Downloadable Materials
CLDN18.2 Testing
Companion Diagnostic
CLDN18.2 status must be determined using an FDA-approved immunohistochemistry (IHC) test prior to initiating treatment with ZELVARA. CLDN18.2 positivity is defined as ≥75% of tumor cells showing moderate-to-strong membranous staining (IHC 2+/3+).
Testing should be performed at a CLIA-certified laboratory using formalin-fixed, paraffin-embedded (FFPE) tumor tissue from a biopsy or surgical specimen.
Ordering Testing
- 1 Submit FFPE tissue to a CLIA-certified lab offering the approved CLDN18.2 IHC assay
- 2 Results typically available within 5-7 business days
- 3 Ensure report includes percentage of positive cells and staining intensity
Patient Support Program
ZELVARA Access
The ZELVARA Access program provides benefit verification, prior authorization support, and financial assistance for eligible patients.
1-800-555-ZELV (9358)
Mon-Fri, 8 AM - 8 PM ET
Co-Pay Assistance
Commercially insured patients may be eligible for co-pay support, reducing out-of-pocket costs to as low as $0 per infusion. Subject to eligibility criteria and annual cap.
Patient Assistance
Uninsured or underinsured patients who meet income eligibility criteria may receive ZELVARA at no cost through the Meridian Patient Assistance Program.
Coding & Reimbursement
| Code Type | Code | Description |
|---|---|---|
| HCPCS J-Code | J9XXX | Injection, celdatuzumab-mkrz, 10 mg |
| ICD-10-CM | C16.9 | Malignant neoplasm of stomach, unspecified |
| ICD-10-CM | C16.0 | Malignant neoplasm of cardia (GEJ) |
| CPT | 96413 | Chemotherapy administration, IV infusion, first hour |
| CPT | 96415 | Chemotherapy administration, IV infusion, each additional hour |
J-code is pending CMS assignment. Contact ZELVARA Access for interim billing guidance. Verify coverage with the patient's specific payer plan.
Nurse & Pharmacist Resources
Administration guides and clinical protocols for infusion nurses, oncology pharmacists, and advanced practice providers managing patients on ZELVARA.
Infusion Administration Guide
Pre-Infusion Checklist
- ☐ Verify CLDN18.2+ and HER2− status confirmed
- ☐ Confirm pregnancy test (if applicable)
- ☐ Administer premedication 30 min prior: dexamethasone 12 mg IV, ondansetron 8 mg IV
- ☐ Optional: diphenhydramine 25-50 mg IV/PO (required Cycle 1)
- ☐ Verify IV access and flush line
- ☐ Confirm dose calculation matches BSA (loading: 800 mg/m², maintenance: 600 mg/m²)
Infusion Rate Schedule
| Cycle | Duration | Initial Rate |
|---|---|---|
| Cycle 1 (Loading) | ~3.5 hours | 50 mL/hr → escalate to 100 mL/hr |
| Cycle 2+ (Maint.) | ~2.5 hours | 100 mL/hr |
Infusion Reaction Management
Grade 1-2 (Mild to Moderate)
- • Interrupt infusion immediately
- • Administer diphenhydramine 50 mg IV + acetaminophen 650 mg PO
- • Monitor for 30 minutes after symptom resolution
- • Resume at 50% reduced infusion rate
Grade 3-4 (Severe / Life-Threatening)
- • Stop infusion immediately
- • Administer epinephrine, corticosteroids, and bronchodilators per protocol
- • Monitor vitals continuously; transfer to higher level of care if needed
- • Permanently discontinue ZELVARA
Monitoring Schedule
- • Vital signs: baseline, q15 min × 1 hr, then q30 min
- • Post-infusion observation: minimum 30 minutes (60 min for Cycle 1)
- • Assess for: flushing, dyspnea, hypotension, rigors, urticaria
Request a Representative
Connect with a Meridian Oncology field representative for product information, clinical data discussion, or patient support resources.
Medical Information
For medical inquiries regarding ZELVARA, including clinical data requests, adverse event reporting, and product complaints, please contact Meridian Oncology Medical Information.
Phone
1-800-555-MERI (6374)
medinfo@meridianonc.com
Adverse Event Reporting
1-800-FDA-1088 (MedWatch)