Version July 2025
Crovalimab, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of crovalimab, unless the risks of delaying therapy with crovalimab outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor.
Patients receiving crovalimab are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, crovalimab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called PIASKY REMS.
Dosage guidance:
Safety: Vaccinate patients against meningococcal infection (serogroups A, C, W, Y, and B) according to current Advisory Committee on Immunization Practices (ACIP) recommendations at least 2 weeks prior to crovalimab initiation; revaccinate according to current ACIP guidelines. If urgent crovalimab initiation is necessary in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial prophylaxis and administer vaccines as soon as possible.
Dosing: With the exception of the day 1 and day 2 loading doses, the crovalimab dosing schedule is allowed to occasionally vary within 2 days of the scheduled dose, although the subsequent dose should be administered according to the original schedule.
Clinical considerations: To reduce the risk for meningococcal disease, consider antimicrobial prophylaxis with oral antibiotics (penicillin, or macrolides if penicillin-allergic) for the duration of crovalimab therapy (Ref).
Paroxysmal nocturnal hemoglobinuria: Note: Dosing consists of an initial IV loading dose, followed by 4 weekly SUBQ loading doses, and then SUBQ maintenance dosing every 4 weeks. Dosing is based on actual body weight; modify the maintenance dose if the patient's weight changes to become consistently above or below 100 kg during the course of maintenance therapy.
Loading dose:
≥40 kg to <100 kg: 1,000 mg IV on day 1, then 340 mg SUBQ on days 2, 8, 15, and 22 (Ref).
≥100 kg: 1,500 mg IV on day 1, then 340 mg SUBQ on days 2, 8, 15, and 22 (Ref).
Maintenance dose:
≥40 kg to <100 kg: SUBQ: 680 mg on day 29 and then every 4 weeks thereafter (Ref).
≥100 kg: SUBQ: 1,020 mg on day 29 and then every 4 weeks thereafter (Ref).
Conversion for switching to crovalimab from another complement C5 inhibitor: When converting from another complement C5 inhibitor (eg, eculizumab or ravulizumab), administer the initial IV crovalimab loading dose no sooner than the time of the next scheduled eculizumab or ravulizumab dose and then administer crovalimab additional SUBQ loading doses and maintenance doses on day 2, 8, 15, 22, 29 and every 4 weeks thereafter. Initiating crovalimab sooner than 5.5 half-lives from the last dose of another C5 inhibitor or initiating another C5 inhibitor sooner than 5.5 half-lives from the last crovalimab dose increases the risk of type III hypersensitivity reactions; allowing the prior C5 inhibitor to clear from the body prior to initiating another C5 inhibitor is expected to allow the patient to no longer be at risk of a reaction.
Missed doses: If a crovalimab entire or partial dose is missed, administer missed dose or remainder of partial missed dose as soon as possible before the day of the next scheduled dose; then administer the next dose on the regularly scheduled dosing day. Do not administer 2 doses or more than the prescribed dose on the same day to make up for a missed dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, kidney impairment had no clinically important effect on crovalimab pharmacokinetics.
Mild hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, mild hepatic impairment had no clinically important effect on crovalimab pharmacokinetics.
Moderate or severe hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Adverse reaction during administration:
Hypersensitivity reaction: Discontinue crovalimab and begin appropriate supportive measures for severe reactions. Administer symptomatic management (eg, topical corticosteroids, antihistamines, antipyretics, and/or analgesics) for mild or moderate reactions; for severe reactions, administer systemic corticosteroids as clinically indicated.
Infusion-related reaction: Slow or interrupt crovalimab infusion. Discontinue crovalimab immediately and manage appropriately for serious reaction.
Infections:
Worsening infection (any): Consider discontinuing crovalimab with worsening signs/symptoms of infection.
Meningococcal infection: Evaluate immediately if meningococcal infection is suspected. Promptly treat known infections. Consider interrupting crovalimab therapy in patients being treated for serious infections, depending on the risks of interrupting treatment in the disease being treated.
Hemolysis (after crovalimab discontinuation): If signs/symptoms of hemolysis occur following crovalimab discontinuation, consider restarting crovalimab (if appropriate), or initiating another treatment for paroxysmal nocturnal hemoglobinuria.
Refer to adult dosing.
