APDS Assist

Hi. Welcome to APDS Assist. We are a comprehensive program and our goal is to make sure patients with activated PI 3-K delta syndrome, or APDS, who are prescribed Joenja receive their medication as quickly and conveniently as possible. APDS Assist helps patients access Joenja and assists with the prescriptions process and refills. We also offer personalized help to patients prescribed Joenja. To make sure APDS Assist runs smoothly, we rely on our care coordinators and APDS Assist pharmacist. Care coordinators are the primary point of contact for the physician’s office, as well as patients and their loved ones when there are questions around access and shipment of Joenja.

Care coordinators help in many ways. They work with the physician’s office and the patient to identify insurance coverage and access needs. Care coordinators can also connect the patient and their caregiver with an APDS clinical educator, or ACE, who is there to advocate, educate, and be a compassionate resource throughout the Joenja journey. Finally, care coordinators can inform physicians and patients about the Joenja Starter program for eligible patients. This program allows quick access to Joenja while the physician’s office works with the insurance company to establish coverage. The APDS Assist pharmacist offers personalized help to each and every patient, assisting with questions about prescription coordination and fulfillment, prior authorization, and the importance of taking their medication as directed by their doctor. The APDS Assist pharmacist is also a knowledgeable resource who can answer questions about receiving and taking Joenja for questions about your health, your healthcare provider should be the primary resource. We know the treatment journey for APDS is different for everyone. At APDS Assist, it’s our goal to open more doors so patients with APDS can move forward with their Joenja treatment.

On screen:
JOENJA^® (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older and
weighing 27 kg or more.

Important Safety Information
Verify pregnancy status in females of reproductive potential prior to initiating treatment with JOENJA.

JOENJA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus and to use highly effective methods of contraception during treatment with JOENJA and for 1 week after the last dose. Additionally, advise women not to breastfeed during treatment with JOENJA and for 1 week after the last dose.

Live, attenuated vaccinations may be less effective if administered during JOENJA treatment.

JOENJA may cause hypersensitivity reaction(s), including anaphylaxis. Advise patients to discontinue JOENJA and to seek immediate medical attention if they develop any signs and symptoms of serious allergic reactions.

Use of JOENJA in patients with moderate to severe hepatic impairment is not recommended. There is no recommended dosage for patients weighing less than 27 kg.

Avoid co-administration of JOENJA with other medications known to be strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, or BCRP, OATP1B1, and OATP1B3 substrates.

Adult and pediatric patients 12 years of age and older: The most common adverse reactions (incidence >10%) seen in clinical trials were headache, sinusitis, atopic dermatitis, and weight gain.

Pediatric patients 4 to 11 years of age: The most common adverse reactions (incidence >10%) were headache, cough, pyrexia, vomiting, diarrhea, and sinusitis.

Seven (33%) patients in the adult and pediatric patients 12 years and older (Study 2201) and 10 (47.6%) of pediatric patients 4 to 11 years of age (Study 3301 Part 1) receiving JOENJA developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL. No patients in either study developed an ANC <500 cells/microL and there were no reports of infection associated with neutropenia.

Joenja is available in 40 mg, 50 mg, and 70 mg tablets.

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