Dosage & Administration
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis :
Juvenile Idiopathic Arthritis :
Pediatric Weight 2 Years of Age and Older | Recommended Dosage |
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 :
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 :
Plaque Psoriasis or Adult Uveitis :
Hidradenitis Suppurativa :
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Hulio Prescribing Information
WARNING: SERIOUS INFECTIONS and MALIGNANCY
See full prescribing information for complete boxed warning.
SERIOUS INFECTIONS :
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- 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.
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- Discontinue HULIO if a patient develops a serious infection or sepsis during treatment.
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- Perform test for latent TB; if positive, start treatment for TB prior to starting HULIO.
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- Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
MALIGNANCY :
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- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.
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- 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.
Rheumatoid Arthritis
HULIO is indicated for 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 rheumatoid arthritis. HULIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Juvenile Idiopathic Arthritis
HULIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HULIO can be used alone or in combination with methotrexate.
Psoriatic Arthritis
HULIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HULIO can be used alone or in combination with non-biologic DMARDs.
Ankylosing Spondylitis
HULIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease
HULIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis
HULIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use
The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7, 14.8)].
Plaque Psoriasis
HULIO is indicated for 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. HULIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5)].
Hidradenitis Suppurativa
HULIO is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
Uveitis
HULIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended subcutaneous dosage of HULIO for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with HULIO. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HULIO to 40 mg every week or 80 mg every other week.
Juvenile Idiopathic Arthritis
The recommended subcutaneous dosage of HULIO for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HULIO.
Pediatric Weight (2 Years of Age and older) | Recommended Dosage |
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 |
There is no dosage form for HULIO that allows weight-based dosing for pediatric patients below 15 kg.
Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
Crohn’s Disease
Adults
The recommended subcutaneous dosage of HULIO for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with HULIO. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HULIO if necessary.
Pediatrics
The recommended subcutaneous dosage of HULIO for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below:
Pediatric Weight | Recommended Dosage | |
Days 1 through 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
Adults
The recommended subcutaneous dosage of HULIO for adult patients with ulcerative colitis is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dosage of 40 mg every other week.
Discontinue HULIO in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with HULIO. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with HULIO if necessary.
Plaque Psoriasis or Adult Uveitis
The recommended subcutaneous dosage of HULIO for adult patients with plaque psoriasis (Ps) or Uveitis (UV) is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of adalimumab products in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies.
Hidradenitis Suppurativa
Adults
The recommended subcutaneous dosage of HULIO for adult patients with hidradenitis suppurativa (HS) is an initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Begin 40 mg weekly or 80 mg every other week dosing two weeks later (Day 29).
Monitoring to Assess Safety
Prior to initiating HULIO and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].
General Considerations for Administration
HULIO is intended for use under the guidance and supervision of a physician. A patient may self-inject HULIO or a caregiver may inject HULIO using either the HULIO Pen or prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
HULIO can be taken out of the refrigerator for 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the HULIO Pen or prefilled syringe for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HULIO does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe.
Instruct patients using the HULIO Pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the Instructions for Use [see Instructions for Use].
Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
HULIO is a clear to slightly opalescent, colorless to pale brownish-yellow solution available as:
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- Pen (HULIO Pen)
Injection: 40 mg/0.8 mL in a single-dose pen. - •
- Prefilled Syringe
Injection: 40 mg/0.8 mL in a single-dose prefilled plastic syringe.
Injection: 20 mg/0.4 mL in a single-dose prefilled plastic syringe.
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).
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Disease-associated maternal and embryo/fetal risk
Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.
Fetal/Neonatal Adverse Reactions
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester (see Data). Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab products in utero [see Use in Specific Populations (8.4)].
Data
Human Data
A prospective cohort pregnancy exposure registry conducted by OTIS/MotherToBaby in the U.S. and Canada between 2004 and 2016 compared the risk of major birth defects in live-born infants of 221 women (69 RA, 152 CD) treated with adalimumab during the first trimester and 106 women (74 RA, 32 CD) not treated with adalimumab.
The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively. The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non-randomized design.
In an independent clinical study conducted in ten pregnant women with IBD treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. The last dose of adalimumab was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16-19.7 mcg/mL in cord blood, 4.28-17.7 mcg/mL in infant serum, and 0-16.1 mcg/mL in maternal serum. In all but one case, the cord blood concentration of adalimumab was higher than the maternal serum concentration, suggesting adalimumab actively crosses the placenta. In addition, one infant had serum concentrations at each of the following: 6 weeks (1.94 mcg/mL), 7 weeks (1.31 mcg/mL), 8 weeks (0.93 mcg/mL), and 11 weeks (0.53 mcg/mL), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth.
Animal Data
In an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the MRHD without methotrexate (on an AUC basis with maternal IV doses up to 100 mg/kg/week). Adalimumab did not elicit harm to the fetuses or malformations.
Lactation
Risk Summary
Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum concentration. Published data suggest that the systemic exposure to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. However, the effects of local exposure in the gastrointestinal tract are unknown. There are no reports of adverse effects of adalimumab products on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HULIO and any potential adverse effects on the breastfed child from HULIO or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of HULIO have been established for:
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- reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.
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- the treatment of moderately to severely active Crohn’s disease in pediatric patients 6 years of age and older.
Pediatric assessments for HULIO demonstrate that HULIO is safe and effective for pediatric patients in indications for which Humira (adalimumab) is approved. However, HULIO is not approved for such indications due to marketing exclusivity for Humira (adalimumab).
Due to their inhibition of TNFα, adalimumab products administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. Data from eight infants exposed to adalimumab in utero suggest adalimumab crosses the placenta [see Use in Specific Populations (8.1)]. The clinical significance of elevated adalimumab concentrations in infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
Post-marketing cases of lymphoma, including hepatosplenic T-cell lymphoma and other malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blockers including adalimumab products [see Warnings and Precautions (5.2)].
Juvenile Idiopathic Arthritis
In Study JIA-I, adalimumab was shown to reduce signs and symptoms of active polyarticular JIA in patients 4 to 17 years of age [see Clinical Studies (14.2)]. In Study JIA-II, the safety profile for patients 2 to <4 years of age was similar to the safety profile for patients 4 to 17 years of age with polyarticular JIA [see Adverse Reactions (6.1)]. Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
The safety of adalimumab in patients in the polyarticular JIA trials was generally similar to that observed in adults with certain exceptions [see Adverse Reactions (6.1)].
The safety and effectiveness of adalimumab products have not been established in pediatric patients with JIA less than 2 years of age.
Pediatric Crohn’s Disease
The safety and effectiveness of adalimumab products for the treatment of moderately to severely active Crohn’s disease have been established in pediatric patients 6 years of age and older. Use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients (6 years to 17 years of age) [see Adverse Reactions (6.1), Clinical Pharmacology (12.2, 12.3), Clinical Studies (14.6)]. The adverse reaction profile in patients 6 years to 17 years of age was similar to adults.
The safety and effectiveness of adalimumab products have not been established in pediatric patients with Crohn’s disease less than 6 years of age.
Geriatric Use
A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies RA-I through IV. No overall difference in effectiveness was observed between these patients and younger patients. The frequency of serious infection and malignancy among adalimumab treated patients 65 years of age and older was higher than for those less than 65 years of age. Consider the benefits and risks of HULIO in patients 65 years of age and older. In patients treated with HULIO, closely monitor for the development of infection or malignancy [see Warnings and Precautions (5.1, 5.2)].
None.