Remicade

Remicade

infliximab

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Contents
Infliximab.
Action
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα), but not to lymphotoxin α (TNFβ). Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays. It prevents disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset allows eroded joints to heal. In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
Indications/Uses
Rheumatoid Arthritis: Remicade is a disease-controlling antirheumatic therapy (DCART) indicated for: Reduction of signs and symptoms; prevention of structural joint damage (erosions and joint space narrowing); and improvement in physical function in patients with active disease despite treatment with methotrexate.
Ankylosing Spondylitis: Reduction of signs and symptoms and improvement in physical function in patients with active disease.
Psoriatic Arthritis: Reduction of signs & symptoms of arthritis; improvement in physical function; reduction in psoriasis as measured by PASI (an index which combines symptom evaluation and body surface area) in patients with active psoriatic arthritis.
Psoriasis: Reduction of signs and symptoms of psoriasis; improvement in the quality of life. In the treatment of adult patients with severe plaque psoriasis who are candidates for systemic therapy and for patients with moderate psoriasis for whom phototherapy is inadequate or inappropriate.
Adult and Paediatric Crohn's Disease: Treatment of moderate to severe Crohn's disease for: Reduction of signs and symptoms; induction and maintenance of clinical remission; induction of mucosal healing; and improvement in quality of life in patients who have an inadequate response to conventional therapies. Remicade therapy enables patients to reduce or eliminate corticosteroid use.
Fistulizing Crohn's Disease: Reduction in the number of draining enterocutaneous and rectovaginal fistulae and maintenance of fistula closure; reduction of signs and symptoms; and improvement in quality of life in patients with fistulizing Crohn's disease.
Ulcerative Colitis: Reducing signs and symptoms; inducing and maintaining clinical remission; induction of mucosal healing; improving quality of life; reducing or discontinuing administration of corticosteroids; reducing ulcerative colitis-related hospitalizations in patients with active ulcerative colitis who have had an inadequate response to conventional therapy.
Dosage/Direction for Use
Remicade is for IV use in adults.
Remicade treatment is to be administered under the supervision of specialized physicians experienced in the diagnosis and treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel diseases, psoriasis, ulcerative colitis.
All patients administered Remicade are to be observed for at least 1 hr post-infusion for side effects. Medications, an artificial airway and other appropriate materials must be available for the treatment of these effects (see Precautions).
Rheumatoid Arthritis: Initially 3 mg/kg IV infusion over a 2-hr period is to be followed with additional 3 mg/kg infusion doses at 2 and 6 weeks after the 1st infusion, then every 8 weeks thereafter. After 22 weeks of therapy, the dose may be increased up to 5-10 mg/kg every 8 weeks if necessary. Remicade should be given in combination with methotrexate.
Ankylosing Spondylitis: 5 mg/kg given as an IV infusion over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the 1st infusion, then every 6-8 weeks thereafter.
Psoriatic Arthritis: 5 mg/kg given as an IV infusion over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the 1st infusion, then every 8 weeks thereafter.
Psoriasis: 5 mg/kg given as IV infusion over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 and 6 week after the 1st infusion, then every 8 weeks thereafter.
Moderate to Severe Crohn's Disease: For optimal long-term symptom therapy, 5 mg/kg given as a single IV infusion over a 2-hr period as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. For patients who have an incomplete response during maintenance treatment, consideration may be given to adjusting the dose up to 10 mg/kg.
Alternatively, an initial 5 mg/kg IV infusion administered over a 2-hr period may be followed by repeat infusions of 5 mg/kg when signs and symptoms of the disease recur; however, there is limited data on dosing intervals beyond 16 weeks.
Paediatric Chron's Disease: 5 mg/kg IV infusion followed by additional 5 mg/kg infusion at weeks 2 and 6 after the 1st infusion, then every 8 weeks therafter. For patients with incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg.
