Kymriah Product Insert

Kymriah Product Insert

Basic Information on Kymriah

English Name: Tisagenlecleucel

Trade Name: Kymriah

Target: CD19

Indications: Acute lymphoblastic leukemia, Diffuse large B-cell lymphoma

Developer: Novartis

Indications

Treatment of pediatric and young adult patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL).

Treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Dosage and Administration

Premedicate with acetaminophen and an H1-antihistamine. Ensure tocilizumab is available prior to infusion. The dose is determined by the number of CAR-positive viable T cells.

For patients ≤50 kg, the recommended dose is 0.2 to 5.0 x 10^6 CAR-positive viable T cells/kg body weight, administered as an intravenous infusion.

For patients >50 kg, the recommended dose is 0.1 to 2.5 x 10^8 CAR-positive viable T cells (non-weight based), administered as an intravenous infusion.

Adverse Reactions

The most common adverse reactions (≥20%) include cytokine release syndrome, hypogammaglobulinemia, infections of unspecified pathogen, pyrexia, decreased appetite, headache, encephalopathy, hypotension, bleeding episodes, tachycardia, nausea, diarrhea, vomiting, viral infectious disorders, hypoxia, acute kidney injury, delirium.

Contraindications

None.

Precautions

1. Allergic Reactions: Monitor for signs and symptoms of allergic reactions during infusion.

2. Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately.

3. Prolonged Cytopenias: Patients may exhibit cytopenia lasting for several weeks. Newborn babies of mothers treated should be monitored for immunoglobulin levels.

4. Secondary Malignancies: Patients may develop secondary malignancies.

5. Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities until the potential adverse reactions are resolved.

Storage

Store in the refrigerator (2°C-8°C).