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.
Anti-IL-5 mAb
Subcutaneous
Every 4 Weeks
300 mg
Calvrix is indicated as an add-on maintenance treatment for adult patients with moderate-to-severe Eosinophilic Granulomatosis with Polyangiitis (EGPA).
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).
Reduction in annualized vasculitic flare rate vs. placebo at Week 52 (p<0.001)
Patients achieving clinical remission (Birmingham Vasculitis Activity Score = 0) at Week 52
Patients able to eliminate oral corticosteroids entirely while maintaining disease control
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.
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.
This is not a complete list of adverse reactions. Please see full Prescribing Information for complete safety data.
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.
Access the full FDA-approved Prescribing Information, including Boxed Warning, dosing tables, and complete safety data.
Eligible licensed prescribers may request Calvrix starter samples for appropriate patients through the verified sample request portal.
Download full ORVAL-1 study reports, subgroup analyses, and supporting publications from the Orvantis Medical Affairs library.
Enroll eligible patients in the Orvantis Patient Assistance Program (PAP) and CALVRIX CONNECT™ copay support program.
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.
1-800-ORV-INFO (1-800-678-4636)
Monday–Friday, 8:00 AM – 8:00 PM ET
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Please complete all fields. An Orvantis MSL will contact you within 2 business days to confirm scheduling.
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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.
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.
HCP or patient enrolls via form, phone, or portal within minutes
Dedicated case managers verify insurance coverage and prior authorization requirements
Eligible commercially insured patients may pay as little as $0/month with the Calvrix Copay Card
Coordinated specialty pharmacy dispensing and direct-to-patient home delivery
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.
Phone: 1-877-ORV-CARE (1-877-678-2273)
Fax: 1-877-ORV-FACS
Hours: Monday–Friday, 8 AM–9 PM ET
Email: connect@calvrix.orvantispharma.com
INDICATION: Calvrix® (calvriumab) is indicated as an add-on maintenance treatment for adult patients with moderate-to-severe Eosinophilic Granulomatosis with Polyangiitis (EGPA).
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.
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.
The clinical data presented on this site (ORVAL-1 trial) is mock/illustrative data created for demonstration purposes. It does not represent real clinical trial results. This is a simulated branded pharmaceutical HCP portal. © 2024 Orvantis Pharma, Inc. All rights reserved. Orvantis Pharma · 500 Innovation Drive · Cambridge, MA 02139 · 1-800-ORV-INFO
Prescription medication — US only
Required program — see PI
Orvantis Pharma, Inc.
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.
Calvrix® (calvriumab)