Version May 2024
The FDA has authorized an extension to the shelf-life of certain lots of Gohibic (vilobelimab) from 24 to 30 months when stored at 2°C to 8°C (36°F to 46°F).
Further information, including lot numbers and extended expiry dates, can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension#COVIDtherapeutics.
COVID-19, treatment (off-label use):
IV: 800 mg once on day 1 (within 48 hours of intubation), followed by 800 mg once daily on days 2, 4, 8, 15, and 22, as long as the patient remains hospitalized (even if discharged from the ICU) (Ref).
There are no dosage adjustments provided (Ref).
There are no dosage adjustments provided (Ref).
Refer to adult dosing.
Vilobelimab is associated with an increased risk of serious infection, including bacterial pneumonia and sepsis. When adjusted for hospital length of stay, the incidence of serious infections and sepsis were statistically similar between treatment and placebo groups, although pneumonia occurred more frequently in patients treated with vilobelimab (Ref).
Risk factors:
• Prolonged hospitalization (>15 days) (Ref)
The following adverse drug reactions and incidences are derived from the FDA issued emergency use authorization (EUA), unless otherwise specified. Refer to EUA for information regarding reporting adverse reactions (FDA 2023).
>10%:
Cardiovascular: Pulmonary embolism (11%)
Infection: Sepsis (22%) (table 1), serious infection (33%) (table 2)
|
Drug (Vilobelimab) + Standard of Care |
Placebo + Standard of Care |
Number of Patients (Vilobelimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
22% |
16% |
175 |
189 |
|
Drug (Vilobelimab) + Standard of Care |
Placebo + Standard of Care |
Number of Patients (Vilobelimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
33% |
29% |
175 |
189 |
Nervous system: Delirium (13%)
Respiratory: Pneumonia (31%) (table 3)
|
Drug (Vilobelimab) + Standard of Care |
Placebo + Standard of Care |
Number of Patients (Vilobelimab) |
Number of Patients (Placebo) |
|---|---|---|---|
|
31% |
23% |
175 |
189 |
1% to 10%:
Cardiovascular: Deep vein thrombosis (6%), hypertension (9%), supraventricular tachycardia (4%)
Dermatologic: Skin rash (3%)
Gastrointestinal: Constipation (3%)
Genitourinary: Urinary tract infection (5%)
Hematologic & oncologic: Thrombocytopenia (5%)
Hepatic: Increased liver enzymes (5%)
Infection: Herpes simplex infection (6%), infection due to enterococcus (6%), septic shock (9%)
Respiratory: Hypoxia (5%), pneumothorax (8%), pulmonary aspergillosis (6%), pulmonary complications (pneumomediastinum: 5%), respiratory tract infection (4%)
Frequency not defined:
Cardiovascular: Hemodynamic deterioration
Dermatologic: Eczema
Hypersensitivity: Hypersensitivity reaction
Miscellaneous: Multi-organ failure
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Serious hypersensitivity reactions have been observed with administration of vilobelimab (FDA 2023).
• Infection: Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving vilobelimab. Consider the risk/benefits of treatment with vilobelimab in patients with COVID-19 and other concurrent infections (FDA 2023).
Dosage form specific issues:
• Sodium: Some products may contain sodium.
Investigational agent; approved for emergency use authorization by the FDA in April 2023.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Gohibic: 200 mg/20 mL (20 mL) [contains polysorbate 80]
Yes
Vilobelimab is not commercially available; it is available as part of ongoing clinical trials and through an emergency use authorization (EUA) from the FDA.
As part of the EUA, fact sheets pertaining to emergency use of vilobelimab are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for vilobelimab administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets and EUA letter may be accessed at https://www.gohibic.com. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with vilobelimab use by submitting FDA Form 3500 (health professional, available at: https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500) online (www.fda.gov/medwatch/report.htm), by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178), or by calling 1-800-FDA-1088 to request a reporting form; a copy of all forms should also be provided to InflaRx GmbH (phone: 1-888-254-0602; fax: 1-866-728-2630; email: [email protected]).
IV: If diluted solution is refrigerated prior to administration, allow to come to room temperature prior to administration. Administer as an IV infusion in a dedicated IV line over 30 to 60 minutes (Ref).
See “Use: Off-Label.”
COVID-19, treatment
Vilobelimab may be confused with belimumab, vilazodone, or viloxazine.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vilobelimab is a chimeric human/mouse immunoglobulin (IgG4) antibody. Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
It is not known if vilobelimab is present in breast milk.
Vilobelimab is a chimeric human/mouse immunoglobulin (IgG4) antibody. Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs and symptoms of new infection during and after treatment.
Vilobelimab is a chimeric human/mouse monoclonal IgG4-kappa antibody that binds to C5a and blocks its interaction with the C5a receptor. C5a is part of the complement system and is activated as part of the innate immune response, initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells (FDA 2023).
Half-life elimination: 95 hours.
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