Version May 2024
Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, treatment: Children ≥12 years and Adolescents, weighing ≥45 kg: Oral: 70 mg every 12 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Children ≥12 years and Adolescents, weighing ≥45 kg: Oral:
Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied. Leniolisib is metabolized extensively (60%) by the liver; monitor closely.
Moderate to severe impairment: Use not recommended; has not been studied.
(For additional information see "Leniolisib: Drug information")
Activated phosphoinositide 3-kinase delta syndrome: Oral: Weight ≥45 kg: 70 mg twice daily, approximately every 12 hours (Ref).
Missed dose : If a dose is missed by >6 hours, skip the missed dose and administer the next dose at the usual time. If a dose is vomited ≤1 hour after administration, administer another dose as soon as possible; if vomited >1 hour after administration, do not readminister the dose (administer the next dose at the usual time).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Moderate to severe impairment (Child-Pugh class B or C): Use is not recommended (effect on leniolisib pharmacokinetics has not been studied).
Neutropenia has been reported with leniolisib. In a clinical study, this absolute neutrophil count (ANC) decrease did not result in infections and was considered mild and transient. No ANC <500 cells/µL or events ≥ grade 3 were reported (Rao 2023).
Transient and mild neutropenia has been reported with leniolisib. In clinical studies, an absolute neutrophil count (ANC) <500 cells/µL, events ≥ grade 3, and infection were not reported (Rao 2023).
Onset: Intermediate; nadir at day 15 with recovery by day 85 has been reported (Rao 2023).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults and adolescents.
>10%:
Dermatologic: Atopic dermatitis
Hematologic & oncologic: Neutropenia
Nervous system: Headache
Respiratory: Sinusitis
1% to 10%:
Cardiovascular: Tachycardia
Dermatologic: Alopecia
Gastrointestinal: Diarrhea
Nervous system: Fatigue
Neuromuscular & skeletal: Back pain, neck pain
Miscellaneous: Fever
There are no contraindications listed in the manufacturer's labeling.
Other warnings/precautions:
• Immunizations: Live attenuated vaccinations may be less effective when administered during leniolisib treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as phosphate:
Joenja: 70 mg
No
Tablets (Joenja Oral)
70 mg (per each): $944.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer with or without food. If patient vomits ≤1 hour after dose, readminister dose as soon as possible; if patient vomits >1 hour after dose, do not readminister dose; wait and administer next dose at scheduled time.
Missed dose: If dose missed by >6 hours, wait and take next dose at scheduled time.
Oral: Administer doses approximately every 12 hours, with or without food. If vomiting occurs ≤1 hour after administration, administer another dose as soon as possible. If vomiting occurs >1 hour after administration, do not readminister the dose; wait and administer the next dose at the usual time.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F); do not refrigerate. Store and dispense in original container.
Treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (FDA approved in ages ≥12 years and adults).
Joenja may be confused with Jolessa, Jorveza.
Leniolisib may be confused with alpelisib, copanlisib, duvelisib, idelalisib, lenvatinib.
Substrate of BCRP/ABCG2, CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Leniolisib may increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Leniolisib may increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Leniolisib. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May decrease the serum concentration of Leniolisib. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Leniolisib. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Leniolisib. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors): Leniolisib may increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Vaccines (Live): Leniolisib may diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
Evaluate pregnancy status prior to use; verify the patient is not pregnant prior to treatment initiation (in patients who could become pregnant).
Patients who could become pregnant should use highly effective contraception during therapy and for 1 week after the last leniolisib dose.
Based on data from animal reproduction studies, in utero exposure to leniolisib may cause fetal harm.
Pregnancy test in patients who can become pregnant (prior to the initiation of therapy and as deemed clinically necessary during treatment and up to 1 week after stopping therapy); liver function tests; complete blood count with differential.
Leniolisib is a kinase inhibitor that selectively targets phosphoinositide 3-kinase (PI3K) delta (Rao 2023). Leniolisib blocks the active binding site of PI3K delta, inhibiting the signaling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and dysregulation of B and T cells.
Distribution: Vd: ~28.5 L.
Protein binding: 94.5%.
Metabolism: Primarily hepatic via CYP3A4, with minor contribution to metabolism by CYP3A5, CYP1A2, and CYP2D6.
Half-life elimination: Terminal: ~10 hours; Effective: ~7 hours.
Time to peak:
Children ≥12 years and Adolescents: Median: ~3 hours (range: 1 to 5 hours).
Adults: Median: ~1 hour.
Excretion: Urine: 25.5% (6.32% as unchanged drug); feces: 67%.
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