Fistulizing Crohn's Disease: 5 mg/kg IV over a 2-hr period and followed with additional 5 mg/kg doses administered at 2 and 6 weeks after the 1st infusion for treatment of fistula(s) in Crohn's disease. If a patient does not respond after these 3 doses, no additional treatment with infliximab should be given.
The strategies for continued treatment are: Additional infusions of 5 mg/kg every 8 weeks; or re-administration if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see Re-administration as follows and Precautions).
In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Ulcerative Colitis: 5 mg/kg given as an IV infusion over a 2-hr period followed by additional 5 mg/kg dose at 2 and 6 weeks after the 1st infusion, then every 8 weeks thereafter. In some patients, consideration may be given to adjusting the dose up to 10 mg/kg to sustain response and remission.
Re-administration for Crohn's Disease and Rheumatoid Arthritis: If the signs and symptoms of the disease recur, Remicade can be re-administered within 16 weeks following the last infusion. Re-administration of an alternate formulation of infliximab with a drug-free interval of 2-4 years following a previous infusion has been associated with a delayed hypersensitivity reaction in 10 patients with Crohn's disease (see Precautions and Adverse Reactions: Delayed Hypersensitivity). After a drug-free interval of 16 weeks to 2 years, the risk of delayed hypersensitivity following re-administration is not known. Therefore, after a drug-free interval of 16 weeks, re-administration cannot be recommended.
Re-administration for Ulcerative Colitis, Psoriatic Arthritis, Psoriasis: Data supporting re-administration, other than every 8 weeks, are not available at this time.
Re-administration for Ankylosing Spondylitis: Data supporting re-administration, other than every 6-8 weeks, are not available at this time.
Administration: Remicade powder for solution is to be reconstituted with 10 mL of Sterile Water for Injection and further diluted in 0.9% sodium chloride solution for infusion.
Preparation and Administration: Calculate the required dose and the number of vials. Each vial contains 100 mg infliximab. Calculate the total volume of reconstituted Remicade solution required.
Reconstitute each vial with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. Upon reconstitution, each mL of reconstituted solution contains 10 mg of infliximab. Remove flip-top from the vial and wipe the top with a 70% alcohol swab. Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of water for injections to the glass wall of the vial. Do not use the vial if the vacuum is not present. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. Do not shake. Foaming of the solution on reconstitution is not unusual. Allow the reconstituted solution to stand for 5 min. Check that the solution is colorless to light yellow and opalescent. The solution may develop a few fine translucent particles, as infliximab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present.
Dilute the total volume of the reconstituted Remicade solution dose to 250 mL with 0.9% w/v sodium chloride solution for infusion. This can be accomplished by withdrawing a volume of the 0.9% w/v sodium chloride solution for infusion equal to the volume of reconstituted Remicade from the 0.9% w/v sodium chloride solution for infusion 250-mL glass bottle or bag. Slowly add the total volume of reconstituted Remicade solution to the 250-mL infusion bottle or bag. Gently mix.
Administer the infusion solution over a period of not less than 2 hrs (at not more than 2 mL/min). Use an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size ≤1.2 micrometer). Since no preservative is present, it is recommended that the administration of the solution for infusion be started as soon as possible and within 3 hrs of reconstitution and dilution. If reconstitution and dilution are performed under strict aseptic conditions, Remicade infusion solution can be used within 24 hrs if stored at 2-8°C. Do not store any unused portion of the infusion solution for reuse.
No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents. Do not infuse Remicade concomitantly in the same IV line with other agents.
Visually inspect parenteral medicinal products for particulate matter or discoloration prior to administration. Do not use if visibly opaque particles, discoloration or foreign particulates are observed.
Discard any unused portion of the solution.
Overdosage
Single doses up to 20 mg/kg have been administered to patients without direct toxic effects. In case of overdosage, it is recommended that patients be monitored for any signs or symptoms of adverse reactions or effects, and appropriate symptomatic treatment be instituted immediately.
Contraindications
Patients with known sensitivity to any of the components of Remicade or to murine proteins.
Patients with severe infections eg, tuberculosis, sepsis, abscesses and opportunistic infections.
