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Lemtrada is an anti-multiple sclerosis drug also known as alemtuzumab. It is a monoclonal antibody that binds to certain receptors on the surface of immune cells and changes the way the immune system works so that it stops attacking nerve fibers. The US Food and Drug Administration (FDA) currently recommends the use of Lemtrada for relapsing forms of multiple sclerosis after two or more courses of classical treatment have failed.

How does Lemtrada work?

Multiple sclerosis is an autoimmune disease in which the immune system attacks the sheaths of nerve fibers necessary for the normal conduction of impulses. The disease is chronic and is currently considered incurable; doctors can only slow down its progression.

The immune system is complex. It consists of different types of cells, they “communicate” with each other and with other tissues of the body using molecular signals. There are special receptor proteins on the surface of immune cells. When they receive a signal and are activated, it leads to certain effects.

One of these receptors is called CD52 (another name is CAMPATH-1 antigen). Leukocytes that carry it on their surface are prone to aggression against the nervous system. They are credited with a leading role in the occurrence of relapsing multiple sclerosis.

Lemtrada attaches to white blood cells that carry the CD52 receptor and causes “genocide” of them. The body is cleansed of “pest leukocytes”, and gradually their place is taken by “useful” immune cells.

This mechanism of action has been studied in transgenic mice. The subtleties of how the drug works in the human body are still not fully known.

Diagnosis of multiple sclerosis

The diagnosis of “Multiple Sclerosis” is established by a neurologist based on the clinical picture and the patient’s complaints. The doctor conducts an examination, assesses motor activity and sensitivity.

Currently, MRI examination is the leading method that confirms the diagnosis of multiple sclerosis, allowing the detection of foci of demyelination. MRI is also used to assess the dynamics of the condition and the rate of progression of the disease.

When establishing a diagnosis of MS, it is important to conduct an ophthalmological examination to determine the characteristic signs of damage to the organ of vision.

Registration of evoked potentials allows one to judge the functional state of the nervous system. Electrodes measure the electrical activity of the nerve fiber.

A spinal puncture is performed to analyze the cerebrospinal fluid, identify antibodies, and the inflammatory process. This diagnostic method allows you to exclude infectious diseases of the central nervous system, which may have symptoms similar to MS.

Who is treated with Lemtrada and how?

The most effective therapy for multiple sclerosis is currently considered to be regimens using DMTs - drugs that change the course of multiple sclerosis. They usually need to be administered every few days or monthly.

When treating with Lemtrada, only two short courses over two years are sufficient:

• The first course lasts 5 days in a row. Every day the drug is administered intravenously over 4 hours, after which the patient’s condition is monitored for 2 hours.
• The second course is carried out a year later, it lasts 3 days.

The main indication for the use of Lemtrada, as we have already mentioned, is relapsing multiple sclerosis, if, despite treatment with other drugs, the patient has had a relapse within the last year or has deteriorated according to MRI results.

Alemtuzumab is sometimes used as a first-line treatment if a person with multiple sclerosis has recently relapsed or an MRI has detected active disease (new lesions in the brain).

Causes and risk factors for developing multiple sclerosis

The development of multiple sclerosis (MS) is caused by an autoimmune response directed at the myelin sheath covering the nerve fiber. Myelin ensures the transmission of nerve impulses. Subsequently, irreversible destruction of the nerve fiber occurs.

MS is a multifactorial disease. Thus, the interaction of environmental factors and hereditary predisposition determine the characteristics of the body’s immune response.

The following factors may increase your risk of developing MS:

• Age. MS can occur at any age. However, people aged 20-40 years most often get sick;
• Hereditary factor. Having close relatives suffering from MS increases the chance of developing this pathology;
• Female. The risk of developing undulating MS in women is 3 times higher than in men;
• Infectious agents. Epstein-Barr virus, which causes mononucleosis, is associated with the development of MS;
• Ethnicity. Caucasians are more likely to develop MS;
• Climatic conditions. MS is more common in temperate climates with fewer sunny days per year;
• Vitamin D: Vitamin D deficiency increases the risk of developing MS;
• The presence of autoimmune pathology;
• Smoking.

How much better is this than classical therapy?

The results of one of the largest studies were published in the authoritative scientific journal The Lancet. The authors concluded that when treated with Lemtrada, the risk of relapse was 54.9% lower than when using a drug from the DMT group - interferon beta-1a (Rebif). It was the publication in The Lancet that largely contributed to the fact that in November 2014 the drug was approved in the United States for the treatment of multiple sclerosis.

