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AURO-CLADRIBINE is a brand name for Cladribine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AURO-CLADRIBINE (cladribine tablets) is indicated as monotherapy for the treatment of adult patients with relapsing- remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. AURO-CLADRIBINE is generally recommended in MS patients who have had an…
Verbatim from this product's HC label. Tap a section to expand.
Treatment with AURO-CLADRIBINE should be initiated and supervised by neurologists experienced in the treatment of patients with MS and who have fully familiarized themselves with the efficacy and safety profile of cladribine. 1 Dosing Considerations The following assessments should be done, prior to initiating treatment, to guide patient selection and treatment.
Refer to 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS for more complete information. e. within 6 months or after discontinuation of prior therapy) result is available (see 7 WARNINGS AND PRECAUTIONS, Hematologic). , Grade 0 or 1) before initiating AURO-CLADRIBINE in year 2.
• Monitor lymphocyte counts periodically between treatment courses (see 7 WARNINGS AND PRECAUTIONS, Hematologic). 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 AURO-CLADRIBINE anymore.
Liver function • Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to initiation of therapy in year 1 and year 2. • Monitoring of liver enzymes and total bilirubin levels prior to administering Week 2 doses should be considered, especially for patients who may be more susceptible to liver injury.
• Treatment should be delayed in patients with clinically significant serum aminotransferase, alkaline phosphatase, or total bilirubin abnormalities (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/ Pancreatic). 4 Drug-Drug Interactions).
Immune system effects AURO-CLADRIBINE causes a reduction in circulating lymphocyte counts and may increase the risk of infections. • Evaluate patients for both active and inactive (“latent”) tuberculosis infection, according to local guidelines.
AURO-CLADRIBINE is contraindicated in patients with active or latent tuberculosis (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Immune, Infections). • Evaluate patients for hepatitis B and C virus (HBV and HCV) (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
• Immunizations should be completed according to immunization guidelines at least 6 weeks prior to treatment with AURO-CLADRIBINE (see,7 WARNINGS AND PRECAUTIONS, Immune, Vaccination). • Check varicella-zoster (VZV) antibody status before starting therapy if there is no health care professional confirmed history of chicken pox or vaccination with varicella vaccine; if negative, vaccination is recommended, with a delay in treatment initiation with AURO- CLADRIBINE for 6 weeks following vaccination (see 7 WARNINGS AND PRECAUTIONS, Immune, Vaccination).
). There is no known specific antidote to an overdose of AURO-CLADRIBINE. Treatment consists of careful observation and initiation of appropriate supportive measures. Discontinuation of AURO-CLADRIBINE may need to be considered. Because of the extensive intracellular and tissue distribution, hemodialysis is unlikely to eliminate cladribine to a significant extent.
Particularly close monitoring of hematological parameters is recommended in patients who have been exposed to an overdose of cladribine. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-800-POISON-X (1- 844-764-7669).
AURO-CLADRIBINE (Cladribine Tablets) Product Monograph Page 10 of 44 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3 Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral tablet 10 mg Hydroxypropyl betadex, Magnesium Stearate and Sorbitol Description: White to off white, uncoated, round, biconvex tablets and engraved with ‘CN’ on one side and “10’’ on the other side.
Packing:
Blister carton pack size of 1, 4 and 6 tablets. AURO-CLADRIBINE is supplied in an aluminum-aluminum blister which is sealed in a cardboard wallet and fixed in a child-resistant carton. 1 Dosing Considerations. During treatment with AURO-CLADRIBINE and following treatment discontinuation: • Instruct patients to promptly report symptoms of infection during treatment and following discontinuation of AURO-CLADRIBINE.
(see 7 WARNINGS AND PRECAUTIONS, Immune, Infections). • Lymphocyte counts must be determined: o before initiating AURO-CLADRIBINE in year 1, o before initiating AURO-CLADRIBINE in year 2, and o periodically between treatment courses and thereafter.
