This webpage is intended for UK Healthcare Professionals only.
Webpage contains promotional material. Prescribing Information can be found at the end of this webpage.
Initiated and funded by Takeda Pharmaceuticals Limited.
TAKHZYRO: RECOMMENDED BY NICE2
National Institute for Health and Clinical Excellence (NICE) recommends Takhzyro®▼ (lanadelumab) as an option for preventing recurrent attacks of hereditary angioedema in people aged 12 and older, only if:
- they are eligible for preventive C1-esterase inhibitor (C1-INH) treatment in line with NHS England’s commissioning policy
- the lowest dosing frequency of lanadelumab is used in line with the summary of product characteristics
- the company provides lanadelumab according to the commercial arrangement
Additional conditions apply. Full guidance details are available from www.nice.org.uk/guidance/ta606
INTRODUCING TAKHZYRO: A NEW PREVENTATIVE TREATMENT FOR USE IN TYPE I/II HAE1
TAKHZYRO: TARGETED PREVENTION OF HAE ATTACKS
As a fully human monoclonal antibody, TAKHZYRO offers targeted inhibition of plasma kallikrein, a critical regulator of HAE attacks1
Results of the HELP study: an international, multicentre, randomised, double-blind, placebo-controlled, parallel-group study that assessed the efficacy and safety of TAKHZYRO in 125 patients with HAE type I or II (≥12 years of age) for 26 weeks (6.5 months, where 1 month was defined as 28 days). The primary endpoint was the rate of investigator-confirmed HAE attacks during the treatment period1
*After 6.5 months, in patients receiving TAKHZYRO 300 mg every 2 weeks
**Mean monthly rate, in patients receiving TAKHZYRO 300 mg every 2 weeks
†In patients receiving TAKHZYRO 300 mg every 2 weeks
SIGNIFICANT REDUCTION IN ATTACKS VS PLACEBO1,3
The efficacy of TAKHZYRO was established in the HELP clinical trial programme1,3
Significant reduction in attacks vs. placebo1,3
The mean reduction in attack rate* with TAKHZYRO 300 mg every 2 weeks vs placebo at 6.5 months (primary endpoint):1,3
87%
REDUCTION
IN ATTACKS
(p<0.001)1,3
MEAN MONTHLY ATTACK RATE
(during treatment1 vs during run in3):
0.26 vs 3.5 for TAKHZYRO 300 mg every 2 weeks (n=27)
0.53 vs 3.7 for TAKHZYRO 300 mg every 4 weeks** (n=29)
1.97 vs 4.0 for placebo (n=41)
Attack reduction was consistent regardless of previous prophylaxis use, history of laryngeal attacks, or baseline attack rate1,3
Significant reduction in attack severity vs. placebo1,3
Mean reduction in rate of moderate or severe attacks with TAKHZYRO 300 mg every 2 weeks vs. placebo (secondary endpoint)1,3
83%
REDUCTION
IN ATTACK SEVERITY
(p<0.001)1,3
MEAN MONTHLY RATE OF MODERATE OR SEVERE ATTACKS
(during treatment3)
0.20 for TAKHZYRO 300 mg every 2 weeks (n=27)
0.32 for TAKHZYRO 300 mg every 4 weeks** (n=29)
1.22 for placebo (n=41)
TAKHZYRO demonstrated statistical significance compared with placebo for all secondary efficacy endpoints (p<0.001)1,3
*Mean monthly attack rate: investigator-confirmed attacks/4 weeks
** A dosing interval of 300 mg every 4 weeks is also effective and may be considered if the patient is stable (e.g. attack-free), especially in patients with low weight
REGAINING CONTROL
The drive for ZERO attacks
Moving towards ZERO attacks could help patients control the anxiety that limits their lives4-6
TAKHZYRO is the first HAE prevention treatment to show a significant proportion of patients experiencing ZERO attacks throughout a clinical trial3
Over the entire 6.5 month study (Days 0-182), 44% of patients taking TAKHZYRO 300 mg every 2 weeks (n=27) had ZERO attacks vs 2% of patients taking placebo (n=41) (prespecified exploratory endpoint)*1,3
IN A POST HOC SENSITIVITY ANALYSIS, AFTER 6 DOSES OF TAKHZYRO (300 MG EVERY 2 WEEKS)
OF PATIENTS HAD ZERO ATTACKS
For the next 4 months of treatment vs. 3% with placebo (estimated steady state from Days 70 – 182)1,3
31% of patients on TAKHZYRO 300 mg every 4 weeks* had zero attacks during this time (n=29)1,3
*These findings are exploratory or post hoc in nature and therefore require further investigation to corroborate the findings
STUDY LIMITATIONS: There were relatively few patients in each treatment group, leading to imbalances in some baseline and clinical characteristics. The study was 26 weeks in duration, therefore conclusions on long-term safety and efficacy cannot be made. The reported number of attacks in the 12 months of pre-screening were based on patient historical recall, and the attacks were not investigator-confirmed3
REDEFINE DOSING AND ADMINISTRATION
One subcutaneous self-injection every 2 weeks1 to suit your patients’ lives
No reconstitution or calculations: Each dose of TAKHZYRO is provided in a ready-to-use, single-dose vial1
The most common adverse reactions (ARs) were injection site reactions1,3
resolved
within 1 day1
minutes
median duration1
Zero treatment-related serious ARs seen for all injection site reactions3
REIMAGINE QUALITY OF LIFE
PATIENTS TAKING TAKHZYRO 300 MG EVERY 2 WEEKS HAD A
PROBABILITY OF ACHIEVING IMPROVED QUALITY OF LIFE VS PLACEBO3
