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Rituximab

Anti-CD20 chimeric monoclonal antibody · Antineoplastic

Also known as Mabthera, Reditux, Ristova, Riximyo, Truxima, Ruxience

START
Screen HBV first; oncology 375 mg/m² IV per regimen; RA 1000 mg days 1 & 15; premedicate
TYPICAL MAX
Regimen-defined (375 mg/m² or 1000 mg ×2)
STOP IF
Severe infusion reaction/CRS, HBV reactivation, suspected PML, severe mucocutaneous reaction
WATCH
HBV serology (baseline + monitoring), infusion reactions, neuro symptoms (PML), CBC, infections
CDSCO approvedSchedule H (Prescription Drug, to be sold by retail on the prescription of a Registered Medical Practitioner only). In India, it is often administered under supervision in a hospital setting due to potential infusion reactions and need for close monitoring. The exact class of schedule H may vary in some states to also include 'Rx' designation (prescription only). This drug is not OTC (Over-The-Counter). The drug should not be supplied to the general public for direct consumption without professional medical advice. It requires specialized handling and administration. As an injectable cytotoxic/immunomodulatory agent, it strictly falls under prescription-only medicine category and typically administered in controlled clinical environments. Thus, it is not OTC and requires prescription. Schedule H drugs are substances which are required to be sold by retail on the prescription of a Registered Medical Practitioner. Rituximab falls under this category. Given its nature and administration, it is also subjected to more stringent control measures beyond simple Schedule H, often requiring hospital-level administration and monitoring. While it fits the general criteria for Schedule H, its complex usage context often leads to it being managed under stricter hospital protocols akin to Schedule H1 or even X in practice for safety, although technically, the molecule itself is often listed as Schedule H. Therefore, Schedule H is the most appropriate classification based on general Indian drug regulations for prescription drugs. It is not an OTC medicine. Thus, it requires a prescription from a Registered Medical Practitioner and is to be sold by retail only on their prescription. Given its nature and administration requirements, it is generally supplied to hospitals and administered in a clinical setting by trained professionals. The legal classification is Schedule H. Many such advanced injectable medications, while technically Schedule H, are managed with heightened vigilance similar to the intent of Schedule H1 or X in practice due to their risk profile and administration complexity. However, strictly speaking, Schedule H is the correct official classification for prescription drugs. Therefore,ATC L01FA01
Dose laddermg/d
500start700titrate1kceiling
Renal dose adjustmenteGFR mL/min/1.73m²
FULLNo dose adjustment at any eGFR (monoclonal antibody)90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
1hONSET4hPEAK3.1w26.1wDURATION
ONSET
1h · absorption onset
PEAK
4h · end of infusion
3.1w · terminal t½ (~22 days)
DURATION
26.1w · B-cell depletion ~6 months
EXCRETION
Reticuloendothelial catabolism; not renal
route + CYP
INTERACTIONS
12 major
incl. contraindicated
PREGNANCY
Avoid unless benefit outweighs risk — transient neonatal B-cell depletion; effective contraception during and 12 months after
FDA category + note
Top interactionssee all 12
  • Live VaccinesContraindicatedDatabaseKimi deep-research + Cla
  • AdalimumabSevereDatabaseDDInter
  • BaricitinibSevereDatabaseDDInter
  • CertolizumabSevereDatabaseDDInter
Available in India

37 branded formulations. Look up specific brands in the Drugs workspace.

Mechanism

Binds CD20 on B-lymphocytes causing depletion via complement-dependent and antibody-dependent cellular cytotoxicity and apoptosis; depletes normal and malignant CD20+ B cells (pre-B to mature, sparing plasma cells/stem cells).

Indications

CD20+ non-Hodgkin lymphoma and chronic lymphocytic leukaemiaRheumatoid arthritis (with methotrexate)ANCA-associated vasculitis (GPA/MPA)Pemphigus vulgaris; off-label many autoimmune diseases

Dosing

Adult
Oncology: 375 mg/m² IV per cycle (schedule by regimen). RA: 1000 mg IV days 1 and 15, repeat ~q6 months. Premedicate (antihistamine, paracetamol ± corticosteroid).
Pediatric
Per protocol (specialist).
Renal adjustment
No adjustment (antibody — not renally cleared).
Hepatic adjustment
No specific adjustment; screen/monitor HBV.
Geriatric
Higher cardiac/infection risk; monitor.
Max dose
Regimen-defined (e.g. 375 mg/m²/dose oncology; 1000 mg ×2 RA)

Pharmacokinetics

Onset
B-cell depletion within days; clinical effect weeks
Peak effect
End of infusion
Duration
B-cell depletion months (often 6–12)
Half-life
~3 weeks (variable; ~18–32 days)
Bioavailability
100% IV (SC formulations exist)
Protein binding
Not applicable (immunoglobulin)
Metabolism
Catabolised to peptides/amino acids (reticuloendothelial)
Excretion
Not renally excreted

Contraindications

  • Active severe infection
  • Active hepatitis B (reactivation risk — screen first)
  • Severe hypersensitivity to rituximab or murine proteins

Side effects

Common
Infusion-related reactions (fever, chills, rigors, hypotension)Infections (esp. respiratory)CytopeniasFatigue, headache
Serious
  • Severe/fatal infusion reactions; cytokine release syndrome
  • Hepatitis B reactivation (fulminant hepatitis)
  • Progressive multifocal leukoencephalopathy (JC virus)
  • Severe mucocutaneous reactions (SJS/TEN)
  • Tumour lysis syndrome; severe prolonged neutropenia; bowel perforation

Pregnancy & lactation

Pregnancy

Avoid unless benefit outweighs risk — transient neonatal B-cell depletion; effective contraception during and 12 months after

Lactation

Limited data; minimal oral infant absorption of IgG — caution

Drug interactions

Live Vaccines
Contraindicated
Database

B-cell depletion/immunosuppression → disseminated vaccine infection + poor response

Complete live vaccines ≥4 weeks before; avoid during therapy

Source: Kimi deep-research + Cla

Adalimumab
Severe
Database

Drug interaction classified as: synergy.

Source: DDInter

Baricitinib
Severe
Database

Drug interaction classified as: others

Source: DDInter

Certolizumab
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Cladribine
Severe
Database

Drug interaction classified as: synergy.

Source: DDInter

Clozapine
Severe
Database

Drug interaction classified as: synergy.

Source: DDInter

Deferiprone
Severe
Database

Clinical effect not specified

Source: DDInter

Etanercept
Severe
Database

Drug interaction classified as: synergy.

Source: DDInter

Fingolimod
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Golimumab
Severe
Database

Clinical effect not specified

Source: DDInter

Infliximab
Severe
Database

.

Source: DDInter

Leflunomide
Severe
Database

.

Source: DDInter

Related guidelines

Ask House about Rituximab

Continue into a citation-backed clinical answer with the drug context already attached.

Sources: KD Tripathi 7e, Goodman & Gilman 14e, Harrison 22e, Katzung·Verified: 2026-05-19 · House clinical team·Cockpit curated: 2026-05-19