Amjevita

AMJEVITA (adalimumab-atto) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). AMJEVITA was created using recombinant DNA technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.

AMJEVITA™ (adalimumab-atto) Injection is supplied as a sterile, preservative-free solution of adalimumab-atto for subcutaneous administration. The drug product is supplied as either a single-use, prefilled SureClick® autoinjector, or as a single-use, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-use, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2.

Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2.

Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2.

Dosage Forms & Strengths

prefilled syringe/pen

• 40mg/0.8mL (Humira, Amjevita)

Biosimilars to Humira

• Amjevita (adalimumab-atto)
• Cyltezo (adalimumab-adbm)

Rheumatoid Arthritis

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms, induction of major clinical response, inhibition of progression of structural damage, and improvement of physical function in adults with moderate-to-severe active rheumatoid arthritis

40 mg SC q2wk

Dosing considerations

• May be administered as monotherapy or combined with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)
• If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Psoriatic Arthritis

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms, inhibition of progression of structural damage, and improvement of physical function in adults with active psoriatic arthritis

40 mg SC q2wk

Dosing considerations

• May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
• If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Ankylosing Spondylitis

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms of active ankylosing spondylitis

40 mg SC q2wk

Dosing considerations

• May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
• If not taken with concomitant methotrexate, additional benefit may be derived from increasing adalimumab dosing frequency to once weekly

Plaque Psoriasis

Humira, Amjevita, Cyltezo

Indicated for treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and for whom other systemic therapies are inappropriate

80 mg SC once, then, after 1 week, 40 mg SC q2wk

Humira prescribing information includes patients with moderate-to-severe fingernail psoriasis

Crohn Disease

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms and induction and maintenance of clinical remission in adults with moderately to severely active Crohn disease who have had inadequate response to conventional therapy; may be used in patients who have lost response to or are intolerant of infliximab

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)

Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk

Dosing considerations

• Some patients may require weekly 40-mg dose for maintenance (Inflamm Bowel Dis 2011 Jan 17(1):141-51; Am J Gastroenterology 2009;104:465-83)

Ulcerative Colitis

Humira, Amjevita, Cyltezo

Indicated for treatment of ulcerative colitis unresponsive to immunosuppressants (eg, corticosteroids, azathioprine, 6-mercaptopurine [6-MP])

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)

Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk

Continue maintenance dose only if evidence of clinical remission is apparent by 8 weeks of therapy

Hidradenitis Suppurativa

Humira

Indicated for treatment of moderate-to-severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)

Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)

Maintenance (beginning Week 4 [Day 29]): 40 mg SC qwk

Uveitis

Humira

Indicated for treatment of noninfectious intermediate, posterior, and panuveitis in adults

80 mg SC once, then, after 1 week, 40 mg SC q2wk

Behcet's Disease (Orphan)

Orphan designation for treatment of Behcet's disease

Sponsor

• Mucora; 32b Eisenberg St; Rehovot 7628810 Israel

Dosage Forms & Strengths

prefilled syringe/pen

• 20mg/0.4mL (Humira, Amjevita)
• 40mg/0.8mL (Humira, Amjevita)

Biosimilars to Humira

• Amjevita (adalimumab-atto)
• Cyltezo (adalimumab-adbm)

Juvenile Idiopathic Arthritis

Humira, Amjevita

Indicated for reduction of signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis

May be administered with methotrexate, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics

Humira

• <2 years or <10 kg: Safety and efficacy not established
• ≥2 years
  • 10 kg to <15 kg: 10 mg SC q2wk
  • 15 kg to <30 kg: 20 mg SC q2wk
  • ≥30 kg: 40 mg SC q2wk

Amjevita, Cyltezo

• <4 years: Safety and efficacy not established
• ≥4 years
  • Amjevita: 15 kg to <30 kg: 20 mg SC q2wk
  • Amjevita or Cyltezo: ≥30 kg: 40 mg SC q2wk

Pediatric Crohn Disease

Humira

Indicated to reduce signs and symptoms, and achieve and maintain clinical remission in pediatric patients with moderately to severely active Crohn disease who have had an inadequate response to corticosteroids or immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate)

<6 years: Safety and efficacy not established

≥6 years (17 kg to <40 kg)