, Immune, Infections). g. hepatitis, tuberculosis) (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections). • Patients with a history of progressive multifocal leukoencephalopathy (PML). • Patients with active malignancy (see 7 WARNINGS AND PRECAUTIONS, Immune).
3 Renal Impairment). 1 Pregnant Women). • Women and men of reproductive potential who do not plan to use effective contraception during dosing and for 6 months after last dose in each treatment course (see 7 WARNINGS AND PRECAUTIONS, Sexual Function/Reproduction).
4 DOSAGE AND ADMINISTRATION Treatment with AURO-CLADRIBINE should be initiated and supervised by neurologists experienced in the treatment of patients with MS and who have fully familiarized themselves with the efficacy and safety profile of cladribine.
1 Dosing Considerations The following assessments should be done, prior to initiating treatment, to guide patient selection and treatment. Refer to 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS for more complete information. e. within 6 months or after discontinuation of prior therapy) result is available (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
, Grade 0 or 1) before initiating AURO-CLADRIBINE in year 2. • Monitor lymphocyte counts periodically between treatment courses (see 7 WARNINGS AND PRECAUTIONS, Hematologic). 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 AURO-CLADRIBINE anymore. Liver function • Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to initiation of therapy in year 1 and year 2.
• Monitoring of liver enzymes and total bilirubin levels prior to administering Week 2 doses should be considered, especially for patients who may be more susceptible to liver injury. • Treatment should be delayed in patients with clinically significant serum aminotransferase, alkaline phosphatase, or total bilirubin abnormalities (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/ Pancreatic).
AURO-CLADRIBINE is contraindicated in: • Patients who are hypersensitive to cladribine or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
g. g. immunodeficiency syndrome) (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections). g. hepatitis, tuberculosis) (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections). • Patients with a history of progressive multifocal leukoencephalopathy (PML).
• Patients with active malignancy (see 7 WARNINGS AND PRECAUTIONS, Immune). 3 Renal Impairment). 1 Pregnant Women). • Women and men of reproductive potential who do not plan to use effective contraception during dosing and for 6 months after last dose in each treatment course (see 7 WARNINGS AND PRECAUTIONS, Sexual Function/Reproduction).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Dosing Considerations, Lymphocyte counts and criteria for initiating and continuing therapy; 7 WARNINGS AND PRECAUTIONS, Hematologic). • A baseline magnetic resonance imaging (MRI) is recommended within 3 months before initiating the first treatment course of AURO-CLADRIBINE (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
2 Neoplasms). 1 Pregnant Women). AURO-CLADRIBINE (Cladribine Tablets) Product Monograph Page 7 of 44 • Women and men of reproductive potential should be warned of the potential for serious risk to the fetus and the need for effective contraception during AURO-CLADRIBINE treatment and for at least 6 months after each treatment course (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Male and Female Potential).
75 mg/kg per year, followed by observation for another 2 years. 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.
The efficacy of cladribine tablets for treatment duration beyond 2 years has not been established (see 1 INDICATIONS). Therefore, no further dosing recommendation can be provided beyond two treatment courses. Distribution of dose The distribution of the total dose over the 2 years of treatment is provided in Table 1.
Note that 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 AURO-CLADRIBINE per year and treatment week by patient weight Weight range Dose in mg (number of 10 mg tablets) per week Year 1 treatment course Year 2 treatment course kg Treatment week 1 Treatment week 2 Treatment week 1 Treatment week 2 40 to < 50 40 mg (4 tablets) 40 mg (4 tablets) 40 mg (4 […]
0 Grade 3 toxicity), active monitoring is recommended until values increase above 500 cells/mm³. 1 Dosing Considerations. Carcinogenesis and Mutagenesis The actions of cladribine yield DNA damage (see 16 Genotoxicity). Due to the known genotoxicity of cladribine and immunosuppression associated with the use of nucleoside analogues like cladribine tablets, cladribine tablets could potentially increase the risk of AURO-CLADRIBINE (Cladribine Tablets) Product Monograph Page 11 of 44 malignancies.
