RETHINK Prevention
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years
and older.1
Help your patients prevent attacks with 1 subcutaneous self-injection every 2 weeks1
The recommended starting dose is TAKHZYRO 300 mg every 2 weeks. In patients who are stably attack free on treatment, a dose reduction of TAKHZYRO 300 mg every 4 weeks may be considered, especially in patients with low weight.1
The efficacy and safety of TAKHZYRO were evaluated in the HELP study and HELP
open-label extension (OLE)1
MEAN ATTACK REDUCTION WITH TAKHZYRO WAS CONSISTENT IN THE
HELP STUDY AND HELP OLE1,7
HELP STUDY
87% relative reduction in attacks vs placebo at 6.5 months (P<0.001)1,8
-
LS mean monthly attack rate* (during treatment): 0.26 with TAKHZYRO (n=27); 1.97 with placebo (n=41) (primary endpoint)1
- Mean monthly attack rate at baseline (during run-in period): 3.5 with TAKHZYRO; 4.0 with placebo8
Secondary endpoint: 83% relative reduction in the number of moderate or severe HAE attacks vs placebo at 6.5 months. LS mean monthly attack rate* (during treatment): 0.20 with TAKHZYRO (n=27); 1.22 with placebo (n=41). TAKHZYRO demonstrated statistical significance compared with placebo for all secondary efficacy endpoints in the HELP study (P<0.001).1,8
HELP OLE
87% reduction in attacks vs baseline† at an average of 2.5 years1,7
-
Change in mean monthly attack rate with TAKHZYRO (N=209) during the HELP OLE treatment period: 3.05 to 0.25 (secondary endpoint)1,7
Secondary endpoint: 84% reduction in the number of moderate or severe HAE attacks vs baseline† at an average of 2.5 years. Change in mean monthly attack rate with TAKHZYRO (N=209) during the HELP OLE treatment period: 2.03 to 0.20.7
ZERO ATTACKS FOR MONTHS AT A TIME1,7
IN THE HELP OLE
More than 8 OUT OF 10 PATIENTS HAD ZERO ATTACKS for ≥6 months7
HELP STUDY
- Over the entire 6.5-month study (Day 0-182), 44% of patients taking TAKHZYRO (n=27) had zero attacks vs 2% of patients taking placebo (n=41) (prespecified exploratory endpoint)1,8‡
- After 6 doses, 77% of patients taking TAKHZYRO (n=26) had zero attacks for 4 months vs 3% of patients taking placebo (n=37) (Day 70-182; anticipated time to reach steady-state concentration is ~70 days) (post hoc sensitivity analysis)1,8‡
HELP OLE
- Over an average of 2.5 years, 82% of patients taking TAKHZYRO (N=209) had zero attacks for ≥6 months (prespecified exploratory endpoint)7‡
IN THE HELP OLE
Patients had zero attacks on average for nearly 15 months§ (415 days,
mean [SD] of 14.8 [12.4] months) in the HELP OLE (N=209; prespecified exploratory endpoint).1,7¶
GET TO KNOW THE HELP OLE
Watch this video to learn more about the long-term safety and efficacy of TAKHZYRO from Dr Susan Waserman
REIMAGINE QUALITY OF LIFE
Significant improvement in quality of life with TAKHZYRO in the HELP study (tertiary endpoint)1,11*
As shown on the Angioedema Quality of Life Questionnaire (AE-QoL), which measures the patient-reported impact of angioedema over a 4-week recall period across 4 domains, patients taking TAKHZYRO in the HELP study reported clinically meaningful improvement (reduction of ≥6) across all domains.1,12
Mean change in total AE-QoL score†: -21.3 with TAKHZYRO (n=26; P<0.05); -4.7 with placebo (n=38) (tertiary endpoint).11*
IN THE HELP STUDY
81% of patients experienced clinically meaningful improvement1
-
Of patients taking TAKHZYRO, 81% experienced clinically meaningful improvement in quality of life vs 37% of patients taking placebo at 6.5 months (P<0.05)1,8,11
All patients, including those taking placebo, were permitted on-demand treatment for attacks.8
Clinically meaningful improvement in quality of life with TAKHZYRO in the HELP OLE (tertiary endpoint)7‡
Rollover patients from the HELP study experienced further quality-of-life improvement in the HELP OLE7
Clinically meaningful improvement in quality of life across all domains with TAKHZYRO in the HELP OLE (tertiary endpoint)7¶
Rollover patients from the HELP study experienced further quality-of-life improvement across all domains in the HELP OLE7,11,12
LONG-TERM SAFETY AND TOLERABILITY
Safety of TAKHZYRO was consistent in the HELP study and HELP OLE7
Additional safety information
Please consult the TAKHZYRO Summary of Product Characteristics (SmPC) before prescribing.
Guidance for use
TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous (SC) injection technique by a healthcare professional.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
Warnings and Precautions
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
General: TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.
Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in international normalised ratio (INR) between treatment groups.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Interactions
No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.
As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor
Immunogenicity
Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralising antibodies.
The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
Adverse Reactions
The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.
Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%)
Very common (frequency ≥1/10): |
Injection site reactions* |
Common (≥1/100 to <1/10): |
Hypersensitivity**, dizziness, rash maculo-papular, myalgia, alanine aminotransferase increased, aspartate aminotransferase increased. |