Adalimumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of adalimumab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Active psoriatic arthritis
Enthesitis-related arthritis
Hidradenitis suppurativa
Juvenile idiopathic arthritis
Plaque psoriasis
Rheumatoid arthritis
Severe active axial spondyloarthritis
Treatment of active Crohn's disease
Ulcerative colitis
Uveitis
Rheumatoid arthritis
Moderate to severe active rheumatoid arthritis, in adults who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate. Used in combination with methotrexate. Monotherapy can be considered where methotrexate is contraindicated or not tolerated.
Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Juvenile idiopathic arthritis
Active polyarticular juvenile idiopathic arthritis in children from the age of 2 years who have had an inadequate response to one or more DMARD.
Enthesitis-related arthritis, in children from the age of 6 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Psoriatic arthritis
Active and progressive psoriatic arthritis, in adults who have had an inadequate response to previous DMARDs.
Axial spondyloarthritis
Severe active ankylosing spondylitis, in adults who have had an inadequate response to conventional therapy.
Severe non-radiographic axial spondyloarthritis, in adults with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDS).
Psoriasis
Moderate to severe chronic plaque psoriasis, in adults who are candidates for systemic therapy.
Chronic severe plaque psoriasis, in children from the age of 4 years who have had an inadequate response to, or are inappropriate candidates for, topical therapy and phototherapies.
Hidradenitis suppurativa (HS) (Not all brands are licensed in paediatric HS)
Active moderate to severe hidradenitis suppurativa (HS), in adults and children from 12 years of age, who have had an inadequate response to conventional systemic HS therapy.
Crohn's disease
Moderately to severely active Crohn's disease, in adults who have had an inadequate response to a full course of corticosteroids and/or an immunosuppressant, or those who have proved intolerant of, or have medical contraindications for such therapies.
Moderately to severely active Crohn's disease, in children from 6 years of age, who have had an inadequate response to conventional therapy (including primary nutrition therapy and a corticosteroid and/or an immunomodulator), or those who have proved intolerant of, or have medical contraindications for such therapies.
Ulcerative colitis
Moderately to severely active ulcerative colitis, in adults who have had an inadequate response to conventional therapy (including corticosteroids, 6-mercaptopurine or azathioprine) or those who have proved intolerant of, or have medical contraindications for such therapies.
Moderately to severely active ulcerative colitis, in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy (including corticosteroids, 6-mercaptopurine or azathioprine) or those who have proved intolerant of, or have medical contraindications for such therapies. Not all brands are licensed in paediatric ulcerative colitis.
Uveitis (Not all brands are licensed in paediatric uveitis)
Non-infectious intermediate, posterior and panuveitis, in adults who have had an inadequate response to corticosteroids, who need corticosteroid-sparing therapy, or in whom corticosteroid treatment is inappropriate.
Chronic non-infectious anterior uveitis, in children from 2 years of age, who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies.
Dosage
During treatment with adalimumab, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Single use devices are not suitable to administer less than a full 20mg or 40mg dose.
Adults
Rheumatoid arthritis
Treatment with glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs or analgesics may continue concurrently during adalimumab treatment.
Combination with methotrexate is recommended. Monotherapy can be considered where methotrexate is contraindicated or not tolerated.
Adalimumab with methotrexate:
40mg once every two weeks.
Adalimumab monotherapy:
40mg once every two weeks.
A decrease in response can occur when used as monotherapy. The dose can be increased to 40mg once a week or 80mg once every two weeks.
Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
40mg once every two weeks.
Crohn's disease
Initial: 80mg, followed after two weeks by 40mg.
Where a more rapid response is required, increase the initial dose to 160mg, followed after two weeks by 80mg. This regime carries a higher risk of adverse effects.
Maintenance: 40mg once every two weeks. If response is poor, increase the dose to 40mg once a week or 80mg once every two weeks.
If relapse occurs, treatment can be restarted using the above regime. Experience in restarting treatment after breaks of more than 8 weeks is limited.
Psoriasis
Initial: 80mg, followed after one week by 40mg.
Maintenance: 40mg once every two weeks. If the response is poor, increase the dose to 40mg once a week or 80mg once every two weeks.
Ulcerative colitis
Initial: 160mg, followed after two weeks by 80mg.
Maintenance: 40mg once every two weeks. If response is poor, increase the dose to 40mg once a week or 80mg once every two weeks.
Hidradenitis suppurativa
Initial: 160mg, followed after two weeks by 80mg.
