These highlights provide only a summary of the prescribing information and do not contain all the details required for the safe and effective use of VIRAPLACEL®. Please refer to the full Prescribing Information before use.

 

 

VIRAPLACEL® (allogeneic placenta-derived mesenchymal stromal cells) suspension for intravenous infusion

Initial Iran Approval: September 2025

 

 

——————————–INDICATIONS AND USAGE————————————–

VIRAPLACEL is an allogeneic placenta-derived mesenchymal stromal cells (P-MSCs) therapy indicated for the treatment of steroid-refractory acute and chronic graft-versus-host disease (SR-aGvHD).

 

—————————–DOSAGE AND ADMINISTRATION——————————–

For intravenous use only. (2)

  • The recommended dosage of VIRAPLACEL is 1 × 106 MSC cells/kg body weight per intravenous infusion given for a total of 4 infusions. Administer infusions at least 3 days apart. Assess response 28 ± 2 days after the first dose and administer further treatment as appropriate, as described in the table below.

    —————————–DOSAGE FORMS AND STRENGTHS—————————-

    VIRAPLACEL is available as a cell suspension for intravenous infusion in a target concentration of 2 × 106 MSCs per mL in a 5 mL vial.

     

    ————————————-CONTRAINDICATIONS————————————–

    • Known hypersensitivity reaction to the MSC product or any of its excipients,

       including dimethyl sulfoxide (DMSO) and human serum albumin (HSA).

    • Uncontrolled, life-threatening infection despite treatment.
    • Active severe sinusoidal obstruction syndrome with significant hepatic/portal

       compromise.

    • Active major thrombosis (pulmonary embolism, arterial/venous thrombosis) not

       yet stabilized.

    • Hemodynamic instability or multiorgan failure. (3)

     

    ——————————WARNINGS AND PRECAUTIONS——————————-

    • Hypersensitivity/Acute Infusion reactions: Monitor for hypersensitivity reactions during infusion and premedicate with corticosteroids and antihistamines. (4.1)
    • Transmission of Infectious Agents: VIRAPLACEL may transmit infectious agents. (4.2)

     

    ————————————–ADVERSE REACTIONS————————————-

    The most common non-laboratory adverse reactions are: headache, flushing, pyrexia, chills, edema, dyspnea, cough, and hypertension (5.1).

     

    To report SUSPECTED ADVERSE REACTIONS, please get in touch with ViraCellule at +98-21-88-21-99-65
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