Patients with moderate to severe heart failure (NYHA class III/IV) (see Precautions and Adverse Reactions).
Special Precautions
Remicade has been associated with acute infusion effects and a delayed hypersensitivity reaction. These differ in their time of onset. Therefore, all patients receiving Remicade should be observed for at least 1 hr post-infusion for side effects.
Acute infusion reactions may develop immediately or within a few hours of infusion and are most likely to occur during the 1st and 2nd infusion. If acute infusion reactions occur, the infusion must be interrupted immediately. Some of these effects have been described as anaphylaxis. Medications (eg, antihistamines, corticosteroids, adrenaline and/or paracetamol), an artificial airway and other appropriate materials for the treatment of these effects must be available for immediate use. Patients may be pretreated with eg, antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Antibodies to infliximab may develop in some patients and have been associated with an increased frequency of infusion reactions. A low proportion of the infusion reactions were serious allergic reactions. In Crohn's disease patients, an association between development of antibodies to infliximab and reduced duration of response have also been observed. Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions. The effect of concomitant immunomodulator therapy was more profound in episodically treated patients than in patients given maintenance therapy. Patients who are not receiving immunosuppressants during Remicade treatment, potentially are at greater risk of developing these antibodies. These antibodies cannot always be detected in serum samples. If serious reactions occur, symptomatic treatment must be given and further Remicade infusions must not be administered.
A delayed hypersensitivity reaction has been observed in a significant number of patients (25% in 1 clinical trial) with Crohn's disease who were re-treated with Remicade following a 2- to 4-year period without Remicade treatment. Signs and symptoms included myalgia and/or arthralgia with fever and/or rash within 12 days following re-treatment. Some patients also experienced pruritus, facial, hand or lip edema, dysphagia, urticaria, sore throat and/or headache. These effects have sometimes been described as serum sickness-like reactions. Advise patients to seek immediate medical advice if they experience any delayed adverse event (see Adverse Reactions: Delayed Hypersensitivity). If patients are re-treated after a prolonged period, they should be closely monitored for signs and symptoms of delayed hypersensitivity.
Tumor necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune response. Experimental data show that TNFα is essential for the clearing of intracellular infections. Clinical experience shows that the host defense against infection is compromised in some patients treated with infliximab.
Caution should be exercised when considering the use of Remicade therapy in patients with a chronic infection or a history of recurrent infection.
Opportunistic infections including tuberculosis and other infections eg, sepsis have been reported in patients treated with infliximab (see Adverse Reactions).
Patients must be evaluated for the risk of tuberculosis, including latent tuberculosis, prior to initiation of Remicade. This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. Appropriate screening tests ie, tuberculin skin test and chest x-ray, should be performed in all patients (local recommendations may apply). Prescribers are reminded of the risk of false-negative tuberculin skin test results especially in patients who are severely ill or immunocompromised. Patients who have clinically manifested infections and/or abscesses must be treated for these conditions prior to treatment with Remicade. If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see Contraindications). If latent tuberculosis is diagnosed, treatment must be initiated prior to treatment with Remicade, in accordance with local recommendations. Patients must be monitored closely for infections, including miliary tuberculosis, while on and after treatment with Remicade. Suppression of TNFα may also mask symptoms of infection eg, fever. Treatment with Remicade must be discontinued if a patient develops a serious infection or sepsis. As the elimination of Remicade may take up to 6 months, close monitoring of the patients throughout this period is important.
Patients with fistulizing Crohn's disease with acute suppurative fistulas should not initiate Remicade therapy until a source for possible infection, specifically abscess, has been excluded (see Contraindications).
There is limited safety experience of surgical procedures in Remicade-treated patients. A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (eg, persistent cough, wasting/weight loss, low-grade fever) appear during or after Remicade treatment.
Concurrent administration of etanercept (another agent that inhibits TNFα) and anakinra (a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist) has been associated with an increased risk of serious infections, an increased risk of neutropenia and no additional benefit compared to these medicinal products alone. The safety and efficacy of anakinra used in combination with infliximab has not been established. Therefore, combination of infliximab and anakinra is not recommended.
