For questions or concerns about obtaining ADZYNMA for your patients, please call Takeda Patient Support at 1-888-229-8379 Monday-Friday, 8 AM to 8 PM ET.
Get information on current codes that can be used for ADZYNMA billing.
Indication & Important Safety Information including Boxed WARNING for Neutralizing Antibodies to ADAMTS13
WARNING: NEUTRALIZING ANTIBODIES TO ADAMTS13
ADZYNMA is contraindicated in patients who have experienced life-threatening hypersensitivity reactions to ADZYNMA or its components.
Neutralizing Antibodies: Neutralizing antibodies to ADAMTS13 with serious outcomes including death have occurred following ADZYNMA administration. Neutralizing antibodies may result in a decreased or lack of response to recombinant or plasma-derived ADAMTS13 which could lead to serious disease related outcomes. Neutralizing antibodies were not reported in the cTTP clinical trials. All subjects had been previously exposed to ADAMTS13 through plasma-based products. There are no data on immunogenicity with ADZYNMA in previously untreated patients (subjects naïve to plasma-based products).
Monitor all patients, including those who were previously exposed or naïve to plasma-based products, by assessing ADAMTS13 activity and ADAMTS13 neutralizing antibodies prior to initiation of ADZYNMA and periodically during the course of treatment. If expected ADAMTS13 activity levels are not attained or if acute TTP exacerbation occurs despite appropriate dose, perform an assay that measures ADAMTS13 neutralizing antibody concentrations. Laboratory tests for monitoring neutralizing antibody levels are not capable of distinguishing between inhibitors directed against ADZYNMA, the patient’s endogenous ADAMTS13, or ADAMTS13 from other plasma sources.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with ADZYNMA. Monitor patients for signs and symptoms of hypersensitivity reactions which may include tachycardia, chest tightness, wheezing and/or acute respiratory distress, hypotension, generalized urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, and restlessness. If signs and symptoms of severe hypersensitivity reactions occur, immediately discontinue administration of ADZYNMA and provide appropriate supportive care.
Adverse Reactions: The most commonly observed adverse reactions (>5% of subjects) associated with ADZYNMA are headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness and vomiting.
Use in Specific Populations: The safety of ADZYNMA for use during pregnancy has not been established in controlled clinical trials. Limited data are insufficient to inform a drug associated risk of adverse developmental outcomes. There is no information regarding the presence of ADZYNMA in human milk, its effects on milk production, or the breastfed infant.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click for Full Prescribing Information.
Thank you! Please click the button below to download results or see the results here.
Takeda does not review, endorse, or control the content of any non-Takeda site. Takeda is not responsible for the accuracy, content, practices, or standards of any non-Takeda resources accessed through a link on this site.
