Hulio
Hulio Uses, Dosage, Side Effects, Food Interaction and all others data.
Hulio is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Hulio binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Hulio also lyses surface TNF expressing cells in vitro in the presence of complement. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Plaque Psoriasis, treatment with Hulio may reduce the epidermal thickness and infiltration of inflammatory cells.
After treatment with adalimumab, a decrease in levels of acute phase reactant proteins of inflammation (C reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was measured compared to baseline in patients diagnosed with rheumatoid arthritis. A decrease in CRP levels was also observed in patients diagnosed with Crohn’s disease. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that lead to the tissue remodeling responsible for cartilage destruction were also found to be decreased after administration of adalimumab , . A reduction in signs and symptoms of disease, the induction of a clinical response, an inhibition of structural damage, and improvements in physical function in adult and pediatric patients with various inflammatory conditions have been demonstrated , , .
Trade Name | Hulio |
Availability | Prescription only |
Generic | Adalimumab |
Adalimumab Other Names | Adalimumab, Adalimumab (genetical recombination), adalimumab-adaz, adalimumab-adbm, adalimumab-afzb, adalimumab-atto, adalimumab-bwwd, adalimumab-fkjp |
Related Drugs | Humira, Entyvio, Otezla, Stelara, Cosentyx, Tysabri, Zeposia, Colazal, prednisone, naproxen |
Type | Subcutaneous |
Formula | C6428H9912N1694O1987S46 |
Weight | 144190.3 Da |
Groups | Approved, Experimental |
Therapeutic Class | Disease-modifying antirheumatic drugs (DMARDs), Immunosuppressant |
Manufacturer | |
Available Country | United States |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Hulio is a tumor necrosis factor (TNF) blocker used for treatment of:
Hulio is a tumor necrosis factor (TNF) blocker used for the treatment of:
- Rheumatoid Arthritis (RA): 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): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS
- Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab
- Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate
- Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Hulio has not been established in patients who have lost response to or were intolerant to TNF blockers
- Plaque Psoriasis (Ps): 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
- Hidradenitis Suppurative (HS): The treatment of moderate to severe hidradenitis suppurativa
Hulio is also used to associated treatment for these conditions: Crohn's Disease (CD), Non-infectious Intermediate, Posterior and Panuveitis, Pediatric Crohn's Disease, Psoriatic arthritis aggravated, Pyoderma Gangrenosum, Severe Plaque psoriasis, Severe Ulcerative Colitis, Active Ankylosing spondylitis, Moderate Hidradenitis Suppurativa, Moderate Juvenile idiopathic arthritis, Moderate Plaque psoriasis, Moderate Rheumatoid arthritis, Moderate Ulcerative colitis, Severe Hidradenitis Suppurativa, Severe Juvenile idiopathic arthritis, Severe Rheumatoid arthritis
How Hulio works
Hulio binds with specificity to tumor necrosis factor-alpha (TNF-alpha) , and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Hulio also lyses surface tumor necrosis factor expressing cells in vitro when in the presence of complement. Hulio does not bind or inactivate lymphotoxin (Tumor necrosis factor-beta). TNF is a naturally occurring cytokine that plays a role in normal inflammatory and immune responses . Increased levels of TNF are found in the joint synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients, and play an imperative role in pathologic inflammation and the joint destruction that are major complications of these diseases. Increased levels of TNF are also measured in psoriasis plaques. In plaque psoriasis, treatment with adalimumab may decrease the epidermal thickness and inflammatory cell infiltration. The relationship between these pharmacodynamics and the mechanism(s) by which adalimumab achieves its clinical effects is not known. Additionally, adalimumab alters biological responses that are induced/regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration during inflammation (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M) .
Dosage
Hulio dosage
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
Administered by subcutaneous injection
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week
Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
Juvenile Idiopathic Arthritis:
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
Adult Crohn's Disease and Ulcerative Colitis:
Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), second dose two weeks later (Day 15): 80 mg, Two weeks later (Day 29): Maintenance dose of 40 mg every other week. For patients with Ulcerative Colitis only.Hulio should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy
Pediatric Crohn’s Disease:
- 17 kg (37 lbs) to < 40 kg (88 lbs.): Initial dose (Day 1): 80 mg (two 40 mg injections in one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later (Day 29): Maintenance dose of 20 mg every other week.
- ≥ 40 kg (88 lbs): Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) , Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
Plaque Psoriasis:
80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2, Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day), Third (Day 29) and subsequent doses: 40 mg every week.
Administered by subcutaneous injection.
Side Effects
The most common adverse reaction with Hulio was injection site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most common adverse reactions leading to discontinuation of Hulio in rheumatoid arthritis were clinical flare reaction, rash and pneumonia. Other adverse reactions of Hulio includes-
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis .
General disorders and administration site conditions: Pyrexia
Hepato-biliary disorders: Liver failure, hepatitis
Immune system disorders: Sarcoidosis , Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (e.g., 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.
Toxicity
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies of adalimumab products have not been performed to study the carcinogenic potential or the drug's effect on fertility .