Similar results were noted in other studies.

With regard to the risk of disability, the situation turned out to be ambiguous. In some studies, alemtuzumab was 42% better than interferon. In others, the difference was 30% - this figure could be due not to drugs, but to random reasons.

Risks associated with drug administration

Lemtrada is not a safe drug. Treatment is associated with certain risks. Some side effects may be life-threatening:

• Autoimmune conditions in which the immune system begins to attack the body's own tissues. With immune thrombocytopenia, increased bleeding develops, with kidney damage - severe renal failure, which may require dialysis or a kidney transplant.
• Reactions to drug administration develop within 24 hours (sometimes later) after infusion and can be very severe. Alarming symptoms that require immediate medical attention: swelling of the face, difficulty breathing, severe weakness, increased or slow heartbeat, a feeling as if the heart is “freezing”, “turning over”, “jumping out of the chest”, chest pain, rash on skin.
• Oncological diseases. Treatment with Lemtrada increases the risk of thyroid cancer, melanoma, and lymphoma.
• Problems with the thyroid gland. It is possible to both increase (hyperthyroidism) and decrease (hypothyroidism) its function. “Alarm bells”: severe sweating, unreasonable weight loss or gain, rapid heartbeat, nervousness, emotional instability, increased fatigue, chilliness in the arms and legs, constipation.
• Blood problems. Due to a decrease in the number of different types of cells in the blood, some disorders develop: frequent infections, jaundice, chest pain, rapid heartbeat, dark urine.
• Severe infections. The likelihood of infection with herpes, hepatitis, and tuberculosis viruses increases.
• Lung disorders. Some patients receiving alemtuzumab develop pneumonitis, a non-infectious inflammation of the lungs.

Lemtrada®

It is necessary to stop taking interferons beta and glatiramer acetate 28 days before starting treatment with Lemtrada®.

The use of Lemtrada® is not recommended for patients with inactive disease or for patients whose disease is stable on therapy.

Before starting treatment, patients should be educated and informed about the risks and benefits of therapy, as well as the need for monitoring from the start of treatment until 48 months after the last infusion of the second course of treatment with Lemtrada. If an additional course is prescribed, patients should continue to be monitored to assess safety until 48 months after the last infusion. The patient should be reminded to monitor their condition closely for symptoms that they may develop and to seek immediate medical attention if any problems occur.

Autoimmune diseases

Autoantibodies may form during treatment with Lemtrada, which may lead to the development of autoimmune diseases, including immune thrombocytopenic purpura (ITP), thyroid disease, or, rarely, nephropathy (eg, anti-GBM disease [glomerulonephritis due to antibodies to the glomerular basement membrane ]), autoimmune hepatitis, cmponeia. Caution should be exercised when treating patients with a history of autoimmune diseases other than multiple sclerosis. At the same time, available data suggest that treatment with alemtuzumab does not worsen the course of existing autoimmune diseases.

— Immune thrombocytopenic purpura (ITP)

Serious cases of ITP were observed in 12 (1%) patients with multiple sclerosis participating in controlled clinical trials (corresponding to an annualized rate of 4.7 events/1000 patients/year). An additional 12 serious cases of ITP were observed over a median follow-up of 6.1 years (maximum 12 years) (summed cumulative annualized rate of 2.8 events/1000 patients/year). One patient developed ITP, which was unrecognized until the introduction of monthly blood test monitoring requirements, and the patient died of hemorrhagic stroke. In 79.5% of cases, ITP usually develops within 4 years after the first drug infusion. However, in some cases, ITP develops several years later. Symptoms of ITP may include, but are not limited to, mild skin hemorrhages, pinpoint hemorrhages (petechiae), spontaneous mucocutaneous bleeding (eg, nosebleeds, hemoptysis) that is heavier than usual, or irregular menstrual bleeding. Hemoptysis may also be a manifestation of anti-GBM disease, so appropriate differential diagnosis should be made. The patient should be informed of the possibility of these symptoms and, if in any doubt, consult a doctor immediately.

A complete clinical blood count with cell count and leukocyte count should be performed before treatment and then monthly for 48 months after the last infusion. After this period, tests are performed based on clinical findings suggesting ITP. If ITP is suspected, a complete blood count should be performed immediately.

