This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog Out ProductsOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

About ATTR-CMAbout
ATTR-CMDisease ImpactWhen to Rule Out ATTR-CMDiagnosing ATTR-CMAbout VYNDAMAXAbout
VYNDAMAXMortality and Hospitalization6MWT/KCCQ-OS5-year DataHow VYNDAMAX WorksSafety Profile Study DesignDosingAccess & SupportAccess & SupportAccessing VYNDAMAXPaying for VYNDAMAXResourcesResourcesEventsMaterialsVideos
Prescribing InformationPatient InformationIndication Patient Site
Diagnosing Transthyretin Cardiac Amyloidosis*Screen for AL

Order the following tests1,2†

  • Serum kappa/lambda free light chains
  • Serum protein electrophoresis with immunofixation
  • Urine protein electrophoresis with immunofixation

Order the following tests1†

  Serum protein electrophoresis (SPEP) with immunofixation Urine protein electrophoresis (UPEP) with immunofixation Serum free light chain assay
Normal range No M-spike present No M-spike present Kappa:lambda ratio=0.26-1.65‡
  Normal range
Serum protein electrophoresis (SPEP) with immunofixation No M-spike present
Urine protein electrophoresis (UPEP) with immunofixation No M-spike present
Serum free light chain assay Kappa:lambda ratio=0.26-1.65‡
Also known as transthyretin amyloid cardiomyopathy (ATTR-CM).Electrophoresis alone is insufficient without immunofixation.2In patients with kidney disease, mild elevations in the kappa:lambda ratio are frequently encountered.1
AL test results3 Diagnosis3
Abnormal AL possible—refer to a hematology specialist for evaluation
Normal AL unlikely—refer to PYP results to determine if ATTR cardiac amyloidosis is possible
99mTc-PYP radionuclide imaging as a diagnostic modality§

ASNC advises utilization of PYP cardiac imaging to diagnose ATTR cardiac amyloidosis2

  • 99mTc-PYP radioactive tracer is a highly sensitive, noninvasive diagnostic imaging technique2,4
    • Used as an adjunct to diagnosis after ruling out AL, though not FDA approved for the diagnosis of ATTR cardiac amyloidosis2,4
Acquisition2
  • The recommended time between injection of 99mTc-PYP and scan is 3 hours to maximize specificity#
If clinical suspicion is high despite a negative or inconclusive scan, a biopsy should be considered.2InterpretationSTEP 1

Visual interpretation

  • Evaluate SPECT images to confirm diffuse radiotracer uptake in the myocardium and differentiate from blood or overlying bone uptake5
    • SPECT provides a more effective method of radiotracer localization compared to planar images, given the inability to distinguish myocardial uptake from blood pool uptake5
  • If myocardial tracer uptake is visually present on SPECT, proceed to Step 2, semi-quantitative visual grading. If no myocardial tracer uptake is present on SPECT, the visual grade is 02
99mTc-PYP planar and SPECT/CT fusion showing myocardial uptake6¶ Illustrative representation.STEP 2

Semi-quantitative grading to distinguish AL from ATTR cardiac amyloidosis (1- or 3-hour approach)2#    

Once myocardial tracer activity is confirmed on SPECT, the degree of activity can be characterized using the following scale:

PYP imaging is used as an adjunct to diagnosis after ruling out AL. AL is ruled out by testing for presence of monoclonal protein via serum and urine protein electrophoresis with immunofixation and serum free light chain assay.

STEP 3

Heart/contralateral lung (H/CL) uptake ratio assessment (when applicable)2

Circular target regions of interest (ROI) are drawn over the heart on the planar images and are mirrored over the contralateral chest to account for background and ribs.

  • An H/CL ratio is calculated as the fraction of heart ROI mean counts to contralateral lung ROI mean counts. If discordant or the visual grade is equivocal, H/CL ratio may be helpful to classify equivocal visual Grade 1 vs 2 as positive or negative
  • H/CL ratios of ≥1.5 at 1 hour can accurately identify ATTR cardiac amyloidosis if myocardial PYP uptake is visually confirmed on SPECT and systemic AL amyloidosis is excluded. An H/CL ratio of ≥1.3 at 3 hours can identify ATTR cardiac amyloidosis
  • NOTE: Diagnosis of ATTR cardiac amyloidosis cannot be made solely based on H/CL ratio alone with PYP. H/CL ratio is not recommended if there is absence of myocardial uptake on SPECT
Quantitation of cardiac 99mTc-PYP||  uptake using H/CL ratio2|| Measurements of anterior grade 3 planar scan image strongly suggesting ATTR cardiac amyloidosisAdapted from Dorbala S, Ando Y, Bokhari S, et al. ASNC/AHA/ASE/EANM/HFSA/ISA/SCMR/SNMMI expert consensus recommendations for multimodality imaging in cardiac amyloidosis; part 1 of 2—evidence base and standardized methods of imaging. Circ Cardiovasc Imaging. 2021;14(7);e000029.Next: See clinical data for VYNDAMAXContinueLoadingYou are now leaving PfizerPro You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to Pfizer medicines or business which it has provided or reviewed. PP-PFE-GBR-3859. November 2021 Not FDA approved for the diagnosis of ATTR cardiac amyloidosis. Please consult individual labeling for risks.The recommended time between injection of 99mTc-PYP and scan is 2 or 3 hours. The 1-hour approach is optional; if excess blood pool activity is noted, 3-hour imaging is recommended.Illustrative representation.AL=amyloid light-chain; ATTR=transthyretin amyloidosis; ASNC=American Society of Nuclear Cardiology; CT=computed tomography; PYP=pyrophosphate; SPECT=single photon emission computed tomography.
References: Witteles RM, Bokhari S, Damy T, et al. Screening for transthyretin amyloid cardiomyopathy in everyday practice. JACC Heart Fail. 2019;7(8):709-716. Dorbala S, Ando Y, Bokhari S, et al. ASNC/AHA/ASE/EANM/HFSA/ISA/SCMR/SNMMI expert consensus recommendations for multimodality imaging in cardiac amyloidosis: part 1 of 2-evidence base and standardized methods of imaging. Circ Cardiovasc Imaging. 2021;14(7):e000029Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18):e895-e1032. Miller EJ, Campisi R, Shah NR, et al. Radiopharmaceutical supply disruptions and the use of 99mTc-hydroxymethylene diphosphonate as an alternative to 99mTc-pyrophosphate for the diagnosis of transthyretin cardiac amyloidosis: an ASNC Information Statement. J Nucl Cardiol. 2022;29(5):2748-2760.Hage FG, Bourque J, Pandey S, et al. American Society of Nuclear Cardiology quality metrics for cardiac amyloid radionuclide imaging. J Nucl Cardiol. 2024;40:102041Data on file. Pfizer Inc., New York, NY.
About ATTR-CMA guide to recognizing some common clues of ATTR cardiac amyloidosis Discover the cluesLoadingA guide to getting your patients started on VYNDAMAX Learn moreLoadingA guide to interpreting PYP scans Learn about PYP and diagnosisLoading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2025 Pfizer Inc. All rights reserved.

PP-VDM-USA-1962
You are now leaving Pfizer You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.

PP-VDM-USA-0908
INDICATION AND LIMITATIONS OF USE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.Please see Full Prescribing Information including Patient Information.
Important Safety InformationAdverse Reactions
In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

Specific Populations

Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.IndicationVYNDAQEL® (tafamidis meglumine) and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Please see Full Prescribing Information including Patient Information.