Index of drugs

Rheumatoid arthritis (RA). The product in combination with Methotrexate (MTX) is indicated for the treatment of: adult patients with moderate to severe active rheumatoid arthritis who have an inadequate response to treatment with disease-modifying antirheumatic drugs (DMARDs), including MTX; adult patients with active severe and progressive rheumatoid arthritis who were not previously treated with MTX. It has been shown that the preparation in combination with MTX reduces the rate of progression of joint damage measured in the X-ray and improves physical performance.Psoriatic arthritis (PsA). The preparation, when used alone or in combination with Methotrexate, is indicated for the treatment of active and progressive forms of psoriatic arthritis in adults when the response to previous treatment with disease-modifying antirheumatic drugs (DMARD) was insufficient. It has been shown that treatment with the preparation causes a slowdown in the progression of peripheral joint damage, confirmed in an X-ray in patients with polyarticular symmetrical subtype of the disease and improves physical activity.Ankylosing spondylitis (AS). The preparation is indicated for the treatment of severe, active forms of ankylosing spondylitis in adult patients who have not responded adequately to conventional therapy.Ulcerative colitis (UC). It is indicated for the treatment of moderate or severe active forms of ulcerative colitis in adult patients who do not respond adequately to standard therapies, including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who tolerate treatment poorly, or who were contraindicated for such treatment.

1 pre-filled pen (0.5 ml) or 1 pre-filled syringe (0.5 ml) contains 50 mg of golimumab. The preparation contains sorbitol.

An immunosuppressant, an inhibitor of tumor necrosis factor alpha (TNF-α). Golimumab is a human monoclonal antibody that forms stable complexes with high affinity for both the soluble and transmembrane form of human tumor necrosis factor alpha (TNF-α), preventing the binding of TNF-α to its receptors. Human TNF binding by golimumab has been shown to neutralize TNF-α induced cell surface expression of E-selectin adhesive molecule, vascular intercellular adhesion molecule (VCAM-1) and intercellular adhesion molecule (ICAM) -1 endothelial cells. In researchin vitr, secretion of interleukin 6 (IL-6), interleukin 8 (IL-8) and granulocyte colony stimulating factor (GM-CSF) induced by TNF was inhibited by golimumab. There was an improvement in the reactive C protein concentration relative to the placebo group and the golimumab group, resulting in a significant reduction from baseline concentrations of interleukin 6 (IL-6), ICAM-1 molecules, metalloproteinase (MMP) -3 and vascular endothelial cell growth factor (VEGF) compared to the control treatment. In addition, TNF-α levels decreased in patients with rheumatoid arthritis and ankylosing spondyloarthropathy, and interleukin-8 (IL-8) levels decreased in patients with psoriatic arthritis. These changes were observed at the first evaluation after administration of the initial dose of the preparation and lasted up to 24 weeks inclusive. Following subcutaneous administration of a single dose, the average time to reach maximum serum concentration is from 2 to 6 days. The mean absolute bioavailability is 51%. Final T_0,5 is 12 ± 3 days. With a dose of 50 mg every 4 weeks, the serum concentration reached steady state by the end of the 12th week.

Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis or other severe infections, such as sepsis, and opportunistic infections. Moderate or severe heart failure (NYHA class III / IV).

