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ICD-10 Support

The ICD-10 Diagnosis Codes for Providers

Please refer to the current policy for the latest codes since these codes are subject to change. The codes provided are not intended to be exhaustive. Please consult your ICD-10 code book for additional information.

Third-party reimbursement is affected by many factors. This content and the information and assistance provided by Janssen CarePath are presented for informational purposes only. They do not constitute reimbursement or legal advice. Janssen CarePath does not promise or guarantee coverage, levels of reimbursement, or payment.

Similarly, all CPT^®* and HCPCS codes are supplied for informational purposes only and represent no statement, promise, or guarantee, expressed or implied, by Janssen and its third-party service providers that these codes will be appropriate or that reimbursement will be made. The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the Medicare program.

Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Accordingly, the information may not be current or comprehensive. Janssen and its third-party service providers make no representations or warranties, expressed or implied, as to the accuracy of the information provided. In no event shall the third-party service providers or Janssen, or their employees or agents, be liable for any damages resulting from or relating to any information provided by, or accessed to or through, Janssen CarePath. All HCPs and other users of this information agree that they accept responsibility for the use of this program.

*CPT^® – Current Procedural Terminology. CPT^® is a registered trademark of the American Medical Association, 2018.

Click below for ICD-10 CODES.

RHEUMATOID ARTHRITIS AND OTHER INFLAMMATORY POLYARTHROPATHIES / OTHER RHEUMATOID ARTHRITIS

ICD-10 Indication

ICD-10 Code

Rheumatoid arthritis with rheumatoid factor

M05

Rheumatoid vasculitis with rheumatoid arthritis

M05.2XX

More codes

... of unspecified site	M05.20
... of right shoulder	M05.211
... of left shoulder	M05.212
... of unspecified shoulder	M05.219
... of right elbow	M05.221
... of left elbow	M05.222
... of unspecified elbow	M05.229
... of right wrist	M05.231
... of left wrist	M05.232
... of unspecified wrist	M05.239
... of right hand	M05.241
... of left hand	M05.242
... of unspecified hand	M05.249
... of right hip	M05.251
... of left hip	M05.252
... of unspecified hip	M05.259
... of right knee	M05.261
... of left knee	M05.262
... of unspecified knee	M05.269
... of right ankle and foot	M05.271
... of left ankle and foot	M05.272
... of unspecified ankle and foot	M05.279
... of multiple sites	M05.29

Rheumatoid heart disease with rheumatoid arthritis

M05.3XX

More codes

... of unspecified site	M05.30
... of right shoulder	M05.311
... of left shoulder	M05.312
... of unspecified shoulder	M05.319
... of right elbow	M05.321
... of left elbow	M05.322
... of unspecified elbow	M05.329
... of right wrist	M05.331
... of left wrist	M05.332
... of unspecified wrist	M05.339
... of right hand	M05.341
... of left hand	M05.342
... of unspecified hand	M05.349
... of right hip	M05.351
... of left hip	M05.352
... of unspecified hip	M05.359
... of right knee	M05.361
... of left knee	M05.362
... of unspecified knee	M05.369
... of right ankle and foot	M05.371
... of left ankle and foot	M05.372
... of unspecified ankle and foot	M05.379
... of multiple sites	M05.39

Rheumatoid myopathy with rheumatoid arthritis

M05.4XX

More codes

arthritis
... unspecified site	M05.40
... right shoulder	M05.411
... left shoulder	M05.412
... unspecified shoulder	M05.419
... right elbow	M05.421
... left elbow	M05.422
... unspecified elbow	M05.429
... right wrist	M05.431
... left wrist	M05.432
... unspecified wrist	M05.439
... right hand	M05.441
... left hand	M05.442
... unspecified hand	M05.449
... right hip	M05.451
... left hip	M05.452
... unspecified hip	M05.459
... right knee	M05.461
... left knee	M05.462
... unspecified knee	M05.469
... right ankle and foot	M05.471
... left ankle and foot	M05.472
... unspecified ankle and foot	M05.479
... multiple sites	M05.49

