Section 04 · Monograph
Cladribine
Reviewed Nov 2026FDA label
MavencladPurine analog
- Forms
- Tab: 10mg, weight-based
- Dose
- 2 short oral courses 1 year apart
- MOA
- Selective lymphocyte depletion
Black Box Warning
- Increased risk of malignancy
- Risk of fetal harm/teratogenicity — contraindicated in pregnancy
Indications
- Relapsing forms of multiple sclerosis, generally reserved for patients with inadequate response to, or unable to tolerate, an alternate MS therapy given its safety profileFDA-labeled
Mechanism of Action
- Synthetic deoxyadenosine analog (purine antimetabolite prodrug)
- Phosphorylated intracellularly to active triphosphate, incorporated into DNA causing strand breaks and interfering with DNA synthesis and repair
- Preferentially reduces circulating T and B lymphocytes
Full Dosing
Adult / usual
- Cumulative dose of 3.5 mg/kg over 2 years, given as one treatment course of 1.75 mg/kg per year
- Each yearly course divided into 2 treatment cycles: first cycle at start of month 1, second cycle at start of month 2, each cycle 4-5 consecutive days
Contraindications
- Pregnancy
- Current malignancy
- HIV infection
- Active chronic infections (tuberculosis, hepatitis)
- Breastfeeding
Drug Interactions
- Avoid concurrent use with other myelosuppressive or immunosuppressive therapies
- Avoid live/attenuated vaccines
Adverse Effects
- Lymphopenia (often severe)
- Headache
- Upper respiratory tract infection
- Nausea
- Increased risk of herpes zoster and other infections
- Neutropenia
- Rash
Monitoring Parameters
- Lymphocyte counts before each treatment cycle and periodically thereafter
- Pregnancy test before each treatment cycle in patients who can become pregnant
- MRI at baseline
- Hepatitis and TB screening before initiation
- Malignancy screening per age-appropriate guidelines
Pregnancy & Lactation
- Contraindicated — teratogenic in animal studies; effective contraception required during and for 6 months after each treatment course for both patients and partners
- Contraindicated during breastfeeding — discontinue nursing during treatment and for 1 week after last dose