Concizumab

Concizumab
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Nehal Eid

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Overview

Concizumab is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the prophylaxis of It is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: - hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors - hemophilia B (congenital factor IX deficiency) with FIX inhibitors. Common adverse reactions include The most frequently reported adverse reactions (incidence ≥5%) were injection site reactions and urticaria..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Administer concizumab by subcutaneous injection to the abdomen or thigh with daily rotation of injection sites. Recommended dosing regimen: o Day 1: Loading dose of 1 mg/kg o Day 2: Once-daily dose of 0.2 mg/kg until individualization of maintenance dose (see below) - 4 weeks after initiation of treatment: For dose optimization, measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose. An FDA-authorized test for the measurement of concizumab-mtci concentration in plasma is not currently available.

o Once the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo no later than 8 weeks after initiation of treatment, based on the following concizumab-mtci plasma concentrations: - Less than 200 ng/mL: adjust to a once-daily dose of 0.25 mg/kg (2.1) - 200 to 4,000 ng/mL: continue once-daily dose of 0.2 mg/kg (2.1) - Greater than 4,000 ng/mL: adjust to a once-daily dose of 0.15 mg/kg

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Concizumab in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Concizumab in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Concizumab 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 Concizumab in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Concizumab in pediatric patients.

Contraindications

There is limited information regarding Concizumab Contraindications in the drug label.

Warnings

There is limited information regarding Concizumab Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Concizumab Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Concizumab Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Concizumab Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Concizumab in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Concizumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Concizumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Concizumab in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Concizumab in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Concizumab in geriatric settings.

Gender

There is no FDA guidance on the use of Concizumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Concizumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Concizumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Concizumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Concizumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Concizumab in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Concizumab Administration in the drug label.

Monitoring

There is limited information regarding Concizumab Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Concizumab and IV administrations.

Overdosage

There is limited information regarding Concizumab 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 Concizumab Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Concizumab Mechanism of Action in the drug label.

Structure

There is limited information regarding Concizumab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Concizumab Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Concizumab Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Concizumab Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Concizumab Clinical Studies in the drug label.

How Supplied

There is limited information regarding Concizumab How Supplied in the drug label.

Storage

There is limited information regarding Concizumab 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 Concizumab Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Concizumab 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 Concizumab Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Concizumab 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.