Redefining Control in Rare Vasculitis — The first anti-IL-5 monoclonal antibody indicated for adult patients with moderate-to-severe Eosinophilic Granulomatosis with Polyangiitis (EGPA).
For US Healthcare Professionals Only · Orvantis Pharma · Rx Only
Calvrix (calvriumab) is a humanized anti-IL-5 monoclonal antibody that selectively binds to interleukin-5 (IL-5) with high affinity, blocking its interaction with the IL-5 receptor alpha chain expressed on eosinophils and basophils. By inhibiting IL-5 signaling, calvriumab directly suppresses eosinophil survival, maturation, and tissue recruitment — the core pathophysiologic drivers of EGPA-related vasculitic injury.
In patients with EGPA, eosinophilic infiltration of blood vessel walls leads to granulomatous inflammation and progressive organ damage. Calvrix interrupts this cascade at the cytokine level, enabling durable eosinophil suppression without broad immunosuppression.
Dosage & Administration
Dose: 300 mg subcutaneous injection every 4 weeks
Site: Abdomen, thigh, or upper arm (rotate sites)
Administration: Prefilled autoinjector or prefilled syringe; may be self-administered after training
Storage: Refrigerate at 36°F–46°F (2°C–8°C); protect from light; do not freeze
Preparation: Allow to reach room temperature for 30 minutes prior to injection
At a Glance
Target
Anti-IL-5 mAb
Route
Subcutaneous
Frequency
Every 4 Weeks
Dose
300 mg
Indication
Calvrix is indicated as an add-on maintenance treatment for adult patients with moderate-to-severe Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Calvrix does not replace oral corticosteroids. Taper corticosteroids under physician supervision only.
Clinical Evidence
Clinical Data Highlights — ORVAL-1 Pivotal Trial
The Phase 3 ORVAL-1 trial enrolled 312 adult patients with relapsing or refractory EGPA across 47 international sites. Patients received Calvrix 300 mg SC Q4W or placebo as add-on to standard-of-care. Primary and key secondary endpoints were met with statistical significance (p<0.001).
67%
Flare Rate Reduction
Reduction in annualized vasculitic flare rate vs. placebo at Week 52 (p<0.001)
Patients able to eliminate oral corticosteroids entirely while maintaining disease control
4.2×
Longer Remission
Duration of sustained remission vs. placebo arm (median weeks in remission)
Data from ORVAL-1 Phase 3 randomized, double-blind, placebo-controlled trial (N=312). Mock data for illustrative purposes only. Please refer to the full Prescribing Information for complete efficacy and safety data.
Efficacy Outcomes
Sustained Efficacy Over 52 Weeks
Reading the Data
The chart illustrates mean eosinophil count (% of baseline) over 52 weeks in the ORVAL-1 trial. Calvrix-treated patients demonstrated a rapid and sustained reduction in peripheral eosinophil counts beginning as early as Week 4, with continued improvement through Week 52.
The placebo arm showed minimal reduction, underscoring the targeted efficacy of IL-5 pathway inhibition with calvriumab.
Key Secondary Endpoints Met
Reduction in BVAS score ≥50% vs. baseline
Improved HRQOL (SF-36 PCS)
Reduction in prednisone-equivalent dose
Safety Information
Safety & Important Risk Information
⚠ WARNING: HYPERSENSITIVITY REACTIONS — Serious hypersensitivity reactions, including anaphylaxis, have been reported following administration of Calvrix. Discontinue immediately and initiate appropriate therapy if a severe reaction occurs. Do not readminister Calvrix to patients who have experienced a severe hypersensitivity reaction. Monitor patients for an appropriate period after administration.
Contraindications
Known hypersensitivity to calvriumab or any excipient in the formulation
Active, severe systemic bacterial or fungal infection at time of administration
Concomitant administration of live attenuated vaccines
Warnings & Precautions
Hypersensitivity: Anaphylaxis and severe allergic reactions reported; observe patients post-injection
Infections: Increased risk of upper respiratory and opportunistic infections
Parasitic Infections: Treat pre-existing helminth infections before initiating therapy
Corticosteroid Tapering: Do not abruptly discontinue systemic corticosteroids upon initiation
Psychiatric Events: Monitor patients with history of neuropsychiatric conditions
Common Adverse Events (≥5% in Clinical Trials)
This is not a complete list of adverse reactions. Please see full Prescribing Information for complete safety data.
HCP Portal
HCP Portal Access & Resources
Access clinical tools, patient support materials, and prescribing resources through the Orvantis Pharma HCP Portal. Verified healthcare professionals may download the full Prescribing Information, request samples, and enroll patients in the Orvantis Patient Support Program.
