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Orladeyo
Orladeyo (generic name: berotralstat) is an oral medication used for the prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. Hereditary angioedema is a rare genetic disorder that causes recurrent episodes of swelling in various parts of the body, such as the hands, feet, face, airways, and gastrointestinal tract. Orladeyo works by inhibiting plasma kallikrein, an enzyme that plays a central role in the overproduction of bradykinin, a protein that leads to swelling during HAE attacks. By controlling kallikrein activity, Orladeyo helps reduce the frequency of these attacks.
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Frequently Asked Questions
How long does it take for Orladeyo to start working?
Orladeyo starts working within a few days to reduce the frequency of HAE attacks. However, it may take a few weeks to see the full benefit of the medication.
Can Orladeyo be used to treat an active HAE attack?
No, Orladeyo is not used to treat an active HAE attack. It is designed to prevent future attacks. For treating acute attacks, other medications like Firazyr or Berinert may be prescribed.
What should I do if I miss a dose of Orladeyo?
If you miss a dose, take it as soon as you remember. If it is close to your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses.
Can Orladeyo be taken with other HAE medications?
Yes, Orladeyo is often taken in combination with other HAE medications, such as acute treatments for on-demand use. However, always consult your doctor before adding any other medications to your regimen.
Is Orladeyo safe for long-term use?
Yes, Orladeyo is considered safe for long-term use when taken as prescribed. Regular monitoring of liver function and overall health is recommended to ensure the medication remains safe and effective.
Comprehensive Drug Guide
How Does Orladeyo Work?
Orladeyo works by inhibiting the activity of plasma kallikrein, which is responsible for the excessive production of bradykinin, a protein that leads to swelling during an HAE attack. By preventing kallikrein from producing too much bradykinin, Orladeyo helps reduce the risk of swelling episodes, preventing the onset of angioedema attacks.
Common Dosages
- 150 mg capsules
Typical Dosing
- The typical dose of Orladeyo for preventing HAE attacks is 150 mg once daily, taken orally.
- The capsules should be swallowed whole with water and can be taken with or without food.
- For patients with certain kidney or liver conditions, the dose may be adjusted by a healthcare provider.
Typical Dosing
FDA Approved Indications
- Prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older.
Who Shouldn't Take Orladeyo?
- Known hypersensitivity to berotralstat or any of the components in the formulation.
- Severe renal impairment or end-stage renal disease.
- Severe hepatic impairment.
Advice From The Pharmacist
- Take Orladeyo once daily, at the same time each day, to maintain consistent blood levels of the medication.
- Orladeyo can be taken with or without food, but taking it with food may reduce the likelihood of stomach upset.
- Do not crush or chew the capsules; swallow them whole with water.
- Avoid missing doses, as this may increase the risk of HAE attacks. If you do miss a dose, take it as soon as you remember, unless it is close to your next scheduled dose. Do not double up doses.
- Continue taking Orladeyo as prescribed even if you are not experiencing symptoms, as it helps prevent future attacks.
- Store Orladeyo at room temperature, away from moisture and heat.
Side Effects of Orladeyo
Common Side Effects
- Nausea
- Diarrhea
- Abdominal pain
- Back pain
- Fatigue
Uncommon/Severe Side Effects
- Liver problems, such as elevated liver enzymes, which may require regular monitoring through blood tests.
- Hypersensitivity reactions, including rash, swelling, or difficulty breathing.
Risks and Warnings of Orladeyo
- Liver Function: Orladeyo may cause liver enzyme elevations. It is important for patients to have their liver function monitored regularly while taking the medication, especially in those with pre-existing liver conditions.
- Cardiovascular Risks: Although rare, Orladeyo may cause a slight increase in the risk of arrhythmias (irregular heartbeat) in some patients. Patients with a history of heart problems should inform their doctor before starting the medication.
- Drug Interactions: Orladeyo can interact with certain other medications, particularly those metabolized by CYP2D6 or CYP3A4 enzymes. Your healthcare provider may need to adjust the dose or monitor for potential interactions.
Interactions with Orladeyo
Common Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): These drugs can increase the concentration of Orladeyo in the blood, potentially increasing the risk of side effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine): These drugs can reduce the effectiveness of Orladeyo by increasing its metabolism.
- P-glycoprotein inhibitors (e.g., verapamil, cyclosporine): These medications can also affect how Orladeyo is processed in the body.
Alternatives to Orladeyo
- Takhzyro (lanadelumab): A monoclonal antibody used for the prevention of HAE attacks, administered by subcutaneous injection.
- Haegarda: A C1 esterase inhibitor that is used to prevent HAE attacks, administered via subcutaneous injection.
- Cinryze: Another C1 esterase inhibitor used for the prevention of HAE attacks, given intravenously.
