Can Paracetamol (PCM) be given to a patient undergoing Rituximab injection?

Can Paracetamol (PCM) Be Given During Rituximab Infusion?

Yes, paracetamol (acetaminophen) should be administered as premedication before each rituximab infusion and is a standard component of the infusion protocol. 1

FDA-Mandated Premedication Protocol

The FDA label for rituximab explicitly requires premedication with acetaminophen and an antihistamine before each infusion to reduce infusion-related reactions 1. This is not optional but rather a mandatory safety measure.

Specific Premedication Requirements by Indication:

• For all patients: Premedicate with acetaminophen and an antihistamine before each rituximab infusion 1

• For rheumatoid arthritis, GPA, MPA, and pemphigus vulgaris patients: Administer methylprednisolone 100 mg IV (or equivalent) 30 minutes prior to each infusion, in addition to acetaminophen and antihistamine 1

• For pediatric patients with mature B-cell NHL/B-AL: Administer acetaminophen and H1 antihistamine (diphenhydramine or equivalent) 30-60 minutes before the start of each rituximab infusion 1

Rationale for Paracetamol Use

Paracetamol is given to mitigate infusion-related reactions, which occur in 50-87% of patients during the first rituximab infusion 2. These reactions typically manifest as:

• Flu-like symptoms (most common) 2
• Fever and chills 2
• Rigors 3

The symptoms generally resolve completely in less than 3 hours 2.

Critical Safety Considerations

Severe Infusion Reactions Can Occur Rapidly

While most infusion reactions occur 30-120 minutes after starting rituximab 1, severe hypotension can develop within 5 minutes of infusion initiation, even in patients with no prior rituximab exposure 3. This emphasizes the importance of:

• Administering premedication (including paracetamol) before every infusion 1
• Close monitoring during the first 30 minutes of infusion 3
• Having emergency medications readily available (glucocorticoids, epinephrine, bronchodilators, oxygen) 1

Severe Reactions Requiring Additional Management

In 10% of patients, flu-like symptoms during the first infusion are accompanied by bronchospasm, hypotension, or severe cytokine release syndrome 2. When these occur:

• Temporarily stop the infusion 3
• Administer additional diphenhydramine and/or acetaminophen as needed 2, 4
• Resume infusion at a minimum 50% reduction in rate after symptoms resolve 1

Common Pitfalls to Avoid

• Never skip premedication: Even if a patient tolerated previous infusions well, premedication with acetaminophen and antihistamine is required before each dose 1

• Do not assume reactions only occur later in the infusion: Severe hypotension can occur within 5 minutes, necessitating immediate monitoring from infusion start 3

• Do not confuse premedication with treatment of active reactions: While paracetamol is part of premedication, active infusion reactions may require additional interventions including stopping the infusion, administering glucocorticoids, epinephrine, or bronchodilators 1