Infliximab

Drug #2196

The Mechanism of infliximab is to bind the Tumor necrosis factor (TNF-alpha) antibody (chimeric IgG1). It was produced initially in mice, as a mouse antibody, later it was developed into human antibody as humans have immune reactions to mouse proteins. It is produced by a recombinant cell line cultured by continuous perfusion.

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Primary Characteristics

It is of Synthetic origin.

Molecular Weight: 144190.3 · pK_a: 8.25 · Non-proprietary name: Infliximab · pH: 7.2.

Pharmacokinetics

Elimination: plasma half-life is 8-9.5 days.

Indications

Infliximab is primarily indicated in conditions like Ankylosing spondylitis, Crohn's disease, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis.

Contraindications

None recorded.

Dosage

Infliximab's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
5 mg/kg	5 mg/kg	Every 24h	IV Induction	at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks (For Crohn's disease). For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue Infliximab in these patients.
5 mg/kg	5 mg/kg	Every 24h	IV Induction	at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active ulcerative colitis.
3 mg/kg	3 mg/kg	Every 24h	IV Inf	followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. (for Rheumatoid Arthritis). For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses.
5 mg/kg	5 mg/kg	Every 24h	IV Inf	followed with additional similar doses at 2 and 6 weeks after the first infusion, then every 6 weeks thereafter. (for Ankylosing Spondylitis)
5 mg/kg	5 mg/kg	Every 24h	IV Inf	followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. (for Psoriatic Arthritis)
5 mg/kg	5 mg/kg	Every 24h	IV Inf	followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. (for Plaque Psoriasis)
Paediatric Dosage (20kg)
5 mg/kg	5 mg/kg	—	IV infusion	Followed by additional 5mg/kg infusion doses at 2 & 6 weeks.
Neonatal Dosage (3kg)
No data.

Drug Interactions

None recorded.

Side Effects

Infliximab in overdosage may give rise to further complications which include Hepatitis , Jaundice , Jaundice , Blood dyscrasias , Cholestasis , Deaths , blood dyscrasias.

Infliximab produces potentially life-threatening effects which include Active tuberculosis, Invasive fungal infections. Careful monitoring is needed with proper medical management.

Infliximab is known to cause more or less tolerable side effects which are usually transient. These include Abdominal pain, Back pain, Diarrhea, Dizziness, Fatigue, Headache, Nausea and vomiting.

Warnings / Precautions

Patients treated with Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Infliximab use and during therapy.1, 2 Treatment for latent infection should be initiated prior to Infliximab use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with Infliximab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Infliximab, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Available Brands

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Single Ingredient

Inf

100 mg

Drug Classification

1.8.2 — Cytotoxic (anti-neoplastic) drugs

Manufacturers

Manufacturers of Infliximab in Pakistan:

Bayer