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DISEASE MANIFESTATIONS

hATTR is a rapidly progressive and fatal disease that requires timely recognition of symptoms¹

Clinical manifestations are variable depending on specific mutation, patient population, and age²

The majority of patients with hATTR have a mixed phenotype*^3-9

WAINUA is not indicated for the treatment of cardiomyopathy symptoms.

Peripheral Neuropathy Manifestation - Active

Peripheral neuropathy^10-13

Rapidly progressive, painful neuropathy in hands and feet
Muscle weakness, difficulty walking, and balance disorder

Autonomic Neuropathy Manifestation - Active

Autonomic neuropathy^10,13,14

GI symptoms of dysautonomia: constipation/diarrhea¹⁰
Orthostatic hypotension¹⁰
Sexual dysfunction¹⁴

Gastrointestinal^{†10,11,13,14}

Weight loss
Early satiety

Musculoskeletal^11-13,15

Carpal tunnel syndrome^11-13
Knee or hip surgery^12,15
Lumbar spinal stenosis

Cardiac^10,13,14,16

Heart failure (included HFpEF)
Poor tolerance to standard HF GDMT
Atrial fibrillation
Conduction abnormalities
Peripheral edema

Nephropathy¹⁰

Proteinuria
Renal failure

Rapidly progressive, painful neuropathy in hands and feet
Muscle weakness, difficulty walking, and balance disorder

GI symptoms of dysautonomia: constipation/diarrhea¹⁰
Orthostatic hypotension¹⁰
Sexual dysfunction¹⁴

Weight loss
Early satiety

Carpal tunnel syndrome^11-13
Knee or hip surgery^12,15
Lumbar spinal stenosis

Heart failure
(included HFpEF)
Poor tolerance to standard HF GDMT
Atrial fibrillation
Conduction abnormalities
Peripheral edema

Proteinuria
Renal failure

Peripheral Neuropathy Manifestation in The Body

Autonomic Neuropathy Manifestation in The Body

Gastrointestinal Manifestation in The Body

Musculoskeletal Manifestation in The Body

This is not a complete list of symptoms associated with hATTR. Each patient’s experience is different and may not exhibit all these symptoms collectively or at the same time. ATTR symptoms may worsen over time.¹
*A mixed phenotype combines features of both cardiomyopathy and polyneuropathy.¹⁷
^†Gastrointestinal symptoms are often considered autonomic symptoms.¹⁰

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FOOTNOTES

ATTR, transthyretin-mediated amyloidosis; GDMT, guideline-directed medical therapy; GI, gastrointestinal; hATTR, hereditary transthyretin-mediated amyloidosis; HF, heart failure; HFpEF, heart failure with preserved ejection fraction.

REFERENCES

1. Adams D, Algalarrondo V, Polydefkis M, Sarswat N, Slama MS, Nativi-Nicolau J. Expert opinion on monitoring symptomatic hereditary transthyretin-mediated amyloidosis and assessment of disease progression. Orphanet J Rare Dis. 2021;16(1):411.
2. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet J Rare Dis. 2013;8:31.
3. Bazell C, Alston M, Kumar N, et al. Descriptive characteristics of patients diagnosed with transthyretin amyloidosis (ATTR) in the Medicare fee-for-service and commercial populations. Poster presented at: International Symposium of Amyloidosis; May 26-30, 2024; Rochester, Minnesota.
4. Planté-Bordeneuve V, Said G. Familial amyloid polyneuropathy. Lancet Neurol. 2011;10(12):1086-1097.
5. Adams D, Ando Y, Beirão JM, et al. Expert consensus recommendations to improve diagnosis of ATTR amyloidosis with polyneuropathy. J Neurol. 2021;268(6):2109-2122.
6. Swiecicki PL, Zhen DB, Mauermann ML, et al. Hereditary ATTR amyloidosis: a single-institution experience with 266 patients. Amyloid. 2015;22(2):123-131.
7. Waddington-Cruz M, Wixner J, Amass L, Kiszko J, Chapman D, Ando Y; THAOS Investigators. Characteristics of patients with late- vs. early-onset Val30Met transthyretin amyloidosis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2021;10(2):753-766.
8. Pinto MV, Pinto LF, Dias M, et al. Late-onset hereditary ATTR V30M amyloidosis with polyneuropathy: characterization of Brazilian subjects from the THAOS registry. J Neurol Sci. 2019;403:1-6.
9. Sattianayagam PT, Hahn AF, Whelan CJ, et al. Cardiac phenotype and clinical outcome of familial amyloid polyneuropathy associated with transthyretin alanine 60 variant. Eur Heart J. 2012;33(9):1120-1127.
10. Gertz M, Adams D, Ando Y, et al. Avoiding misdiagnosis: expert consensus recommendations for the suspicion and diagnosis of transthyretin amyloidosis for the general practitioner. BMC Fam Pract. 2020;21(1):198.
11. National Institute for Health and Care Excellence. Highly specialised technology evaluation: inotersen for treating hereditary transthyretin-related amyloidosis [ID1242]. 2018.
12. Nativi-Nicolau JN, Karam C, Khella S, Maurer MS. Screening for ATTR amyloidosis in the clinic: overlapping disorders, misdiagnosis, and multiorgan awareness. Heart Fail Rev. 2022;27(3):785-793.
13. Conceição I, González-Duarte A, Obici L, et al. "Red-flag"-symptom clusters in transthyretin familial amyloid polyneuropathy. J Peripher Nerv Syst. 2016;21(1):5-9.
14. Gonzalez-Duarte A, Valdés-Ferrer SI, Cantú-Brito C. Characteristics and natural history of autonomic involvement in hereditary ATTR amyloidosis: a systematic review. Clin Auton Res. 2019;29(suppl 1):1-9.
15. Rubin J, Alvarez J, Teruya S, et al. Hip and knee arthroplasty are common among patients with transthyretin cardiac amyloidosis, occurring years before cardiac amyloid diagnosis: can we identify affected patients earlier? Amyloid. 2017;24(4):226-230.
16. Kittleson MM, Ruberg FL, Ambardekar AV, et al; Writing Committee. 2023 ACC Expert Consensus Decision Pathway on comprehensive multidisciplinary care for the patient with cardiac amyloidosis: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023;81(11):1076-1126.
17. Brito D, Albrecht FC, de Arenaza DP, et al. World Heart Federation consensus on transthyretin amyloidosis cardiomyopathy (ATTR-CM). Glob Heart. 2023;18(1):59.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Reduced Serum Vitamin A Levels and Recommended Supplementation WAINUA leads to a decrease in serum vitamin A levels. Supplement with recommended daily allowance of vitamin A. Refer patient to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.

ADVERSE REACTIONS

Most common adverse reactions (≥9% in WAINUA-treated patients) were vitamin A decreased (15%) and vomiting (9%).

INDICATION

WAINUA injection, for subcutaneous use, 45 mg is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

hATTR is a rapidly progressive and fatal disease that requires timely recognition of symptoms¹

Clinical manifestations are variable depending on specific mutation, patient population, and age²