Alemtuzumab

Administered by iv infusion. The initial dose is 3 mg. In the future, the dose is set in accordance with the treatment regimen. The maximum duration of treatment is 12 weeks. With the development of severe infection or pronounced signs of hematological toxicity, treatment is stopped until they disappear. Treatment should be discontinued if symptoms of disease progression are present.

On the part of the organism as a whole.

often - back pain, neutropenic fever, chest pain, edema of the oral mucosa, asthenia, malaise, flu-like symptoms, feeling of change in body temperature; rarely - fainting, peripheral edema, pain in the legs, allergic reactions.

Cardiovascular

very often - arterial hypotension; often - arterial hypertension, tachycardia, angiospasm, facial hyperemia, palpitations; rarely - cardiac arrest, myocardial infarction, atrial fibrillation, supraventricular tachycardia, ECG abnormalities, arrhythmia, bradycardia, peripheral circulatory disorders.

The nervous system

very often - a headache; often - tremor, paresthesia, dizziness, hyperkinesia, paresthesia, confusion, anxiety, drowsiness, depression, insomnia; rarely - gait disturbance, dystonia, hyperesthesia, hypertonia, neuropathy, nervousness, impaired thinking, depersonalization, impotence, personality disorders.

From the senses

often - loss of taste, conjunctivitis; rarely - enophthalmos, hearing loss, tinnitus, taste perversion.

On the part of the digestive system

very often - nausea, vomiting, diarrhea; often - abdominal pain, gastrointestinal bleeding, stomatitis, mucositis, abnormal liver function, constipation, dyspepsia, ulcerative stomatitis, meteorism; rarely - gastroenteritis, gingivitis, belching, hiccups, dry mouth, ulcerative lesions of the mucous membrane, ulcerative lesions of the tongue.

From the hemopoietic system

often - granulocytopenia, thrombocytopenia, anemia, pancytopenia, leukopenia, lymphopenia, purpura; rarely, bone marrow aplasia, decrease in haptoglobin level, DIC, hemolytic anemia, inhibition of bone marrow hematopoiesis, nasal bleeding, bleeding from the nose, from the gums, changes in blood parameters.

Metabolism

often - hyponatremia, dehydration, weight loss, hypocalcemia, thirst; rarely, exacerbation of diabetes mellitus, periorbital edema, hypokalemia.

From the musculoskeletal system

often - bone pain, arthralgia, myalgia.

By the respiratory system

very often - pneumonia, shortness of breath; often - pneumonitis, bronchospasm, sinusitis, cough, hypoxia, infections of the upper respiratory tract, bronchitis, pharyngitis, hemoptysis; rarely - pulmonary edema, difficulty in breathing, infiltration of lung tissue, respiratory diseases, weakening of breath, laryngitis, irritation of the pharynx, effusion in the pleural cavity.

Urinary System

often urinary tract infections; rarely - renal dysfunction, polyuria, hematuria, urinary incontinence, oliguria.

Allergic reactions

very often - hives.

Dermatological reactions

very often - rash, itching, excessive sweating; often - erythematous rash, bullous eruptions; rarely - fungal dermatitis, onychomycosis, maculo-papular rash.

Local Reactions

often - irritation, redness; rarely - hemorrhage, dermatitis, pain.

Effects due to immunosuppressive effects

very often - sepsis, infections caused by herpes simplex; often - infections caused by cytomegalovirus, Pneumocystis carnii, Herpes zoster, Candidomycosis, fungal infection, abscess; rarely, viral infection, bacterial infection.

Other

rarely - lymphoma syndrome.

Acute or exacerbation of chronic systemic infectious process; HIV infection; concomitant tumors requiring treatment; pregnancy, lactation; hypersensitivity to alemtuzumab.

Use during pregnancy and lactation is contraindicated. Women and men of childbearing age should use reliable methods of contraception during treatment and for 6 months after its termination. Pregnant women are forbidden to work with alemtuzumab. Breastfeeding should be discontinued during treatment and for a period of 4 weeks after its termination.

The use of alemtuzumab in patients with liver disease is not recommended, unless the expected benefit of therapy outweighs the potential risk of side effects.

The use of alemtuzumab in patients with kidney disease is not recommended, unless the expected benefit of therapy outweighs the potential risk of side effects.

The safety and efficacy of alemtuzumab in children has not been studied.

During the period of treatment, the clinical condition of elderly patients should be carefully monitored.

Use with caution in patients with coronary artery disease and receiving antihypertensive drugs. Premedication with antihistamines, glucocorticoids and non-opioid analgesics should be carried out before the first injection of alemtuzumab, with each subsequent administration of the drug, as well as for clinical reasons. During therapy and for at least 2 months after its termination, infection prophylaxis should be carried out. For severe infectious complications, alemtuzumab should be discontinued until they disappear. During the treatment period, a detailed analysis of peripheral blood parameters should be carried out. With the development of severe hematotoxicity, alemtuzumab should be discontinued until it disappears completely. During the period of treatment, the clinical condition of elderly patients should be carefully monitored. The safety and efficacy of alemtuzumab in children, patients with liver and kidney diseases have not been studied. The use of alemtuzumab in patients with liver and kidney disease is not recommended, unless the expected benefit of therapy outweighs the potential risk of side effects. The recommended interval between administration of alemtuzumab and other chemotherapeutic drugs is at least 3 weeks. The use of live viral vaccines is not recommended for at least 12 months after alemtuzumab therapy.

Considering the described cases of drowsiness and confusion during therapy, the patient should be careful when driving motor vehicles and other potentially dangerous activities.