Rheumatoid polyneuropathy with rheumatoid arthritis

M05.5XX

More codes

... of unspecified site	M05.50
... of right shoulder	M05.511
... of left shoulder	M05.512
... of unspecified shoulder	M05.519
... of right elbow	M05.521
... of left elbow	M05.522
... of unspecified elbow	M05.529
... of right wrist	M05.531
... of left wrist	M05.532
... of unspecified wrist	M05.539
... of right hand	M05.541
... of left hand	M05.542
... of unspecified hand	M05.549
... of right hip	M05.551
... of left hip	M05.552
... of unspecified hip	M05.559
... of right knee	M05.561
... of left knee	M05.562
... of unspecified knee	M05.569
... of right ankle and foot	M05.571
... of left ankle and foot	M05.572
... of unspecified ankle and foot	M05.579
... of multiple sites	M05.59

Rheumatoid arthritis with involvement of other organs and systems

M05.6XX

More codes

... of unspecified site	M05.60
... of right shoulder	M05.611
... of left shoulder	M05.612
... of unspecified shoulder	M05.619
... of right elbow	M05.621
... of left elbow	M05.622
... of unspecified elbow	M05.629
... of right wrist	M05.631
... of left wrist	M05.632
... of unspecified wrist	M05.639
... of right hand	M05.641
... of left hand	M05.642
... of unspecified hand	M05.649
... of right hip	M05.651
... of left hip	M05.652
... of unspecified hip	M05.659
... of right knee	M05.661
... of left knee	M05.662
... of unspecified knee	M05.669
... of right ankle and foot	M05.671
... of left ankle and foot	M05.672
... of unspecified ankle and foot	M05.679
... of multiple sites	M05.69

Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

M05.7XX

More codes

... of unspecified site	M05.70
... of right shoulder	M05.711
... of left shoulder	M05.712
... of unspecified shoulder	M05.719
... of right elbow	M05.721
... of left elbow	M05.722
... of unspecified elbow	M05.729
... of right wrist	M05.731
... of left wrist	M05.732
... of unspecified wrist	M05.739
... of right hand	M05.741
... of left hand	M05.742
... of unspecified hand	M05.749
... of right hip	M05.751
... of left hip	M05.752
... of unspecified hip	M05.759
... of right knee	M05.761
... of left knee	M05.762
... of unspecified knee	M05.769
... of right ankle and foot	M05.771
... of left ankle and foot	M05.772
... of unspecified ankle and foot	M05.779
... of multiple sites	M05.79

Other rheumatoid arthritis with rheumatoid factor

M05.8XX

More codes

... of unspecified site	M05.80
... of right shoulder	M05.811
... of left shoulder	M05.812
... of unspecified shoulder	M05.819
... of right elbow	M05.821
... of left elbow	M05.822
... of unspecified elbow	M05.829
... of right wrist	M05.831
... of left wrist	M05.832
... of unspecified wrist	M05.839
... of right hand	M05.841
... of left hand	M05.842
... of unspecified hand	M05.849
... of right hip	M05.851
... of left hip	M05.852
... of unspecified hip	M05.859
... of right knee	M05.861
... of left knee	M05.862
... of unspecified knee	M05.869
... of right ankle and foot	M05.871
... of left ankle and foot	M05.872
... of unspecified ankle and foot	M05.879
... of multiple sites	M05.89

