pharmacopeia
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/api/v1/drug/adalimumab

Boxed warning

SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue Adalimumab-aacf if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab-aacf. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ) : Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-aacf are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] .

Mechanism of action

Sourced from openFDA

Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement.

Indications

Sourced from openFDA
  • Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.ICD-10: M06.9

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 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 Crohn's Disease ( 2.3 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29. Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 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 Ulcerative Colitis ( 2.4 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57). Plaque Psoriasis or Adult Uveitis ( 2.5 ): Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Warnings & precautions

Sourced from openFDA

Serious infections: Do not start Adalimumab-aacf during an active infection. If an infection develops, monitor carefully, and stop Adalimumab-aacf if infection becomes serious. ( 5.1 ) Invasive fungal infections: For patients who develop a systemic illness on Adalimumab-aacf, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. ( 5.1 ) Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls ( 5.2 ) Anaphylaxis or serious hypersensitivity reactions may occur ( 5.3 ) Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Adalimumab-aacf and begin anti- viral therapy. ( 5.4 ) Demyelinating disease: Exacerbation or new onset, may occur. ( 5.5 ) Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop and consider stopping Adalimumab-aacf. ( 5.6 ) Heart failure: Worsening or new onset, may occur. ( 5.8 ) Lupus-like syndrome: Stop Adalimumab-aacf if syndrome develops. ( 5.9 ) 5.1 Serious Infections Patients treated with adalimumab products including Adalimumab-aacf are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancies [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Hepatitis B Virus Reactivation [see Warnings and Precautions ( 5.4 )] Neurologic Reactions [see Warnings and Precautions ( 5.5 )] Hematological Reactions [see Warnings and Precautions ( 5.6 )] Heart Failure [see Warnings and Precautions ( 5.8 )] Autoimmunity [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>10%) are infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088- or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with adalimumab was injection site reactions. In placebo- controlled trials, 20% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects. Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab. Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease-matched comparison cohort. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects (see Data ) . Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant (see Clinical Considerations ) . In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate (see Data ) .

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of adalimumab were linear over the dose range of 0.5 to 10 mg/kg following administration of a single intravenous dose (adalimumab products are not approved for intravenous use). Following 20, 40, and 80 mg every other week and every week subcutaneous administration, adalimumab mean serum trough concentrations at steady state increased approximately proportionally with dose in RA patients.

Overdosage

Sourced from openFDA

Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Approval history

Sourced from openFDA
  • Dec 31, 2002BLABLA125057Abbvie Inc
  • Sep 23, 2016BLABLA761024Amgen Inc
  • Aug 25, 2017BLABLA761058Boehringer Ingelheim
  • Oct 30, 2018BLABLA761071Sandoz Inc
  • Jul 23, 2019BLABLA761059Samsung Bioepis Co Ltd
  • Nov 15, 2019BLABLA761118Pfizer Inc
  • Jul 6, 2020BLABLA761154Mylan Pharms Inc
  • Dec 17, 2021BLABLA761216Coherus Biosciences Inc

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Hyrimoz, Injection, 40 mg/.4 mL (NDC 61314-473-64)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Hyrimoz, Injection, 80 mg/.8 mL (NDC 61314-454-36)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Hyrimoz, Injection, 80 mg/.8 mL (NDC 61314-454-68)To be discontinued
    Sponsor: Sandoz Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
715,352 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective92,76713%
  2. 2Pain50,4907.1%
  3. 3Arthralgia49,4896.9%
  4. 4Injection Site Pain48,0546.7%
  5. 5Fatigue40,4685.7%
  6. 6Rheumatoid Arthritis36,5135.1%
  7. 7Headache29,2744.1%
  8. 8Nausea27,8593.9%
  9. 9Diarrhoea26,5143.7%
  10. 10Rash25,9943.6%
  11. 11Psoriasis25,1523.5%
  12. 12Pain In Extremity24,9683.5%
  13. 13Joint Swelling23,7883.3%
  14. 14Off Label Use23,4303.3%
  15. 15Incorrect Dose Administered22,6083.2%

Literature

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Recent PubMed references pinned to Adalimumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 790 ClinicalTrials.gov registrations naming Adalimumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Adalimumab. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • TNFCPIC C (provisional)

Frequently asked questions

How does Adalimumab work?
Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement.
What is Adalimumab used for?
According to FDA labeling, Adalimumab carries indications including: Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Adalimumab?
Adalimumab is classified as Tumor necrosis factor alpha (TNF-alpha) inhibitors, Tumor Necrosis Factor Blocker, Biological Response Modifiers, Tumor Necrosis Factor alpha Receptor Blocking Activity, Tumor Necrosis Factor Receptor Blocking Activity, Immunologic Activity Alteration.
What are the brand names for Adalimumab?
Adalimumab is marketed under brand names including Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio.
What are the contraindications for Adalimumab?
Adalimumab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for adalimumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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