Maintenance: 40mg once a week or 80mg once every two weeks.
Treatment should include topical antiseptics, applied to lesions on a daily basis. Prophylactic antibiotic treatment may be continued if necessary.
Uveitis
Initial: 80mg, followed after one week by 40mg.
Maintenance: 40mg once every two weeks.
Treatment can be combined with corticosteroids and/or other non-biological immunomodulatory agents. Two weeks after initiation, corticosteroids can be tapered (in accordance with clinical practice).
Children
Polyarticular Juvenile Idiopathic Arthritis
Combination with methotrexate is recommended. Monotherapy can be considered where methotrexate is contraindicated or not tolerated.
Children and adolescents aged 2 to 18 years weighing between 10kg and 30kg:
20mg once every two weeks.
Children and adolescents aged 2 to 18 years weighing 30kg or more:
40mg once every two weeks.
Enthesitis-related arthritis
Children and adolescents aged 6 to 18 years weighing between 15kg and 30kg:
20mg once every two weeks.
Children and adolescents aged 6 to 18 years weighing 30kg or more:
40mg once every two weeks.
Paediatric plaque psoriasis
Children and adolescents aged 4 to 18 years weighing between 15kg and 30kg:
Initial: 20mg
Maintenance: 20mg once every two weeks starting one week after the initial dose.
Children and adolescents aged 4 to 18 years weighing 30kg or more:
Initial: 40mg
Maintenance: 40mg once every two weeks starting one week after the initial dose.
Crohn's disease
Children and adolescents aged 6 to 18 years weighing less than 40kg:
Initial: 40mg, followed after two weeks by 20mg.
Where a more rapid response is required, increase the initial dose to 80mg, followed after two weeks by 40mg. This regime carries a higher risk of adverse effects.
Maintenance: 20mg once every two weeks. If response is poor, increase the dose to 20mg once a week.
Children and adolescents aged 6 to 18 years weighing 40kg or more:
Initial: 80mg, followed two weeks later by 40mg.
Where a more rapid response is required, increase the initial dose to 160mg, followed two weeks later by 80mg. This regime carries a higher risk of adverse effects.
Maintenance: 40mg once every two weeks. If response is poor, increase the dose to 40mg once a week or 80mg once every two weeks.
Paediatric Ulcerative colitis
Children and adolescents aged 6 to 18 years weighing less than 40kg:
Initial: 80mg, followed two weeks later by 40mg.
Maintenance: 40mg once every two weeks.
Children and adolescents aged 6 to 18 years weighing 40kg or more:
Initial: 160mg, followed two weeks later by 80mg.
Maintenance: 80mg once every two weeks.
Paediatric Uveitis
Treatment must be combined with methotrexate.
Children and adolescents aged 2 to 18 years weighing less than 30kg:
20mg once every two weeks, in combination with methotrexate.
A loading dose of 40mg may be administered one week prior to starting the maintenance dose. Loading doses have not been studied in children under 6 years of age.
Children and adolescents aged 2 to 18 years weighing 30kg or more:
40mg once every two weeks, in combination with methotrexate.
A loading dose of 80mg may be administered one week prior to starting the maintenance dose. Loading doses have not been studied in children under 6 years of age.
Hidradenitis suppurativa (HS)
Adalimumab has not been studied in adolescent patients with HS. Recommended doses are based on pharmacokinetic modelling and simulation.
Children aged 12 to 18 years weighing at least 30kg:
Initial: 80mg followed after one week by 40mg.
Maintenance: 40mg once every two weeks. If response is poor, increase the dose to 40mg once a week or 80mg once every two weeks.
Treatment should include topical antiseptics, applied to lesions on a daily basis. Prophylactic antibiotic treatment may be continued if necessary.
Additional Dosage Information
Ongoing treatment should be regularly reviewed.
Consider discontinuing treatment if no benefit is seen after 8 weeks for ulcerative colitis, 12 weeks for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, HS and Crohn's disease and after 16 weeks for psoriasis.
For uveitis, review the benefits and risks of long term treatment on an annual basis.
Administration
For subcutaneous injection.
Following appropriate training in injection technique, patients may self-administer. A medical follow up is necessary in these cases.
Doses below 40mg should be administered using the 20mg/0.2ml prefilled syringe or the 20mg/0.4ml prefilled syringe.
