Leniolisib dosing, indications, interactions, adverse effects, and more

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Dosing & Uses

Activated Phosphoinositide 3-kinase Delta Syndrome

Pending FDA approval for treatment of immune dysregulation in activated phosphoinositide 3-kinase delta syndrome (APDS), formerly known as PASLI disease

Mechanism of Action

Selective PI3Kδ kinase inhibitor; inhibition reduces hyperactivity in the PI3K/AKT pathway

Balanced signaling in PI3Kδ pathway is essential for physiological immune function; when the pathway is hyperactive, immune cells fail to mature and function properly, leading to immunodeficiency and dysregulation

Leniolisib inhibits phosphatidylinositol-3-4-5-trisphosphate (PIP3) production; PIP3 is a cellular messenger that activates protein kinase B (AKT) via PDK1 and regulates many cell functions (eg, proliferation, differentiation, cytokine production, cell survival, angiogenesis, metabolism)

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Patient Handout

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections leniolisib
Dosing & Uses
Pharmacology
Images
Patient Handout
Formulary

leniolisib (Rx)

Dosing & Uses

Activated Phosphoinositide 3-kinase Delta Syndrome

Pharmacology

Mechanism of Action

Images

Patient Handout

Formulary

Plans

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