Lanadelumab-flyo

What is Lanadelumab-flyo?[edit | edit source]

Lanadelumab-flyo (TAKHZYRO) is a plasma kallikrein inhibitor (monoclonal antibody) used to prevent attacks of Hereditary Angioedema (HAE).

This medicine used to prevent attacks of Hereditary Angioedema (HAE) in people 12 years of age and older.

Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein and inhibits its proteolytic activity.
Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE.
In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks.
Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

Recommended Dosage

The recommended starting dose is 300 mg every 2 weeks.
A dosing interval of 300 mg every 4 weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

Administration

TAKHZYRO is administered subcutaneously only.
TAKHZYRO is provided as a ready-to-use solution in a single-dose vial that does not require additional reconstitution or dilution for administration. TAKHZYRO is supplied as a clear to slightly opalescent, colorless to slightly yellow solution.
Do not use the vial if it appears discolored or contains visible particles.
Avoid vigorous agitation of the vial.
TAKHZYRO is intended for self-administration or administration by a caregiver.
The patient or caregiver should be trained by a healthcare professional.
Take the TAKHZYRO vial out of the refrigerator 15 minutes before injecting to allow it to equilibrate to room temperature.
Using aseptic technique, withdraw the prescribed dose of TAKHZYRO from the vial using an 18-gauge needle.
Change the needle on the syringe to a 27-gauge, ½-inch needle or other needle suitable for subcutaneous injection.
Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm.
Patients should inject the complete dose as prescribed by their physician.
In clinical studies, the majority of patients self-administered TAKHZYRO over 10 to 60 seconds.
TAKHZYRO should be administered within 2 hours of preparing the dosing syringe.
After the dosing syringe is prepared, it can be refrigerated at 36ºF to 46ºF (2°C to 8°C) and must be used within 8 hours.
Discard any unused portions of drug remaining in the vial and syringe.

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

TAKHZYRO may cause serious side effects, including allergic reactions

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

There are no available data on TAKHZYRO use in pregnant women to inform any drug associated risks.

The safety and efficacy of TAKHZYRO were evaluated in a subgroup of patients (N=10) aged 12 to <18 years.
The safety and efficacy of TAKHZYRO in pediatric patients < 12 years of age have not been established.

Active ingredient: lanadelumab
Inactive ingredients: citric acid monohydrate, L-histidine, sodium chloride, sodium phosphate dibasic dihydrate and water for injection.

Manufactured by: Dyax Corp 300 Shire Way Lexington, MA 02421

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