Remicade®

GoodRx

Infliximab · intravenous infusion

Misc., Injections & Implants

OFF-LABELNot in the FDA label for this product

Refractory non-infectious uveitis

Intravenous infusion at weeks 0, 2 and 6, then every 8 weeks, with dose escalation permitted for breakthrough inflammation in the trial

Open-label · n=23 · toxicity

A prospective open-label phase 2 trial enrolled 23 patients with refractory autoimmune uveitis. 18 of 23 (78%) met a composite success endpoint at week 10, and all patients who completed 50 weeks maintained it. The safety signal is the reason to read this row carefully rather than the efficacy: 5 of the 14 enrolled for a year stopped early for significant adverse events, serious events potentially related to infliximab included pulmonary embolus, congestive heart failure, lupus-like reaction in 2 patients and vitreous haemorrhage in 2, and antinuclear antibodies developed in 15 of 20 patients receiving 3 or more infusions. The authors call the rate of serious toxic effects unexpectedly high.

Suhler EB, Smith JR, Wertheim MS, et al. A prospective trial of infliximab therapy for refractory uveitis: preliminary safety and efficacy outcomes. Arch Ophthalmol. 2005;123(7):903-12

Contraindications

The use of REMICADE at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. REMICADE is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions.

Available Forms

100 mg

Mechanism of Action

Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα.

Warnings & Precautions

Serious infections: Do not give REMICADE during an active infection. If an infection develops, monitor carefully and stop REMICADE if infection becomes serious.
Malignancies: The incidence of malignancies, including invasive cervical cancer and lymphoma, was greater in REMICADE-treated patients than in controls.
Hepatitis B virus reactivation: Test for HBV infection before starting REMICADE. Monitor HBV carriers during and several months after therapy.
Hepatotoxicity: Severe hepatic reactions, some fatal or necessitating liver transplantation. Stop REMICADE in cases of jaundice and/or marked liver enzyme elevations.
Heart failure: New onset or worsening symptoms may occur. ( 4 , 5.5 ) Cytopenias – advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping REMICADE.
Hypersensitivity: Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.

Common Side Effects

The most common serious infection (requiring hospitalization) was abscess (skin, throat, and peri-rectal) reported by 5 (0.7%) patients in the 5 mg/kg REMICADE group.

Pregnancy & Lactation

Pregnancy: Available observational studies in pregnant women exposed to REMICADE showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. However, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct .

Lactation: Published literature show that infliximab is present at low levels in human milk. Systemic exposure in a breastfed infant is expected to be low because infliximab is largely degraded in the gastrointestinal tract.

Pediatric Use

The safety and effectiveness of REMICADE have been established in pediatric patients 6 to 17 years of age for induction and maintenance treatment of CD and UC.