PracticeUpdate Neurology February 2019

MAVENCLAD ® cladribine tablets

PBS LISTED IN RRMS 1 1st January 2019

† 2-5

† In RRMS, MAVENCLAD ® is an oral therapy with a ‘Tailored Dosing Regimen’ (Weight-based, short-course treatment, with a maximum of 20 days treatment over 2 years) . PBS, Pharmaceutical Benefits Scheme. RRMS, relapsing-remitting multiple sclerosis.

PBS information: Authority Required. Refer to PBS Schedule for full authority information.

Before prescribing, please review the Full Product Information available from Merck Australia (1800 633 463)

MAVENCLAD ® Minimum Product Information: Indications: MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied. Contraindications: Patients with hypersensitivity to cladribine or to any of the tablet excipients, infected with the human immunodeficiency virus (HIV), active chronic infections (tuberculosis, hepatitis), immunocompromised patients, including patients receiving immunosuppressive or myelosuppressive therapy, moderate or severe renal impairment (creatinine clearance < 60 mL/min), during pregnancy and breastfeeding. Precautions: Haematological monitoring is required prior to and during therapy. Lymphopenia; Infections; Malignancies; Switching to and from MAVENCLAD treatment; Renal impairment; Hepatic impairment; Fructose intolerance; Effects on fertility (incl. male patients), Use in pregnancy (Category D) and lactation; Use in Paediatric or Elderly; Carcinogenicity, Genotoxicity. Interactions: 3 hours interval required for administration of other oral medicines. Concomitant treatment with immunosuppressive or myelosuppressive agents is contraindicated; must not be initiated within 4 to 6 weeks after vaccination with live/live-attenuated vaccines. Recommendations to avoid co-administration with potent ENT1, CNT3 and ABCG2 transporter inhibitors. Adverse reactions: Very Common: Lymphopenia (may be severe, Grade 3 or 4). Common: Rash, alopecia, oral herpes, dermatomal herpes zoster, decrease in neutrophil count. Dosage and administration: Haematological and infections screening criteria for starting and continuing therapy have to be met before initiating MAVENCLAD therapy or administering any subsequent treatment course. The recommended cumulative dose of MAVENCLAD is 3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 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 year. 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. Patients should receive no more than 2 treatment courses over two consecutive years. The recommended dose should not be exceeded. Following completion of the 2 treatment courses, no further cladribine treatment is required in year 3 and year 4. Re-initiation of therapy after year 4 has not been studied. Based on approved PI dated 5 December 2017. Sponsor: Merck Serono Australia Pty Ltd, 3-4/25 Frenchs Forest Rd East, Frenchs Forest NSW 2086. ®Registered Trade Mark. References: 1. Schedule of Pharmaceutical Benefits, January 2019. 2. MAVENCLAD ® Product Information, Date of most recent amendment 5 December 2017. 3. Giovannoni G et al. N Engl J Med 2010;362:416–26. 4. Giovannoni G et al. N Engl J Med 2010;362:416–26 (supplementary information). 5. Giovannoni G et al. Multiple Sclerosis Journal 2017; Online, first published 5 Sept 2017:1–11.

Merck Serono Australia Pty Ltd | ABN 72 006 900 830. Unit 3–4, 25 Frenchs Forest Road East, Frenchs Forest NSW 2086 Australia. Phone (02) 8977 4100 | Fax (02) 9975 1516. ® = Registered Trademark. MAV033 | Date of preparation: January 2019 | AUS/CLA/1218/0195