The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process in a subgroup of genetically susceptible patients. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, treatment should be discontinued (see Adverse Reactions).
Infliximab and other agents that inhibit TNFα have been associated with rare cases of optic neuritis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disorders including multiple sclerosis (see Adverse Reactions). A careful risk/benefit evaluation is recommended when prescribing Remicade to patients with preexisting or recent onset of central nervous system demyelinating disorders.
Remicade should be used with caution in patients with mild heart failure (NYHA class I/II) (see Contraindications and Adverse Reactions).
Effects on the Ability to Drive or Operate Machinery: Remicade is unlikely to produce an effect on the ability to drive or operate machinery; however, patients who are fatigued should be cautioned to avoid driving or operating machinery.
Use in Pregnancy & Lactation: Because Remicade does not cross-react with TNFα in lower species, animal reproduction studies have not been conducted. It is not known whether Remicade can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. It should be given to a pregnant woman only if clearly needed. In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, no evidence of maternal toxicity, embryotoxicity or teratogenicity was observed. However, since it takes 6 months to assure that Remicade is not present in the blood system, it is recommended that adequate contraceptive measures should be taken for at least 6 months after the last Remicade treatment.
It is not known if Remicade is excreted in human milk or absorbed systemically after ingestion by the infant. Because many substances and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Remicade, a decision should be made to discontinue nursing for at least 6 months after Remicade treatment, taking into account the importance of the medicinal product to the mother.
Use in Children: Safety and effectiveness of Remicade in pediatric patients with Crohn's disease have been established. A pediatric Crohn's disease pharmacokinetic study was conducted in patients 17 years. No notable differences in single-dose pharmacokinetics were observed between pediatric and adult Crohn's disease patients.
Use in the Elderly: No major differences were observed in the pharmacokinetics of Remicade in elderly (65-80 years) rheumatoid arthritis patients. The pharmacokinetics of Remicade in elderly Crohn's disease patients has not been studied. Studies have not been performed in patients with liver or renal disease.
Use In Pregnancy & Lactation
Because Remicade does not cross-react with TNFα in lower species, animal reproduction studies have not been conducted. It is not known whether Remicade can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. It should be given to a pregnant woman only if clearly needed. In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, no evidence of maternal toxicity, embryotoxicity or teratogenicity was observed. However, since it takes 6 months to assure that Remicade is not present in the blood system, it is recommended that adequate contraceptive measures should be taken for at least 6 months after the last Remicade treatment.
It is not known if Remicade is excreted in human milk or absorbed systemically after ingestion by the infant. Because many substances and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Remicade, a decision should be made to discontinue nursing for at least 6 months after Remicade treatment, taking into account the importance of the medicinal product to the mother.
Adverse Reactions
In clinical trials with Remicade, adverse drug reactions (ADRs) reasonably attributable to treatment were observed in 36% of placebo-treated patients and 57% of Remicade-treated patients. Reasonably-related ADRs are listed as follows by system organ class and frequency (common >1/100, <1/10; uncommon >1/1000, <1/100; rare >1/10,000, <1/1000). Frequency is based on the excess incidence of the ADR compared with placebo in pooled data from clinical trials involving 227 patients receiving placebo and 1421 patients receiving Remicade (Crohn's disease and rheumatoid arthritis). Most ADRs were mild to moderate in severity. Infusion-related reactions were the most common ADRs reported. The most common causes for discontinuation of treatment were the infusion-related reactions: Dyspnea, urticaria and headache.
Resistance Mechanism Disorders: Common: Viral infection (eg, influenza, herpes infections), fever. Uncommon: Abscess, cellulitis, moniliasis, sepsis, impaired healing, bacterial infection, tuberculosis, fungal infection. Rare: Granulomatous lesion.
Immune Disorders: Common: Serum sickness-like reactions. Uncommon: Autoantibodies, lupus-like syndrome, complement factor abnormality.
