GNH USA

Europe — EMA

Orladeyo (Berotralstat)

GNH USA supplies Orladeyo (Berotralstat), a plasma kallikrein inhibitor for prophylaxis of hereditary angioedema attacks in adults. Request a quote.

Berotralstat

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What is Berotralstat?

Berotralstat, the active ingredient in Orladeyo, is a plasma kallikrein inhibitor presented as a 150 mg oral tablet. It is indicated for the prophylactic treatment of hereditary angioedema attacks in adult patients.

GNH USA supplies Orladeyo as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics worldwide. The medication is manufactured to meet EU regulatory standards and is distributed under strict quality controls.

What is Berotralstat used for?

Orladeyo (berotralstat) is used in the hereditary angioedema (HAE) pathway to prevent swelling episodes.

Hereditary angioedema (adult): reduces the frequency and severity of angioedema attacks, providing long‑term prophylaxis.

What are the side effects of Berotralstat?

Berotralstat may cause adverse reactions; they are categorized by frequency and severity.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Abdominal pain: discomfort in the upper abdomen. - Diarrhea: loose stools occurring intermittently. - Dyspepsia: indigestion or heartburn. - Headache: mild to moderate tension‑type pain. - Fatigue: feeling unusually tired.

Serious or Rare Side Effects: - Anaphylaxis: severe allergic reaction requiring immediate medical attention. - Angioedema: paradoxical swelling of face, lips, or throat. - Hepatic enzyme elevation: increased liver function tests. - Severe skin reactions: such as Stevens‑Johnson syndrome. - Thrombosis: rare clot formation in veins or arteries.

What precautions apply to Berotralstat?

Before initiating therapy, consider the following precautions. - Renal impairment: assess kidney function and adjust monitoring as needed. - Hepatic impairment: monitor liver enzymes regularly during treatment. - Concomitant ACE inhibitors or ARBs: watch for increased risk of angioedema. - Pregnancy and lactation: use only if the potential benefit justifies the potential risk to the fetus or infant. - Drug interactions: review all concomitant medications for possible interactions. - Store at ambient temperature: keep below 25 °C, protect from moisture, and retain in the original packaging.

What does Berotralstat interact with?

Berotralstat may interact with other medicines; interactions are grouped by clinical significance.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin): may increase berotralstat exposure and risk of toxicity. - Potent CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce berotralstat effectiveness.

Moderate Interactions (Monitor Closely): - ACE inhibitors or ARBs: may augment the risk of angioedema. - Estrogen‑containing oral contraceptives: may affect bradykinin metabolism and require monitoring. - Warfarin: monitor INR as berotralstat could alter anticoagulant metabolism.

Frequently asked questions

What is Orladeyo used for?+
Orladeyo is prescribed for the prophylaxis of hereditary angioedema (HAE) attacks in adult patients. By preventing the formation of swelling episodes, it helps maintain a more stable quality of life for individuals who experience recurrent, potentially life‑threatening edema.
How does berotralstat work?+
Berotralstat works by reversibly inhibiting plasma kallikrein, the enzyme responsible for generating bradykinin. Reduced bradykinin levels lower vascular permeability, which in turn prevents the sudden swelling characteristic of hereditary angioedema attacks.
What is the usual dose of Orladeyo?+
The specific dose of Orladeyo is determined by the prescribing healthcare professional based on the patient’s clinical condition, weight, and response to therapy. The prescriber will provide individualized dosing instructions and any necessary adjustments.
Is Orladeyo safe during pregnancy or breastfeeding?+
Safety data for berotralstat in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.
How do I order Orladeyo from GNH USA?+
To order Orladeyo, 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 (including any cold‑chain requirements), and necessary import documentation.
How does Orladeyo compare with other HAE prophylactic treatments?+
Orladeyo (berotralstat) is an oral plasma kallikrein inhibitor, offering a convenient daily tablet compared with injectable options such as C1‑esterase inhibitor concentrates or monoclonal antibodies like lanadelumab. While injectables provide rapid onset, the oral route may improve adherence for patients preferring non‑invasive therapy.
What are the storage and handling requirements for Orladeyo?+
Orladeyo tablets should be stored at ambient temperature, preferably below 25 °C, in their original packaging to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.
How is Orladeyo administered?+
Orladeyo is taken orally as a whole tablet with water. The prescriber will advise whether it should be taken with or without food, and patients should follow the exact timing and frequency recommended to maintain consistent drug levels.
What are the most serious risks associated with Orladeyo?+
Serious, though rare, risks include anaphylaxis, severe allergic reactions, paradoxical angioedema, and significant liver enzyme elevations. Patients should seek immediate medical attention if they experience symptoms such as difficulty breathing, swelling of the face or throat, or signs of liver dysfunction.
Who should not use Orladeyo?+
Orladeyo is contraindicated in individuals with known hypersensitivity to berotralstat or any tablet excipients. Patients with severe hepatic impairment should avoid use, and those taking medications that strongly interact with CYP3A4 should be evaluated carefully by their healthcare provider.
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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