Due to the risk of infections, including tuberculous infections, patients must be carefully monitored before, during and after treatment with the preparation. Elimination of golimumab may last up to 5 months, which is why observation of patients in this period is very important. It should not be used in patients with clinically significant active infections. In patients with a history of chronic infection or recurring infections, care should be taken when administering the preparation. Patients should avoid exposure to factors potentially increasing the risk of infection. Patients with a new infection should be closely monitored and the overall diagnostic process should be performed. If a patient develops a serious infection or sepsis, discontinue the preparation and start the appropriate antibacterial or antifungal treatment until the infection is controlled. In patients who have lived or traveled in endemic areas with invasive fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, the benefit-risk balance of the preparation should be carefully evaluated before treatment. Before starting treatment, each patient must be examined for the presence of active or latent tuberculosis. This study should include a detailed history of tuberculosis or any possible contact with people with tuberculosis and prior and / or current immunosuppressive therapy. It should also be performed in all patients (local recommendations can be used) appropriate screening tests, eg radiological examination (photo) of the chest, tuberculin test, blood tests. It is recommended that these tests be recorded in the Patient Safety Card. It should be remembered that a false negative tuberculin test may occur, especially in severely ill patients or immunocompromised patients. If active tuberculosis is diagnosed, treatment with the preparation can not be started. If there is a suspicion of latent tuberculosis, it should be consulted with a doctor who has experience in the treatment of tuberculosis. In all situations related to the diagnosis of tuberculosis described below, the benefits and risks of treatment with the product should be carefully considered. If latent tuberculosis is diagnosed, prophylactic tuberculosis treatment for latent tuberculosis must be initiated in accordance with local recommendations before treatment begins. In patients with several risk factors for tuberculosis or a serious risk factor for tuberculosis and a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before initiation of treatment with the preparation. The use of anti-tuberculosis therapy before starting treatment with the medicine should also be considered in patients with latent or active tuberculosis history in the past when it can not be confirmed whether they have received appropriate treatment. Patients treated with the preparation should be carefully monitored for signs and symptoms of active tuberculosis. This applies to patients with a negative test for latent tuberculosis, patients treated for latent tuberculosis and patients who have been previously treated for tuberculosis. Because of the risk of hepatitis B recurrence, patients should be examined for HBV infection before initiating therapy with patients. For patients who are positive, it is advisable to consult a physician experienced in the treatment of hepatitis B. Hepatitis B carriers who require treatment with golimumab should be closely monitored for signs of active HBV infection during treatment and a few months after the end of therapy. Appropriate data regarding the treatment of patients who carry HBV, antiviral drugs in combination with TNF antagonist therapy to suppress HBV recurrence are not available. In patients who have had hepatitis B recurrence, treatment should be discontinued and effective antiviral therapy and appropriate supportive care started. In patients with a history of malignancy or when considering continuing treatment in patients who have a malignancy, caution should be used when considering treatment with TNF-antagonists. The risk of developing malignancies in children and adolescents treated with TNF antagonists can not be excluded.In patients receiving treatment that inhibits TNF activity, there is an increased risk of lymphomas and leukemia. The risk of developing hepatoprotective T-cell lymphoma (HSTCL) in patients treated with TNF antagonists can not be ruled out (most cases were found in adolescents and young adult men, with almost all of them taking either azathioprine (AZA) or 6-mercaptopurine (6- MP) due to inflammatory bowel disease - the possible risks associated with the use of AZA or 6-MP in combination with the preparation should be carefully considered). In controlled clinical trials, there was no increased risk of malignant neoplasms that were not lymphomas (excluding non-melanoma skin cancer) in patients receiving the preparation. All patients with ulcerative colitis who have an