(For additional information see "Crovalimab: Pediatric drug information")
Dosage guidance:
Safety: Vaccinate with meningococcal vaccine at least 2 weeks prior to treatment initiation; revaccinate according to current guidelines. If urgent crovalimab initiation is necessary and patient is not up to date with meningococcal vaccines (based on Advisory Committee on Immunization Practices [ACIP] recommendations), administer vaccination as soon as possible and provide antibacterial drug prophylaxis.
Clinical considerations: After day 1 and day 2 loading doses are completed, the crovalimab dosing schedule is allowed to occasionally vary within 2 days of the scheduled dose; if this occurs, subsequent dose should be administered according to the original schedule. To reduce the risk for meningococcal disease, consider antimicrobial prophylaxis with oral antibiotics (penicillin, or macrolides if penicillin-allergic) for the duration of crovalimab therapy (Ref).
Paroxysmal nocturnal hemoglobinuria (PNH): Adolescents weighing ≥40 kg:
Note: Loading dose consists of 5 doses: an initial IV infusion on day 1, followed by 4 weekly SUBQ loading doses. After the 5 loading doses, maintenance doses are administered SUBQ every 4 weeks. Dosing is based on actual body weight; modify the maintenance dose if the patient's weight changes to become consistently above or below 100 kg during the course of maintenance therapy.
Adolescents weighing 40 to <100 kg:
Loading dose (5-dose series):
IV infusion: 1,000 mg once on day 1.
SUBQ: 340 mg on days 2, 8, 15, and 22.
Maintenance dose: SUBQ: 680 mg starting on day 29 and then every 4 weeks thereafter.
Adolescents weighing ≥100 kg:
Loading dose (5-dose series):
IV infusion: 1,500 mg once on day 1.
SUBQ: 340 mg on days 2, 8, 15, and 22.
Maintenance dose: SUBQ: 1,020 mg starting on day 29 and then every 4 weeks thereafter.
Conversion for switching to crovalimab from another complement C5 inhibitor (eg, ravulizumab): When converting from another complement C5 inhibitor, administer the initial IV crovalimab loading dose no sooner than the time of the next scheduled C5 inhibitor dose and then administer additional crovalimab SUBQ loading doses and maintenance doses per standard schedule.
There are no dosage adjustments provided in the manufacturer's labeling; however, kidney impairment had no clinically important effect on crovalimab pharmacokinetics.
Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, mild liver impairment had no clinically important effect on crovalimab pharmacokinetics.
Moderate or severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Hypersensitivity: Infusion-related reaction (16%), type III hypersensitivity reaction
Infection: Viral infection (11%)
Respiratory: Respiratory tract infection (13%)
1% to 10%:
Endocrine & metabolic: Hyperuricemia (8%)
Gastrointestinal: Diarrhea (7%)
Local: Injection-site reaction (6%)
Nervous system: Headache (8%)
Respiratory: Epistaxis (1%), pneumonia (1%)
<1%:
Endocrine & metabolic: Hypovolemic shock
Nervous system: Axonal peripheral polyneuropathy (grade 3), peripheral demyelinating polyneuropathy (grade 3)
Renal: Pyelonephritis
Frequency not defined: Infection: Meningococcal infection
Serious hypersensitivity to crovalimab or any component of the formulation; initiation in patients with an unresolved serious N. meningitidis infection.
Concerns related to adverse effects:
• Hypersensitivity reactions: Patients who switch from another complement C5 inhibitor to crovalimab or from crovalimab to another C5 inhibitor are at risk for serious type III hypersensitivity reactions related to the formation of drug-target-drug complexes (because crovalimab and other C5 inhibitors bind to different C5 epitopes. Type III hypersensitivity reactions have occurred in up to one-fourth of patients being switched to crovalimab from another C5 inhibitor or from crovalimab to another C5 inhibitor; reactions may be serious and require hospitalization. Symptoms of type III hypersensitivity included arthralgia, myalgia, headache, fatigue, rash, fever, bruising, and/or abdominal pain; type III hypersensitivity may also cause kidney abnormalities. A case of grade 3 axonal neuropathy related to type III hypersensitivity was reported. Allowing the prior C5 inhibitor to clear from the body prior to initiating another C5 inhibitor would be expected to allow the patient to no longer be at risk of a reaction.
