Humira(Cf) Pedi Crohns Starter (adalimumab)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk, recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibodies, are tumor necrosis factor (TNF) inhibitors that are biologic disease-modifying antirheumatic drugs (DMARDs).
Adalimumab-aacf (Idacio(R)), adalimumab-aaty (Yuflyma(R)), adalimumab-adaz (Hyrimoz(R)), adalimumab-adbm (Cyltezo(R)), adalimumab-afzb (Abrilada(R)), adalimumab-aqvh (Yusimry(R)), adalimumab-atto (Amjevita(R)), adalimumab-bwwd (Hadlima(R)), adalimumab-fkjp (Hulio(R)), and adalimumab-ryvk (Simlandi(R)) are biosimilar to adalimumab (Humira(R)). FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).
Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch.
Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Of the available adalimumab biosimilars, adalimumab-aaty (Yuflyma(R)), adalimumab-afzb (Abrilada(R)), adalimumab-atto (Amjevita(R)), adalimumab-adbm (Cyltezo(R)), adalimumab-bwwd (Hadlima(R)), adalimumab-adaz (Hyrimoz(R)), adalimumab-fkjp (Hulio(R)) and adalimumab-ryvk (Simlandi(R)) are designated as interchangeable with adalimumab (Humira(R)).
In this monograph, unless otherwise stated, the term ''adalimumab products'' refers to adalimumab (the reference drug) and its biosimilars (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp, and adalimumab-ryvk).
Adalimumab, a human monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-alpha), is a biologic response modifier. Adalimumab 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.
Adalimumab has high specificity and affinity for TNF (TNF-alpha); adalimumab does not bind to or inactivate lymphotoxin alpha (TNF-beta). Adalimumab binds to TNF before TNF can interact with the p55 and p75 cell surface tumor necrosis factor receptors (TNFRs). By preventing the binding of TNF to cell surface TNFRs, adalimumab blocks the biologic activity of TNF.
In vitro, adalimumab lyses surface TNF-expressing cells in the presence of complement.
TNF, a naturally occurring cytokine, has a broad spectrum of biologic activities; TNF is involved in normal inflammatory and immune responses and also plays a role in a number of autoimmune and inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. While the causes of rheumatoid arthritis have not been fully elucidated, increased concentrations of TNF in the synovial fluid of rheumatoid arthritis patients play a critical role in the progression of inflammatory synovitis and articular matrix degradation in these patients. TNF promotes the synthesis of other proinflammatory cytokines, stimulates endothelial cells to express adhesion molecules that attract leukocytes into affected joints, accelerates the production of metalloproteinases, and inhibits the synthesis of cartilage proteoglycans.
Increased concentrations of TNF also are found in psoriatic plaques. Adalimumab treatment may reduce epidermal thickness and infiltration of inflammatory cells in plaque psoriasis. Elevated levels of proinflammatory cytokines, including TNF, also have been observed in hidradenitis suppurativa lesions and in aqueous humor in patients with noninfectious uveitis.
Adalimumab modulates responses that are induced or regulated by TNF, including expression of adhesion molecules, serum concentrations of matrix metalloproteinase, and serum concentrations of cytokines.
The bioavailability of subcutaneous adalimumab is approximately 64%, with peak serum concentrations achieved at 131 hours. Adalimumab has been detected in synovial fluid. The elimination route for adalimumab has not been determined.
The half-life of adalimumab is approximately 2 weeks, but may range from 10-20 days. Clearance of adalimumab is increased among patients with adalimumab antibodies and decreased among patients over 40 years of age.
Several adalimumab biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in Table 1. Biosimilarity to originator adalimumab is additionally supported by comparative clinical studies in patients with rheumatoid arthritis (adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp), Crohn disease (adalimumab-adbm), and/or psoriasis (adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-ryvk).
Generic name: adalimumab
Pronunciation: (AY-da-LIM-ue-mab)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Humira(Cf) Pedi Crohns Starter
Indications
The following indications are listed for Humira(Cf) Pedi Crohns Starter:
- Ankylosing Spondylitis
- Crohn's Disease
- Hidradenitis Suppurativa
- Moderate To Severe Plaque Psoriasis
- Non-Infectious Uveitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ulcerative Colitis
Also known as: Acne Inversa, Arthritis Deformans, Arthrosis Deformans, Axial Spondyloarthritis With Radiographic Sacroiliitis, Bekhterev's Arthritis, Bekhterev's Disease, Bekhterev's Spondylitis, Colitis Ulcerativa, Marie-Strumpell Disease, Marie-Strumpell Spondylitis, Nodose Rheumatism, Noninfectious Uveitis, Psoriasis Arthropica, Psoriatic Arthropathy, Regional Enteritis, Regional Ileocolitis, Rheumatic Arthritis, Rheumatic Gout, Rheumatoid Spondylitis, Rhizomelic Spondylitis, Rhizomelic Spondylosis, Spondylosis Deformans, Strumpell-Marie Disease, Suppurative Hidradenitis, Verneuil's Disease.