increased risk of dysplasia or colorectal cancer (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis) and patients who have been diagnosed with dysplasia or colorectal cancer in the past should be given before and during the course of the disease, examine at regular intervals for dysplasia. The test should include a colonoscopy and biopsy in accordance with local recommendations. In patients with newly diagnosed dysplasia treated with the preparation, the individual risks and benefits should be carefully considered and whether further treatment should be continued. In patients with severe persistent asthma, there was a higher incidence of malignancies in the patients treated with the preparation than in the control group. The importance of these data is unknown. Due to the increased risk of malignant tumors, caution should be exercised when using any TNF antagonist in patients with COPD and in patients - heavy smokers who are at increased risk of malignancy. Periodic skin examinations are recommended, especially in patients with risk factors for developing skin cancer. Due to the risk of worsening congestive heart failure, caution should be used in patients with mild heart failure (NYHA class I / II); these patients should be closely monitored. The treatment should be discontinued in patients who develop new symptoms of congestive heart failure or exacerbation of existing symptoms. The use of TNF-blocking agents, including formulation, has been associated with the onset or exacerbation of clinical and / or radiological signs of demyelinating o.n.n., including multiple sclerosis and demyelinating diseases of the peripheral nervous system. It is recommended to carefully consider the benefits and risks of TNF antagonists in patients with pre-existing or recent symptoms of demyelinating disorders prior to initiating therapy with the preparation. If these disorders occur, discontinuation of treatment should be considered. The safety experience of the preparation in patients after surgery, including arthroplasty, is limited. When planning a surgical procedure, a long half-life should be taken into account. A patient requiring surgery during treatment with the preparation must be carefully monitored for possible infections and appropriate measures should be taken. It is possible that treatment with TNF antagonists may affect the body's defenses against infections and tumors. The relative TNFα deficiency induced by TNF antagonist therapy may result in the activation of autoimmune phenomena. If the patient is treated with symptoms that indicate a lupus-like syndrome and double-stranded DNA antibodies are found, treatment with the preparation should be discontinued. In the case of signs and symptoms suggesting a change in peripheral blood composition (discrepancy) (eg persistent fever, bruising, bleeding, paleness) the patient should receive immediate medical attention. In patients with confirmed significant haematological abnormalities discontinuation of treatment with the preparation should be considered. Co-administration of TNF antagonists with anakinra or abatacept is not recommended.It is not recommended to administer the medicine concomitantly with other biological medicines used to treat the same conditions as those treated with golimumab. When changing one DMARDS biological agent to another DMARDS biological drug, caution should be exercised and patients should continue to be monitored, as the overlap of biological activities may further increase the risk of side effects, including infection. Patients treated with the product may receive vaccines at the same time, except for vaccines containing live microorganisms. When vaccines containing live microorganisms are administered, clinical infections may develop, including spreading infections. Administration of other infectious agents with therapeutic use, such as live attenuated bacteria (eg, intravesical BCG vaccine as part of anti-cancer immunotherapy), may lead to the development of clinical infections, including disseminated infections. It is not recommended to administer infectious agents with therapeutic use simultaneously with the preparation. If an anaphylactic reaction or other serious allergic reaction occurs, administration should be discontinued immediately and appropriate treatment initiated. The pen needle casing is made of dry natural rubber containing latex and may cause hypersensitivity reactions in people with hypersensitivity to latex. There are no studies on the use of the drug in patients with impaired renal or hepatic function. Caution should be exercised in elderly patients and patients with impaired hepatic function. It is not recommended for use in patients under 18 years of age due to lack of data on the efficacy and safety of the medicine in this age group. The preparation contains sorbitol - should not be used in patients with congenital fructose intolerance.

