment.
5). When switching from another MS medicinal product, a baseline MRI should be performed (see subsection […]