Blood Disorders: Uncommon: Anemia, leukopenia, lymphadenopathy, lymphocytosis, lymphopenia, neutropenia, thrombocytopenia.
Psychiatric Disorders: Uncommon: Depression, confusion, agitation, amnesia, apathy, nervousness, somnolence, insomnia.
Central and Peripheral Nervous System Disorders: Common: Headache, vertigo/dizziness. Uncommon: Exacerbation of demyelinating disease suggestive of multiple sclerosis. Rare: Meningitis.
Vision and Hearing Disorders: Uncommon: Conjunctivitis, endophthalmitis, keratoconjunctivitis.
Cardiovascular Disorders: Common: Flushing. Uncommon: Ecchymosis/hematoma, hypertension, hypotension, syncope, petechia, thrombophlebitis, bradycardia, palpitation, vasospasm, cyanosis, peripheral ischemia, arrhythmia, worsening heart failure*. Rare: Circulatory failure, tachycardia.
Respiratory System Disorders: Common: Upper respiratory tract infection, lower respiratory tract infection (eg, bronchitis, pneumonia), dyspnea, sinusitis. Uncommon: Epistaxis, bronchospasm, pleurisy, respiratory tract allergic reaction, pulmonary edema. Rare: Pleural effusion.
Gastrointestinal System Disorders: Common: Nausea, diarrhea, abdominal pain, dyspepsia. Uncommon: Constipation, gastroesophageal reflux, cheilitis, diverticulitis. Rare: Intestinal perforation, intestinal stenosis, gastrointestinal hemorrhage.
Liver and Biliary System Disorders: Common: Abnormal hepatic function. Uncommon: Cholecystitis. Rare: Hepatitis
Skin and Appendages Disorders: Common: Rash, pruritus, urticaria, increased sweating, dry skin. Uncommon: Fungal dermatitis/onychomycosis, eczema/seborrhea, hordeolum, bullous eruption, furunculosis, periorbital edema, hyperkeratosis, rosacea, verruca, abnormal skin pigmentation/coloring, alopecia.
Musculoskeletal System Disorders: Uncommon: Myalgia, arthralgia, back pain.
Urinary System Disorders: Uncommon: Urinary tract infection, pyelonephritis.
Reproductive Disorders: Uncommon: Vaginitis.
Body as a Whole: General Disorders: Common: Fatigue, chest pain, infusion-related reactions. Uncommon: Edema, hot flashes, infusion syndrome, pain, chills/rigors, anaphylactic reactions.
Administration/Application Site Disorders: Uncommon: Injection site reactions.
*Reported in early phase studies evaluating Remicade in patients with congestive heart failure.
Post-Marketing Reports: In post-marketing spontaneous reporting, infections are the most common serious adverse event. Some of the cases have resulted in fatal outcome. Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location (see Precautions) and other opportunistic infections eg, atypical mycobacteria, pneumocystis carinii pneumonia (PCP), histoplasmosis, coccidiomycosis, cryptococcosis, aspergillosis, listeriosis, candidiasis and salmonellosis have been reported rarely (<1/1000) or very rarely (<1/10,000). In addition, demyelinating disorders (eg, multiple sclerosis and optic neuritis), Guillain-Barre syndrome, neuropathies, numbness, tingling, seizure, transverse myelitis, pancytopenia, hemolytic anemia, idiopathic purpura, thrombotic thrombocytic purpura, hepatocellular damage, anaphylactic shock, interstitial pneumonitis/fibrosis have been reported rarely (<1/1000) or very rarely (<1/10,000).
Infusion-Related Reactions: An infusion-related reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1-2 hrs after an infusion. Approximately twice as many Remicade-treated patients experienced an infusion-related reaction compared to placebo-treated patients. Among all Remicade infusions, approximately 3% of infusions were accompanied by nonspecific symptoms eg, fever or chills; <1% were accompanied by pruritus or urticaria, 1% were accompanied by cardiopulmonary reactions (primary chest pain, hypotension, hypertension or dyspnea), and 0.1% were accompanied by combined symptoms of pruritus/urticaria and cardiopulmonary reactions. Discontinuation of treatment resulted in 2% of patients, and all patients recovered with or without medical therapy. Infusion-related effects in patients were more likely to occur during the 1st (7%) and less likely on subsequent infusions (2nd, 6%; 3rd, 6%; and 4th, 5%; etc).
