Amjevita
Name: Amjevita
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Description
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.
Dosing & Uses
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
Adverse Effects
>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
Uses of Amjevita
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.
Amjevita Interactions
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.
Amjevita and Lactation
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.
Amjevita Usage
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.
Amjevita Overdose
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.
What should I discuss with my healthcare provider before using Amjevita (adalimumab)?
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.
What should I avoid while using Amjevita (adalimumab)?
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.