Rheumatoid arthritis with rheumatoid factor, unspecified

M05.9

Other Rheumatoid Arthritis

M06

Rheumatoid arthritis without rheumatoid factor

M06.0XX

More codes

... of unspecified site	M06.00
... of right shoulder	M06.011
... of left shoulder	M06.012
... of unspecified shoulder	M06.019
... of right elbow	M06.021
... of left elbow	M06.022
... of unspecified elbow	M06.029
... of right wrist	M06.031
... of left wrist	M06.032
... of unspecified wrist	M06.039
... of right hand	M06.041
... of left hand	M06.042
... of unspecified hand	M06.049
... of right hip	M06.051
... of left hip	M06.052
... of unspecified hip	M06.059
... of right knee	M06.061
... of left knee	M06.062
... of unspecified knee	M06.069
... of right ankle and foot	M06.071
... of left ankle and foot	M06.072
... of unspecified ankle and foot	M06.079
... of vertebrae	M06.08
... of multiple sites	M06.09

Adult-onset Still's disease

M06.1

Rheumatoid bursitis

M06.2XX

More codes

... of unspecified site	M06.20
... of right shoulder	M06.211
... of left shoulder	M06.212
... of unspecified shoulder	M06.219
... of right elbow	M06.221
... of left elbow	M06.222
... of unspecified elbow	M06.229
... of right wrist	M06.231
... of left wrist	M06.232
... of unspecified wrist	M06.239
... of right hand	M06.241
... of left hand	M06.242
... of unspecified hand	M06.249
... of right hip	M06.251
... of left hip	M06.252
... of unspecified hip	M06.259
... of right knee	M06.261
... of left knee	M06.262
... of unspecified knee	M06.269
... of right ankle and foot	M06.271
... of left ankle and foot	M06.272
... of unspecified ankle and foot	M06.279
... of vertebrae	M06.28
... of multiple sites	M06.29

Rheumatoid nodule

M06.3XX

More codes

... of unspecified site	M06.30
... of right shoulder	M06.311
... of left shoulder	M06.312
... of unspecified shoulder	M06.319
... of right elbow	M06.321
... of left elbow	M06.322
... of unspecified elbow	M06.329
... of right wrist	M06.331
... of left wrist	M06.332
... of unspecified wrist	M06.339
... of right hand	M06.341
... of left hand	M06.342
... of unspecified hand	M06.349
... of right hip	M06.351
... of left hip	M06.352
... of unspecified hip	M06.359
... of right knee	M06.361
... of left knee	M06.362
... of unspecified knee	M06.369
... of right ankle and foot	M06.371
... of left ankle and foot	M06.372
... of unspecified ankle and foot	M06.379
... of vertebrae	M06.38
... of multiple sites	M06.39

Other specified rheumatoid arthritis

M06.8XX

More codes

... of unspecified site	M06.80
... of right shoulder	M06.811
... of left shoulder	M06.812
... of unspecified shoulder	M06.819
... of right elbow	M06.821
... of left elbow	M06.822
... of unspecified elbow	M06.829
... of right wrist	M06.831
... of left wrist	M06.832
... of unspecified wrist	M06.839
... of right hand	M06.841
... of left hand	M06.842
... of unspecified hand	M06.849
... of right hip	M06.851
... of left hip	M06.852
... of unspecified hip	M06.859
... of right knee	M06.861
... of left knee	M06.862
... of unspecified knee	M06.869
... of right ankle and foot	M06.871
... of left ankle and foot	M06.872
... of unspecified ankle and foot	M06.879
... of vertebrae	M06.88
... of multiple sites	M06.89

Rheumatoid arthritis, unspecified

M06.9

Juvenile arthritis

M08

Code also any associated underlying condition, such as:
regional enteritis [Crohn's disease] (K50.-)
ulcerative colitis (K51.-)

Unspecified juvenile rheumatoid arthritis of unspecified site

M08.00

More codes

..., unspecified shoulder	M08.019*
..., unspecified elbow	M08.029*
..., unspecified wrist	M08.039*
..., unspecified hand	M08.049*
..., unspecified hip	M08.059*
..., unspecified knee	M08.069*
..., unspecified ankle and foot	M08.079*
..., vertebrae	M08.08
..., multiple sites	M08.09
*Please refer to the ICD-10 book for lateral codes.