Contraindications
Children under 2 years
Severe infection
New York Heart Association class III failure
Tuberculosis
Precautions and Warnings
Elderly
History of recurrent infection
Predisposition to demyelinating disorder
Predisposition to infection
Surgery
Tobacco smoking
Central nervous system demyelinating disorder
Chronic obstructive pulmonary disease
Hepatic impairment
Hepatitis B
Hereditary fructose intolerance
History of cancer
History of hepatitis B
Latent or healed tuberculosis
Malignant neoplasm
New York Heart Association class I failure
Pregnancy
Renal impairment
Administration of live vaccines is not recommended
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen all patients for hepatitis B infection
Before starting therapy ensure immunisations are up to date in children
Consider prophylactic anti-tuberculosis therapy if appropriate
Monitor patients for non-melanoma skin cancer prior to and during treatment
Not all available brands are indicated for all uses
Prior to starting therapy rule out active tuberculosis
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Uveitis: Neurological evaluation required prior to and during therapy
Contains polysorbate
May contain citrate
Needle cover contains a derivative of latex in some brands
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Record name and batch number of administered product
Self-admin. - only if adequately trained and have access to expert advice
Continue to monitor for infection for 4 months following discontinuation
Crohn's disease: Lack of response may indicate fixed fibrotic stricture
May cause activation / exacerbation of latent / intercurrent infections
Monitor closely any patient who develops new infection while on treatment
Monitor for dysplasia in patients at increased risk of colon cancer
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor patient for signs of serious infection
Review if an adequate response not obtained within 3 months
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Advise patient to seek urgent medical advice if blood dyscrasias suspected
Discontinue if a serious infection develops
Discontinue if hepatitis develops
Reactivation of hepatitis B may occur in chronic carriers
Risk of developing opportunistic infections
Consider discontinuation if demyelinating disorders develop or worsen
Discontinue and investigate if symptoms of lupus-like syndrome develop
Discontinue if haematological abnormalities develop
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue or review if symptoms of congestive heart failure occur
Discontinue permanently if invasive systemic fungal infection occurs
Not licensed for all indications in all age groups
Female: Contraception required during & for at least 5 months after therapy
Hidradenitis Suppurativa: Use topical antiseptic wash daily on lesions
Remind patient of importance of carrying Alert Card with them at all times
Continue to monitor patients for infections during treatment and, due to the long elimination half life, for up to 4 months after treatment is discontinued.
Reported infections have included tuberculosis. Pre-treatment infection screening results should be documented on the patient's alert card. If active tuberculosis is identified, do not initiate adalimumab. If latent (inactive) tuberculosis is identified, consult an appropriate specialist. Where assessment is negative for active or latent tuberculosis but the patient has significant or multiple risk factors for developing tuberculosis, consider using anti-tuberculosis medication as prophylaxis. Continue to monitor patients during and for several months after discontinuing treatment.
Reactivation of hepatitis B virus (HBV) in previously infected patients has been reported. Pre-treatment infection screening should include evaluation for HBV infection. If HBV infection is detected, discuss ongoing management with an appropriate specialist. Monitor HBV carriers for signs of active infection during and for several months after treatment. If HBV infection occurs during treatment, discontinue adalimumab and initiate appropriate supportive treatment.
CNS demyelinating disorders and peripheral demyelinating disorders have been reported with adalimumab. In patients with pre-existing or recent onset of demyelinating disease or in those at an increased risk of developing demyelinating disease, perform a neurological assessment before initiating treatment and consider potential risks and benefits. If these conditions develop, consider discontinuing treatment. Patients receiving adalimumab for non-infectious intermediate uveitis should undergo neurologic evaluation to rule out presence of demyelinating diseases prior to and during treatment as intermediate uveitis has been associated with the development of central demyelinating disorders.
Malignancies have been reported in post marketing studies in patients using adalimumab. It is difficult to establish causative links due to increased background risks in some patient groups. A risk cannot be ruled out entirely. Use caution in patients with a history of malignancy and those with COPD (higher risk of malignancy due to increased incidence of smoking).
Reports have also included Merkel cell carcinoma, melanoma and non-melanoma skin cancer. Skin examination is advised prior to treatment and periodically during/after treatment, particularly in patients with a history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA therapy.
Treatment with adalimumab may result in formation of autoimmune antibodies. Should patients develop symptoms of lupus-like syndrome, test for antibodies and if positive, discontinue treatment.
The frequency of serious infections reported in adalimumab treatment was shown to be higher in patients aged over 65 years. Monitor elderly patients more closely, particularly regarding infections.
Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following mother's last adalimumab treatment during pregnancy.
