Drug Guide
Infliximab-qbtx
Classification
Therapeutic: Immunosuppressant/Anti-TNF alpha agent
Pharmacological: Monoclonal antibody
FDA Approved Indications
- Crohn's disease
- Ulcerative colitis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
Mechanism of Action
Infliximab-qbtx is a chimeric monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-α), inhibiting its activity and thereby reducing inflammation.
Dosage and Administration
Adult: Typically 5 mg/kg IV at weeks 0, 2, and 6, then every 8 weeks; dose adjustments based on response and tolerability.
Pediatric: Dosing based on weight, generally similar to adult dosing, administered IV; specific protocols vary based on condition.
Geriatric: Use with caution; consider hepatic and renal function, comorbidities, and concomitant medications.
Renal Impairment: Adjust dosing cautiously; no specific dose adjustments established, monitor renal function.
Hepatic Impairment: Use with caution; no specific dose adjustments established, assess hepatic function regularly.
Pharmacokinetics
Absorption: Administered IV, so bypasses absorption barriers.
Distribution: Distributed mainly in plasma and extracellular fluid.
Metabolism: Metabolized via catabolic pathways typical for monoclonal antibodies, principally by proteolytic degradation.
Excretion: Eliminated via protein catabolism; no renal or hepatic clearance data available indicating significant elimination.
Half Life: Approximately 8-10 days.
Contraindications
- Hypersensitivity to infliximab or its components.
- Active infections, including TB.
Precautions
- Screen for latent TB prior to initiation.
- Monitor for infections during therapy.
- Use with caution in patients with congestive heart failure, demyelinating diseases, or a history of malignancies.
Adverse Reactions - Common
- Infusion reactions (fever, chills, pruritus, rash) (Common)
- Infections (upper respiratory, urinary tract) (Common)
- Headache (Common)
Adverse Reactions - Serious
- Severe infections (e.g., pneumonia, sepsis) (Less common)
- Lymphoma and other malignancies (Rare)
- Hepatosplenic T-cell lymphoma (mainly in young males with IBD) (Very rare)
Drug-Drug Interactions
- Other immunosuppressants (e.g., azathioprine, methotrexate)
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of infection, infusion reactions, adverse effects; assess for TB before and during treatment.
Diagnoses:
- Risk for infection
- Impaired skin integrity
Implementation: Administer IV infusion as prescribed; premedicate if necessary; monitor vital signs during infusion.
Evaluation: Assess effectiveness in controlling disease symptoms; monitor for adverse reactions and infections.
Patient/Family Teaching
- Report signs of infection immediately.
- Attend all scheduled infusions and follow-up appointments.
- Inform healthcare provider of all medications and supplements.
Special Considerations
Black Box Warnings:
- Serious infections, including tuberculosis and opportunistic infections.
- Lymphomas and other malignancies.
Genetic Factors: Increased risk of lymphoma may be associated with concomitant immunosuppressants.
Lab Test Interference: May cause false-positive tests for infection (e.g., TB tests).
Overdose Management
Signs/Symptoms: Unknown, but may include severe infections or infusion reactions.
Treatment: Supportive care; manage symptoms; no specific antidote.
Storage and Handling
Storage: Store vials refrigerated at 2-8°C.
Stability: Unopened vials can be stored for up to 24 months; do not freeze after reconstitution.