Orladayo (Berotralstat)

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Non-english packaging - English label and English insert included. Plan in advance - allow us 7 days to ship your medicine

Marketing Authorisation Holder in Europe: BioCryst Ireland Limited Block 4, Harcourt Centre, Harcourt Road, DUBLIN 2, D02HW77 Ireland Manufacturer in Europe Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60

Information about Orladayo (Berotralstat)

Orladayo (Berotralstat) is an oral medication used for the prevention of hereditary angioedema (HAE) attacks. HAE is a rare, genetic disorder characterized by recurrent episodes of swelling (angioedema) that can affect the skin, gastrointestinal tract, and airway. Orladayo works by inhibiting the C1 esterase inhibitor (C1-INH) pathway, a key component in the inflammatory response that causes swelling during an HAE attack. By reducing the frequency of these attacks, Orladayo improves quality of life for individuals with this condition.

Product Highlights

• Orladayo is specifically indicated for the long-term prevention of HAE attacks in individuals aged 12 years and older. HAE is a genetic disorder that causes episodes of severe swelling in various parts of the body, including the hands, feet, face, airways, and gastrointestinal system.
• By inhibiting the bradykinin-producing pathway, Orladayo helps to reduce the frequency of angioedema attacks, potentially preventing life-threatening episodes, such as those involving the airway.

Key Ingredient

• Berotralstat

Key Benefits of Orladayo (Berotralstat)

• Orladayo is designed to reduce the frequency of angioedema attacks in people with hereditary angioedema, leading to fewer episodes of painful and disabling swelling.
• Unlike some other HAE treatments that require intravenous or subcutaneous administration, Orladayo is taken as an oral capsule, which offers convenience for long-term management.
• By reducing the frequency and severity of HAE attacks, Orladayo can improve a patient’s overall quality of life, reducing the need for emergency treatments and hospitalization.
• Orladayo is taken once daily, which improves patient compliance compared to medications that require more frequent dosing.

Direction of Use

• The recommended starting dose of Orladayo is 150 mg once daily. Depending on the individual's response and tolerability, the dose may be adjusted to 200 mg once daily if needed.
• Orladayo should be taken once daily with food. The capsules should be taken whole and not broken, chewed, or crushed.
• It is important to take Orladayo at the same time each day to help remember and maintain a consistent level of the medication in the body.
• The dose may be adjusted based on clinical response, and the healthcare provider will guide you on whether a higher or lower dose is necessary.

Safety Concerns

• Berotralstat may affect liver function. Liver enzyme levels should be monitored during treatment, especially if the patient has pre-existing liver conditions.
• Some patients may experience gastrointestinal issues such as nausea, abdominal pain, or diarrhea. These side effects are usually mild but should be monitored.
• Orladayo may interact with other medications, especially those that affect liver enzymes. It is important to inform the healthcare provider about all other medications being taken, including over-the-counter drugs, vitamins, and herbal supplements.
• Although rare, allergic reactions such as skin rashes, swelling, or difficulty breathing can occur. Seek medical attention if any signs of an allergic reaction are present.
• While not common, kidney problems may occur, and patients with existing kidney conditions should use Orladayo with caution.
• The safety of Orladayo during pregnancy and breastfeeding has not been fully established. It should be used during pregnancy only if clearly needed, and breastfeeding while on Orladayo should be discussed with a healthcare provider.

Avoid Orladayo (Berotralstat) If

• Avoid Orladayo if you have a known allergy or hypersensitivity to berotralstat or any of the other ingredients in the medication.
• Orladayo is contraindicated in individuals with severe liver impairment (e.g., cirrhosis or active liver disease). Liver function should be evaluated prior to initiating treatment.
• Caution is advised in patients with severe kidney disease, and it may not be suitable for individuals with compromised renal function.
• Orladayo should be used during pregnancy only if the potential benefit justifies the risk to the fetus. There is limited data on its use in pregnant women, so it should be avoided unless deemed absolutely necessary by the healthcare provider.
• It is not known whether berotralstat passes into breast milk. Women who are breastfeeding should discuss the risks and benefits of using Orladayo with their healthcare provider.