Joenja

About Joenja 

• Joenja is an antineoplastic group belonging to the pharmacological family called PI3K (phosphoinositide 3-kinase delta) Inhibitors. 
• Joenja is a prescription medication designed to address activated phosphoinositide 3-kinase delta syndrome (APDS). 
• APDS is a rare genetic disorder affecting the immune system. APDS is a type of primary immunodeficiency disorder that heightens susceptibility to infections. It results from genetic mutations in either the PIK3CD or PIK3R1 genes, leading to overactivity in the PI3Kδ (phosphoinositide 3-kinase delta) pathway. 
• Proper signaling in the PI3Kδ pathway is crucial for the normal development and functioning of immune cells in the body. 
• APDS symptoms include recurrent and severe infections in the ears, sinuses, upper and lower respiratory tracts, as well as autoimmune and inflammatory symptoms. 
• Individuals with APDS may also face an elevated risk of developing cancers like lymphoma. 
• Joenja, as a selective PI3Kδ inhibitor, treats APDS by blocking the production of phosphatidylinositol-3-4-5-trisphosphate, a cellular messenger that regulates numerous cell functions.

Strength: 

Tablet: Joenja tablet are delivered in a strength of 70 mg, respectively, for oral consumption.

Recommended Dosage:

Swallow the tablet as a whole with water; do not crush, chew or mixed it in the water. 

• In adults and pediatric patients aged 12 and older who weigh 45 kg or more, the recommended Joenja tablet dosage is 70 mg to be taken orally twice a day, with a 12-hour gap between doses, and it can be taken with or without food. There is no specified dosage for patients weighing less than 45 kg.
• Patients should be instructed that if they miss a dose by more than 6 hours, they should wait and take the next dose at the regular scheduled time.
• Patients should also be informed that if they vomit within 1 hour after taking Joenja, they should take another dose as soon as possible. However, if vomiting occurs more than 1 hour after the scheduled dose, they should wait and take the next dose at the usual time.

Important

To ensure the effectiveness of Joenja, it’s essential not to miss any doses. If you happen to miss a dose, take it as soon as you remember. However, if your next dose is approaching, skip the missed one and return to your regular dosing schedule. Never take two doses together. 

Make sure to keep your doctor informed about all the medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, as some of them could interact with Joenja and potentially lead to severe side effects. If you have any questions or concerns regarding the use of this medication, discuss them with your doctor. It’s crucial to follow these instructions diligently to maximize the medicine’s benefits while minimizing the risk of side effects.

Warnings & Precautions

• Live, attenuated vaccines may have reduced effectiveness when administered while receiving Joenja treatment.
• Joenja can cause harm to an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant.
• It is advised to use effective birth control during treatment, and for one week after the last dose.
• Pregnancy status should be excluded prior to initiation of Joenja
• Joenja is not recommended for use in patients with moderate to severe hepatic impairment. 
• Patients should inform their healthcare provider about all their medical conditions before starting Joenja treatment. 

Common Joenja SideEffects:

• Headache
• Sinusitis
• Atopic dermatitis
• Diarrhea
• Fatigue
• Tachycardia
• Cough
• Nausea
• Abdominal pain
• Back pain
• Fever
• Neck pain
• Hair loss

Use in Specific Population

• Safety and effectiveness of Joenja for treating activated phosphoinositide 3-kinase delta syndrome have been proven in patients aged 12 and older, supported by well-controlled studies in both adults and pediatric patients of the same age group. 
• There is no recommended dose for pediatric patients aged 12 and older weighing less than 45 kg. However, its safety and efficacy haven’t been established for those under 12.
• Regarding juvenile animal studies, tests on young rats showed that high doses of Leniolisib led to fatalities and delayed puberty in some cases, while a dose with no discernible effects was identified at lower exposure levels.
• In terms of geriatric use, it’s unclear whether response of Joenja in patients aged 65 and older differs from that in younger adults since no such studies were conducted.

Storage and Handling

• Joenja should be stored refrigerated at 2°C to 8°C (36°F to 46°F) within the original carton to shield it from light. 
• Keep in the original container at a temperature range of 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C to 30°C (59°F to 86°F) in accordance with USP Controlled Room Temperature guidelines. 
• Do not refrigerate or freeze the products. Keep the medicine away from light and moisture.