Pregnancy and Lactation
Pregnancy
Use adalimumab with caution during pregnancy.
Manufacturers state that approximately 2100 pregnancies exposed to adalimumab did not indicate an increase in birth defects.
Due to inhibition of TNF-alpha adalimumab could affect immune response in the infant and therefore should be used only if clearly necessary.
Lactation
Adalimumab is considered safe for use during breastfeeding.
Adalimumab is excreted in breast milk at very low levels and no effects on breastfed infants are expected.
Side Effects
Abnormal serum sodium levels
Alopecia
Anaemia
Anaphylaxis
Antibody formation
Anxiety
Aortic aneurysm
Arrhythmias
Candidiasis
Cardiac arrest
Cellulitis
Cerebrovascular accident
Changes in mood
Chest pain
Cholecystitis
Cholelithiasis
Coagulation disorders
Congestive cardiac failure
Dehydration
Demyelinating disorders
Diverticulitis
Dysphagia
Erectile dysfunction
Exacerbation of obstructive pulmonary disease
Eye disorder
Flushing
Gastro-intestinal haemorrhage
Gastrointestinal disorder
Genitourinary infections
Haematoma
Haematuria
Headache
Hearing disturbances
Hepatic steatosis
Herpes infections
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypocalcaemia (symptomatic)
Hypokalaemia
Hypophosphataemia
Idiopathic thrombocytopenic purpura (ITP)
Impaired healing
Impetigo
Increase in lactate dehydrogenase
Increased risk of skin cancer
Increased uric acid level
Increases in hepatic enzymes
Infections
Influenza
Injection site reactions
Insomnia
Interstitial lung disease
Kaposi's Sarcoma
Leucocytosis
Leukaemia
Leukopenia
Lichenoid rash
Lymphoma
Migraine
Multiple sclerosis
Muscle spasm
Musculoskeletal pain
Myocardial infarction
Necrotising fasciitis
Neoplasms
Neuropathy
Night sweats
Nocturia
Oedema
Onychoclasis
Opportunistic infections
Pancreatitis
Pancytopenia
Paraesthesia
Pleural effusion
Pulmonary embolism
Pulmonary fibrosis
Reactivation of hepatitis B
Renal impairment
Respiratory disorders
Respiratory tract infection
Rhabdomyolysis
Rise in blood lipids
Sarcoidosis
Sciatica
Sepsis
Serum bilirubin increased
Sjogren's syndrome
Skin disorder
Systemic lupus erythematosus
Tachycardia
Thrombocytopenia
Thrombophlebitis
Tremor
Tuberculosis
Vascular disorders
Vertigo
Visual disturbances
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2020
Reference Sources
Summary of Product Characteristics: Amgevita pre-filled pen. Amgen Ltd. Revised Feburary 2020.
Summary of Product Characteristics: Amgevita pre-filled syringe. Amgen Ltd. Revised Feburary 2020.
Summary of Product Characteristics: Humira 40mg/0.4ml Pre-filled Pen. AbbVie Ltd. Revised November 2020.
Summary of Product Characteristics: Humira 20mg/0.2ml Solution for Injection in Pre-filled Syringe. AbbVie Ltd. Revised November 2020.
Summary of Product Characteristics: Humira 80mg/0.8ml solution for injection in pre-filled pen. AbbVie Ltd. Revised November 2020.
Summary of Product Characteristics: Hyrimoz 40mg solution for injection in pre-filled pen. Sandoz Limited. Revised October 2020.
Summary of Product Characteristics: Hyrimoz 40mg solution for injection in pre-filled syringe. Sandoz Limited. Revised October 2020.
Summary of Product Characteristics: Idacio 40mg solution pre-filled pen. Fresenius Kabi Ltd. Revised January 2020.
Summary of Product Characteristics: Idacio 40mg solution pre-filled syringe. Fresenius Kabi Ltd. Revised January 2020.
Summary of Product Characteristics: Imraldi 40mg solution for injection in pre-filled pen. Biogen Idec Ltd. Revised October 2020.
Summary of Product Characteristics: Imraldi 40mg solution for injection in pre-filled syringe. Biogen Idec Ltd. Revised October 2020.
Summary of Product Characteristics: Yuflyma 40mg/0.4ml solution for injection in pre-filled pen. Celltrion Healthcare UK Ltd. Revised June 2021.
Summary of Product Characteristics: Yuflyma 40mg/0.4ml solution for injection in pre-filled syringe. Celltrion Healthcare UK Ltd. Revised June 2021.
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