ICD-10 Support

ICD-10 Support

The ICD-10 Diagnosis Codes For Providers

Easy access to the information you may need

If you’re a provider, you’ll want to get familiar with billing codes that went into effect October 1, 2015. While sample ICD-9-CM codes have been mapped to the latest ICD-10-CM codes so that coders can become familiar with the new codes, the ultimate responsibility for correct coding lies with the provider of services. The codes included in the charts below are not intended to be promotional, or to encourage or suggest a use of any drug that is inconsistent with FDA-approved use.

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.

Click below for an ICD-10 Crosswalk Sample.

RHEUMATOID ARTHRITIS AND OTHER INFLAMMATORY POLYARTHROPATHIES / OTHER RHEUMATOID ARTHRITIS

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Rheumatoid Arthritis and Other Inflammatory Polyarthropathies 714 Inflammatory Polyarthropathies M05
Rheumatoid arthritis 714.0 Rheumatoid myopathy with rheumatoid M05.4XX
Use additional code to identify manifestation, as:   arthritis  
myopathy (359.6)   unspecified site M05.40
polyneuropathy (357.1)   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 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 with 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
    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
    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
    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
    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
    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
    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
Other rheumatoid arthritis with visceral or systemic involvement 714.2 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 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
    Adult-onset Still's disease M06.1
    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

PSORIATIC ARTHRITIS

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Psoriasis and similar disorders 696 Psoriasis L40
Psoriatic arthropathy 696.0 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 juvenile arthropathy L40.59

PSORIASIS, OTHER

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Other psoriasis 696.1 Psoriasis vulgaris L40.0

ANKYLOSING SPONDYLITIS AND OTHER INFLAMMATORY SPONDYLOPATHIES / ANKYLOSING SPONDYLITIS

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Ankylosing spondylitis and other inflammatory spondylopathies 720 Ankylosing spondylitis M45
Ankylosing Spondylitis 720.0 Juvenile ankylosing spondylitis M08.1
    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-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Regional enteritis 555 Crohn's disease K50
    Use additional code to identify manifestations, such as pyoderma gangrenosum (L88)
Regional enteritis, small intestine 555.0 Crohn's disease of small intestine without complications K50.00
    Crohn's disease of small intestine with complications K50.01X *
Regional enteritis, large intestine 555.1 Crohn's disease of large intestine without complications K50.10
    Crohn's disease of large intestine with complications K50.11X *
Regional enteritis, small and large intestine 555.2 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 *
Regional enteritis, unspecified site 555.9 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-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Ulcerative Colitis 556 Ulcerative Colitis K51
    Use additional code to identify manifestations, such as pyoderma gangrenosum (L88)
Ulcerative (chronic) enterocolitis 556.0 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 (chronic ) ileocolitis 556.1 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 (chronic) proctitis 556.2 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) proctosigmoiditis 556.3 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 ulcerative (chronic) colitis 556.5 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
Universal ulcerative (chronic) colitis 556.6 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
Other ulcerative colitis 556.8 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 556.9 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

OTHER DISORDERS OF INTESTINE / OTHER DISEASES OF INTESTINE

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Other disorders of intestine 569 Other diseases of intestine K63
Fistula of intestine, excluding rectum and anus 569.81 Fistula of intestine K63.2

ANAL FISSURE AND FISTULA / FISSURE AND FISTULA OF ANAL AND RECTAL REGIONS

ICD-9 Indication ICD-9 Code ICD-10 Indication ICD-10 Code
Anal fissure and fistula 565 Fissure and fistula of anal and rectal regions K60
Anal fistula 565.1 Anal fistula K60.3
    Rectal fistula K60.4
    Anorectal fistula K60.5

 

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

SOURCES
American Medical Association, “2016 The Complete Official Codebook ICD10-CM”

THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND REPRESENTS NO STATEMENT, PROMISE, OR GUARANTEE BY JANSSEN BIOTECH, INC. CONCERNING LEVELS OF REIMBURSEMENT, PAYMENT, OR CHARGE. SIMILARLY, ALL CPT® (©AMA) AND HCPCS CODES ARE SUPPLIED FOR INFORMATIONAL PURPOSES ONLY AND REPRESENT NO STATEMENT, PROMISE, OR GUARANTEE BY JANSSEN BIOTECH, INC. THAT THESE CODES WILL BE APPROPRIATE OR THAT REIMBURSEMENT WILL BE MADE. IT IS NOT INTENDED TO INCREASE OR MAXIMIZE REIMBURSEMENT BY ANY PAYER. WE STRONGLY RECOMMEND THAT YOU CONSULT YOUR PAYER ORGANIZATION WITH REGARD TO ITS REIMBURSEMENT POLICIES.

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 and pneumocystosis. 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 and Listeria.

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.

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 rarely 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. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.

NEUROLOGIC EVENTS

TNF inhibitors, including REMICADE®, have been associated in rare cases 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, rarely, in 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 full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion. (Requires Adobe® Reader®. Click here to download.)

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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