
Orladeyo
Orladeyo (berotralstat) is a plasma kallikrein inhibitor. It's taken once daily to prevent swelling attacks in the body in adults and children 12 years and older with a genetic condition called hereditary angioedema (HAE). Orladeyo (berotralstat) is the only currently available HAE medication that's taken by mouth. Side effects include stomach pain, vomiting, and diarrhea, but they should get better over time as you continue to take the medication.
What is Orladeyo (berotralstat)?
What is Orladeyo (berotralstat) used for?
- Prevention of hereditary angioedema (HAE) attacks in people 12 years and older
How Orladeyo (berotralstat) works
Orladeyo (berotralstat) is a plasma kallikrein inhibitor. It blocks the activity of kallikrein, which is a protein in your blood that's involved in causing swelling and pain related to hereditary angioedema (HAE). By lowering kallikrein activity, Orladeyo (berotralstat) can help prevent pain and swelling attacks in people with HAE.
Drug facts
| Common Brands | Orladeyo |
|---|---|
| Drug Class | Plasma kallikrein inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Orladeyo (berotralstat)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Stomach pain (16%)
- Vomiting (12%)
- Diarrhea (12%)
- Headache (9%)
- Heartburn (7%)
Less Common Side Effects
- Back pain
- Fatigue
- Passing gas
Orladeyo (berotralstat) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Abnormal heart rhythm (QT prolongation): chest pounding, irregular heartbeat, chest pain, short of breath, feeling faint or lightheaded
The following Orladeyo (berotralstat) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Orladeyo (berotralstat)
Pros
- Works well to prevent HAE attacks
- The only HAE medication that's taken by mouth (i.e., not an injection)
- Need to take only once per day
Cons
- Can't treat an HAE attack that's already happening
- Can cause stomach upset (e.g., stomach pain, vomiting, diarrhea)
- Can't use in children under 12 years old because it hasn't been studied yet
Pharmacist tips for Orladeyo (berotralstat)
- Orladeyo (berotralstat) is only meant to be used to prevent HAE attacks, so you should have a different medication on hand to use if you experience a sudden HAE attack.
- Take Orladeyo (berotralstat) exactly as prescribed and at the same time every day with food. Don't take more doses or higher doses than prescribed because this can raise your risk for side effects, including a serious and potentially life-threatening heart rhythm problem (QT prolongation).
- Don't open, crush, or chew the capsules. Contact your provider if you're having trouble swallowing the capsules. You might need to switch to a different medication to help prevent HAE attacks.
- Side effects like stomach upset and heartburn typically get better or go away with time as you continue to take Orladeyo (berotralstat). Talk to your provider if any side effects become too bothersome. Your provider can recommend treatment options to ease these side effects or suggest to lower your Orladeyo (berotralstat) dose.
- Don't start any new medications while you're taking Orladeyo (berotralstat) without asking your provider or pharmacist first. Orladeyo (berotralstat) can interact with other medications, such as digoxin (Lanoxin) and cyclosporine (Sandimmune or Neoral). Your providers can check for interactions to make sure your medications are safe to take.
- Let your provider know if you're pregnant, planning to become pregnant, or breastfeeding before you start taking Orladeyo (berotralstat). It's not known whether the medication can harm your unborn baby or pass into breast milk because it hasn't been studied.
Risks and warnings for Orladeyo (berotralstat)
Orladeyo (berotralstat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Life-threatening abnormal heart rhythm (QT prolongation) with higher-than-recommended doses
- Risk factors: Taking more than 150 mg of Orladeyo (berotralstat) per day | History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | Personal or family history of long QT syndrome | Abnormal electrolyte levels | Taking other medications that cause QT prolongation
Taking more than the daily recommended dose — 150 mg of Orladeyo (berotralstat) per day — can raise your risk of a serious and potentially life-threatening heart rhythm problem called QT prolongation, or long QT syndrome. This happens when your heart doesn't contract and relax when it's supposed to, which can lead to an abnormal heart rhythm.
Let your providers know about your medical history and all the medications you take so they can check your risk for QT prolongation. Your risk might be higher if you have other heart rhythm problems or if you take medications that also cause QT prolongation.
Call your provider right away if you accidentally took more than your prescribed dose of Orladeyo (berotralstat). And call 911 right away if you experience chest pain, shortness of breath, lightheadedness, or abnormal heart rhythm.
Orladeyo (berotralstat) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 28 capsules of 150mg | 1 carton | $48,884.79 | $48,884.79 |
| 28 capsules of 110mg | 1 carton | $48,884.79 | $48,884.79 |
| 28 packets of 96mg | 1 carton | $47,736.83 | $47,736.83 |
| 28 packets of 108mg | 1 carton | $47,736.83 | $47,736.83 |
| 28 packets of 132mg | 1 carton | $47,736.83 | $47,736.83 |
| 28 packets of 72mg | 1 carton | $47,736.83 | $47,736.83 |
Typical dosage for Orladeyo (berotralstat)
The typical dose is 150 mg by mouth once daily with food.
Your dose might differ if you have liver problems or if you're having side effects that don't go away with time.
How much does Orladeyo (berotralstat) cost?
$47,736.83
What are alternatives to Orladeyo (berotralstat)?
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