Lanadelumab-flyo

What is Lanadelumab-flyo?

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

What are the uses of this medicine?

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

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No dedicated drug interaction studies have been conducted.
• No clinically important drug interactions have been observed with OXERVATE.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg/2 mL (150 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• TAKHZYRO

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reactions (pain, redness, and bruising)
• upper respiratory infections
• headache

TAKHZYRO may cause serious side effects, including allergic reactions

• wheezing
• difficulty breathing
• chest tightness
• fast heartbeat
• faintness
• rash
• hives

What special precautions should I follow?

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

What to do in case of emergency/overdose?

• There is no clinical experience with overdosage of TAKHZYRO.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

• 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.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

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

What should I know about storage and disposal of this medication?

• Store vials refrigerated at 36°F to 46°F (2°C to 8°C).
• Do not freeze. Do not shake.
• Keep the vial in the original carton in order to protect the vial from light.

• Dailymed label info on Lanadelumab-flyo
• FDA Lanadelumab-flyo

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