• Infection: Crovalimab blocks terminal complement activation and therefore may increase susceptibility to bacterial infections, especially encapsulated bacteria including Neisseria species (other than Neisseria meningitidis), but also Streptococcus pneumoniae, Haemophilus influenzae, and, to a lesser extent, Neisseria gonorrhoeae. Pediatric patients receiving crovalimab may be at increased risk for serious S. pneumoniae and H. influenzae type b (Hib) infections; vaccinate for S. pneumoniae and Hib according to the Advisory Committee on Immunization Practices (ACIP) recommendations. Patients may be at increased risk for infection despite developing antibodies after vaccination.
• Infusion reactions: Administration of crovalimab may result in infusion-related reactions or systemic injection-related reactions (depending on administration route); symptoms may include anaphylaxis and hypersensitivity. Other symptoms included erythema, headache, injection site pain, and/or myalgia. Serious infusion-related reaction resolved 4 days after crovalimab interruption in one case.
• Meningococcal infection: Complement inhibitors increase the risk of serious infections caused by N. meningitidis; life-threatening and fatal meningococcal infections have occurred in patients who received complement inhibitors. Meningococcal disease due to any serogroup, including nongroupable strains, may occur. If not recognized and treated early, infections may rapidly become life-threatening or fatal. Patients receiving crovalimab are at increased susceptibility to serious life-threatening or fatal meningococcal infections (septicemia and/or meningitis) if vaccinated or unvaccinated, and even if antibodies develop following vaccination. For patients receiving complement inhibitors, the ACIP vaccination recommendations differ from the administration schedule in the vaccine prescribing information. If urgent crovalimab therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide at least 2 weeks of antibacterial prophylaxis. Educate patients on signs/symptoms of meningitis and steps necessary to seek immediate medical care. Consider interruption of crovalimab therapy in patients who are undergoing treatment for serious meningococcal infection.
Special populations:
• Older adults: While studies did not include sufficient numbers of patients ≥65 years of age to determine the clinical relevance, for patients who were both complement inhibitor naive and who had received prior complement inhibitor therapy, serious adverse reactions were reported in a higher percentage of patients who were ≥65 years of age, when compared to patients <65 years of age.
Other warnings/precautions:
• Discontinuation in paroxysmal nocturnal hemoglobinuria: Patients with paroxysmal nocturnal hemoglobinuria who discontinue crovalimab or do not switch to other treatment may be at increased risk for serious hemolysis; monitor closely for at least 20 weeks after treatment discontinuation.
• REMS program: Counsel patients about the risk of meningococcal infection/sepsis; provide REMS educational materials to patients, and ensure patients are vaccinated with meningococcal vaccines. Additional information is available at https://www.PIASKYREMS.com or 1-866-469-7599.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection [preservative free]:
Piasky: Crovalimab-akkz 340 mg/2 mL (2 mL)
No
Solution (Piasky Injection)
340 mg/2 mL (per mL): $10,614.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Should only be administered by a health care provider.
IV: Administer through an infusion set with a 0.2-micron in-line filter over 50 to 70 minutes (1,000 mg dose) or over 80 to 100 minutes (1,500 mg dose). Flush infusion line after administration to ensure complete administration of entire dose. Incompatibilities have not been observed with infusion sets or infusion aids made of PVC, polyethylene, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, or polytetrafluoroethylene.
SUBQ: Administer into the abdominal area to intact skin with a 25-, 26-, or 27-gauge, 3/8- to 1/2-inch, latex-free, and nonpyrogenic needle. Each injection should be a volume of 2 mL; if dose requires multiple injections, administer each consecutive injection at least 2 inches apart. Rotate injection site. Do not inject into moles, scars, or bruised, hard, red, tender, or nonintact areas.
IV: Must be diluted prior to administration. Administer through an infusion set that contains a 0.2 micron in-line filter over 50 to 70 minutes for 1,000 mg dose or over 80 to 100 minutes for a 1,500 mg dose. Flush infusion line after administration to ensure complete administration of entire dose. Slow or interrupt crovalimab infusion and treat as appropriate if the patient develops any signs of infusion-associated reactions; if serious hypersensitivity reactions (including anaphylaxis) occur, immediately discontinue infusion and provide emergency care.
