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Nucala▼: significant reduction in nasal obstruction1

Explore how Nucala▼ improves the most common nasal polyps symptoms1,2

Nucala▼ improved quality of life (total SNOT-22) scores by 30-points from baseline vs. 14-points with placebo.1

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Nucala▼ (n=206): improvement of -4.41 from baseline
of 9.0; placebo (=201); -0.82 from 9.1 (p<0.0001)1†

Nucala▼ treats recurrent nasal polyps and improves the most common symptoms.1,2*

  •  Nasal obstruction was the nasal polyps symptom reported most by both patients and physicians.2
  •  60% of patients on Nucala▼ (n=124/206) had an improvement of more than 3-points in nasal obstruction scores vs. 36% with placebo (n=73/201).1†
    • Nucala▼ (n=206): median improvement of -4.41 from baseline of 9.0; placebo (n=201): -0.82 from 9.1 (p<0.0001).1
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Nucala▼ improves patients’ quality of life1*,‡

  • 60% of patients treated with Nucala▼ had more than a 3-point improvement in nasal obstruction scores vs. 36% with placebo.1†
  • Nucala▼ improved total SNOT-22 scores by 30-points from baseline vs. 14-points with placebo1 (MCID ≥8.95), with improvements across all 6 symptom domains.4‡
  • Nucala▼ reduced OCS use by 42% vs. placebo in patients with recurrent nasal polyps (n=407; odds ratio: 0.58, 95% CI: 0.36, 0.92),1§ and by 51% vs. placebo in patients with eosinophil levels of 300 cells/μL or above (n=278; odds ratio: 0.49, 95% CI: 0.28, 0.86).3¶

Choose Nucala▼ to reduce nasal obstruction1

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Nucala▼ (pre-filled pen, pre-filled syringe) Safety Information

SAFETY

Contraindications

Hypersensitivity to mepolizumab or to any of the excipients.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA▼. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA▼ should be discontinued.

Acute Asthma Symptoms or Deteriorating Disease

NUCALA▼ should not be used to treat acute asthma symptoms or acute exacerbations. Do not use NUCALA▼ to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with NUCALA▼.

Opportunistic Infections: Herpes Zoster

Herpes zoster has occurred in subjects receiving NUCALA▼ 100 mg in controlled clinical trials. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA▼. Reductions in corticosteroid dosage, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

Eosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical trials. It is unknown if NUCALA▼ will influence a patient’s response against parasitic infections. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA▼. If patients become infected while receiving treatment with NUCALA▼ and do not respond to anti helminth treatment, discontinue treatment with NUCALA▼ until infection resolves.

Adverse Reactions

Adverse reactions that occurred in ≥ 3% of NUCALA▼-treated patients and more frequently than in patients treated with placebo in the CRSwNP trial: oropharyngeal pain, arthralgia, abdominal pain, upper, diarrhea, pyrexia, nasal dryness, rash.
Adverse reactions with NUCALA▼ with ≥3% incidence and more common than placebo in patients with severe asthma (in the 2 confirmatory efficacy and safety trials): headache, injection site reaction, back pain, fatigue, influenza, urinary tract infection, abdominal pain upper, pruritus, eczema, muscle spasms.

Footnotes

*SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala▼ 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.1

†Co-primary endpoint: median change in mean nasal obstruction VAS score during Weeks 49–52, Nucala▼: -4.41, placebo: -0.82 (p<0.0001). Score decreases and baseline scores are medians. Score decrease indicates improvement. Baseline scores are out of 10. Nucala▼, n=206; placebo, n=201.1

‡Health-related quality of life assessed through SNOT-221 – a 110-point health-related quality of life scale.5 Secondary endpoint: change from baseline in total SNOT-22 score. Point improvements are medians. Median baseline score for both groups was 64.0.1 SNOT-22 is a 22-item self-reported questionnaire developed to measure symptoms and impacts on health-related quality of life, related to chronic rhinosinusitis. Score range is from 0 to 110, with each item scored from 0 (no problem) to 5 (the problem is as bad as it can be).4

§Number of participants with ≥1 course of OCS, Nucala▼: 52/206 (25%), placebo 74/201 (37%).1

Post-hoc subgroup analysis in participants with ≥300 eosinophils/µL. Participants with ≥1 course of OCS, Nucala▼: 37/139 (27%), placebo: 58/139 (42%).3

References

  1. Han JK, Bachert C, Fokkens W et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021; published online April 16.
  2. Benson VS, Sousa AR, Small M et al. Nasal Polyps Symptoms: How Well Do Physicians Know Their Patients? AAAAI 2020. Poster no. 475.
  3. GlaxoSmithKline. GlaxoSmithKline. Comorbidity/Subgroup data for SYNAPSE Study (205687). Data on File: 2021N465191_00.
  4. GlaxoSmithKline. SYNAPSE Study Data. Data on File: 2020N442969_00. REF-123390.
  5. Hopkins C, Gillett S, Slack R et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447–454.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via P.O Box 55850, Jeddah, 21544, Kingdom of Saudi Arabia. Telephone: +966 12 653 6666 or via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via saudi.safety@gsk.com
To report the Quality related product complaint/s associated with the use of GSK product/s, please contact us via ksa.productqualitycomplaint@gsk.com

▼ This medicine is subjected to additional monitoring. This will allow quick identification of new safety information.
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PM-SA-MPL-WCNT-240002 October 2024