2 Neoplasms). Cladribine is contraindicated in MS patients with active malignancies (see 2 CONTRAINDICATIONS). Patients with prior malignancy were excluded from participating in the clinical development program; therefore, an individual benefit-risk evaluation should be performed before initiating AURO-CLADRIBINE in patients with prior malignancy.
Patients treated with AURO-CLADRIBINE should be advised to follow standard cancer screening guidelines. Cladribine was clastogenic in nonclinical in vitro and in vivo studies, but not mutagenic in bacterial and mammalian cell assays and did not cause any tumors of clinical significance in mice (see 16 Genotoxicity).
Endocrine and metabolism AURO-CLADRIBINE contains sorbitol. Patients with hereditary problems of fructose intolerance should not take this medicinal product. Hematologic Cladribine's mode of action is closely linked to a reduction in lymphocyte count.
2 Pharmacodynamics). Decreases in neutrophil count, red blood cell count, hematocrit, hemoglobin or platelet count compared to baseline values have also been observed in clinical studies, although these parameters usually remain within normal limits.
A complete blood count (CBC) is recommended prior to initiating treatment with AURO-CLADRIBINE and monitoring lymphocyte counts is recommended after initiating treatment with AURO-CLADRIBINE (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
4 Hematotoxic, immunomodulating or immunosuppressive agents). 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 hematologist is advised. Hepatic/Biliary/Pancreatic Liver injury, including serious cases, has been reported uncommonly during post-marketing AURO-CLADRIBINE (Cladribine Tablets) Product Monograph Page 12 of 44 experience in patients treated with cladribine tablets.
Cases involved mainly patients with a history of abnormal liver tests, a history of liver injury associated with other medications, or concomitant or recent treatment with medications known to cause liver injury. Liver injury has occurred from days to several months after initiating treatment with cladribine tablets, but in the majority of serious cases the time to onset was within the first 4 weeks of the most recent dose of cladribine tablets.
Caution is recommended when considering treatment with AURO- CLADRIBINE in patients who may be susceptible to liver injury such as patients with a history of abnormal liver tests, history of liver injury during treatment with other drugs, including other disease modifying therapies used for treatment of multiple sclerosis or, patients treated concomitantly or recently with medications known to cause liver injury.
For all patients, obtain serum aminotransferase, […]
4 Drug-Drug Interactions). Immune system effects AURO-CLADRIBINE causes a reduction in circulating lymphocyte counts and may increase the risk of infections. • Evaluate patients for both active and inactive (“latent”) tuberculosis infection, according to local guidelines.
AURO-CLADRIBINE is contraindicated in patients with active or latent tuberculosis (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Immune, Infections). • Evaluate patients for hepatitis B and C virus (HBV and HCV) (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
• Immunizations should be completed according to immunization guidelines at least 6 weeks prior to treatment with AURO-CLADRIBINE (see,7 WARNINGS AND PRECAUTIONS, Immune, Vaccination). • Check varicella-zoster (VZV) antibody status before starting therapy if there is no health care professional confirmed history of chicken pox or vaccination with varicella vaccine; if negative, vaccination is recommended, with a delay in treatment initiation with AURO- CLADRIBINE for 6 weeks following vaccination (see 7 WARNINGS AND PRECAUTIONS, Immune, Vaccination).
1 Dosing Considerations, Lymphocyte counts and criteria for initiating and continuing therapy; 7 WARNINGS AND PRECAUTIONS, Hematologic). • A baseline magnetic resonance imaging (MRI) is recommended within 3 months before initiating the first treatment course of AURO-CLADRIBINE (see 7 WARNINGS AND PRECAUTIONS, Immune, Infections).
2 Neoplasms). 1 Pregnant Women). AURO-CLADRIBINE (Cladribine Tablets) Product Monograph Page 7 of 44 • Women and men of reproductive potential should be warned of the potential for serious risk to the fetus and the need for effective contraception during AURO-CLADRIBINE treatment and for at least 6 months after each treatment course (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Male and Female Potential).
75 mg/kg per year, followed by observation for another 2 years. 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 […]