Product image of Orladeyo (Berotralstat) supplied by GNH India

Orladeyo

Active Ingredient:
Berotralstat
Origin:
EU

Orladeyo (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 India 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.

Manufacturer / TM Owner

Biocryst Ireland Limited

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Indications & Clinical Uses

  • 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.

How It Works

  • Berotralstat reversibly inhibits plasma kallikrein, the enzyme that cleaves high‑molecular‑weight kininogen to generate bradykinin. By lowering kallikrein activity, the drug decreases bradykinin production, a peptide that increases vascular permeability and triggers swelling. The resulting reduction in bradykinin levels helps prevent the episodic edema characteristic of hereditary angioedema.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

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.

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.

To order Orladeyo, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India 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.

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.

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.

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.

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.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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