AMJEVITA- adalimumab injection
A-S Medication Solutions
Patients treated with adalimumab products including AMJEVITA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1)] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue AMJEVITA if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy 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.
Carefully consider the risks and benefits of treatment with AMJEVITA prior to initiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with AMJEVITA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products [see Warnings and Precautions (5.2)]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF-blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF-blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males.
Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF-blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF-blocker or a TNF-blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2)].
AMJEVITA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate.
AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
AMJEVITA can be used alone or in combination with non-biologic DMARDs.
AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
AMJEVITA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
AMJEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use
AMJEVITA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5)].
AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
The recommended subcutaneous dosage of AMJEVITA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDs, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with AMJEVITA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of AMJEVITA to 40 mg every week or 80 mg every other week.
The recommended subcutaneous dosage of AMJEVITA for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with AMJEVITA.
| Pediatric Weight(2 Years of Age and Older)||Recommended Dosage|
| 15 kg (33 lbs) to less than 30 kg (66 lbs)||20 mg every other week|
| 30 kg (66 lbs) and greater||40 mg every other week|
There is no dosage form for AMJEVITA that allows weight based dosing for pediatric patients below 15 kg.
Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
The recommended subcutaneous dosage of AMJEVITA for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with AMJEVITA. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with AMJEVITA if necessary.
The recommended subcutaneous dosage of AMJEVITA for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below:
| Pediatric Weight|| Recommended Dosage|
|Days 1 through 15||Starting on Day 29|
| 17 kg (37 lbs) to less than 40 kg (88 lbs)||Day 1: 80 mgDay 15: 40 mg||20 mg every other week|
| 40 kg (88 lbs) and greater||Day 1: 160 mg (single dose or split over two consecutive days)Day 15: 80 mg||40 mg every other week|
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