This site is intended only for healthcare professionals resident in the Republic of Ireland




Sign in or RegisterLog out Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up
AboutAbout ATTR-CMUrgencySuspectDetectDiagnostic flowchartAbout ATTR-PNUrgencyAwarenessPartnershipStudy DesignStudy DesignAbout ATTR-PNUrgencyAwarenessPartnershipEfficacy & SafetyPivotal efficacyLong-term survivalSubgroup analysisKey secondary endpointsEarly efficacy measuresSafety profileATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileDosingATTR-CM dosingATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileMOD/MOARole of TTRATTR-CM MODATTR-CM MOAATTR-PNATTR-PN MODATTR-PN MOASupport & ResourcesMaterialsVideosATTR-PNATTR-PN MODATTR-PN MOA

Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

When ATTR-CM is suspected,  Diagnosis may be made noninvasively with nuclear scintigraphy and testing to rule out AL amyloidosis1,2​​​​​​​ View Diagnostic Flowchart Diagnosing with nuclear scintigraphy

Nuclear scintigraphy with [99mTc-PYP*/99mTc-DPD/99mTc-HMDP] provides a unique myocardial uptake pattern in amyloid and may identify ATTR deposits early in the course of disease3   

  • Studies comparing [99mTc-PYP/99mTc-DPD/99mTc-HMDP] scintigraphy with endomyocardial biopsy (EMB) found that bone radiotracers have avidity for ATTR deposits, whereas avidity for AL cardiac amyloid deposits is minimal or absent3
  • The recommended time between injection of [99mTc-PYP/99mTc-DPD/99mTc-HMDP]* and scan is 2 or 3 hours.3 1-hour planar-only imaging is not recommended3
  • SPECT imaging is required in all studies (irrespective of time between injection and scan) to ensure direct visualization of tracer uptake in the myocardium3
Learn how to interpret nuclear scintigraphy scans using the 3 steps belowStep 1: Visual interpretation3

Planar and SPECT images should be evaluated to confirm diffuse radiotracer uptake in the myocardium3

  • Use SPECT imaging to differentiate myocardial radiotracer uptake from residual blood pool activity, focal myocardial infarct, and overlapping bone (eg, from rib hot spots from fractures)3
  • If excess blood pool is noted, recommend repeat SPECT imaging at 3 hours3 

If myocardial tracer uptake is visually present on SPECT, proceed to step 2, semiquantitative grading3

If no myocardial tracer uptake is present on SPECT, the visual grade is 03​​​​​​​

Illustrative representation of 99mTc-PYP myocardial uptake.
Step 2: Semiquantitative visual grading comparison to bone (rib) uptake at 3 hours3

Examine both planar and SPECT images for tracer uptake in the myocardium relative to ribs and grade using the following scale3,4

Grade 0

Grade 1

Grade 2

Grade 3

Planar SPECT No myocardial uptake and normal bone uptake
Planar SPECT Myocardial uptake less than rib uptake
Planar SPECT Myocardial uptake equal to rib uptake
Planar SPECT Myocardial uptake greater than rib uptake with mild/absent bone uptake
  • Nuclear scintigraphy should be performed using standard protocols. The recommended time between injection of [99mTc-PYP/99mTc-DPD/99mTc-HMDP]* and scanning is 2 or 3 hours3
  • Once AL is ruled out, Grade 2/3 myocardial uptake of radiotracer on SPECT combined with consistent echo or CMR findings is diagnostic of ATTR-CM5

Strongly suggestive of ATTR-CM3:
Visual scores of ≥2 on planar and SPECT images with concurrent testing to rule out AL

Not suggestive or equivocal of ATTR-CM3:
Visual scrores of <2

Step 3: H/CL uptake ratio assessment (when applicable)3

Diagnosis of ATTR-CM cannot be made solely based on heart-to-contralateral lung (H/CL) ratio. H/CL ratio is not recommended if there is absence of myocardial uptake on SPECT imaging.3

H/CL ratio is typically concordant with visual grade3​​​​​​​

  • ​​​​​​​​​​​​​​If the visual grade is 2 or 3, diagnosis is confirmed, and H/CL ratio assessment is not necessary​​​​​​​
  • 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