• Induction: 80 mg SC on Day 1 (administer as two 40 mg injections in one day); THEN 2 weeks later (Day 15) give 40 mg
• Maintenance (beginning Week 4 [Day 29]): 20 mg SC q2wk

≥6 years (>40 kg)

• Induction: 160 mg SC on Day 1 (administer as four 40 mg injections in one day or as two 40 mg injection per day for two consecutive days); THEN 2 weeks later (Day 15) give 80 mg (as two 40 mg injections in one day)
• Maintenance (beginning Week 4 [Day 29]):40 mg SC q2wk

Ulcerative Colitis (Orphan)

Orphan designation for pediatric ulcerative colitis

Orphan sponsor

• Abbott Laboratories; Global Pharmaceutical Research & Development; Abbott Park, IL 60064

>10%

Injection site pain (12-20%)

Upper respiratory tract infection (URTI) (17%)

Increased creatine phosphokinase (15%)

Headache (12%)

Rash (12%)

Sinusitis (11%)

1-10%

Nausea (9%)

Urinary tract infection (UTI) (8%)

Abdominal pain (7%)

Flulike syndrome (7%)

Hyperlipidemia (7%)

Back pain (6%)

Hypercholesterolemia (6%)

Hematuria (5%)

Hypertension (5%)

Increased alkaline phosphatase (5%)

<1%

Allergic reactions

Hematologic disorder (leukopenia, thrombocytopenia, pancytopenia, aplastic anemia)

Postmarketing Reports

General disorders and administration site conditions: Pyrexia

Hepato-biliary disorders: Liver failure, hepatitis

Immune system disorders: Sarcoidosis

Neoplasms benign, malignant and unspecified (incl cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)

Nervous system disorders: Demyelinating disorders (eg, optic neuritis, Guillain-Barré syndrome), cerebrovascular accident

Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism

Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia

Vascular disorders: Systemic vasculitis, deep vein thrombosis

Amjevita is a prescription medication used to reduce the signs and symptoms of: 

• Moderate to severe rheumatoid arthritis (RA) in adults
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 and up 
• Active psoriatic arthritis (PsA) in adults
• Active ankylosing spondylitis (AS) in adults
• Moderate to severe active Crohn’s disease (CD) in adults
• Moderate to severe active ulcerative colitis (UC) in adults
• Moderate to severe plaque psoriasis (Ps) in adults

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Orencia (abatacept)
• Kineret (anakinra)
• Remicade (infliximab)
• Enbrel (etanercept)
• Cimzia (certolizumab pegol)
• Simponi (golimumab)
• Rituxan (rituximab)
• Imuran (azathioprine)
• Purinethol (6-mercaptopurine)
• Live vaccines

This is not a complete list of Amjevita drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

You and your doctor should decide if you will breastfeed or use Amjevita. You should not do both. 

Administer Amjevita exactly as prescribed. Do not inject Amjevita more often than you were prescribed.

Amjevita is given by an injection under the skin. Your doctor will tell you how often to take an injection of Amjevita. This is based on your condition to be treated.

• Amjevita is typically administered every other week
• Amjevita can be injected into the thigh, and stomach area (except for a 2 inch area right around the navel)
• Make sure to rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard

Make sure you have been shown how to inject Amjevita before you do it yourself. 

Do not miss any doses unless your doctor says it is okay. If you miss a dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject Amjevita, call your doctor or pharmacist.

If you take too much Amjevita, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Amjevita is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.  

You should not use this medicine if you are allergic to adalimumab, or if you have an active infection.

Some people using adalimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using adalimumab or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma.

To make sure adalimumab is safe for you, tell your doctor if you have ever had:

• chronic infections;

• cancer;

• hepatitis B;

• congestive heart failure;

• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;

• an allergy to latex rubber; or

• if you have recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start treatment with adalimumab.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you have a baby after receiving adalimumab during pregnancy, tell the baby's doctor before your baby is given any vaccines.

It is not known whether adalimumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Adalimumab should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease). Children using adalimumab should be current on all childhood immunizations before starting treatment.

Using adalimumab may increase your risk of certain types of cancer, such as lymphoma (cancer of the lymph nodes), or melanoma (a tumor that usually affects the skin). You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.