No

Monoclonal Antibody

Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapy or for the treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)

C

It is not known whether infliximab is secreted in human milk. Because many immunoglobulins are secreted in milk, and the potential for serious adverse reactions exists, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Known hypersensitivity to murine proteins or any component

Hypersensitivity reactions, including urticaria, dyspnea, and hypotension have occurred; discontinue the drug if a reaction occurs. Medications for the treatment of hypersensitivity reactions should be available for immediate use. Autoimmune antibodies and a lupus-like syndrome have been reported; if antibodies to double-stranded DNA are confirmed in a patient with lupus-like symptoms, treatment should be discontinued. May affect normal immune responses; effects on development of lymphoma and infection in Crohn's patients are unknown. Treatment may result in the development of human antichimeric antibodies (HACA); presence of these antibodies may predispose patients to infusion reactions.

>10%:

Central nervous system: Headache (22.6%), fatigue (10.6%), fever (10.1%)

Gastrointestinal: Nausea (16.6%), abdominal pain (12.1%)

Local: Infusion reactions (16%)

Respiratory: Upper respiratory tract infection (16.1%)

Miscellaneous: Infections (21%)

1% to 10%:

Cardiovascular: Chest pain (5.5%)

Central nervous system: Pain (8.5%), dizziness (8%)

Dermatologic: Rash (6%), pruritus (5%)

Gastrointestinal: Vomiting (8.5%)

Neuromuscular & skeletal: Myalgia (5%), back pain (5%)

Respiratory: Pharyngitis (8.5%), bronchitis (7%), rhinitis (6%), cough (5%), sinusitis (5%)

Miscellaneous: Development of antibodies to double-stranded DNA (9%), candidiasis (5%), serious infection (3%)

<1%: Lupus-like syndrome (2 patients); a proportion of patients (12%) with fistulizing disease developed new abscess 8-16 weeks after the last infusion of infliximab

Specific drug interaction studies have not been conducted

Store vials at 2°C to 8°C (36°F to 46°F); do not freeze; does not contain preservative

Onset of effect: Within 2 weeks

Distribution: V_d: 3.0 L (volume may be increased 17% in patients receiving corticosteroids)

Half-life: 9.5 days

Moderately to severely active Crohn's disease: Adults: I.V.: 5 mg/kg as a single infusion over a minimum of 2 hours

Fistulizing Crohn's disease: 5 mg/kg as an infusion over a minimum of 2 hours, dose repeated at 2 and 6 weeks after the initial infusion

Dosing adjustment in renal impairment: No specific adjustment recommended

Dosing adjustment in hepatic impairment: No specific adjustment recommended

Fatigue is common; may cause dizziness

None noted

No information available to require special precautions

Candidiasis reported in ~5% of patients

This drug can only be administered by infusion. Report adverse symptoms: headache or unusual fatigue; increased nausea or abdominal pain; cough, runny nose, difficulty breathing; chest pain or persistent dizziness; fatigue, muscle pain or weakness, back pain; fever or chills, mouth sores, vaginal itching or discharge, sore throat, unhealed sores, or frequent infections. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Do not shake reconstituted vials

Powder for injection: 100 mg