An H/CL ratio is calculated as the fraction of heart ROI mean counts to contralateral lung ROI mean counts3​​​

  • ​​​​​​​​​​​​​​H/CL ratios of ≥1.5 at 1 hour can accurately identify ATTR cardiac amyloidosis if myocardial 99mTc-PYP* uptake is visually confirmed on SPECT imaging and systemic AL amyloidosis is excluded
  • An H/CL ratio of ≥1.3 at 3 hours can identify ATTR cardiac amyloidosis

Quantification of cardiac 99mTc-PYP* uptake using H/CL ratio4

Biopsy-proven ATTR cardiac amyloidosis with H/CL=2.084​​​​​​​

Illustrative representation.

If clinical suspicion for cardiac amyloidosis remains high despite a negative or inconclusive scintigraphy scan, consider EMB3

Endomyocardial biopsy: an invasive approach to diagnose ATTR-CM6

Congo red positive staining of myocardial tissue on light microscopy and apple-green birefringence on polarized light microscopy images1

Congo red positive staining for amyloid myocardial biopsy
To determine amyloid type, immunohistochemistry (IHC) tests and/or mass spectrometry should be performed.1 

Illustrative representation.

Apple-green birefringence myocardial biopsy 
Risk of complications and the need for specialized centers and expertise may contribute to a diagnostic delay.1,6 

Illustrative representation.

Genetic testing can confirm ATTR-CM type

Used to determine if the disease is hereditary due to a mutation in the TTR gene or if it is wild type7

Genetic counseling and gene sequencing are recommended following confirmation of hATTR-CM7

*Please consult individual labeling for risks.

[99mTc-DPD=99mtechnetium-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid]; [99mTc-HMDP=99mtechnetium-hydroxymethylene diphosphonate];[99mTc-PYP=99mtechnetium-pyrophosphate]; AL=immunoglobulin light chain amyloidosis; ATTR=transthyretin amyloidosis; CMR=cardiac magnetic resonance; ROI=region of interest; SPECT=single photon emission computed tomography.
Nuclear scintigraphy, endomyocardial biopsy and genetic testing can support an early ATTR-CM diagnosis 
Explore More Pivotal and 5-year data for ATTR-CM View the Body of Evidence ATTR-CM MOD Learn the Mechanism of Disease
NEXT: ATTR-CM diagnostic flowchart 
References:Gillmore JD, Maurer MS, Falk RH, et al. Nonbiopsy diagnosis of cardiac transthyretin amyloidosis. Circulation. 2016;133(24):2404-2412.doi:10.1161/CIRCULATIONAHA.116.021612
Bokhari S, Castano A, Pozniakoff T, Deslisle S, Latif F, Maurer MS. 99mTc-pyrophosphate scintigraphy for differentiating light-chain cardiac amyloidosis from the transthyretin-related familial and senile cardiac amyloidosis. Circ Cardiovasc Imaging. 2013;6(2):195-201. doi:10.1161/CIRCIMAGING.112.000132Dorbala 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. J Nucl Cardiol. 2019;26(6):2065-2123. doi:10.1007/s12350-019-01760-6. Addendum: J Nucl Cardiol. Published on line July 1, 2021. doi:10.1007/s12350-020-02455-z American Society of Nuclear Cardiology (ASNC). ASNC practice points: 99mTechnetium-pyrophosphate imaging for transthyretin cardiac amyloidosis. Available at: © 2019 American Society of Nuclear Cardiology. 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 2 of 2—diagnostic criteria and appropriate utilization. J Nucl Cardiol. 2020;27(2):659-673. doi:10.1007/s12350-019-01761-5Narotsky DL, Castano A, Weinsaft JW, Bokhari S, Maurer MS. Wild-type transthyretin cardiac amyloidosis: novel insights from advanced imaging. Can J Cardiol. 2016;32(9):1166.e1-1166.e10. doi:10.1016!J.cjca.2016.05.008 Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing common questions encountered in the diagnosis and management of cardiac amyloidosis. Circulation. 2017;135(14):1357-1377. doi:10.1161/CIRCULATIONAHA.116.024438
VYNDAQEL Prescribing InformationLoading

Legal Category: S1A.Further information available upon request

PP-VYN-IRL-0177. December 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit


This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.


Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.