Juvenile rheumatoid arthritis with systemic onset, unspecified site

M08.20

More codes

..., unspecified shoulder	M08.219*
..., unspecified elbow	M08.229*
..., unspecified wrist	M08.239*
..., unspecified hand	M08.249*
..., unspecified hip	M08.259*
..., unspecified knee	M08.269*
..., unspecified ankle and foot	M08.279*
..., vertebrae	M08.28
..., multiple sites	M08.29
*Please refer to the ICD-10 book for lateral codes.

Juvenile rheumatoid polyarthritis (seronegative)

M08.3

Pauciarticular juvenile rheumatoid arthritis, unspecified site

M08.40

More codes

..., unspecified shoulder	M08.419*
..., unspecified elbow	M08.429*
..., unspecified wrist	M08.439*
..., unspecified hand	M08.449*
..., unspecified hip	M08.459*
..., unspecified knee	M08.469*
..., unspecified ankle and foot	M08.479*
..., vertebrae	M08.48
*Please refer to the ICD-10 book for lateral codes.

Other juvenile arthritis, unspecified site

M08.80

More codes

..., unspecified shoulder	M08.819*
..., unspecified elbow	M08.829*
..., unspecified wrist	M08.839*
..., unspecified hand	M08.849*
..., unspecified hip	M08.859*
..., unspecified knee	M08.869*
..., unspecified ankle and foot	M08.879*
..., other specified site	M08.88
..., multiple sites	M08.89
*Please refer to the ICD-10 book for lateral codes.

Juvenile arthritis, unspecified, unspecified site

M08.90

More codes

..., ..., unspecified shoulder	M08.919*
..., ..., unspecified elbow	M08.929*
..., ..., unspecified wrist	M08.939*
..., ..., unspecified hand	M08.949*
..., ..., unspecified hip	M08.959*
..., ..., unspecified knee	M08.969*
..., ..., unspecified ankle and foot	M08.979*
..., ..., vertebrae	M08.98
..., ..., multiple sites	M08.99
*Please refer to the ICD-10 book for lateral codes.

PSORIATIC ARTHRITIS

ICD-10 Indication	ICD-10 Code
Psoriasis	L40
Arthropathic psoriasis, unspecified	L40.50
Distal interphalangeal psoriatic arthropathy	L40.51
Psoriatic arthritis mutilans	L40.52
Psoriatic spondylitis	L40.53
Psoriatic juvenile arthropathy	L40.54
Other psoriatic arthropathy	L40.59

ANKYLOSING SPONDYLITIS AND OTHER INFLAMMATORY SPONDYLOPATHIES / ANKYLOSING SPONDYLITIS

ICD-10 Indication	ICD-10 Code
Ankylosing spondylitis	M45
Multiple sites in spine	M45.0
Occipito-atlanto-axial region	M45.1
Cervical region	M45.2
Cervicothoracic region	M45.3
Thoracic region	M45.4
Thoracolumbar region	M45.5
Lumbar region	M45.6
Lumbosacral region	M45.7
Sacral and sacrococcygeal region	M45.8
Unspecified sites in spine	M45.9

REGIONAL ENTERITIS / CROHN'S DISEASE

ICD-10 Indication	ICD-10 Code
Crohn's disease [regional enteritis]	K50
Use additional code to identify manifestations, such as pyoderma gangrenosum (L88)
Crohn's disease of small intestine without complications	K50.00
Crohn's disease of small intestine with complications	K50.01X *
Crohn's disease of large intestine without complications	K50.10
Crohn's disease of large intestine with complications	K50.11X *
Crohn's disease of both small and large intestine without complications	K50.80
Crohn's disease of both small and large intestine with complications	K50.81X *
Crohn's disease, unspecified, without complications	K50.90
Crohn's disease, unspecified, with complications	K50.91X *

*Please refer to the ICD-10 book for codes with different complications.

