GNH USA

Europe — EMA

Orladeyo (Berotralstat)

GNH USA supplies Orladeyo (Berotralstat), a plasma kallikrein inhibitor for prevention of hereditary angioedema attacks. Request a quote for global supply.

Berotralstat

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1
Pack/s

What is Berotralstat?

Berotralstat, the active ingredient in Orladeyo, is a plasma kallikrein inhibitor presented as a tablet for oral use. It is indicated for the prevention of hereditary angioedema attacks in patients with hereditary angioedema.

GNH USA supplies Orladeyo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Berotralstat used for?

Orladeyo (berotralstat) acts within the hereditary angioedema (HAE) pathway to prevent swelling episodes.

- Hereditary angioedema type I: reduces the frequency and severity of swelling attacks. - Hereditary angioedema type II: reduces the frequency and severity of swelling attacks. - Hereditary angioedema with normal C1‑INH: reduces the frequency and severity of swelling attacks.

What are the side effects of Berotralstat?

Common side effects are generally mild and reversible.

Common Side Effects: - Abdominal pain - Diarrhea - Nausea - Headache - Fatigue - Dyspepsia

Serious or Rare Side Effects: - Elevated liver enzymes - Angioedema of the face, throat or airway - Anaphylactic reaction (rare) - Severe hypersensitivity - Hepatic injury (very rare)

What precautions apply to Berotralstat?

Before initiating therapy, consider the following safety measures. - Assess liver function: obtain baseline hepatic enzymes and monitor periodically. - Monitor for signs of angioedema: seek immediate medical attention if facial or airway swelling occurs. - Avoid use in severe hepatic impairment: contraindicated in patients with marked liver dysfunction. - Pregnancy and breastfeeding: safety not established; use only if potential benefit justifies risk. - Review concomitant medications: assess for drugs that may affect berotralstat metabolism. - Store at ambient temperature: keep below 25°C, protect from moisture and keep in original packaging.

What does Berotralstat interact with?

Berotralstat may interact with other medicines that influence its metabolism or target pathway.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may markedly increase berotralstat exposure. - Co‑administration with other plasma kallikrein inhibitors: risk of excessive bradykinin suppression.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise plasma levels. - Oral contraceptives: potential alteration of hormonal metabolism. - Antifungal azoles (e.g., ketoconazole): may increase berotralstat concentrations. - Statins metabolized by CYP3A4: monitor for additive hepatic effects.

Frequently asked questions

What is Orladeyo used for?+
Orladeyo contains berotralstat and is prescribed to prevent attacks of hereditary angioedema, a rare condition that causes sudden swelling of the skin and mucosal tissues. It is used as a long‑term prophylactic therapy in patients diagnosed with hereditary angioedema.
How does berotralstat work?+
Berotralstat works by inhibiting plasma kallikrein, an enzyme that generates bradykinin. By reducing bradykinin production, the drug decreases vascular permeability and prevents the swelling episodes that characterize hereditary angioedema.
What is the usual dose of Orladeyo?+
The dosage of Orladeyo is individualized by the prescribing healthcare professional based on the patient’s clinical condition, weight, and response. The prescriber determines the appropriate dose and dosing schedule.
Is Orladeyo safe during pregnancy or breastfeeding?+
Safety data for berotralstat in pregnancy and lactation are limited. It should only be used if the potential benefit outweighs any possible risk to the fetus or infant, and the decision should be made in consultation with a qualified healthcare provider.
How do I order Orladeyo from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Orladeyo compare with other hereditary angioedema prophylactics?+
Orladeyo is an oral plasma kallikrein inhibitor, offering a convenient once‑daily tablet compared with injectable C1‑esterase inhibitor concentrates or monoclonal antibodies. Its oral route may improve adherence, while efficacy and safety profiles are comparable to other approved prophylactic agents.
How should Orladeyo be stored and handled?+
Store Orladeyo tablets at ambient temperature, below 25 °C, in the original blister pack to protect from moisture. Keep the medication out of reach of children and avoid exposure to direct sunlight or extreme humidity.
How is Orladeyo administered?+
Orladeyo is taken orally as a whole tablet with water. It is usually taken once daily, preferably at the same time each day, and can be taken with or without food unless otherwise directed by the prescriber.
What are the most serious risks associated with Orladeyo?+
Serious risks include potential liver enzyme elevations, rare cases of severe angioedema involving the airway, and hypersensitivity reactions such as anaphylaxis. Patients should be monitored for signs of liver dysfunction and any sudden swelling, and seek immediate medical attention if these occur.
Who should not use Orladeyo?+
Orladeyo is contraindicated in patients with severe hepatic impairment and in individuals who have demonstrated hypersensitivity to berotralstat or any of the tablet’s excipients. Caution is also advised for patients taking strong CYP3A4 inhibitors.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Berotralstat
Route
Oral Use
Manufacturer
Biocryst Ireland Limited
Origin
EU

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