Table 1.

Summary of screening requirements at initiation of therapy and related contraindications to the use of cladribine tablets for RRMS

	Initiation and monitoring	Contraindications
Lymphocyte count/immunosuppression	Lymphocytes must be in the noraml range (year 1) or ≥ 800/mm3 (year 2) before initiating cladribine tablets	Lymphocyte count < 800/mm3 before second course (monitor actively until recovery if lymphocyte count is < 500/mm3)
		Do not initiate cladribine tablets if patient is on immunosuppressive or myelosuppressive therapy
	Screen for immunocompromised status
Active chronic infection and vaccination	Screen for latent infections, especially TB and hepatitis B and C (prior to treatment in years 1 and 2)	Active chronic infection, e.g. TB or hepatitis
	Exclude HIV infection before initiation	HIV infection
	Vaccinate patients who are antibody negative for Varicella zoster virus prior to initiation of therapy	Do not initiate cladribine tablets within 4–6 weeks after vaccination with live or attenuated vaccines
		PML
Malignancy	Screen for active malignancy before initiation of therapy	Active malignancy
Renal or hepatic impairment	Screen for renal or hepatic impairment prior to initiation	Moderate or severe renal or hepatic impairment
MRI	A baseline MRI should be performed before initiating cladribine tablets (usually within 3 months)	None
Pregnancy and breastfeeding	Exclude pregnancy before initiation of cladribine tablets in Years 1 and 2	Pregnancy
	Maintain contraception during treatment and for at ≥ 6 months after the last dose	Breastfeeding is contraindicated during treatment with Cladribine Tablets and for 1 week after the last dose

HIV human immunodeficiency virus, PML progressive multifocal leukoencephalopathy, TB tuberculosis;