Adalimumab Brand And Generic Names

Pharmacological group

Selective immunosuppressant. Monoclonal antibodies to TNF.

Pharmacological action

Adalimumab is a recombinant monoclonal antibody with peptide sequence identical to the human IgG1.The agent modifies biological responses that are monitored by TNF, including changes in adhesion molecules inducing migration of leukocytes. In patients with rheumatoid arthritis, Adalimumab causes rapid decrease in concentration of acute-phase parameters of inflammation (C-reactive protein and erythrocyte sedimentation rate) and serum levels of cytokines. Decrease in the concentrations of C-reactive protein was also observed in patients with juvenile idiopathic arthritis or Crohn's disease.

Indications

• Moderate to severe active rheumatoid arthritis (as monotherapy or in combination with methotrexate or other anti-inflammatory drugs);
• Active psoriatic arthritis (as monotherapy or in combination with methotrexate or other anti-inflammatory drugs);
• Active ankylosing spondylitis;
• Crohn's disease (moderate or severe) with an inadequate response to conventional therapy or ineffectiveness (or decrease in the efficiency) of Infliximab;
• Chronic plaque psoriasis (moderate and severe) with systemic therapy or phototherapy, and when other systemic therapy options are not optimal;
• Juvenile idiopathic arthritis in patients aged 4 to 17 years as monotherapy or in combination with methotrexate.

Contraindications

Hypersensitivity (including to latex), simultaneous intake with anakinra (risk of severe infection), infectious diseases including tuberculosis, children's age (less than 18 years), pregnancy, lactation.

Adalimumab is taken with caution: recurrent infections in history, patients with hepatitis B virus, malignancies (including history), heart failure, demyelinating diseases of the nervous system (including history), patients older than 65 years.

Dosing regimen

The drug is injected subcutaneously.
In adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis - the recommended dose is 40 mg 1 time in 2 weeks.

Some patients may not respond to therapy with Adalimumab during the first 4 weeks, but treatment should be continued, because positive effect can be achieved within 12 weeks. The decision on the termination of therapy may be taken if the therapeutic effect is not observed during this period.

Use of Adalimumab in children under 4 years in juvenile idiopathic arthritis has not been studied. No data concerning the use of the drug in children weighing less than 15 kg.

Treatment with Adalimumab agent is carried out under medical supervision. The drug is injected in the region of the thigh or abdomen.

Side effects

Approximately 14% of patients can be expected to develop reactions at the injection site, as one of the most common side effects when administered Adalimumab in controlled clinical trials.

The nervous system: common - headache, dizziness, paresthesia; infrequent - headache, drowsiness, fainting, neuralgia, tremor, neuropathy, depression, anxiety disorders (including nervousness and agitation), insomnia, confusion.

The sensory organs: infrequent - conjunctivitis, blepharitis; pain, redness, dryness of the eyes, eyelid edema, glaucoma, pain, tinnitus, dysgeusia.

The cardio-vascular system: frequent - increase in blood pressure; infrequent - flushes, hematoma, tachycardia, palpitations.

The respiratory system: often - cough, sore throat, stuffy nose; infrequent - dyspnea, bronchospasm, hoarseness, pulmonary crackles, ulceration of the nasal mucosa, edema of the upper respiratory tract, throat congestion.

The digestive system: common - nausea, abdominal pain, diarrhea, dyspepsia, ulceration of the mucous membrane of the mouth; infrequent - vomiting, flatulence, constipation, gastroesophageal reflux, gastritis, dysphagia, colitis, hemorrhoids, hemorrhoidal bleeding, vesicular eruptions in the mouth, toothache, dry mouth, gingivitis, ulceration language, stomatitis (including aphthous).

Hematopoiesis: frequent - anemia, lymphopenia; infrequent - leukopenia, leukocytosis, lymphadenopathy, neutropenia, thrombocytopenia.

Metabolism: infrequent - hypercholesterolemia, hyperuricemia, anorexia, decreased appetite, hyperglycemia, increase or decrease in body weight.

Skin disorders: frequent - rash, pruritus, alopecia; infrequent - macular or papular rash, dry skin, sweating, eczema, dermatitis, psoriasis, urticaria, ecchymosis, purpura, acne, skin ulceration, angioedema, change of the nail plate, photosensitivity, skin peeling, rheumatoid nodules.

The musculoskeletal system: infrequent - arthralgia, pain in limbs, back and shoulder girdle, muscle cramps, myalgia, joint swelling, synovitis, bursitis, tendonitis.

The Genitourinary system: infrequent - hematuria, dysuria, nocturia, pollakiuria, pain in the kidneys; menorrhagia.

Local reactions: very common - pain, swelling, redness, itching at the injection site.

Other: frequent - fatigue (including asthenia), flu-like symptoms; infrequent - allergic reactions (including anaphylaxis, seasonal allergies), fever , hot flashes, chills, chest pain, impaired wound healing.

Laboratory parameters: frequent - increased activity of "liver" enzymes; infrequent - an increase of alkaline phosphatase, urea and creatinine in the blood, hypokalemia, proteinuria.

Overdose

The maximum tolerated dose has not been established.
Treatment: symptomatic.

Interaction

Single and repeated use with methotrexate reduces the clearance of Adalimumab by 29% and 44% respectively, but this does not require correction dose of methotrexate and Adalimumab.

Specific guidance

There are rare cases of tuberculosis, fungal and other opportunistic infections, including fatal ones, in the treatment with Adalimumab. Before treatment, it is necessary to conduct a survey to identify active and inactive tuberculosis (including contacts with patients, immunosuppressive therapy, chest radiography, tuberculin skin test). Immunocompromised patients may have false negative tuberculin skin test. With active tuberculosis, treatment with Adalimumab is not provided.  With latent tuberculosis, previously preventive TB treatment is performed. If signs of tuberculosis infection during treatment occur (persistent cough, weight loss, low-grade fever), patients should consult a doctor.

Patients with hepatitis B virus may suffer from reactivation of the virus. The decision to start therapy is taken after the examination (presence of hepatitis virus B), taking into account the possible risk to the patient. During treatment and for several months after treatment medical supervision is carried out. In the case of virus reactivation, treatment with Adalimumab should be stopped.

Possible risks of lymphoma or other malignancies can not be excluded during treatment with TNF blockers.

During treatment patients may observe pancytopenia (thrombocytopenia, leukopenia, aplastic anemia). If you suffer from persistent fever, bruising, bleeding, pallor, you should consult your doctor.

During treatment vaccination is possible, except for live vaccines.

When applying other TNF antagonists, the development or worsening of heart failure was noted.

In animal studies, the damaging effect of Adalimumab on the fetus was not revealed, but controlled studies in pregnant women have not been conducted. Women of reproductive age should use reliable methods of contraception during treatment.

In elderly patients, hypersensitivity to Adalimumab is possible.