Daratumumab (Daratumumab)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Antineoplastic agents - monoclonal antibodies

Included in the formulation
  • Darzaleks
    concentrate d / infusion 
    Johnson & Johnson, LLC     Russia
    • АТХ:

    L.01.X.C   Monoclonal antibodies

    Pharmacodynamics:

    Immunoglobulin monoclonal antibody G1k connects Cd38 glycoprotein, thereby inhibiting the growth of myeloid cells that express Cd38, and as a result causes apoptosis of tumor cells. It induces immune-mediated lysis of tumor cells.

    Pharmacokinetics:

    After intravenous administration, the half-life period with monotherapy is 18 days, with combined therapy - 23 days. Subjected to tissue catabolism up to amino acids. Penetrates through the placental barrier, is found in breast milk.

    Elimination by the kidneys.

    Indications:

    Used for monotherapy of multiple myeloma as the fourth line of therapy. It is used to treat multiple myeloma in combination chemotherapy with lenalidomide and dexamethasone.

    ICD-10

    II.C81-C96.C90.0   Multiple myeloma

    Contraindications:

    Hepatic insufficiency, age under 18, pregnancy and lactation, individual intolerance.

    Carefully:

    Thrombocytopenia, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - Category D. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Intravenously slowly, with an initial rate of 50 ml / h, gradually increasing by 50 ml every hour, bringing to a maximum of 200 ml / h, at a dosage of 16 mg / kg body weight. The treatment schedule is determined individually.

    The highest daily dose: 16 mg / kg body weight.

    The highest single dose: 16 mg / kg body weight.

    Side effects:

    Central and peripheral nervous system: chronic fatigue, headache, peripheral neuropathy.

    Respiratory system: cough, nasopharyngitis, pneumonia.

    Hemopoietic system: lymphocytopenia, leukopenia, thrombocytopenia.

    The cardiovascular system: arterial hypotension, bradycardia, chest pain, rarely - thromboembolism of the pulmonary artery

    Digestive system: vomiting, anorexia, diarrhea.

    Musculoskeletal system: low back pain.

    Dermatological reactions: night sweats.

    Sense organs: cataract.

    urinary system: rarely - acute renal failure.

    Infusion reactions: hyperthermia, fever, chills.

    Allergic reactions.

    Overdose:

    Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:

    Clinically significant interactions are not described.

    Special instructions:

    Persons of reproductive age during treatment, and also during 6 weeks (women) and 4 months (men) after its termination are recommended to use reliable methods of contraception.

    When taking the drug is not recommended driving and working with moving machinery.

    Instructions
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