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Takhzyro

Last reviewed on RxList: 12/3/2018
Takhzyro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/03/2018

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older. Common side effects of Takhzyro include:

  • injection site reactions
    • pain,
    • redness,
    • bruising,
    • bleeding,
    • itching,
    • a hard lump,
    • numbness and tingling,
    • warmth,
    • swelling, and
    • rash)
  • upper respiratory infections,
  • headache,
  • rash,
  • muscle pain,
  • dizziness, and
  • diarrhea

Administer a 300 mg dose of Takhzyro every 2 weeks. Dosing every 4 weeks may be considered in some patients. Patients may self-administer the dose of Takhzyro. Takhzyro may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Takhzyro; it is unknown how it would affect a fetus. It is unknown if Takhzyro passes into breast milk. Consult your doctor before breastfeeding.

Our Takhzyro (lanadelumab-flyo) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Takhzyro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats, difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • headache;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • rash; or
  • pain, redness, or bruising where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Takhzyro (Lanadelumab-flyo Injection)

Takhzyro Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of TAKHZYRO is primarily based on a 26-week, randomized, double-blind, parallel-group and placebo-controlled study (Trial 1) in 125 patients with Type I or II HAE. Eligible patients were also able to participate in an open-label extension study (Trial 2) up to 130 weeks. In Trial 1, a total of 84 patients with HAE aged 12 years and older received at least one dose of TAKHZYRO. Overall, 70% of patients were female and 90% of patients were Caucasian with a mean age of 41 years. The proportion of patients who discontinued study drug prematurely due to adverse events was 1.2% for TAKHZYRO-treated patients and 4.9% for placebo-treated patients. No deaths occurred in the trial.

The safety profile of TAKHZYRO was generally similar across all subgroups of patients, including analysis by age, sex, and geographic region.

Table 1 shows adverse reactions occurring in ≥10% of patients in any TAKHZYRO treatment group that also occurred at a higher rate than in the placebo treatment group in Trial 1.

Table 1: Adverse Reactions Observed in ≥10% of Patients Treated with TAKHZYRO in Trial 1

Adverse Reaction Placebo
(N=41)
TAKHZYRO
150 mg q4wks
(N=28)
300 mg q4wks
(N=29)
300 mg q2wks
(N=27)
Total
(N=84)
n (%) n (%) n (%) n (%) n (%)
Injection site reactionsa 14 (34) 16 (57) 13 (45) 15 (56) 44 (52)
Upper respiratory infectionb 13 (32) 3 (11) 9 (31) 12 (44) 24 (29)
Headachec 9 (22) 3 (11) 6 (21) 9 (33) 18 (21)
Rashd 2(5) 2 (7) 3 (10) 1 (4) 6 (7)
Myalgia 0 1 (4) 0 3 (11) 4 (5)
Dizziness 0 1 (4) 3 (10) 1 (4) 5 (6)
Diarrhea 2 (5) 3 (11) 0 1 (4) 4 (5)
N= number of patients; n =number of patients experiencing the event; q2wks = every 2 weeks; q4wks = every 4 weeks
a Injection site reactions include: pain, erythema, bruising, hematoma, hemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, edema and rash.
b Includes upper respiratory infection, viral upper respiratory infection
c Includes headache, tension headache, sinus headache
d Includes rash, rash maculopapular, rash erythematous

Injection site reactions primarily consisted mainly of pain, erythema, and bruising at the injection site. There was no meaningful difference in injection site reactions with self-administration.

Less Common Adverse Reactions

Other adverse reactions that occurred at a higher incidence in TAKHZYRO-treated patients compared to placebo include hypersensitivity (1% vs 0%), increased aspartate transaminase (2% vs 0%), and increased alanine transaminase (2% vs 0%).

Safety data from the ongoing open-label extension study, consisting of 109 rollover patients from Trial 1 and 103 non-rollover HAE patients, is consistent with controlled safety data from Trial 1.

Laboratory Abnormalities

Transaminase elevations

During the placebo-controlled treatment period in Trial 1, the number of TAKHZYRO-treated patients with maximum transaminase (ALT or AST) levels >8, >5, or >3 times the upper limit of normal (ULN) was 1 (1.2%), 0 (0%), or 3 (3.6%) respectively, compared to 0 in the placebo-treated patients. These transaminase elevations were asymptomatic and transient. No patients had elevated total bilirubin >2x ULN. One TAKHZYRO-treated patient permanently discontinued treatment due to elevated transaminases (4.1x ULN AST). None of the patients were reported to have serious adverse reactions of elevated transaminases.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to lanadelumab-flyo in the study described below with the incidence of antibodies in other studies or to other products may be misleading.

In Trial 1, 10 (12%) lanadelumab-flyo-treated and 2 (5%) placebo-treated patients had at least 1 anti-drug antibody (ADA)-positive sample during the treatment period; antibody titers were low (range: 20 to 1280). The ADA response observed was transient in 2/10 lanadelumab-flyo and 1/2 placebo-treated patients. Pre-existing low titer antibodies were observed in 3 lanadelumab-flyo-treated patients and 1 placebo-treated patient with ADAs. Two patients receiving 150 mg q4wks had low titer antibodies classified as neutralizing.

The development of ADA including neutralizing antibodies against lanadelumab-flyo did not appear to adversely affect pharmacokinetics (PK), pharmacodynamics (PD), safety or clinical response.

Read the entire FDA prescribing information for Takhzyro (Lanadelumab-flyo Injection)

Related Resources for Takhzyro

© Takhzyro Patient Information is supplied by Cerner Multum, Inc. and Takhzyro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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