Formulary
Ublituximab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
MedNext Academy | 3 min read
Ublituximab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Drug action
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Indications and dose
**Multiple sclerosis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 150 mg for 1 dose, then 450 mg, to be given 2 weeks after the initial dose; maintenance 450 mg every 24 weeks, the first maintenance dose should be given 24 weeks after the first initial dose; a minimum interval of 5 months should be kept between each maintenance dose, for dose interruption, adjustment of infusion rate or discontinuation of treatment due to infusion-related reactions or side-effects-consult product literature.
Cautions
B carriers (seek expert advice before starting); immunisation Cautions, further information Immunisation Patients should receive all recommended vaccinations before starting treatment; live vaccines should be given at least 4 weeks before, and inactivated vaccines ideally at least 2 weeks before, starting ublituximab. M
Contraindications
Active malignancies; severe active infection; severely immunocompromised patients
Side effects
For all anti-lymphocyte monoclonal antibodies Common or very common Anaemia; anaphylactic reaction; arthralgia; conjunctivitis; cough; hypersensitivity (discontinue permanently); increased risk of infection; infusion related reaction; neutropenia; pain in extremity; thrombocytopenia; vomiting Uncommon Haemolytic anaemia Side-effects, further information Infusion-related side-effects In rare cases infusion reactions may be fatal. Infusion-related side-effects occur predominantly during the first infusion. Patients should receive premedication before administration of anti-lymphocyte monoclonal antibodies to reduce these effects-consult product literature for details of individual regimens. The infusion may have to be stopped temporarily and the infusion-related effects treated-consult product literature for appropriate management. Cytokine release syndrome Fatalities following severe cytokine release syndrome (characterised by severe dyspnoea) and associated with features of tumour lysis syndrome have occurred after infusions of anti-lymphocyte monoclonal antibodies. Patients with a high tumour burden as well as those with pulmonary insufficiency or infiltration are at increased risk and should be monitored very closely (and a slower rate of infusion considered). Progressive Multifocal Leukoencephalopathy (PML) If suspected, treatment should be suspended until PML has been excluded. If a patient develops an opportunistic infection or PML, anti-lymphocyte monoclonal antibodies should be permanently discontinued.
Interactions
**Other interactions (2):**
- Vaccinations The safety of immunisation with live or liveattenuated vaccines following ublituximab therapy has not been studied, and vaccination with liveattenuated or live vaccines is not...
- Immunosuppressants It is not recommended to use other immunosuppressives concomitantly with ublituximab except corticosteroids for symptomatic treatment of relapses.
Pregnancy
Avoid unless potential benefit outweighs risk (toxicity in animal studies); if exposed during pregnancy, monitor infant for B-lymphocyte depletion. M
Breast feeding
Specialist sources indicate use with caution, especially if breast-feeding a neonate or preterm infant (no information available). Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract; waiting for at least 2 weeks postpartum to resume treatment may minimise transfer to infant.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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