Refer to the "Adverse Effects" section for more information on adverse effects and "Blackbox Warnings" section for important black box information/warnings.
Rare side effects include: worsening or initiation of congestive heart failure, a lupus-like syndrome, lymphoma, medically significant cytopenias, and worsening or initiation of multiple sclerosis/neurological diseases. There has been reported pancytopenia and increased liver transaminases with the use of adalimumab, which suggests that laboratory value monitoring blood counts and liver function, at least intermittently, are important .
Precaution
Serious infections: Hulio should not be started during an active infection. If an infection develops, it should be carefully monitored and if the infection becomes serious Hulio should be stopped.
- Invasive fungal infections: For patients who develop a systemic illness on Hulio, empiric antifungal therapy should be considered for those who reside or travel to regions where mycoses are endemic
- Malignancies: Incidence of malignancies was greater in Hulio-treated patients than in controls
- Anaphylaxis or serious allergic reactions may occur Hepatitis B virus reactivation: HBV carriers should be monitored during and several months after therapy. If reactivation occurs, Hulio should be stopped and antiviral therapy should be started
- Demyelinating disease: Exacerbation or new-onset, may occur Cytopenias, pancytopenia: Patients should be advised to seek immediate medical attention if symptoms develop, and should be considered stopping Hulio
- Heart failure: Worsening or new-onset, may occur
- Lupus-like syndrome: Hulio should be stopped if syndrome develops
Interaction
Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines: Hulio use should be avoided
Food Interaction
No interactions found.Hulio Drug Interaction
Major: etanercept, etanerceptModerate: acetaminophen / hydrocodone, acetaminophen / hydrocodoneUnknown: duloxetine, duloxetine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, metoprolol, metoprolol, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ergocalciferol, ergocalciferol, cholecalciferol, cholecalciferol, ondansetron, ondansetron
Hulio Disease Interaction
Major: infections, malignancies, neurologic reactions, tuberculosisModerate: CHF, COPD, hematologic abnormalities, hepatitis B
Volume of Distribution
The distribution volume (Vss) ranged from 4.7-6.0 L . Hulio concentrations in the synovial fluid from five rheumatoid arthritis patients ranged from 31-96% of those in serum .
Elimination Route
The maximum serum concentration (Cmax) and the time to reach the maximum concentration (Tmax) were 4.7 ± 1.6 μg/mL and 131 ± 56 hours respectively, following a single 40 mg subcutaneous administration of adalimumab to healthy adult subjects. The average absolute bioavailability of adalimumab estimated from three clinical studies after a single 40 mg subcutaneous dose of adalimumab was 64%. The pharmacokinetics of adalimumab showed a linear pattern over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose .
Half Life
The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies .
Clearance
12 mL/hr [RA patients with dose 0.25-10 mg/kg] . Population pharmacokinetic analyses in patients with rheumatoid arthritis showed a trend toward a higher apparent clearance of adalimumab in the presence of anti-adalimumab antibodies, and a lower clearance with increasing age in patients aged 40 years old to greater than 75 years old .
Pregnancy & Breastfeeding use
Pregnancy Category B
Adequate and well controlled studies with Hulio have not been conducted in pregnant women. Hulio is an IgG1 monoclonal antibody and IgG1 is actively transferred across the placenta during the third trimester of pregnancy.
Lactation
Limited data from published literature indicate that Hulio is present in low levels in human milk and is not likely to be absorbed by a breastfed infant. However, no data is available on the absorption of Hulio from breast milk in newborn or preterm infants. Caution should be exercised when Hulio is administered to a nursing woman.
Pediatric Use
Safety and efficacy of Hulio in pediatric patients for uses other than polyarticular juvenile idiopathic arthritis (JIA) and pediatric Crohn’s disease have not been established.
Contraindication
Hulio should not be administered to patients with known hypersensitivity to Hulio or any of its components.
Special Warning
Pediatric Use: Safety and efficacy of Hulio in pediatric patients for uses other than polyarticular juvenile idiopathic arthritis (JIA) and pediatric Crohn’s disease have not been established.
Geriatric Use: A total of 519 patients 65 years of age and older, including 107 patients 75 years and older, received Hulio in clinical studies. No overall difference in effectiveness was observed between these subjects and younger subjects. The frequency of serious infection and malignancy among Hulio treated subjects over age 65 was higher than for those under age 65. Because there is a higher incidence of infections and malignancies in the elderly population in general, caution should be used when treating the elderly.
Acute Overdose
The maximum tolerated dose of Hulio has not been established in humans. Multiple 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.
Interaction with other Medicine
Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines: Hulio use should be avoided
Storage Condition
Do not use beyond the expiration date on the container. Hulio must be refrigerated at 2-8° C. DO NOT FREEZE. Protect the pre-filled syringe from exposure to light. Store in original carton until time of administration.
Innovators Monograph
You find simplified version here Hulio
Hulio contains Adalimumab see full prescribing information from innovator Hulio Monograph, Hulio MSDS, Hulio FDA label