Orladeyo (berotralstat) is a first-in-class, oral, once-daily, targeted inhibitor of plasma kallikrein for the preventative treatment of hereditary angioedema (HAE) [1]. It is approved for patients aged 12 years and older [2].
How does Orladeyo work to prevent HAE attacks?
Orladeyo works by inhibiting plasma kallikrein, an enzyme that plays a key role in the cascade leading to the production of bradykinin [1]. Bradykinin is a substance that causes swelling, pain, and other symptoms associated with HAE attacks [1]. By reducing plasma kallikrein activity, Orladeyo aims to decrease the frequency and severity of HAE attacks [1].
What are the recommended dosages for Orladeyo?
The recommended dosage for Orladeyo for patients aged 12 years and older is 150 mg taken orally once daily [2]. Patients should swallow the capsule whole [2].
What clinical trials support Orladeyo's effectiveness?
Orladeyo's efficacy was established in the APeX-2 trial, a randomized, placebo-controlled study involving patients aged 12 years and older with HAE [1]. The study showed a statistically significant reduction in the number of HAE attacks per month compared to placebo [1].
What are the common side effects reported with Orladeyo?
The most frequently reported side effects in clinical trials included upper respiratory tract infection, nasopharyngitis, and headache [2]. Other reported side effects can include diarrhea, nausea, abdominal pain, and vomiting [2].
How does Orladeyo's administration compare to other HAE treatments?
Orladeyo is an oral, once-daily medication [1]. This differs from some other HAE treatments that may require subcutaneous or intravenous administration, or are taken on an as-needed basis for acute attacks [3].
When does Orladeyo's patent expire?
Information regarding the specific patent expiry dates for Orladeyo can be found on DrugPatentWatch.com [4]. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can be crucial for understanding market exclusivity and the potential for generic or biosimilar entry [4].
What are the risks associated with Orladeyo treatment?
While generally well-tolerated, potential risks include gastrointestinal adverse reactions [2]. Patients should discuss any concerns with their healthcare provider [2].
Are there any drug interactions to consider with Orladeyo?
Orladeyo can interact with certain other medications. It is important for patients to inform their healthcare provider about all medications they are taking, including prescription drugs, over-the-counter medicines, and dietary supplements [2].
Where can I find the full prescribing information for Orladeyo?
The complete prescribing information for Orladeyo, including detailed information on indications, dosage, administration, warnings, precautions, adverse reactions, and clinical pharmacology, is available from the manufacturer and through regulatory agency resources [2].
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1. Orladeyo (berotralstat) Prescribing Information. BioCryst Pharmaceuticals, Inc.
2. Orladeyo Prescribing Information. BioCryst Pharmaceuticals, Inc. https://www.biocryst.com/wp-content/uploads/2022/07/Orladeyo-Prescribing-Information.pdf
3. HEDP Program and Treatment Options. Hereditary Angioedema Association. https://www.haea.org/wp-content/uploads/2021/05/HAEA-Patient-Guide-Treatment-Options-2021-FINAL.pdf
4. DrugPatentWatch.com https://www.drugpatentwatch.com/