TAKHZYRO 300 mg every 2 weeks (n=26)
odds ratio: 7.2; p=0.013
TAKHZYRO 300 mg every 4 weeks (n=27)
odds ratio: 2.91; p=0.043
Clinically meaningful improvement in quality of life vs. placebo, measured by a disease-specific questionnaire1,3
Mean change in Angioedema Quality of Life Questionnaire (AE-QoL) total score: –20 with TAKHZYRO vs. –5 with placebo (p<0.01) (tertiary endpoint)
A negative score shows improvement1
PATIENTS REPORTED CLINICALLY MEANINGFUL IMPROVEMENT (CHANGE OF ≥6) ACROSS ALL DOMAINS WITH TAKHZYRO VS. PLACEBO1,3
-
LESS FEAR AND SHAME
about unpredictable attacks1,7
(mean change: -19 with TAKHZYRO vs. -9 with placebo) -
LESS IMPAIRMENT
in their ability to work, socialise, and perform other physical activities1,7 (mean change: –29 with TAKHZYRO vs –5 with placebo)
-
REDUCED FATIGUE
during the day, and better sleep at night1,7
(mean change: –13 with TAKHZYRO vs –2 with placebo) -
FEWER RESTRICTIONS
in what they can eat and drink1,7
(mean change: –17 with TAKHZYRO vs 0.5 with placebo)
REIMAGINE THE WAY YOU
TREAT HAE
REFERENCES
- TAKHZYRO Summary of Product Characteristics.
- NICE. Lanadelumab for preventing recurrent attacks of hereditary angioedema. Technology Appraisal (TA606); October 2019; Available at www.nice.org.uk/guidance/ta606 (Accessed October 2019).
- Banerji A et al. JAMA 2018; 320:2108–2121.
- Kaplan AP. J Allergy Clin Immunol 2010; 126:918–925.
- Bygum A et al. Acta Derm Venereol 2015; 95:706–710.
- Caballero T et al. Allergy Asthma Proc 2014; 35:47–53.
- Weller K et al. Allergy 2012; 67:1289–1298.
PRESCRIBING INFORMATION
TAKHZYRO®▼ 300 mg solution for injection (lanadelumab)
Prescribing Information. Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Each vial contains 300 mg lanadelumab in 2 ml solution. Indication: Routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients 12 years and older.
Dosage and administration: The recommended starting dose is 300 mg lanadelumab every 2 weeks. In stably attack free patients on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight. TAKHZYRO should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema.
Method of administration: Subcutaneous (sc) administration only.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Warnings and precautions: To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded. In the case of a severe hypersensitivity reaction, administration must be stopped immediately, and appropriate treatment initiated. TAKHZYRO is not intended for treatment of acute HAE attacks, individualised treatment should be initiated with an approved rescue medication in the event of a breakthrough HAE attack. Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay, this increase is not associated with bleeding adverse events in treated patients. Sodium: This medicinal product contains less than 1mmol sodium (23 mg) per vial, essentially ‘sodium-free’.
Interactions: No dedicated drug-drug interactions have been conducted, based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products are expected.
Pregnancy and lactation: As a precaution it is preferable to avoid the use of lanadelumab during pregnancy and in the few days following childbirth. If clinically needed, lanadelumab can be administered during breast-feeding.
Effects on ability to drive and use machines: None Adverse effects: Very common (≥1/10 patients): Injection site reactions (includes erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash). Common (≥1/100, <1/10 patients): Hypersensitivity (includes pruritus, discomfort and tingling of tongue, dizziness, rash maculo-papular, myalgia, alanine and aspartate aminotransferase increased. Prescribers should consult the summary of product characteristics in relation to other adverse reactions.
Package quantity and price for the UK: 1 vial contains 300 mg of lanadelumab, £12,420 per vial.
Pharmaceutical precautions: Store in a refrigerator (2°C to 8°C). Do not freeze. Keep vial in the outer carton in order to protect from light. Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date. Do not return TAKHZYRO to refrigerated storage after storage at room temperature.
Legal category: POM.
Date of revision: March 2019
Marketing authorisation numbers and holder: EU/1/18/1340/001-003, Shire Pharmaceuticals Ireland Limited, Blocks 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland.
Email: medinfoemea@shire.com. Further information is available on request. TAKHZYRO is a registered trade name.
Date of preparation: March 2019
Job code: [EXA/UKI//0070]
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. UK: Adverse events should be reported. Reporting forms and information can be found at Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland: Adverse events should be reported to the Pharmacovigilance Unit at the Health Products Regulatory Authority (HPRA) at: www.hpra.ie UK and Ireland: Adverse events should also be reported to Shire Pharmaceuticals Ltd at: drugsafety@shire.com
Job code: C-APROM/UK//3323
Date of preparation: October 2019
