UpToDate خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده:
4
September 2025
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).
Refer to adult dosing.
(For additional information see "Leniolisib: Pediatric drug information")
Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome: 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.
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.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, have been reported. Discontinue use and institute appropriate therapy if severe hypersensitivity occurs.
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): $990.00
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 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.
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.
Activated phosphoinositide 3-kinase delta syndrome: Treatment of activated phosphoinositide 3-kinase (PI3K) delta syndrome in adults and pediatric patients ≥12 years of age.
Joenja may be confused with Jolessa, Jorveza.
Leniolisib may be confused with alpelisib, copanlisib, duvelisib, idelalisib, lenvatinib.
Substrate of BCRP, CYP3A4 (Major), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BCRP, OATP1B1/1B3;
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Atogepant: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Atogepant. Management: For episodic migraine, the recommended atogepant dose is 10 mg or 30 mg once daily if given with OATP1B1/1B3 inhibitors. For chronic migraine, the recommended atogepant dose is 30 mg once daily with OATP1B1/1B3 inhibitors. Risk D: Consider Therapy Modification
Atrasentan: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Atrasentan. Risk X: Avoid
BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Leniolisib may increase serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid
Brincidofovir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Brincidofovir. Management: Consider alternatives to OATP1B/1B3 inhibitors in patients treated with brincidofovir. If coadministration is required, administer OATP1B1/1B3 inhibitors at least 3 hours after brincidofovir and increase monitoring for brincidofovir adverse reactions. Risk D: Consider Therapy Modification
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Leniolisib. Risk X: Avoid
CYP3A4 Inducers (Strong): May decrease serum concentration of Leniolisib. Risk X: Avoid
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Leniolisib. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Leniolisib. Risk X: Avoid
Elagolix, Estradiol, and Norethindrone: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elagolix, Estradiol, and Norethindrone. Specifically, concentrations of elagolix may be increased. Risk X: Avoid
Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elagolix. Risk X: Avoid
Elbasvir and Grazoprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elbasvir and Grazoprevir. Risk X: Avoid
Eluxadoline: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with OATP1B1/1B3 inhibitors and monitor patients for increased eluxadoline effects/toxicities. Risk D: Consider Therapy Modification
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Grapefruit Juice: May increase serum concentration of Leniolisib. Risk C: Monitor
OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors): Leniolisib may increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid
PAZOPanib: BCRP/ABCG2 Inhibitors may increase serum concentration of PAZOPanib. Risk X: Avoid
Taurursodiol: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Taurursodiol. Risk X: Avoid
Topotecan: BCRP/ABCG2 Inhibitors may increase serum concentration of Topotecan. Risk X: Avoid
Ubrogepant: BCRP/ABCG2 Inhibitors may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider Therapy Modification
Vaccines (Live): Leniolisib may decrease therapeutic effects of Vaccines (Live). Risk C: Monitor
Voxilaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Voxilaprevir. Risk X: Avoid
Zavegepant (Nasal): OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Zavegepant (Nasal). Risk X: Avoid
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.
It is not known if leniolisib is present in human milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 week after the last leniolisib dose.
Phosphoinositide 3-kinase-delta mutation status. Evaluate pregnancy status prior to use (in patients who could become pregnant).
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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