Pozelimab-bbfg
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Edzel Lorraine Co, DMD, MD[2]
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
Receiving pozelimab-bbfg injection may increase the risk that you will develop a meningococcal infection (an infection that may affect the covering of the brain and spinal cord and/or may spread through the bloodstream) during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a meningococcal vaccine at least 2 weeks before you begin your treatment with pozelimab-bbfg injection to decrease the risk that you will develop this type of infection. If you have received this vaccine in the past, you may need to receive a booster dose before you begin your treatment. If your doctor feels that you need to begin treatment with pozelimab-bbfg injection right away, you will receive your meningococcal vaccine as soon as possible and take an antibiotic for 2 weeks.
Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with pozelimab-bbfg injection. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; rash and fever; confusion; muscle aches and other flu-like symptoms; or if your eyes are sensitive to light. Tell your doctor if you have fever or other signs of infection before you begin your treatment with pozelimab-bbfg injection. Your doctor will not give you pozelimab-bbfg injection if you already have a meningococcal infection. Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 3 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk. |
Overview
Pozelimab-bbfg is a complement inhibitor that is FDA approved for the treatment of adults and children 1 year of age and older with CD55-deficient protein-losing enteropathy by blocking the activity of the part of the immune system that may damage cells in the digestive tract.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pozelimab-bbfg FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pozelimab-bbfg FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Pozelimab-bbfg Contraindications in the drug label.
Warnings
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{{{blackBoxWarningTitle}}}
See full prescribing information for complete Boxed Warning.
Receiving pozelimab-bbfg injection may increase the risk that you will develop a meningococcal infection (an infection that may affect the covering of the brain and spinal cord and/or may spread through the bloodstream) during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a meningococcal vaccine at least 2 weeks before you begin your treatment with pozelimab-bbfg injection to decrease the risk that you will develop this type of infection. If you have received this vaccine in the past, you may need to receive a booster dose before you begin your treatment. If your doctor feels that you need to begin treatment with pozelimab-bbfg injection right away, you will receive your meningococcal vaccine as soon as possible and take an antibiotic for 2 weeks.
Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with pozelimab-bbfg injection. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; rash and fever; confusion; muscle aches and other flu-like symptoms; or if your eyes are sensitive to light. Tell your doctor if you have fever or other signs of infection before you begin your treatment with pozelimab-bbfg injection. Your doctor will not give you pozelimab-bbfg injection if you already have a meningococcal infection. Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 3 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk. |
There is limited information regarding Pozelimab-bbfg Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
hair loss redness, swelling, and itching at the injection site bleeding gums
Postmarketing Experience
There is limited information regarding Pozelimab-bbfg Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pozelimab-bbfg Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pozelimab-bbfg in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pozelimab-bbfg in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pozelimab-bbfg during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pozelimab-bbfg in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pozelimab-bbfg in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pozelimab-bbfg in geriatric settings.
Gender
There is no FDA guidance on the use of Pozelimab-bbfg with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pozelimab-bbfg with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pozelimab-bbfg in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pozelimab-bbfg in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pozelimab-bbfg in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pozelimab-bbfg in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pozelimab-bbfg Administration in the drug label.
Monitoring
There is limited information regarding Pozelimab-bbfg Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pozelimab-bbfg and IV administrations.
Overdosage
There is limited information regarding Pozelimab-bbfg 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 Pozelimab-bbfg Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pozelimab-bbfg Mechanism of Action in the drug label.
Structure
There is limited information regarding Pozelimab-bbfg Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pozelimab-bbfg Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pozelimab-bbfg Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pozelimab-bbfg Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pozelimab-bbfg Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pozelimab-bbfg How Supplied in the drug label.
Storage
There is limited information regarding Pozelimab-bbfg Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Pozelimab-bbfg Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pozelimab-bbfg interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
VEOPOZ
Look-Alike Drug Names
There is limited information regarding Pozelimab-bbfg 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.