Joenja (leniolisib) is an oral medication that’s used to treat a rare genetic condition called activated phosphoinositide 3-kinase delta syndrome (APDS), which affects your immune system. It’s for people 12 years of age and older who weigh 99 lbs or more. Joenja (leniolisib) can cause inflammation-related side effects such as sinus pressure and headaches.
When you have APDS, there’s a protein in your immune system called phosphoinositide 3-kinase (PI3K) delta that doesn’t function correctly. As a result, your immune system becomes weak. This raises your chances of getting sick and catching infections.
Joenja (leniolisib) is a kinase inhibitor known as PI3K delta inhibitor. It works by blocking the PI3K delta protein’s activity. This helps regulate your immune system and protect your body from infection.
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.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
If you miss your Joenja (leniolisib) dose by more than six hours or vomit more than one hour after taking the medication, skip that dose. Then, wait to take your next dose at the regular time you take your medication. But if you vomit within one hour of taking Joenja (leniolisib), you should take another dose as soon as possible. To avoid missing doses, try placing your medication in an area where you’ll see it every day. You can also set a reminder on your phone or use a pill organizer to help you remember to take Joenja (leniolisib).
If your skin gets dry or itchy while you’re taking Joenja (leniolisib), try keeping it moisturized throughout the day. To help add moisture to your skin, you can apply a moisturizing lotion to your skin during the day or try using a humidifier in your home. There are many over-the-counter (OTC) products, like skin moisturizers (Vaseline, Aquaphor) and hydrocortisone, that can help with skin irritation as well. Talk to your pharmacist or healthcare provider about which OTC product might be right for you. They can also recommend other ways to help treat or prevent dry, itchy, or irritated skin.
So far, one small clinical study showed that people who took Joenja (leniolisib) for 3 months noted improvements in immune-related symptoms of APDS. For example, people who took Joenja (leniolisib) had a larger rise in the amount of certain white blood cells in their body than people who took placebo. Their lymph nodes also shrunk more noticeably than those of people who took placebo. These improvements are important because people with APDS typically have low numbers of white blood cells, which raise their risk of infection. They can also have swollen lymph nodes, which can be a sign of infection. In fact, it’s common for people with APDS to get ear, sinus, upper respiratory tract, and lung infections that won’t go away or come back often. It’s not known whether Joenja (leniolisib) helps with other symptoms of APDS, such as long-term coughing and stomach pain.
Maybe. It’s best to get all routine or recommended vaccinations before starting Joenja (leniolisib). And once you start treatment, let your healthcare provider know that you’re taking this medication before getting any vaccines. They can discuss with you whether it’s okay for you to get vaccinated. Some vaccines, such as live vaccines, might not work as well if you get them while you’re taking Joenja (leniolisib). These vaccines include the measles, mumps, and rubella vaccine (MMR) and varicella (chicken pox) vaccine. It’s not known whether other vaccines, such as influenza (flu) and Tdap (tetanus, diphtheria, and pertussis), interact with Joenja (leniolisib).
It’s not known whether Joenja (leniolisib) is found in breast milk or what harm it can cause to your infant if you choose to breastfeed during treatment. There’s a possible risk that your infant can experience serious side effects from the medication if the medication does pass into your breast milk. Because of this, you’re recommended to avoid breastfeeding while taking Joenja (leniolisib) until 1 week after your last dose. Talk to your healthcare provider about the risks and benefits if you’re considering breastfeeding while taking Joenja (leniolisib).
Joenja (leniolisib) 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.
Based on animal studies, it’s possible that Joenja (leniolisib) can cause harm or birth defects to an unborn baby when taken during pregnancy. While Joenja (leniolisib) hasn’t been studied in human pregnancy, it’s important to be aware of this risk. If you're able to get pregnant, you must take a pregnancy test before starting this medication. Make sure to use birth control while you’re taking Joenja (leniolisib) as well as 1 week after your last dose. Talk to your healthcare provider if you think you might be pregnant or are wanting to become pregnant.
Talk to your healthcare provider before getting any vaccines while you’re taking Joenja (leniolisib). Your provider can check to see whether the vaccine is safe for you. Certain vaccines might not work as well to protect you from infection if you get them while you’re taking Joenja (leniolisib). These include live vaccines, such as measles, mumps, and rubella (MMR), varicella (chicken pox), yellow fever, and rotavirus vaccines.
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 70mg | 60 tablets | $48,951.85 | $815.86 |
Joenja (leniolisib) is a tablet that you take by mouth. The typical dose is 70 mg by mouth twice a day (about every 12 hours).