Patients who became positive for antibodies to infliximab were more likely (approximately 2-3 fold) to have an infusion reaction than those who were negative. Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Delayed Hypersensitivity: In a clinical trial of 41 patients re-treated with Remicade following a 2- to 4-year period without Remicade treatment, 10 patients experienced undesirable effects manifesting 3-12 days following infusion. In 6 of these patients, the effects were considered serious. Signs and symptoms included myalgia and/or arthralgia with fever and/or rash. Some patients also experienced pruritus, facial, hand or lip edema, dysphagia, urticaria, sore throat and/or headache. The clinical data are not adequate to determine if occurrence of these reactions is due to the different formulations administered to these patients in this study. Patients' signs and symptoms improved substantially or resolved with treatment in all cases. There are insufficient data on the incidence of these events after drug-free intervals of 1-2 years. These events have been observed only infrequently in clinical studies and post-marketing surveillance with re-treatment intervals up to 1 year.
Immunogenicity: Patients who developed antibodies to infliximab were more likely to develop infusion-related reactions. In clinical trials using single and multiple infliximab doses ranging from 1-20 mg/kg, antibodies to infliximab were detected in approximately 14% of patients with any immunosuppressant therapy, and in approximately 24% of patients without immunosuppressant therapy. In rheumatoid arthritis patients who received the recommended repeated treatment dose regimen with methotrexate, approximately 8% of patients developed antibodies to infliximab. Of Crohn's disease patients who received maintenance treatment, approximately 6-13% developed antibodies to infliximab. The antibody incidence was 2- to 3-fold higher for patients treated episodically. Due to methodological shortcomings, a negative assay did not exclude the presence of antibodies to infliximab. Some patients who developed high titers of antibodies to infliximab had evidence of reduced efficacy.
Infections: In clinical trials, 35% of Remicade-treated patients experienced infections compared with 22% of placebo-treated patients. Serious infections eg, pneumonia, were reported in 5% of both Remicade-treated patients and placebo-treated patients (see Precautions).
Malignancies and Lymphoproliferative Disorders: Cases of lymphoma, myeloma and other malignancies have occurred in Crohn's disease and rheumatoid arthritis patients treated with Remicade, but these were within the expected incidence ranges reported in the literature for these diseases. It is unknown if chronic exposure to Remicade can cause the development of these disorders.
Heart Failure: In a phase II study aimed at evaluating Remicade in moderate to severe congestive heart failure (CHF), higher incidence of mortality due to worsening of heart failure was seen in patients treated with Remicade, especially those treated with the higher doses of 10 mg/kg.
Antinuclear Antibodies (ANA)/Double-Stranded DNA (dsDNA) Antibodies: In clinical studies, approximately 52% (of 1261) infliximab-treated patients who were ANA negative at baseline developed a positive ANA during the trial (compared with approximately 19% of 129 placebo-treated patients). Anti-dsDNA antibodies developed in approximately 17% (261) of patients treated with Remicade (compared with 0% of 162 placebo-treated patients). At the last evaluation, 150 of these 261 infliximab-treated patients (57%) remained anti-dsDNA positive.
Clinical signs consistent with a lupus-like syndrome remain uncommon.
Drug Interactions
In rheumatoid arthritis and Crohn's disease patients, the formation of antibodies to infliximab has been shown to be reduced when Remicade is administered concomitantly with methotrexate and other immunomodulators. No other information is available regarding possible effects of other immunosuppressive drugs or their effects on the pharmacokinetics of infliximab.
Storage
Store at 2-8°C. Do not freeze.
ATC Classification
L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Infusion 100 mg (lyophilized powd, single-use vial) x 1's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in