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How is orladeyo administered? A guide to oral use for HAE

3 min read

Orladeyo is the first and only oral medication approved by the FDA for the prophylactic treatment of hereditary angioedema (HAE) attacks. Its introduction marked a significant advancement for patients who previously relied on injectable or infused therapies for prevention. A key part of its effectiveness lies in understanding precisely how is orladeyo administered to manage the condition successfully.

Quick Summary

Orladeyo (berotralstat) is administered orally as a capsule once daily with food to prevent hereditary angioedema (HAE) attacks in eligible patients. Adjustments to administration may be necessary for individuals with moderate to severe liver impairment or those experiencing persistent gastrointestinal side effects. It is not intended for the treatment of acute HAE attacks.

Key Points

  • Oral Capsule: Orladeyo is administered as a capsule, taken by mouth once daily.

  • Take with Food: To improve absorption and minimize gastrointestinal side effects, it must be taken with a meal.

  • Consistency is Key: For optimal effectiveness, take the capsule around the same time each day.

  • Administration Adjustment: Adjustments to administration may be used for patients with liver impairment, persistent GI side effects, or those taking certain interacting medications.

  • Prophylaxis Only: Orladeyo is for preventing HAE attacks, not for treating an acute attack that is already in progress.

  • No Extra Doses: Never take more than one capsule per day, as higher amounts can lead to serious heart rhythm problems.

  • Missed Dose Guidance: If a dose is missed, take it as soon as you remember, unless it's nearly time for the next dose. Do not double up.

In This Article

Oral Administration: The Core of Orladeyo Treatment

Orladeyo (berotralstat) is a prescription medicine delivered as an oral capsule, differentiating it from many other HAE treatments that are injectable. This makes its administration more convenient for many patients, provided the instructions are followed correctly to ensure maximum effectiveness and safety.

Administration and Timing

For most eligible patients, Orladeyo is taken by mouth once daily.

To help maintain consistent medication levels, it is recommended to take the capsule around the same time every day. The capsule must be swallowed whole and should never be opened, crushed, or chewed.

The Importance of Taking Orladeyo with Food

One of the most critical administration instructions for Orladeyo is to take it with food.

  • Enhances Absorption: Taking Orladeyo with a meal can improve the body's absorption of the medication, potentially leading to more consistent levels in the bloodstream.
  • Reduces Side Effects: Gastrointestinal issues like stomach pain, diarrhea, and vomiting are among the most common side effects, especially when treatment begins. Taking the capsule with food can help mitigate these effects.

Potential Administration Adjustments

While a standard approach is used for many, a healthcare provider may recommend adjustments to the administration in certain situations. A healthcare provider will determine if changes are necessary based on a patient's specific health profile. Potential reasons for adjustment include:

  • Moderate to Severe Liver Impairment: Patients with moderate or severe hepatic impairment (Child-Pugh B or C) may require adjustments because liver function affects how the body processes the medication.
  • Persistent Gastrointestinal Reactions: If a patient experiences ongoing and bothersome gastrointestinal side effects, a healthcare provider may adjust the administration plan. These side effects often lessen over time, but adjustments can be considered if they persist.
  • Chronic Use of Certain Medications: Taking specific P-gp or BCRP inhibitor medications, such as cyclosporine, can affect how Orladeyo is processed by the body. In these cases, adjustments to administration may be recommended.

Not for Acute Attacks: A Key Distinction

It is crucial for patients and caregivers to understand that Orladeyo is a prophylactic treatment, designed to prevent HAE attacks from occurring. It is not an on-demand medication and should never be used to treat an active attack. For managing an acute HAE attack, patients should use their prescribed "on-demand" treatment.

Taking extra Orladeyo is not recommended and can be dangerous. Doing so can lead to a serious heart rhythm problem called QT prolongation.

Taking Orladeyo vs. Takhzyro

To illustrate the unique administration of Orladeyo, here is a comparison with Takhzyro, another HAE prophylactic treatment.

Feature Orladeyo (berotralstat) Takhzyro (lanadelumab)
Administration Method Oral capsule, taken by mouth. Subcutaneous injection.
Frequency Once daily. Every 2 or 4 weeks.
Dose Format Capsules available. Pre-filled syringe or vial.
With Food Must be taken with food. Does not require administration with food.
Patient Involvement Patient-administered capsule at home. Patient-administered injection at home or with healthcare provider assistance.
Acute Attacks Not for treating acute attacks. Not for treating acute attacks.

How to Manage a Missed Dose

Adherence to a daily schedule is important for maintaining consistent drug levels and helping to prevent attacks. If a dose is missed, patients should take it as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped. Patients should never take additional doses to make up for a missed one, as this increases the risk of serious side effects. For clarification on any missed doses, a pharmacist or healthcare provider should be consulted.

Conclusion: A Simple Yet Strict Regimen

In conclusion, Orladeyo is administered orally as a single daily capsule, providing a convenient alternative to injectable therapies for HAE prophylaxis. The administration protocol is straightforward but strict: take one capsule once daily with food, at roughly the same time each day. It is critical to adhere to the prescribed administration plan and never use it for acute attacks. By following these clear administration guidelines and communicating any issues with a healthcare provider, patients can potentially manage their HAE and improve their quality of life. For additional information, patients can visit the manufacturer's official website at www.ORLADEYO.com.

Frequently Asked Questions

Orladeyo is typically taken once daily by mouth with food.

Yes, you must take Orladeyo with food. This can help your body absorb the medication better and may reduce the risk of gastrointestinal side effects.

No, Orladeyo is not for treating acute HAE attacks. It is a prophylactic treatment for attack prevention. You should use your specific on-demand rescue medication for an active attack.

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Never take extra doses.

Yes, Orladeyo is available in different strengths of capsules. A healthcare provider will determine the appropriate strength for a patient.

Orladeyo capsules should be stored at room temperature, between 68ºF and 77ºF (20ºC to 25ºC). Keep the capsules in their original packaging and out of reach of children.

Yes, Orladeyo is approved for pediatric patients aged 12 years and older.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.