Cytochrome P450 2D6 Inhibitors

Cytochrome P450 3A4 Inhibitors

Kallikrein Inhibitors

P-Glycoprotein Inhibitors

Plasma Kallikrein Inhibitor

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">ORLADEYO (berotralstat) capsules is a plasma kallikrein inhibitor. Berotralstat is presented as the dihydrochloride salt with the chemical name 1-[3-(aminomethyl)phenyl]-<span class="Italics">N</span>-(5-{(<span class="Italics">R</span>)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1<span class="Italics">H</span>-pyrazole-5-carboxamide dihydrochloride. The chemical structure is:</p><div class="Figure"><img alt="Chemical Structure" src="orladeyo-01.jpg"/></div><p>Berotralstat dihydrochloride is a white to off-white powder that is soluble in water at pH ≤4. The molecular formula is C<span class="Sub">30</span>H<span class="Sub">26</span>F<span class="Sub">4</span>N<span class="Sub">6</span>O ∙ 2HCl and the molecular weight is 635.49 (dihydrochloride).</p><p>ORLADEYO is supplied as 150 mg (equivalent to 169.4 mg berotralstat dihydrochloride) and 110 mg (equivalent to 124.3 mg berotralstat dihydrochloride) hard gelatin capsules for oral administration. Each capsule contains the active ingredient berotralstat dihydrochloride and the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, and pregelatinized starch.</p></section>

Orladeyo

berotralstat

berotralstat 150 MG Oral Capsule

berotralstat 150 MG Oral Capsule [Orladeyo]

berotralstat 110 MG Oral Capsule

berotralstat 110 MG Oral Capsule [Orladeyo]

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Lanadelumab-flyo, a plasma kallikrein inhibitor, is a non-plasma derived, recombinant, fully human, monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells. Based on the amino acid sequence, the molecular weight of the non-glycosylated lanadelumab-flyo is 146 kDa. The calculated molecular mass of the fully reduced light chain is 23 kDa. The calculated molecular mass of the fully reduced and non-glycosylated heavy chain is 49 kDa.</p><p>TAKHZYRO (lanadelumab-flyo) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use.</p><p>Each mL of ready-to-use TAKHZYRO solution contains 150 mg of lanadelumab-flyo, citric acid monohydrate (4.1 mg), L-histidine (7.8 mg), polysorbate 80 (0.1 mg), sodium chloride (5.3 mg), sodium phosphate dibasic dihydrate (5.3 mg), and Water for Injection, USP. The solution has a pH of approximately 6.0.</p></section>

TAKHZYRO

lanadelumab-flyo

lanadelumab

2 ML lanadelumab-flyo 150 MG/ML Injection

Takhzyro

2 ML lanadelumab-flyo 150 MG/ML Injection [Takhzyro]

2 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe

2 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]

1 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe

1 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]

Orladeyo is prescribed to prevent hereditary angioedema (HAE) attacks in individuals aged 12 and above.

It should not be used to treat an ongoing HAE attack.

The safety and effectiveness of Orladeyo in children under 12 years of age are currently unknown.

Report Adverse Event

Prescribing Information

Medication Guide

Medication Guide: Spanish

Submit MSL Request 

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeal 

Orladeyo Start Form 

Enroll in Patient Savings Program 

Bridge Program 

Other HCP Resources 

About Orladeyo

Side Effects

Comprehensive Support Program 

Patient Stories 

Instructions For Use: Hereditary Angioedema (HAE)

Patient Brochure

Doctor Discussion Guide: Patients Not Yet Taking Preventative Therapy

Doctor Discussion Guide: Currently Taking Preventative Therapy

Orladeyo Mentor Program Brochure

Patient Resources: Orladeyo Educational Classes

Orladeyo Follow Up Discussion Guide

Takhzyro is a monoclonal antibody that controls an overactive enzyme in individuals with hereditary angioedema, a rare genetic immune system disorder. It is prescribed to prevent angioedema attacks in patients aged 2 and above.

Hereditary angioedema leads to elevated bradykinin levels. Takhzyro (lanadelumab-flyo) effectively reduces bradykinin levels, mitigating swelling and associated angioedema symptoms.

Takhzyro injections are FDA-approved for patients aged 2 and older to prevent hereditary angioedema attacks.

Medication Guide 

Submit MSL Request

Coverage Authorization Appeals 

Formulary Exception Letter

Letter of Medical Necessity

Letter of Intent to Treat

Claim Denial Letter

Enroll in Patient Savings Program

Quick Start Program 

One Path Start Form 

Takhzyro Brochure - English

Takhzyro Brochure - Spanish 

HAE Attack Plan

Caregiver Resources

Doctor Discussion Guide 

About Takhzyro

Injection Training Materials

Taking Takhzyro

Dosing Reminders

Patient Stories

Takhzyro For Children 

Instructions For Use: HAE 

One Path Patient Support 

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Berinert

Cinryze

Haegarda

Kalbitor

Firazyr

Sajazir

Ruconest

Orladeyo®(berotralstat)	Takhzyro®(lanadelumab-flyo)

Prescription Only Orladeyo is prescribed to prevent hereditary angioedema (HAE) attacks in individuals aged 12 and above. It should not be used to treat an ongoing HAE attack. The safety and...	Prescription Only Takhzyro is a monoclonal antibody that controls an overactive enzyme in individuals with hereditary angioedema, a rare genetic immune system disorder. It is prescribed to prevent...
Dosage & Administration
Administration
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Dosing
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Latin Shorthand
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Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
Learn more.	Learn more.
Assistance Expiration
Calendar year. Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions (≥10%) are abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.. Learn more.	The most common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia.. Learn more.
Mechanism of Actions (MoA)
Drugs used in Hereditary Angioedema. Learn more.	Drugs used in Hereditary Angioedema. Learn more.
Special Populations

Orladeyo® Alternatives