Tagraxofusp-erzs

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Uma Maveli[2] {{DrugProjectFormSinglePage |authorTag= Uma Maveli[3]

|genericName=generic name |aOrAn=a |drugClass= monoclonal antibody |indicationType= treatment |indication= |hasBlackBoxWarning=Yes |adverseReactions= Some adverse reactions that occur in patients undergoing treatment with Tagraxofusp-erzs are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight gain. Some lab abnormalities that occur include decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST.

|blackBoxWarningTitle= CAPILLARY LEAK SYNDROME |blackBoxWarningBody=

• There have been fatal and life-threatening cases of Capillary Leak Syndrome
• Before initiating treatment, check patient to ensure proper cardiac function and that serum albumin is greater than 3.2 g/dL
• Measure Albumin levels periodically during treatment, and monitor closely after ending treatment for a period of time that is clinically instructed
• Additionally, assess patients periodically and monitor carefully for signs or symptoms of CLS. Some signs and symptoms include weight gain, [[edema] (new or progressively deteriorating), pulmonary edema, hypotension, orhemodynamic instability

|fdaLIADAdult=

Administration of ULTOMIRIS

|offLabelAdultGuideSupport=

There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

|offLabelAdultNoGuideSupport=

There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

|fdaLIADPed= There is limited information regarding ULTOMIRIS FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

|offLabelPedGuideSupport= There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

|offLabelPedNoGuideSupport=

There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

|contraindications=

|warnings =

Serious Meningococcal Infections

Monitoring Disease Manifestations after ULTOMIRIS Discontinuation

Treatment Discontinuation for PNH

Treatment Discontinuation for aHUS

Infusion Reactions

|clinicalTrials =

Immunogenicity

|postmarketing= There is limited information regarding Ravulizumab Postmarketing Experience in the drug label.

|drugInteractions= There is limited information regarding Ravulizumab Drug Interactions in the drug label.

|useInPregnancyFDA= There are no available data on ULTOMIRIS use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. |useInLaborDelivery= The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. |useInNursing= |useInPed= The safety and efficacy of Ultomiris for the treatment of PNH in pediatric patients have not been established. |useInGeri= Clinical studies of Ultomiris did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. |useInGender= There is no FDA guidance on the use of Ultomiris with respect to specific gender populations. |useInRace= There is no FDA guidance on the use of Ultomiris with respect to specific racial populations. |useInRenalImpair= There is no FDA guidance on the use of Ultomiris in patients with renal impairment. |useInHepaticImpair= There is no FDA guidance on the use of Ultomiris in patients with hepatic impairment. |useInReproPotential= There is no FDA guidance on the use of Ultomiris in women of reproductive potentials and males. |useInImmunocomp= There is no FDA guidance one the use of Ultomiris in patients who are immunocompromised.

|useInOthers=(Description) |administration=

|monitoring =

|overdose =

|drugBox=

Tagraxofusp-erzs
Systematic (IUPAC) name
?
Identifiers
CAS number	1803171-55-2
ATC code	?
PubChem	?
Chemical data
Formula	?
Mol. mass	188303.705 Da
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

|mechAction=

|structure= There is limited information regarding Ultomiris Structure in the drug label. |PD=

• The extent and duration of the pharmacodynamic response in patients with PNH and aHUS were exposure-dependent for ULTOMIRIS. Free C5 levels of <0.5 mcg/mL were correlated with maximal intravascular hemolysis control and complete terminal complement inhibition in patients with PNH.
• Complete terminal complement inhibition following initiation of ULTOMIRIS treatment led to normalization of serum LDH by week 4 in complement-inhibitor naïve patients with PNH, and maintained LDH normalization in patients previously treated with eculizumab with PNH.

|PK= Ravulizumab-cwvz pharmacokinetics increase proportionally over a dose range of 200 to 5400 mg.

Specific Populations

|nonClinToxic=

Carcinogenesis, Mutagenesis, Impairment of Fertility

|clinicalStudies=

Study in Pediatric Patients with aHUS [ALXN1210-aHUS-312; NCT03131219]

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|storage=

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This image is provided by the National Library of Medicine.

|fdaPatientInfo=

Infusion reactions

• Advise patients that administration of ULTOMIRIS may result in infusion reactions.

|nlmPatientInfo=(Link to patient information page) |lookAlike= There is limited information regarding Ultomiris Look-Alike Drug Names in the drug label.

|brandNames= Elzonris |drugShortage= Drug Shortage

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