Adult Dosing
Rheumatoid arthritis
- 40 mg SC q2 wk
- May increase dosing frequency to 40 mg qwk in patients not taking concomitant methotrexate
Psoriatic arthritis
Ankylosing spondylitis
Note:
- Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics or other disease-modifying anti-rheumatic drugs can be continued during treatment with this drug
Crohn’s disease
- Initial dose: 160 mg SC at day 1 followed by 80 mg 2 wks later
- Maintenance dose: 40 mg q2 wk
Note:
- Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., 6-mercaptopurine and azathioprine) may be continued during therapy with this drug. Therapy beyond one year has not been evaluated
Plaque psoriasis
- Initial dose: 80 mg SC followed by 40 mg q2 wk starting 1 wk after the initial dose. Therapy beyond one year has not been evaluated
Ulcerative Colitis
- Initial dose: 160 mg SC at day 1 followed by 80 mg 2 wks later
- Continue with a dose of 40 mg after 2 wks for every other week
Note:
- Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., 6-mercaptopurine and azathioprine) may be continued during therapy with this drug
Pediatric Dosing
Juvenile idiopathic arthritis
4-17 yrs, 15 kg-30 kg
30 Kg
[Outline]
- Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have occurred in patients receiving TNF-blockers (US Black Box Warning)
- Tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis are the most commonly occurring opportunistic infections
- Patients taking concomitant immunosuppressants such as methotrexate or corticosteroids with this drug, frequently present with disseminated rather than localized disease
- Avoid initiation of therapy in patients with an active infection, including localized infections
- Consider risks and benefits of therapy prior to initiation of therapy in patients with chronic or recurrent infection, patients exposed to tuberculosis, patients residing or traveling in areas of endemic tuberculosis or endemic mycoses, or in those patients with underlying conditions predisposing to infections [US Black Box Warning]
- Reactivation of tuberculosis or new tuberculosis infections (both pulmonary and extrapulmonary) have occurred in patients receiving therapy and also in patients who have previously received treatment for latent or active tuberculosis
- To reduce the risk of tuberculosis reactivation, initiate treatment of latent tuberculosis infection prior to therapy with TNF blockers [US Black Box Warning]
- Consider anti-tuberculosis therapy prior to use of this drug in patients with a history of latent or active tuberculosis in whom an adequate course of therapy cannot be confirmed, and for patients tested as negative for latent tuberculosis but having risk factors for tuberculosis infection. Reactivation of tuberculosis have also been reported in some patients in spite of prophylactic treatment. Consult a physician expert in the treatment of tuberculosis to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient
- Closely monitor patients for the development of signs and symptoms of infection during and after treatment including the possible occurrence of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiation of therapy [US Black Box Warning]. Tests for latent tuberculosis infection may be falsely negative while on therapy with this drug
- Discontinue therapy on occurrence of a serious infection or sepsis. Closely monitor a patient who develops a new infection during therapy with this drug. Undertake a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy
- On occurrence of serious systemic illness, suspect invasive fungal infections for patients residing or traveling to regions were mycoses are endemic. Testing of antigen and antibody for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients having severe systemic illness with risk for invasive fungal infections [US Black Box Warning]
- Lymphoma and other malignancies including death have occurred in children and adolescent patients treated with TNF blockers [US Black Box Warning]
- There have been post-marketing reports of Hepatosplenic T-cell lymphoma (HSTC), a rare form of T-cell lymphoma occurring in adolescent and young adults with Crohn's disease or ulcerative colitis receiving TNF blockers, including adalimumab [US Black Box Warning]
- Adult patients receiving TNF-blockers, including adalimumab have been reported to have a higher incidence of malignancies as compared to control patients
- Anaphylaxis and angioneurotic edema have been reported in patients receiving adalimumab. On occurrence of an anaphylactic or other serious allergic reaction, immediately discontinue the drug and institute appropriate therapy
- TNF blockers may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Fatal reactions have occurred following HBV reactivation occurring in conjunction with TNF blocker. Patients who are receiving concomitant medications resulting in suppression of immune system are more prone to HBV reactivation
- Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV
- Adequate safety and efficacy for treating HBV carriers patients with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation is not established
- Closely monitor patients who are carriers of HBV and require treatment with TNF blockers for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy
- Discontinue therapy and consider effective anti-viral therapy with appropriate supportive treatment for patients developing HBV reactivation. Exercise caution while considering resumption of therapy
- Rare occasions of pancytopenia including aplastic anemia have occurred with TNF blockers
- Adverse reactions of the hematologic system, including medically significant cytopenias (e.g., thrombocytopenia, leukopenia) have occurred. Consider discontinuation of therapy in patients with confirmed significant hematologic abnormalities
- Combination with this drug and anakinra is not recommended
- Carefully monitor patients having history of congestive heart failure
- Discontinue therapy on occurrence of lupus-like syndrome
- Prior to initiation of therapy immunize juvenile idiopathic arthritis patients following current immunization guidelines
- Safety and efficacy in patients with immunosuppression have not been established
Cautions: Use cautiously in:
- History of opportunistic infection
- Latent tuberculosis
- Chronic or recurrent infections
- Risk of tuberculosis
- History of malignancy
- Concurrent immunosuppressants
- HBV carrier
- CNS demyelinating disease
- Myelosuppression
- Residing/traveling in areas with endemic TB or mycoses
- CHF
Pregnancy Category:B
Breastfeeding: Safety Unknown; limited literature indicates that this drug produces low levels in milk and does not adversely affect the nursing infant. Little is excreted into breastmilk and is unlikely to be absorbed, some experts feel that the drug is a low risk to the nursing infant and can be used during breastfeeding. Until more data become available, prefer an alternative drug especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 December 2010). Manufacturer advises caution when administering adalimumab to nursing women.
Pricing data from www.DrugStore.com in U.S.A.
- Humira 20 MG/0.4ML KIT [Box] (ABBOTT)
2 0.4ml = $2144.99
6 0.4ml = $6163.92 - Humira Pen 40 MG/0.8ML KIT [Box] (ABBOTT)
2 0.8ml = $2055.07
4 0.8ml = $4046.03 - Humira 40 MG/0.8ML KIT [Box] (ABBOTT)
2 0.8ml = $2040.01
4 0.8ml = $4036.14
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