ULCERATIVE COLITIS

ICD-10 Indication

ICD-10 Code

Ulcerative Colitis

K51

Use additional code to identify manifestations, such as pyoderma gangrenosum (L88)

Ulcerative (chronic) pancolitis without complications

K51.00

More codes

... with rectal bleeding	K51.011
... with intestinal obstruction	K51.012
... with fistula	K51.013
... with abscess	K51.014
... with other complication	K51.018
... with unspecified complications	K51.019

Ulcerative (chronic) proctitis without complications

K51.20

More codes

... with rectal bleeding	K51.211
... with intestinal obstruction	K51.212
... with fistula	K51.213
... with abscess	K51.214
... with other complication	K51.218
... with unspecified complications	K51.219

Ulcerative (chronic) rectosigmoiditis without complications

K51.30

More codes

... with rectal bleeding	K51.311
... with intestinal obstruction	K51.312
... with fistula	K51.313
... with abscess	K51.314
... with other complication	K51.318
... with unspecified complications	K31.319

Left sided colitis without complications

K51.50

More codes

... with rectal bleeding	K51.511
... with intestinal obstruction	K51.512
... with fistula	K51.513
... with abscess	K51.514
... with other complication	K51.518
... with unspecified complications	K51.519

Other ulcerative colitis without complications

K51.80

More codes

... with rectal bleeding	K51.811
... with intestinal obstruction	K51.812
... with fistula	K51.813
... with abscess	K51.814
... with other complication	K51.818
... with unspecified complications	K51.819

Ulcerative colitis, unspecified, without complications

K51.90

More codes

..., with rectal bleeding	K51.911
..., with intestinal obstruction	K51.912
..., with fistula	K51.913
..., with abscess	K51.914
..., with other complication	K51.918
..., with unspecified complications	K51.919

For more information on ICD-10, visit the CMS Web site.

SOURCE:
American Medical Association. ICD-10-CM 2018: The Complete Official Codebook. 2017. American Medical Association.

INDICATIONS

REMICADE^® is indicated for:

Crohn's Disease

Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD

Pediatric Crohn's Disease

Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy

Ulcerative Colitis

Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy

Pediatric Ulcerative Colitis

Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy

Rheumatoid Arthritis

Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)

Psoriatic Arthritis

Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)

Ankylosing Spondylitis

Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)

Plaque Psoriasis

The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
REMICADE^® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Important Safety Information For REMICADE^®

SERIOUS INFECTIONS

Patients treated with REMICADE^® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE^® if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE^®.^1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE^®.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. 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, including Legionella, Listeria, and Salmonella.

The risks and benefits of treatment with REMICADE^® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE^®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE^® included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE^®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE^®. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE^® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE^® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE^®, especially in these patient types.

In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE^®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE^® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE^®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE^® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE^® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE^®.

CONTRAINDICATIONS

REMICADE^® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE^® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE^® if new or worsening CHF symptoms appear. REMICADE^® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

HEPATITIS B REACTIVATION

TNF inhibitors, including REMICADE^®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE^®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE^® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE^®. Discontinue REMICADE^® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE^® and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE^® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE^® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE^® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE^® in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITY

REMICADE^® has been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE^®. Medications for the treatment of hypersensitivity reactions should be available.

CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE^® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE^® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

NEUROLOGIC EVENTS

TNF inhibitors, including REMICADE^®, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE^® in patients with these disorders and consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with REMICADE^® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

ADVERSE REACTIONS

In clinical trials, the most common REMICADE^® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

USE WITH OTHER DRUGS

Concomitant use of REMICADE^® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE^® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Live vaccines or therapeutic infectious agents should not be given with REMICADE^® due to the possibility of clinical infections, including disseminated infections.

Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE^®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE^®.

For more information, please see the full Prescribing Information and Medication Guide for REMICADE^®. Provide the Medication Guide to your patients and encourage discussion.

References:

1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.

2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

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