SUBQ: Administer undiluted into the abdominal area using a 25-, 26-, or 27-gauge 3/8 to 1/2 inch, latex-free needle. Each injection is 2 mL (340 mg); if dose requires multiple injections, administer each consecutive injection at least 2 inches apart. Rotate injection sites. Do not inject into moles, scars, or areas that are tender, bruised, red, hard, or not intact.
Missed doses: If a crovalimab entire or partial dose is missed, administer missed dose or remainder of partial missed dose as soon as possible before the day of the next scheduled dose; then administer the next dose on the regularly scheduled dosing day. Do not administer 2 doses or more than the prescribed dose on the same day to make up for a missed dose.
Paroxysmal nocturnal hemoglobinuria: Treatment of paroxysmal nocturnal hemoglobinuria in adult and pediatric patients ≥13 years of age and ≥40 kg.
Crovalimab may be confused with eculizumab, ravulizumab.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Avacincaptad Pegol: May increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions is increased. Avacincaptad Pegol may decrease serum concentration of Crovalimab. Risk C: Monitor
Avacopan: May increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions is increased. Avacopan may decrease serum concentration of Crovalimab. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. 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 increase immunosuppressive effects 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 increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Eculizumab: Crovalimab may increase adverse/toxic effects of Eculizumab. Specifically, the risk of type III hypersensitivity reactions is increased. Eculizumab may decrease serum concentration of Crovalimab. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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 increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of 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
Pozelimab: May increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions may be increased. Pozelimab may decrease serum concentration of Crovalimab. Risk C: Monitor
Ravulizumab: May increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions is increased. Ravulizumab may decrease serum concentration of Crovalimab. Risk C: Monitor
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects 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 Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects 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
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects 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
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Zilucoplan: May increase adverse/toxic effects of Crovalimab. Specifically, the risk of type III hypersensitivity reactions may be increased. Zilucoplan may decrease serum concentration of Crovalimab. Risk C: Monitor
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Crovalimab is a humanized monoclonal antibody (IgG1). 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 (Ref).
Pregnant patients with paroxysmal nocturnal hemoglobinuria and their fetuses have high rates of morbidity and mortality during pregnancy and the postpartum period. Adverse maternal outcomes include bleeding, infections, miscarriages, worsening cytopenias, and thrombotic events; increased fetal death and premature delivery are also reported.
It is not known if crovalimab is present in breast milk.
Crovalimab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Ref).
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 9 months after the last dose of crovalimab.
Assess immunization status (prior to crovalimab treatment initiation). Monitor for early signs/symptoms of meningococcal infection (N. meningitidis); evaluate immediately if infection is suspected. Monitor closely for signs/symptoms of worsening infection (if administering crovalimab to patients with active systemic infections). Monitor for signs/symptoms of hypersensitivity/infusion-related reactions.
When switching to or from another C5 inhibitor, monitor for 30 days on the new therapy for signs/symptoms of type III hypersensitivity reaction.
After discontinuation: Monitor closely for signs/symptoms of intravascular hemolysis (including elevated lactate dehydrogenase, sudden decrease in hemoglobin, hemoglobinuria, anemia, fatigue, abdominal pain, dyspnea, thrombosis); monitor for at least 20 weeks after discontinuation.
Crovalimab is a humanized monoclonal antibody directed against complement C5; it binds specifically and with high affinity to the complement protein C5, inhibiting cleavage into C5a and C5b to prevent formation of the membrane attack complex (MAC) and inhibit terminal complement-mediated intravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria (Ref). Crovalimab utilizes an anti-C5 sequential monoclonal antibody recycling technology to prolong half-life and bioavailability. Unlike other C5 inhibitors which bind on the C5 alpha chain, crovalimab binds to an epitope on the C5 beta chain, allowing for additional efficacy in patients with a C5 R885H polymorphism (which would otherwise respond poorly to other C5 inhibitors) (Ref).
Distribution: Central Vd: 3.23 L; peripheral Vd: 2.32 L.
Metabolism: Expected to be degraded into small peptides and amino acids through catabolic pathways via lysosomal proteolysis.
Bioavailability: SUBQ: 83%.
Half-life elimination: 53.1 days (in treatment-naive patients).
Excretion: Clearance: 0.0791 L/day.