Dosing
No dosing information is available for this tab.
Adalimumab products are administered by subcutaneous injection. Adalimumab products are intended for use under the guidance and supervision of a clinician; however, the drug may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary.
Adalimumab products are available in various formulations including single-dose prefilled syringes, prefilled pens, autoinjectors, and vials for institutional use only; please refer to the prescribing information of each individual product for further formulation information. Various packaging configurations (e.g., starter packs) may be available, depending on the specific product; contact the individual product manufacturer for more information. Some adalimumab products may not be available in presentations suitable for pediatric use, even if the product is labeled for pediatric use; consult the specific product information and manufacturer website for details.
Prior to administration, adalimumab product solutions should be inspected visually for particulate matter or discoloration; if either is present, the solution should be discarded. Adalimumab products contain no preservatives, and any unused portions of solution should be discarded. Adalimumab products should be stored at 2-8degreesC and protected from light; the prefilled syringes should be stored in the original carton until administration. The injection may be allowed to sit outside of refrigeration for 15-30 minutes prior to injection to allow the liquid to come to room temperature; the cap or cover should not be removed while the drug is warming to room temperature. The injection should not be frozen; solutions that have been frozen should not be used.
Storage requirements for the adalimumab products vary dependent upon the individual product and/or formulation; please refer to the prescribing information of each individual product for further information.
Subcutaneous injections of adalimumab products should be made into the anterior thighs or abdomen; however, abdominal injections should not be made within 5.18 cm (2 inches) of the umbilicus. Injection sites should be rotated. New injections should be given at least 2.54 cm (1 inch) from an old site, and injections should not be made into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks. Injections into psoriatic lesions also should be avoided.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Common adverse effects reported in 10% or more of patients receiving adalimumab include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of adalimumab for uses other than polyarticular juvenile idiopathic arthritis, Crohn disease, ulcerative colitis, and noninfectious uveitis have not been established in pediatric patients. Use of adalimumab for the management of hidradenitis suppurativa in adolescents is supported by clinical trials in adults. For marketing exclusivity reasons, adalimumab biosimilars are not labeled for use in pediatric patients with ulcerative colitis, hidradenitis suppurativa, or noninfectious uveitis.
Use of adalimumab for the management of polyarticular juvenile idiopathic arthritis in pediatric patients 2 years of age or older is supported by results of a safety and efficacy study in pediatric patients 4-17 years of age and additional data from a study in children 2 to <4 years of age indicating that the safety profile in this age group is similar to that in pediatric patients 4-17 years of age. In these studies, the types and frequencies of adverse effects generally were similar to those observed in adults. Safety and efficacy of adalimumab for the management of polyarticular juvenile idiopathic arthritis have not been established in pediatric patients less than 2 years of age or in those who weigh less than 10 kg.
Use of adalimumab for the management of Crohn disease in pediatric patients 6 years of age or older is supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 192 pediatric patients 6-17 years of age with moderately to severely active Crohn disease. Safety and efficacy for the management of Crohn disease have not been established in pediatric patients less than 6 years of age.
Use of adalimumab for the management of ulcerative colitis in pediatric patients 5 years of age or older is supported by evidence from adequate and well-controlled studies in adults and additional data from a randomized, double-blind, 52-week clinical study of 2 dosage levels of the drug in 93 pediatric patients 5-17 years of age with moderately to severely active ulcerative colitis. The recommended dosage of adalimumab in pediatric patients with ulcerative colitis is based on modeled dose/exposure-efficacy relationships and pharmacokinetic data; clinically relevant differences between the studied higher dosage administered in the clinical trial and the recommended dosage are not anticipated. Efficacy of adalimumab has not been established in patients who have lost response or were intolerant to TNF blocking agents. Safety and efficacy for the management of ulcerative colitis have not been established in pediatric patients less than 5 years of age.
Use of adalimumab for the management of noninfectious uveitis in pediatric patients 2 years of age or older is supported by evidence from adequate and well-controlled studies in adults and a randomized, controlled study in 90 pediatric patients. Safety and efficacy for the management of noninfectious uveitis have not been established in pediatric patients less than 2 years of age.