If the diagnosis of ITP is confirmed, appropriate action should be taken immediately, including urgent referral to a specialist. Data from multiple sclerosis clinical trials have shown that adherence to blood test monitoring regimens, as well as education to recognize the signs and symptoms of ITP, resulted in early diagnosis and treatment of ITP in the majority of cases that developed during the first course of therapy.

Potential risk of developing ITP associated with repeated treatment with Lemtrada® in patients who have developed ITP. unknown

— Nephropathy

Nephropathy, including anti-GBM disease, was observed in 6 (0.4%) patients with multiple sclerosis participating in clinical trials with a median follow-up of 6.1 years (maximum 12 years). As a rule, they were observed within 39 months after the last infusion of Lemtrada®. Two cases of anti-GBM disease were noted in clinical studies. Both cases were severe, but thanks to clinical and laboratory monitoring, they were detected in a timely manner and their treatment was successful.

Clinical manifestations of nephropathy may include increased serum creatinine concentrations, hematuria and/or proteinuria. Although there were no cases of alveolar hemorrhage in clinical studies, this type of bleeding, manifested by hemoptysis, can occur in anti-GBM disease.

Hemoptysis can also be a sign of ITP (see above), so a proper differential diagnosis should be made. The patient should be informed of the need to be attentive to the possibility of these symptoms, and if they develop, seek immediate medical attention.

Anti-GBM disease can lead to the development of renal failure, requiring dialysis and/or transplantation if therapy is not started in a timely manner. If left untreated, it can be life-threatening.

It is necessary to determine the creatinine concentration and conduct a clinical urine analysis with sediment microscopy before starting therapy with Lemtrada®. These examinations must be carried out monthly during the course of treatment, and also for a further period of 48 months after the last infusion of Lemtrada®. Identification of clinically significant deviations from baseline serum creatinine concentration, unexplained hematuria and/or proteinuria may require additional evaluation for nephropathy, including referral to an appropriate specialist. Early diagnosis and treatment of nephropathy can reduce the risk of poor outcome. After the end of the 48-month period after the last infusion, tests are performed based on clinical evidence suggesting renal impairment.

Potential risk of developing nephropathy associated with repeated treatment with Lemtrada after the patient develops nephropathy. unknown

— Thyroid diseases

Endocrine disorders, including autoimmune thyroid disease, were observed in 36.8% of patients treated with Lemtrada 12 mg over a median follow-up of 6.1 years (maximum 12 years) after initial Lemtrada administration. Both in the group of patients receiving Lemtrada® and in the group of patients receiving interferon beta-1a (INFbeta-1a), the incidence of thyroid disease was higher in patients with a history of such pathology.

Patients with thyroid disease should receive Lemtrada only in cases where the expected benefit of therapy outweighs the expected risk. Study participants had both hyperthyroidism and hypothyroidism.

In most cases, these disorders were mild or moderate in severity.

Severe endocrine diseases were observed in 4.4% of patients, diffuse toxic goiter (Graves disease), hyperthyroidism, hypothyroidism, autoimmune thyroiditis and goiter (increase in the volume of the thyroid gland) were observed in more than one patient. Standard drug therapy was used to treat thyroid disease, but some patients required surgery. In clinical studies, patients who developed thyroid disease were allowed to undergo a repeat course of treatment with Lemtrada®. There is limited evidence that patients receiving a repeat course generally do not experience worsening of their thyroid disease. The question of continuing treatment with Lemtrada should be considered individually, taking into account the clinical condition of the patient.

Thyroid function tests, such as monitoring thyroid-stimulating hormone concentrations, should be performed before starting treatment and then every 3 months for 48 months after the last infusion. At the end of this period, tests are carried out on the basis of clinical data suggesting a dysfunction of the thyroid gland.

Thyroid disease poses a particular risk in pregnant women (see section “Use during pregnancy and breastfeeding”).

In clinical studies, 74% of patients with initial positive titers of antibodies to thyroid peroxidase (Ab-TPO) and 38% of patients with initial negative titers of Ab-TPO subsequently developed thyroid disease.

The vast majority (approximately 80%) of patients who developed adverse events from the thyroid gland had an initial negative TPO Ab titer. Therefore, the patient may develop adverse thyroid events regardless of the initial TPO-AT result, and the patient should periodically undergo all examinations as described above.

