Dosage & Administration
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1):
Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 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):
| 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):
| Pediatric Weight | Recommended Dosage | |
| Days 1 through 15 | Starting on Day 29* | |
| 20 kg (44 lbs) to less than 40 kg (88 lbs) | Day 1: 80 mg Day 8: 40 mg Day 15: 40 mg | 40 mg every other week or 20 mg every week |
| 40 kg (88 lbs) and greater | Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg | 80 mg every other week or 40 mg every week |
| * Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen. | ||
Plaque Psoriasis or Adult Uveitis ( 2.5):
Hidradenitis Suppurativa ( 2.6):
| Adolescent Weight | Recommended Dosage |
| 30 kg (66 lbs) to less than 60 kg (132 lbs) | Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week |
| 60 kg (132 lbs) and greater | Day 1: 160 mg (given in one day or split over two consecutive days) Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week |
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Humira Prescribing Information
SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
● Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
● Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
● Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1) and Adverse Reactions ( 6.1)].
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA [see Warnings and Precautions ( 5.2)]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2)].
1.1 Rheumatoid Arthritis
HUMIRA 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. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
1.2 Juvenile Idiopathic Arthritis
HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.
1.3 Psoriatic Arthritis
HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.
1.4 Ankylosing Spondylitis
HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
1.5 Crohn’s Disease
HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
1.6 Ulcerative Colitis
HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
Limitations of Use
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7, 14.8)].
1.7 Plaque Psoriasis
HUMIRA 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. HUMIRA 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)].
1.8 Hidradenitis Suppurativa
HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
1.9 Uveitis
HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended subcutaneous dosage of HUMIRA 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 HUMIRA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HUMIRA to 40 mg every week or 80 mg every other week.
2.2 Juvenile Idiopathic Arthritis or Pediatric Uveitis
The recommended subcutaneous dosage of HUMIRA for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) or pediatric uveitis is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.
| 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 |
HUMIRA has not been studied in patients with polyarticular JIA or pediatric uveitis less than 2 years of age or in patients with a weight below 10 kg.
2.3 Crohn’s Disease
Adults
The recommended subcutaneous dosage of HUMIRA 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 HUMIRA. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2)] or MTX may be continued during treatment with HUMIRA if necessary.
Pediatrics
The recommended subcutaneous dosage of HUMIRA 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 |
2.4 Ulcerative Colitis
Adults
The recommended subcutaneous dosage of HUMIRA 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 HUMIRA 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 HUMIRA. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2)] may be continued during treatment with HUMIRA if necessary.
Pediatrics
The recommended subcutaneous dosage of HUMIRA for pediatric patients 5 years of age and older with ulcerative colitis is based on body weight as shown below:
| Pediatric Weight | Recommended Dosage | |
| Days 1 through 15 | Starting on Day 29* | |
| 20 kg (44 lbs) to less than 40 kg (88 lbs) | Day 1: 80 mg Day 8: 40 mg Day 15: 40 mg | 40 mg every other week or 20 mg every week |
| 40 kg (88 lbs) and greater | Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg | 80 mg every other week or 40 mg every week |
| * Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen. | ||
2.5 Plaque Psoriasis or Adult Uveitis
The recommended subcutaneous dosage of HUMIRA 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 HUMIRA in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies.
2.6 Hidradenitis Suppurativa
Adults
The recommended subcutaneous dosage of HUMIRA 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).
Adolescents
The recommended subcutaneous dosage of HUMIRA for adolescent patients 12 years of age and older weighing at least 30 kg with hidradenitis suppurativa (HS) is based on body weight as shown below [see Use in Specific Populations ( 8.4) and Clinical Pharmacology ( 12.3)]:
| Body Weight of Adolescent Patients (12 years of age and older) | Recommended Dosage |
| 30 kg (66 lbs) to less than 60 kg (132 lbs) |
|
| 60 kg (132 lbs) and greater |
|
2.7 Monitoring to Assess Safety
Prior to initiating HUMIRA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1)].
2.8 General Considerations for Administration
HUMIRA is intended for use under the guidance and supervision of a physician. A patient may self-inject HUMIRA or a caregiver may inject HUMIRA using either the HUMIRA 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.
HUMIRA 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 HUMIRA Pen, prefilled syringe, or single-dose institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HUMIRA does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe. NOTE: Instruct patients sensitive to latex not to handle the needle cover of the HUMIRA 40 mg/0.8 mL Pen and 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL prefilled syringe because it may contain natural rubber latex [see How Supplied/Storage and Handling ( 16)].
Instruct patients using the HUMIRA 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.
