Tocilizumab (RoActemra) | is an expensive medication for rheumatoid arthritis from the Roche pharmaceutical company for which there is still no evidence of its safety and efficacy and, according to the laboratory, its frequent or very frequent side effects are “respiratory tract infection , pneumonia, abdominal pain, oral ulceration” among others.| Some data indicated in the product data sheet: Severe infections and in some fatal cases have been reported in patients receiving immunosuppressive agents including RoActemra | Viral reactivation (eg, hepatitis B virus) has been reported in RA patients who were receiving biological therapies.| Serious hypersensitivity reactions associated with RoActemra infusion have been reported. These reactions can be serious and life-threatening. | Cases of interstitial lung disease (including pneumonia and pulmonary fibrosis) have been reported during marketing, some of which were fatal.|
Tozilizumab (Actemra ® ) is an expensive drug for rheumatoid arthritis from the pharmaceutical company Roche from which< a href=”https://saludconlupa.com/news/tocilizumab-a-pharmaco-in-monopoly-to-treat-covid-19-without-proven-efficacy/” target=”_blank” rel=”noopener noreferrer” >there is still no evidence on its safety and efficacy andaccording to the laboratory, its frequent or very frequent side effects are“respiratory tract infection, pneumonia, pain abdominal, oral ulceration” among others.
RoActemra is indicated, in combination with methotrexate (MTX), for:
• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.< /p>
• the treatment of active RA
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Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1)
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Hepatic impairment: RoActemra has not been studied in patients with hepatic impairment. Therefore, no dosage recommendations can be made.
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4.3 Contraindications
Serious and active infections (see section 4.4).
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4.4 Special warnings and precautions for use
Infections
Severe and in some cases fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8 Adverse reactions) . RoActemra should not be initiated in patients with active infections (see section 4.3). RoActemra should be withheld if a patient develops a serious infection, until the infection is controlled (see section 4.8). Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurrent or chronic infections or underlying conditions (eg, diverticulitis, diabetes, and interstitial lung disease) that may predispose patients to infections.</p > _________________________________________________
Viral reactivation
Viral reactivation (eg, hepatitis B virus) has been reported in RA patients who were receiving biological therapies. In clinical trials with tocilizumab, patients with positive screening for hepa were excluded.titis.
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Hypersensitivity reactions
Serious hypersensitivity reactions associated with the infusion of RoActemra have been reported (see section 4.8). These reactions may be more serious and life-threatening in patients who have experienced hypersensitivity reactions during previous infusions, even if they have received premedication with steroids and antihistamines.
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Serious cases of liver injury, including acute liver failure, hepatitis and jaundice, have been observed with RoActemra (see section 4.8).
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It is not recommended to start treatment, in patients who have not been previously treated with RoActemra, if the absolute neutrophil count is below 2 x 109</ span>/l. Caution should be exercised when considering initiation of RoActemra treatment in patients with low platelet counts (ie, platelet counts below 100 x 103/μl). It is not recommended to continue treatment in patients who develop an absolute neutrophil count < 0.5 x 109/l or a platelet count < 50 x 103/μl.
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Pregnancy
There are insufficient data from the use of tocilizumab in pregnant women. An animal study has shown an increased risk of spontaneous abortion/embryofoetal death at a high dose (see section 5.3).
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4.8 Adverse reactions
Very common: Upper respiratory tract infection
Common: Pneumonia
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Interstitial Lung Disease
Impaired lung function may increase the risk of developing infections. Cases of interstitial lung disease (including pneumonia, and pulmonary fibrosis) have been reported during marketing, some of which were fatal.