— Cytopenia

In clinical studies in patients with multiple sclerosis, autoimmune cytopenias such as neutropenia, hemolytic anemia and pancytopenia were reported infrequently. For timely detection of cytopenias, a complete clinical blood test should be performed monthly (see subsection “Immune thrombocytopenic purpura”). If cytopenia is confirmed. Appropriate measures should be taken immediately, including referring the patient to a specialist.

— Autoimmune hepatitis (ALH) and liver damage

Autoimmune hepatitis (including fatal cases), causing clinically significant liver damage, including acute liver failure requiring transplantation, has been reported in patients receiving Lemtrada in the post-marketing period. If a patient develops clinical signs such as unexplained elevated liver enzymes or symptoms suggestive of liver dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine), evaluation should be performed immediately. laboratory tests to determine the concentration of serum transaminases and total bilirubin. Treatment with Lemtrada should be interrupted or discontinued depending on the clinical situation.

Liver function tests should be monitored before and during treatment. Patients should be advised of the risk of liver damage and associated symptoms. If these symptoms occur, re-treatment should only be prescribed after careful consideration of all factors.

Infusion-related reactions (IRRs)

In clinical studies, infusion-related reactions were defined as any adverse events occurring during the infusion of Lemtrada or within 24 hours after completion of the infusion. Most of these may be due to the release of cytokines when patients with multiple sclerosis who received Lemtrada developed mild to moderate infusion reactions during and/or within 24 hours after administration of Lemtrada 12 mg. The incidence of SIR was higher during the first course of treatment than in subsequent courses. Among all available observations, including observations of patients. who received additional courses of treatment, the most common SIRs were headache, rash, pyrexia (fever), nausea, urticaria, itching, insomnia, chills, hot flashes, fatigue, shortness of breath, dysgeusia. chest discomfort, generalized rash, tachycardia, bradycardia, dyspepsia, dizziness and pain. Serious reactions occurred in 3% of patients and included cases of headache, pyrexia, urticaria, tachycardia,

manifestations of anaphylaxis may be similar to clinical manifestations

infusion reactions, but they are usually more severe and life-threatening. Unlike infusion reactions, anaphylactic reactions are rare. Cases have also been reported with post-marketing use of alemtuzumab within 48 hours of Lemtrada administration.

To reduce the severity of infusion reactions, premedication is recommended. In controlled clinical studies, the majority of patients received antihistamines and/or antipyretics (antipyretics) at least before the first Lemtrada infusion. Premedication does not exclude the development of infusion reactions. It is recommended to carefully monitor the patient's condition during the infusion of Lemtrada® and for 2 hours after its completion. If infusion reactions develop, appropriate symptomatic treatment should be provided if necessary. Typically, the duration of the infusion is 4 hours. If the infusion is poorly tolerated by the patient, the rate of drug administration can be reduced. If severe infusion reactions occur, the drug infusion should be stopped immediately. During clinical studies, anaphylactic or other serious reactions requiring treatment interruption were very rare.

The physician should be informed of the patient's cardiovascular history, as infusion reactions may cause cardiac complications such as tachycardia. Physicians should also inform patients about the possibility of infusion-related reactions within 48 hours after administration of Lemtrada. Treatments for anaphylactic or other serious reactions should be available during the infusion.

Other serious reactions that are temporarily related to Lemtrada infusion

Cases of pulmonary alveolar hemorrhage, myocardial infarction, stroke (ischemic and hemorrhagic stroke) and cervicocephalic artery dissection have been reported during post-marketing use of Lemtrada. Adverse reactions may develop after administration of any dose during the course of treatment. In most cases they developed within 1-3 days after Lemtrada® infusion. Patients should be informed of the signs and symptoms of these adverse reactions and that they should seek immediate medical attention if any of these symptoms occur.

Vital signs, including blood pressure, should be monitored before and periodically during Lemtrada infusion. If clinically significant changes in vital body functions are observed, discontinuation of the infusion and additional ECG monitoring should be considered.

— Stroke and dissection (dissection) of the walls of the cervicocephalic arteries

Serious and life-threatening strokes (ischemic and hemorrhagic) and cervicocephalic artery dissection (eg, vertebral, carotid) have been reported with post-marketing use of alemtuzumab, with some cases occurring within 3 days of Lemtrada administration.

Patients should be informed about the symptoms of stroke and cervicocephalic artery wall dissection (facial asymmetry, sudden severe headache, weakness on one side of the body, difficulty speaking, neck pain) and the need to immediately seek medical attention if such symptoms develop.