The HUMIRA single-dose institutional use vial is for administration within an institutional setting only, such as a hospital, physician’s office or clinic. Withdraw the dose using a sterile needle and syringe and administer promptly by a healthcare provider within an institutional setting. Only administer one dose per vial. The vial does not contain preservatives; therefore, discard unused portions.
HUMIRA is a clear and colorless solution available as:
- Pen (HUMIRA Pen)
Injection: 80 mg/0.8 mL in a single-dose pen.
Injection: 40 mg/0.8 mL in a single-dose pen.
Injection: 40 mg/0.4 mL in a single-dose pen.
- Prefilled Syringe
Injection: 80 mg/0.8 mL in a single-dose prefilled glass syringe.
Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe.
Injection: 40 mg/0.4 mL in a single-dose prefilled glass syringe.
Injection: 20 mg/0.4 mL in a single-dose prefilled glass syringe.
Injection: 20 mg/0.2 mL in a single-dose prefilled glass syringe.
Injection: 10 mg/0.2 mL in a single-dose prefilled glass syringe.
Injection: 10 mg/0.1 mL in a single-dose prefilled glass syringe.
- Single-Dose Institutional Use Vial
Injection: 40 mg/0.8 mL in a single-dose, glass vial for institutional use only.
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 HUMIRA Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn’s disease (CD). 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 HUMIRA 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 HUMIRA, 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 HUMIRA was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16-19.7 µg/mL in cord blood, 4.28-17.7 µg/mL in infant serum, and 0-16.1 µg/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 µg/mL), 7 weeks (1.31 µg/mL), 8 weeks (0.93 µg/mL), and 11 weeks (0.53 µg/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.
8.2 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 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 HUMIRA and any potential adverse effects on the breastfed child from HUMIRA or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of HUMIRA have been established for:
- reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.
- the treatment of moderately to severely active Crohn’s disease in pediatric patients 6 years of age and older.
- the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
- the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
- the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older.
Due to its inhibition of TNFα, HUMIRA administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. Data from eight infants exposed to HUMIRA 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 HUMIRA [see Warnings and Precautions ( 5.2)].
Juvenile Idiopathic Arthritis
In Study JIA-I, HUMIRA 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)]. HUMIRA has 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 HUMIRA 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 HUMIRA have not been established in pediatric patients with JIA less than 2 years of age.
Pediatric Crohn’s Disease
The safety and effectiveness of HUMIRA 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 HUMIRA 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 HUMIRA 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 HUMIRA have not been established in pediatric patients with Crohn’s disease less than 6 years of age.
Pediatric Ulcerative Colitis
The safety and effectiveness of HUMIRA for the treatment of moderately to severely active ulcerative colitis have been established in pediatric patients 5 years of age and older. Use of HUMIRA 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 HUMIRA in 93 pediatric patients (5 years to 17 years of age) [see Adverse Reactions ( 6.1), Clinical Pharmacology ( 12.3), Clinical Studies ( 14.8)]. The adverse reaction profile in patients 5 years to 17 years of age was similar to adults.
The effectiveness of HUMIRA has not been established in patients who have lost response or were intolerant to TNF blockers.
The safety and effectiveness of HUMIRA have not been established in pediatric patients with ulcerative colitis less than 5 years of age.
Pediatric Uveitis
The safety and effectiveness of HUMIRA for the treatment of non-infectious uveitis have been established in pediatric patients 2 years of age and older. The use of HUMIRA is supported by evidence from adequate and well-controlled studies of HUMIRA in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients [see Clinical Studies ( 14.12)]. The safety and effectiveness of HUMIRA have not been established in pediatric patients with uveitis less than 2 years of age.
Hidradenitis Suppurativa
Use of HUMIRA in pediatric patients 12 years of age and older for HS is supported by evidence from adequate and well-controlled studies of HUMIRA in adult HS patients. Additional population pharmacokinetic modeling and simulation predicted that weight-based dosing of HUMIRA in pediatric patients 12 years of age and older can provide generally similar exposure to adult HS patients. The course of HS is sufficiently similar in adult and adolescent patients to allow extrapolation of data from adult to adolescent patients. The recommended dosage in pediatric patients 12 years of age or older is based on body weight [see Dosage and Administration ( 2.6), Clinical Pharmacology ( 12.3), and Clinical Studies ( 14.10)].
The safety and effectiveness of HUMIRA have not been established in patients less than 12 years of age with HS.
8.5 Geriatric Use
A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received HUMIRA 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 HUMIRA 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 HUMIRA in patients 65 years of age and older. In patients treated with HUMIRA, closely monitor for the development of infection or malignancy [see Warnings and Precautions ( 5.1, 5.2)].
None.