Indications

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, alone or in combination with...Read more

CONTINUE TREATMENT SEAMLESSLY WITH
CITRATE-FREE AMJEVITA

Dosing is similar to HUMIRA®—patients receive Citrate-Free AMJEVITA
as their next scheduled dose of adalimumab (loading or maintenance dose)1

CURRENT ADALIMUMAB PATIENTS DO NOT NEED TO REPEAT THEIR LOADING DOSE

AMJEVITA is available through an open distribution network and can be delivered to a preferred address.

  • FAMILIAR DOSING1,2
  • FAMILIAR ADMINISTRATION1,2

ADULT DOSING

Ankylosing Spondylitis*, Psoriatic Arthritis*, Moderate to Severe Rheumatoid Arthritis*,†
40
mg
Every other week
*Methotrexate (MTX), other non-biologic disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, nonsteroidal anti-inflammatory
drugs (NSAIDs), and/or analgesics may be continued during treatment with AMJEVITA.
†Some patients with moderate to severe RA 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.
Moderate to Severe Crohn’s Disease*,†,‡, Moderate to Severe Ulcerative Colitis*,§,**, Moderate to Severe Hidradenitis Suppurativa††
Initial dose (day 1)
160
mg
Given as 2 x 80 mg in 1 day or 1 x 80 mg per day
for 2 consecutive days
Second dose (day 15)
80
mg
Maintenance dose (beginning day 29)
40
mg
Every other week
*Aminosalicylates and/or corticosteroids may be continued during treatment with AMJEVITA.
†In moderate to severe CD, azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with AMJEVITA if necessary.
‡In a maintenance clinical trial, among patients with moderate to severe CD who were not responsive by week 12, therapy continued beyond 12 weeks did not result in significantly more responses.
§In moderate to severe UC, azathioprine and 6-MP may be continued during treatment with AMJEVITA if necessary.
**In moderate to severe UC, discontinue AMJEVITA in adult patients without evidence of clinical remission by 8 weeks (day 57) of therapy.
††In moderate to severe HS, maintenance doses may be given as 40 mg weekly or 80 mg every other week
Adult Uveitis (UV), Moderate to Severe Chronic Plaque Psoriasis
Initial dose (day 1)
80
mg
Maintenance dose (beginning day 8)
40
mg
Every other week

PEDIATRIC DOSING

Moderate to Severe Crohn’s Disease (aged ≥ 6 years)
17 kg (37 lbs) to < 40 kg (88 lbs)
80
mg
Day 1
40
mg
Day 15
20
mg
Every other week (beginning day 29)
≥ 40 kg (88 lbs)
160
mg
Day 1 (single dose or split over 2 consecutive days)
80
mg
Day 15
40
mg
Every other week (beginning day 29)
Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) (aged ≥ 2 years)*,†
10 kg (22 lbs) to < 15 kg (33 lbs)
10
mg
Every other week
15 kg (33 lbs) to < 30 kg (66 lbs)
20
mg
Every other week
≥ 30 kg (66 lbs)
40
mg
Every other week
*MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with AMJEVITA.
†Adalimumab products have not been studied in patients with moderate to severe polyarticular JIA less than 2 years of age or in
patients with a weight below 10 kg.
Amgevita Pro
Monitoring to assess safety: Prior to initiating AMJEVITA and periodically during therapy, evaluate patients for active tuberculosis
and test for latent infection
AMJEVITA is available in both the SureClick Autoinjector and the prefilled syringe. Patients should be sure to read and follow the Instructions for Use that comes with the medication.

AMJEVITA is distributed by both AMGEN and Nuvaila™, and the dosage presentations may vary. Review the full list of products available by distributor and their associated labeling.

SureClick® Autoinjector

  • Designed so patients do not see the needle
  • Medicine is injected automatically
  • Does not need to be mixed or prepared
AMJEVITA® (adalimumab-atto) SureClick® Autoinjector

40 mg/0.4 mL

AMJEVITA® (adalimumab-atto) SureClick® Autoinjector

80 mg/0.8 mL

See the SureClick® Autoinjector injection overview video and other resources*
It is important that patients thoroughly review the Instructions for Use. The information in this video does not replace the Instructions for Use.

Prefilled Syringe

  • Does not need to be mixed or prepared
AMJEVITA® (adalimumab-atto) Prefilled Syringe
AMJEVITA® (adalimumab-atto) Prefilled Syringe
AMJEVITA® (adalimumab-atto) Prefilled Syringe
See the prefilled syringe injection overview video and other resources†
It is important that patients thoroughly review the Instructions for Use. The information in this video does not replace the Instructions for Use.
Amgevita Pro
The AMJEVITA prefilled syringe and prefilled SureClick® Autoinjector are not made with natural rubber latex

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IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS

Patients treated with AMJEVITA 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 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: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to 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.

  • Do not start AMJEVITA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of AMJEVITA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing 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 of these patients had received treatment with azathioprine or 6-mercaptopurine 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.

  • Consider the risks and benefits of AMJEVITA prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials of some TNF blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with AMJEVITA.
  • In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY

Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop AMJEVITA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including AMJEVITA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after AMJEVITA treatment. Discontinue AMJEVITA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming AMJEVITA after HBV treatment.

NEUROLOGIC REACTIONS

TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering AMJEVITA for patients with these disorders; discontinuation of AMJEVITA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGICAL REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping AMJEVITA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

Worsening or new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.

AUTOIMMUNITY

Treatment with adalimumab products 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.

IMMUNIZATIONS

Patients on AMJEVITA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating AMJEVITA therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Please see the accompanying AMJEVITA full Prescribing Information, including Medication Guide.

INDICATIONS

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, alone or in combination with methotrexate or other non-biologic DMARDs.
  • reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, alone or in combination with methotrexate.
  • reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis, alone or in combination with non-biologic DMARDs.
  • reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
  • 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.
  • the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

HUMIRA® is a registered trademark of AbbVie, Inc.

AMJEVITA® is a trademark of Amgen Inc.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS
Patients treated with AMJEVITA 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.