Crovalimab-akkz
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
SERIOUS MENINGOCOCCAL INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (PIASKY increases the risk of serious and life-threatening infections caused by Neisseria meningitidis.
Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of PIASKY, unless the risks of delaying PIASKY outweigh the risks 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 (5.1). Patients receiving PIASKY are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected (5.1). PIASKY is available only through a restricted program called the PIASKY REMS) |
Overview
Crovalimab-akkz is a complement C5 inhibitor that is FDA approved for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include *infusion-related reaction,
- respiratory tract infection,
- viral infection, and
- Type III hypersensitivity reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Start with one loading dose administered by intravenous infusion, followed by 4 additional loading doses administered by subcutaneous injection. Then administer a maintenance dose every 4 weeks by subcutaneous injection.
- For patients switching from another complement inhibitor, the first loading dose of PIASKY should be administered no sooner than the time of the next scheduled complement inhibitor administration. See Full Prescribing Information for considerations when switching from another C5 inhibitor.
- Administer doses based on the patient's actual body weight.
- Injection: 340 mg/2 mL (170 mg/mL) in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Crovalimab-akkz in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Crovalimab-akkz in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Crovalimab-akkz FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Crovalimab-akkz in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Crovalimab-akkz in pediatric patients.
Contraindications
PIASKY is contraindicated:
- For initiation in patients with an unresolved serious Neisseria meningitidis infection.
- In patients with a known serious hypersensitivity reaction to crovalimab or any of the excipients.
Warnings
|
SERIOUS MENINGOCOCCAL INFECTIONS
See full prescribing information for complete Boxed Warning.
Condition Name: (PIASKY increases the risk of serious and life-threatening infections caused by Neisseria meningitidis.
Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of PIASKY, unless the risks of delaying PIASKY outweigh the risks 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 (5.1). Patients receiving PIASKY are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected (5.1). PIASKY is available only through a restricted program called the PIASKY REMS) |
Serious Meningococcal Infection
- PIASKY, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (meningococcemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of PIASKY is contraindicated in patients with a serious unresolved Neisseria meningitidis infection.
- Complete or update meningococcal vaccination (for serogroups A, C, W, Y, and B) at least 2 weeks prior to administration of the first dose of PIASKY, according to the current Advisory Committee on Immunization Practices (ACIP) recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of PIASKY therapy.
- Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information.
- If urgent PIASKY therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including PIASKY. The benefits and risks of treatment with PIASKY, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by N. meningitidis.
- Vaccination does not eliminate the risk of meningococcal infections, despite development of antibodies following vaccination.
- Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of PIASKY in patients who are undergoing treatment for serious meningococcal infection.
- PIASKY is available only through a restricted program under a REMS.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Crovalimab-akkz Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Crovalimab-akkz Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Crovalimab-akkz Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Crovalimab-akkz in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Crovalimab-akkz in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Crovalimab-akkz during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Crovalimab-akkz in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Crovalimab-akkz in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Crovalimab-akkz in geriatric settings.
Gender
There is no FDA guidance on the use of Crovalimab-akkz with respect to specific gender populations.
Race
There is no FDA guidance on the use of Crovalimab-akkz with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Crovalimab-akkz in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Crovalimab-akkz in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Crovalimab-akkz in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Crovalimab-akkz in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Crovalimab-akkz Administration in the drug label.
Monitoring
There is limited information regarding Crovalimab-akkz Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Crovalimab-akkz and IV administrations.
Overdosage
There is limited information regarding Crovalimab-akkz overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Crovalimab-akkz Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Crovalimab-akkz Mechanism of Action in the drug label.
Structure
There is limited information regarding Crovalimab-akkz Structure in the drug label.
Pharmacodynamics
There is limited information regarding Crovalimab-akkz Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Crovalimab-akkz Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Crovalimab-akkz Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Crovalimab-akkz Clinical Studies in the drug label.
How Supplied
There is limited information regarding Crovalimab-akkz How Supplied in the drug label.
Storage
There is limited information regarding Crovalimab-akkz Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Crovalimab-akkz |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Crovalimab-akkz |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Crovalimab-akkz Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Crovalimab-akkz interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Crovalimab-akkz Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Crovalimab-akkz Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.