Hemophagocytic lymphohistiocytosis

During post-marketing use, hemophagocytic lymphohistiocytosis (HLH) has been reported in patients receiving Lemtrada. HLH is a life-threatening syndrome of pathological activation of the immune system, characterized by clinical signs and symptoms of severe systemic inflammation. In the absence of early diagnosis and timely treatment, HLH is associated with high mortality rates. Symptoms of HLH appear within a few months to four years after starting treatment with Lemtrada®. Patients who develop early signs of pathological activation of the immune system should be promptly assessed and the possibility of developing HLH should be considered.

Infectious diseases

In controlled clinical studies of up to two years in patients with multiple sclerosis, infections occurred in 71% of patients receiving Lemtrada 12 mg, compared with interferon beta-1a (IFN-beta-1a) (44 mcg). 3 times a week), they occurred in 53% of patients; most of these infectious diseases were mild or moderate in severity. Infectious diseases that occurred more frequently in patients receiving Lemtrada® compared to the IFNbeta-1a group included nasopharyngitis, urinary tract infections, upper respiratory tract infections, sinusitis, oral herpes, influenza and bronchitis. In controlled clinical trials in patients with multiple sclerosis, severe infections occurred in 2.7% of patients treated with Lemtrada and in 1% of patients treated with IFNbeta-1a. Severe infectious diseases in the group of patients receiving Lemtrada® included appendicitis, castroenteritis, pneumonia, herpes zoster and dental infections. As a rule, the duration of the illnesses was normal and they resolved after standard drug treatment.

The cumulative incidence of infections per year of follow-up was 0.99 with a median follow-up of 6.1 years (maximum 12 years) after the first administration of Lemtrada, compared with 1.27 in controlled clinical trials.

In clinical studies, serious infections caused by varicella zoster virus ( Varicella zoster)

), including primary and re-infection, were more often observed in patients receiving Lemtrada 12 mg (0.4%) than in patients receiving IFNbeta-1a (0%).

In patients receiving Lemtrada 12 mg, there were also cases of infections caused by the human papillomavirus (HPV) (2%), including cervical dysplasia. It is recommended that patients be screened annually for HPV.

Infections caused by cytomegalovirus (CMV) have been observed with the simultaneous use of Lemtrada® with glucocorticosteroids. Most cases were observed within 2 months after using Lemtrada®. In patients with symptoms of an infectious disease, clinical evaluation should be performed to exclude cytomegalovirus infection during and for at least two months after each course of treatment with Lemtrada.

In controlled clinical trials, cases of tuberculosis were also identified, both in the group of patients receiving Lemtrada® and in the group of patients receiving IFNbeta-1a. Active and latent tuberculosis was detected in 0.3% of patients receiving Lemtrada®. Most often, these cases were recorded in endemic areas. Before starting treatment with Lemtrada®, screening for active or latent tuberculosis should be carried out in accordance with local requirements.

Cases of listeriosis/listeriosis meningitis have been reported in patients treated with Lemtrada®. The duration of the increased risk of listeria meningitis is unclear, although such cases typically occurred within one month after the Lemtrada infusion. Without proper treatment, listeria infection can lead to severe complications or death. Patients should avoid eating foods that may be a potential source of Listeria monocytogenes

, or subject such food to sufficient heat treatment. To reduce this risk, patients receiving Lemtrada® should avoid eating raw and undercooked meats, soft cheeses and unpasteurized dairy products at least 2 weeks before, during and for one month after treatment with Lemtrada® .

In controlled clinical trials in patients with multiple sclerosis, superficial mycoses, especially oral candidiasis and vaginal candidiasis, occurred more frequently in patients treated with Lemtrada (12%) than in patients treated with IFNbeta-la (3%).

Pneumonitis has been reported in patients treated with Lemtrada. Most cases occurred within the first month after treatment with Lemtrada. Patients should be informed to report symptoms of pneumonitis (rapid breathing, cough, wheezing, chest pain or tightness, and hemoptysis) to their healthcare provider.

If a patient has an active infectious disease, the physician should delay initiation of treatment with Lemtrada until the disease is completely controlled. Patients taking Lemtrada should be advised to report symptoms of infectious diseases to their physician.

Prophylaxis with oral antiherpetic drugs should begin on the first day of treatment with Lemtrada and continue for at least another 1 month after each course of therapy.

The drug Lemtrada® for the treatment of multiple sclerosis was not used simultaneously or immediately after courses of antitumor or immunosuppressive therapy.