The use of golimumab in pregnant women is not recommended (may interfere with the normal immune response in the newborn). The drug should only be used during pregnancy if it is absolutely necessary. Golimumab passes through the placenta. After treatment with the monoclonal antibody TNF antagonist during pregnancy, the antibody in the serum of an infant born to a woman taking the preparation was detectable for up to 6 months. Consequently, these infants may be at higher risk of infection. It is not recommended to give vaccines containing live microbes to infants if less than 6 months have passed since the last injection of golimumab in pregnant mothers. Women of childbearing potential must use appropriate contraceptive precautions to prevent pregnancy, including for at least 6 months after finishing the last golimumab treatment. Women should not breastfeed for at least 6 months after golimumab treatment.

Very common: upper respiratory tract infections (nasal pharyngitis, pharyngitis, laryngitis and rhinitis). Common: bacterial infections (eg cellulitis), viral infections (eg influenza and herpes), bronchitis, sinusitis, surface fungal infections, anemia, allergic reactions (bronchospasm, hypersensitivity, urticaria), the presence of autoantibodies, aches and pains dizziness, hypertension, indigestion, gastrointestinal pain and abdominal pain, nausea, increased ALT and AST, pruritus, rash, fever, asthenia, infusion-related reactions (including erythema at the injection site, urticaria, induration, pain, bruising , pruritus, irritation and paraesthesia). Uncommon: septic shock, sepsis, lower respiratory tract infections (eg pneumonia), opportunistic infections (eg invasive fungal infections - histoplasmosis, coccidioidomycosis, pneumocystosis, bacterial, atypical mycobacteriosis and protozoa), abscess, bacterial arthritis, tumors ( e.g. skin cancer, squamous cell carcinoma of the skin and melanocytic nevi), leukopenia, thrombocytopenia, pancytopenia, thyroid disorders (eg hypothyroidism, hyperthyroidism and thyroid enlargement), elevated blood Glucose, elevated fat levels, depression, insomnia, demyelinating diseases (central and peripheral nervous system), balance disorders, taste disorders, paresthesia, visual disturbances (eg blurred vision and reduced visual acuity), conjunctivitis, ocular allergy (e.g.pruritus and irritation), congestive heart failure (onset or worsening), arrhythmia, symptoms of ischemic heart disease, thrombosis (e.g., deep veins and aorta), Raynaud's phenomenon, redness of the skin, asthma and related symptoms (eg wheezing and hyperactivity) bronchi), interstitial lung disease, constipation, inflammatory diseases of the gastrointestinal tract (eg gastritis and colitis), gastro-oesophageal reflux, oral mucositis, cholelithiasis, liver disorders, psoriasis (first occurrence or exacerbation previously) diagnosed psoriasis, palmar-plantar psoriasis and pustular psoriasis), urticaria, vasculitis (cutaneous), alopecia, dermatitis, bladder disorders, kidney disorders, breast disorders, menstrual disorders, chest discomfort, bone fractures. Rare: hepatitis B recurrence, tuberculosis, pyelonephritis, bursitis, synovitis, lymphoma, leukemia, melanoma, severe systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (generalized), sarcoidosis, exfoliation, lupus-like syndrome , healing is difficult. Not known: Merkel cell carcinoma, hepatoblastoma T-cell lymphoma, aplastic anemia (found with other TNF antagonists, but not confirmed in other clinical trials with golimumab).

Subcutaneously. Adults. Treatment should be initiated and maintained by a qualified physician experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or ulcerative colitis. Rheumatoid arthritis: 50 mg once a month, on the same date each month; drug should be given at the same time as methotrexate. Psoriatic dermatitis and ankylosing spondylitis: 50 mg once a month, on the same day each month. Clinical response is usually achieved within 12-14 weeks of treatment (after 3-4 doses). In patients who did not benefit from treatment during this period, continuation of treatment should be considered. An increase in the dose of golimumab to 100 mg once a month may be considered in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis with a body weight greater than 100 kg who have not responded adequately to 3 or 4 doses. However, be aware of the increased risk of some serious side effects. Re-consideration of continuing treatment in patients in whom no therapeutic benefit has been achieved after receiving 3 to 4 additional doses of 100 mg should be reconsidered. Ulcerative colitis: patients with mc. less than 80 kg: the preparation is given in an initial dose of 200 mg, in a dose of 100 mg in the second week, and then in a dose of 50 mg once every 4 weeks; patients with mc. at least 80 kg: the preparation is given in an initial dose of 200 mg, at a dose of 100 mg in the second week, and then at a dose of 100 mg once every 4 weeks. During maintenance therapy, the dose of corticosteroids may be gradually reduced in accordance with the recommendations adopted in practice clinical. Clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). In patients who experience no therapeutic benefit during this period, further treatment should be reconsidered. If the patient forgets to inject the preparation on the scheduled day, the missed dose should be accepted as soon as he remembers. The patient should be advised that no double dose should be injected to make up for a forgotten dose. The Next dose should be given according to the following guidelines: if the dose is delayed less than 2 weeks, the patient should take the missed dose and then continue the treatment according to the original dosing schedule; if the dose is delayed by more than 2 weeks, the patient should take the missed dose and then set a new dosing regimen, starting on the date of this injection. No dose adjustment is necessary in elderly patients. The drug has not been studied in patients with renal or hepatic impairment - no recommendation on a posology can be made.
Patients can inject themselves on their own after adequate subcutaneous injection technique if the physician decides that this is appropriate and will be related to medical observation. Patients should be advised to inject the entire amount of the preparation as instructed. If several injections are required, they should be carried out at various parts of the body.