Use of adalimumab for the management of hidradenitis suppurativa in pediatric patients 12 years of age or older is supported by evidence from adequate and well-controlled studies in adults. The course of hidradenitis suppurativa in adults and adolescents is sufficiently similar to allow extrapolation of data from adults to adolescents. Population pharmacokinetic modeling and simulation data suggest that weight-based dosing in pediatric patients 12 years of age or older will provide exposure levels that are generally similar to those achieved in adults. Safety and efficacy for the management of hidradenitis suppurativa have not been established in pediatric patients less than 12 years of age.
When use of adalimumab is being considered for pediatric patients, review the vaccination status of the child and administer all age-appropriate vaccines included in current immunization guidelines.
Malignancies, some fatal, have been reported in children and adolescents who received treatment with TNF blocking agents, including adalimumab.
Neonates and infants who were exposed to adalimumab in utero may have impaired immune responses. Data from 8 infants exposed to adalimumab in utero suggest that the drug crosses the placenta; the clinical importance of elevated adalimumab concentrations in infants is unknown. Consider the risks and benefits of administering live vaccines to infants who were exposed to adalimumab in utero, since the safety of live vaccines in these infants is unknown.
Available studies of adalimumab use during pregnancy do not reliably establish an association between the drug and major birth defects. Results of a prospective, controlled, observational, pregnancy registry cohort study of pregnancy outcomes in adalimumab-treated females with rheumatoid arthritis or Crohn disease indicated that 10% of females in the adalimumab-exposed cohort (8.7% of those with rheumatoid arthritis, 10.5% of those with Crohn disease) delivered a live-born infant with a major birth defect, compared with 7.5% of females with rheumatoid arthritis or Crohn disease who had not been exposed to the drug (6.8% of those with rheumatoid arthritis, 9.4% of those with Crohn disease); however, no pattern of major birth defects was observed, and differences in the cohorts may have affected the observed occurrence rates. All females in the adalimumab-exposed cohort were exposed to the drug for some period of time during the first trimester of pregnancy; 65% were exposed to the drug in all 3 trimesters. The study utilized data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby pregnancy registry from 2004-2016 and included data for 602 pregnant females, including 257 females with rheumatoid arthritis or Crohn disease who had been exposed to adalimumab during pregnancy, 120 disease-matched unexposed females, and 225 healthy unexposed females. Methodologic limitations of the registry study (e.g., small sample size, voluntary nature of the study, nonrandomized design) preclude drawing definitive conclusions regarding the risk of major birth defects.
In an embryofetal-perinatal development study in cynomolgus monkeys, no fetal harm or malformations were observed at adalimumab exposure levels of up to approximately 373 times the exposure achieved at the maximum recommended human dosage (MRHD) for use without methotrexate.
Data suggest that increased disease activity in females with rheumatoid arthritis or inflammatory bowel disease is associated with an increased risk of adverse pregnancy outcomes (e.g., preterm delivery, low birth weight, small size for gestational age at birth).
As pregnancy progresses, monoclonal antibodies are increasingly transported across the placenta, with the largest amount transferred during the third trimester. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy. Results of a study in 10 pregnant females receiving adalimumab for treatment of inflammatory bowel disease (last dose administered 1-56 days prior to delivery) suggest that adalimumab may be detectable in the serum of infants exposed to the drug in utero for at least 3 months following birth. Adalimumab concentrations in cord blood were higher than maternal serum concentrations in 9 women in this study, and one infant had detectable serum concentrations of the drug measured through 11 weeks of age.
Adalimumab may affect immune response in infants exposed to the drug in utero. Consider the risks and benefits of administering live vaccines to such infants, since the safety of live vaccines in infants exposed to the drug in utero is unknown.
Limited data indicate that small amounts of adalimumab distribute into human milk (0.1-1% of maternal serum concentrations) and suggest that systemic exposure to adalimumab in nursing infants is likely to be low since the drug is a large molecule and is degraded in the GI tract. However, the effects of local exposure in the GI tract are unknown. There are no reports of adverse effects of adalimumab on breast-fed infants or effects of the drug on milk production.
Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for adalimumab and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients.
No substantial differences in efficacy have been observed in geriatric patients with rheumatoid arthritis relative to younger adults. The incidence of serious infection and malignancy in adalimumab-treated patients greater than 65 years of age is higher than the incidence in younger adults receiving the drug. Because the overall incidence of infection and malignancy is higher in the geriatric population in general than in younger adults, consider the risks and benefits of adalimumab in geriatric patients and closely monitor for the development of infection or malignancy if adalimumab is used.
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Last reviewed · Source: First Databank (FDB) drug data
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