Concomitant use of Lemtrada with any other of these drugs may increase the risk of immunosuppression.

There are no data on the effect of Lemtrada on the reactivation of hepatitis B virus (HB-B) or hepatitis C virus (HCV-C), since patients with signs of active or chronic infectious diseases were excluded from participation in clinical trials. Before starting treatment with Lemtrada®, screening for carriage of the HB-B and/or HH-C viruses should be carried out. Caution should be exercised when prescribing Lemtrada® to carriers of the HV-B and/or HV-C viruses, since there is a risk of virus reactivation and the development of irreversible liver failure in patients in this group.

Acute non-calculous cholecystitis

The use of Lemtrada® may increase the risk of developing acute non-calculous cholecystitis. In controlled clinical studies in 0.2% of patients receiving Lemtrada®. developed acute noncalculous cholecystitis compared with 0% of patients receiving IFNbeta-la. During post-registration use of alemtuzumab, cases of acute non-calculous cholecystitis were observed in patients treated with Lemtrada®. The time of onset of symptoms ranged from less than 24 hours to 2 months after Lemtrada infusion. Most patients received conservative treatment with antibiotics and recovered without surgery, while other cases required cholecystectomy.

Symptoms of acute noncalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting. The patient should be informed of the need to consult a doctor if such symptoms appear. Acute noncalculous cholecystitis is a disease that, if not diagnosed and treated early, can be associated with severe complications and high mortality. If acute non-calculous cholecystitis is suspected, immediate diagnosis and treatment is necessary.

Malignant neoplasms

As with other immunomodulators, Lemtrada should be prescribed with caution to patients with previous and/or existing malignancies. It is currently unknown whether alemtuzumab increases the risk of developing thyroid malignancy, since autoimmune thyroid disease may itself be a risk factor for malignancy.

Contraception

Transplacental entry of alemtuzumab into the blood of fetuses and the possibility of pharmacological action of Lemtrada® on them were observed in mice both during gestation and after the birth of offspring. Women of childbearing potential should use reliable methods of contraception during treatment with Lemtrada® and for 4 months after the last infusion of Lemtrada®.

Vaccination

It is recommended to complete the course of immunization in accordance with national vaccination requirements at least 6 weeks before starting treatment with Lemtrada. The body's ability to mount an immune response to any vaccine after treatment with Lemtrada has not been studied.

The safety of immunization with live viral vaccines after treatment with Lemtrada has not been studied in controlled clinical trials in patients with multiple sclerosis. Immunization with live viral vaccines is not recommended for patients recently treated with Lemtrada.

zoster
virus antibody testing Varicella zoster
virus infection vaccination As with any immunomodulatory drug, prior to initiation of treatment with the drug, Lemtrada® should be administered to patients with no history of varicella zoster infection or vaccination against the disease . Varicella
zoster virus ,
you should be tested for antibodies to the
Varicella zoster .

Varicella zoster
virus antibody test should be vaccinated before starting treatment with Lemtrada. In order for the effect of vaccination to fully manifest itself, treatment with Lemtrada® should be prescribed no earlier than 6 weeks after vaccination.

Recommended laboratory tests for monitoring patients

Laboratory tests should be performed at regular intervals throughout the course of treatment, as well as for 48 months after the last infusion of Lemtrada®, which will allow timely diagnosis of autoimmune diseases:

- a complete clinical blood test with calculation of formed elements and leukocyte formula (before the start of treatment and then monthly);

- determination of creatinine concentration in blood serum (before the start of treatment and then monthly);

-general urine analysis and sediment microscopy (before treatment and then monthly);

- a study of thyroid function, for example, determining the concentration of thyroid-stimulating hormone (TSH) (before starting treatment and then every 3 months).

At the end of a period of 48 months after the last infusion, additional examinations are carried out if any clinical signs of nephropathy or thyroid dysfunction appear.

What is important to tell your doctor before starting treatment?

The risk of serious side effects can be reduced by taking the drug exactly as directed and not using it on people who already have health problems. If the patient suffers from at least one of the following conditions, the doctor must know about it:

• increased bleeding;
• dysfunction of the thyroid gland;
• renal dysfunction;
• HIV;
• any infections, including recent ones;
• cancer;
• vaccination with live vaccine within the previous 6 weeks.

Pregnancy and breastfeeding are also contraindications to the use of the drug. If you take any medications, vitamins, dietary supplements, be sure to tell your doctor about it.

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