Prescribing Information
Access the full FDA-approved Prescribing Information, including Boxed Warning, dosing tables, and complete safety data.
Orvantis Medical Science Liaisons (MSLs) are field-based medical experts available to support healthcare professionals with scientific exchange on calvriumab, EGPA pathophysiology, clinical data, and real-world evidence.
MSL engagements are non-promotional and governed by Orvantis Medical Affairs policy. All interactions comply with applicable PhRMA guidelines and institutional requirements.
To Request an MSL:
Complete the MSL request form (right panel)
Call Medical Affairs: 1-800-ORV-MEDU (1-800-678-6338)
Email: medicalaffairs@orvantispharma.com
Medical Information Hotline
1-800-ORV-INFO (1-800-678-4636) Monday–Friday, 8:00 AM – 8:00 PM ET After hours: Leave a message for next-business-day callback
MSL Visit Request Form
Please complete all fields. An Orvantis MSL will contact you within 2 business days to confirm scheduling.
Requestor Information
Full Name · Degree/Credentials · Specialty · Institution/Practice Name · NPI Number
Contact Details
Office Address · City · State · ZIP · Direct Phone · Email Address
Meeting Preferences
Preferred Date(s) · Format (In-Person / Virtual) · Topic(s) of Interest
Topics of Interest
EGPA Pathophysiology · ORVAL-1 Data · Safety Profile · Real-World Evidence · Other
The following resources are available exclusively to verified US Healthcare Professionals. All materials reflect the most current FDA-approved labeling and Orvantis Medical Affairs guidance. Please ensure you are referencing the most current version of each document by checking the revision date prior to use.
Full Prescribing Information (PI)
Complete FDA-approved labeling including Boxed Warning, Indications & Usage, Dosage & Administration, Contraindications, Warnings & Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, and Patient Counseling Information.
Calvrix is available under a Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare providers must complete REMS certification training before prescribing. Includes enrollment forms, patient acknowledgment documents, and pharmacy certification requirements.
Quick-reference dosing guide for Calvrix 300 mg SC Q4W. Includes injection technique instruction, site rotation guidance, missed dose management, dose modification criteria, and preparation/storage summary for clinical and outpatient settings.
Plain-language patient education brochure covering what EGPA is, how Calvrix works, what to expect during treatment, and how to self-inject. Available in English and Spanish. Share directly with patients or download for your waiting room.
Orvantis Pharma is committed to ensuring that eligible patients with EGPA have access to Calvrix. CALVRIX CONNECT™ is a comprehensive patient support program designed to help remove barriers to treatment access.
Patient Enrollment
HCP or patient enrolls via form, phone, or portal within minutes
Benefits Verification
Dedicated case managers verify insurance coverage and prior authorization requirements
Copay Support
Eligible commercially insured patients may pay as little as $0/month with the Calvrix Copay Card
Specialty Delivery
Coordinated specialty pharmacy dispensing and direct-to-patient home delivery
Enroll a Patient
To enroll a patient in CALVRIX CONNECT™, complete the Patient Enrollment Form and submit via fax to 1-877-ORV-CARE, or enroll online through the HCP portal. A dedicated case manager will follow up within one business day.
Important Safety Information & Regulatory Disclaimer
INDICATION: Calvrix® (calvriumab) is indicated as an add-on maintenance treatment for adult patients with moderate-to-severe Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Important Safety Information Summary
CONTRAINDICATIONS: Calvrix is contraindicated in patients with known hypersensitivity to calvriumab or any excipient.
WARNINGS & PRECAUTIONS: Hypersensitivity reactions including anaphylaxis have been reported. Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of Calvrix. Treat pre-existing helminth infections prior to therapy initiation. Live attenuated vaccines should not be administered concurrently.
ADVERSE REACTIONS: Most common adverse reactions (≥5%) include injection site reactions, upper respiratory tract infections, headache, fatigue, nasopharyngitis, back pain, arthralgia, and nausea.
DRUG INTERACTIONS: No formal pharmacokinetic drug interaction studies have been conducted. Calvriumab is not metabolized by CYP450 enzymes.
Regulatory & Legal Disclaimer
This website is intended for US Healthcare Professionals only. The information contained herein is for educational and informational purposes and does not constitute medical advice. Calvrix® (calvriumab) is a prescription medication — refer to the full Prescribing Information for complete dosing, safety, and administration guidance.
Calvrix® is a registered trademark of Orvantis Pharma, Inc. All other trademarks referenced herein are the property of their respective owners.
PP-CAL-US-0001 | Rev. 09/2024 · For adverse event reporting, contact Orvantis Pharmacovigilance at 1-800-ORV-SAFE or report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.