alpelisib (Rx)

Brand and Other Names:Piqray
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 50mg
  • 150mg
  • 200mg

Breast Cancer

Kinase inhibitor indicated in combination with fulvestrant for treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Alpelisib 300 mg PO qDay AND

Fulvestrant 500 mg IM on Days 1, 15, and 29, and once monthly thereafter

Continue treatment until disease progression or unacceptable toxicity occurs

Refer to the full prescribing information for fulvestrant

Dosage Modifications

Dosage modifications for adverse reactions

  • First-dose reduction: 250 mg PO qDay
  • Second-dose reduction: 200 mg PO qDay
  • Only 1 dose reduction permitted for pancreatitis
  • If dose reduction <200 mg qDay required, discontinue treatment

Hyperglycemia

  • Monitor by using only fasting glucose (FG) values (fasting plasma glucose [FPG] or fasting blood glucose)
  • Initiate or adjust applicable antihyperglycemic medications, including metformin, SGLT2 inhibitors, or insulin sensitizers (eg, thiazolidinediones, dipeptidyl peptidase-4 inhibitors)
  • Metformin dose was recommended in SOLAR-1 trial: Initiate metformin 500 mg PO qDay; may increase to 500 mg BID based on tolerability, followed by 500 mg with breakfast, and 1,000 mg with dinner, followed by further increase to 1,000 mg BID if needed
  • May use insulin for 1-2 days until hyperglycemia resolves; may not be necessary in most drug-induced hyperglycemia, given short half-life of alpelisib and glucose levels normalizing after dose interruption
  • Grade 1
    • FG >ULN to 160mg/dL OR >ULN to 8.9 mmol/L
    • No dosage adjustment required
    • Initiate/intensify antidiabetic therapy
  • Grade 2
    • FG >160-250 mg/dL OR >8.9-13.9 mmol/L
    • No dosage adjustment required
    • Initiate/intensify antidiabetic treatment
    • If FG not decreased to ≤160 mg/dL or 8.9 mmol/L within 21 days under appropriate antidiabetic treatment, reduce dose by 1 level and follow FG value specific recommendation
  • Grade 3
    • FG >250-500 mg/dL OR >13.9-27.8 mmol/
    • Interrupt dose
    • Initiate/intensify oral antidiabetic therapy and consider additional antidiabetic medications (eg, insulin) for 1-2 days until hyperglycemia improves
    • Administer IV hydration and consider appropriate treatment (eg, intervention for electrolyte/ketoacidosis/hyperosmolar disturbances)
    • If FG decreases to ≤160 mg/dL or 8.9 mmol/L within 3-5 days under appropriate antidiabetic treatment, resume at 1 lower dose level
    • If FG not decreased to ≤160 mg/dL or 8.9 mmol/L within 3-5 days under appropriate antidiabetic treatment, consult with a physician specialist for treatment of hyperglycemia
    • If FG not decreased to ≤160 mg/dL or 8.9 mmol/L within 21 days following appropriate antidiabetic treatment, permanently discontinue
  • Grade 4
    • FG >500 mg/dL or ≤27.8 mmol/L
    • Interrupt dose
    • Initiate/intensify appropriate antidiabetic treatment
    • Administer IV hydration and consider appropriate treatment (eg, intervention for electrolyte/ketoacidosis/hyperosmolar disturbances); recheck FG within 24 hr and as clinically indicated
    • If FG decreases to ≤500 mg/dL or 27.8 mmol/L, follow recommendations for Grade 3 hyperglycemia
    • If FG confirmed at >500 mg/dL or 27.8 mmol/L, permanently discontinue

Cutaneous adverse reactions

  • Confirmed etiology is severe cutaneous adverse reaction (SCAR)
    • Permanently discontinue
    • Do not reintroduce in patients who previously experienced SCAR during treatment
  • Grade 1
    • <10% BSA with active skin toxicity
    • No dosage adjustment required
    • Initiate topical corticosteroid treatment; consider adding oral antihistamine to manage symptoms
    • Active rash not improved ≤28 days of appropriate treatment: Add a low dose systemic corticosteroid
  • Grade 2
    • 10-30% BSA with active skin toxicity
    • No dosage adjustment required
    • Initiate or intensify topical corticosteroid and oral antihistamine treatment
    • Consider low-dose systemic corticosteroid treatment
    • Rash improves to Grade ≤1 within 10 days: May discontinue systemic corticosteroid
  • Grade 3
    • Severe rash not responsive to medical management; >30% BSA with active skin toxicity
    • Interrupt dose Initiate or intensify topical/systemic corticosteroid and oral antihistamine treatment
    • If etiology is not SCAR, once improved to Grade ≤1, resume at next lower dose level
  • Grade 4
    • Severe bullous, blistering, or exfoliating skin conditions; any % BSA associated with extensive superinfection, with IV antibiotics indicated; life-threatening consequences
    • Permanently discontinue treatment

Diarrhea

  • All grades: Initiate or intensify appropriate medical therapy and monitor as clinically indicated
  • Grade 1: No dosage adjustment required
  • Grade 2: Interrupt dose until recovery to Grade ≤1, then resume at same dose level
  • Grade ≥2 recurs or Grade 3: Interrupt dose until recovery to Grade ≤1, then resume at next lower dose level
  • Grade 4: Permanently discontinue

Other toxicities

  • Grade 1 or 2: No dosage adjustment required; initiate appropriate medical therapy and monitor as clinically indicated
  • Grade 3: Interrupt dose until recovery to Grade ≤1, then resume at the next lower dose level
  • Grade 4: Permanently discontinue treatment
  • Grade 2 and 3 pancreatitis: Interrupt dose until recovery to Grade <2 and resume at next lower dose level; only 1 dose reduction is permitted; if toxicity recurs, permanently discontinue treatment
  • Grade 2 elevated total bilirubin: Interrupt dose until recovery to Grade ≤1 and resume at same dose if resolved in ≤14 days or resume at next lower dose level if resolved in >14 days

Renal impairment

  • Mild-to-moderate (CrCl 30 to <90 mL/min): No dosage adjustment required
  • Severe (CrCl <30 mL/min): Pharmacokinetic data are unknown

Dosing Considerations

Patient selection

  • Select based on presence of ≥1 PIK3CA mutations in tumor tissue or plasma specimens
  • If no mutation is detected in a plasma specimen, test tumor tissue
  • Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics

Monitoring parameters

  • Before initiation: FPG, HbA1c, and optimize blood glucose
  • Verify pregnancy status in females of reproductive potential
  • During treatment
    • FG: At least qWeek for first 2 weeks, then at least q4Weeks, and as clinically indicated
    • HbA1c: Every 3 months and as clinically indicated
    • Closely monitor FG for first few weeks in patients with risk factors for hyperglycemia, such as obesity (BMI ≥30), elevated FG, HbA1c ≥ULN, use of systemic corticosteroids, or age ≥75 yr
    • Signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, lymphadenopathy)

PIK3CA-related Overgrowth (Orphan)

Orphan designation for treatment of PIK3CA-related overgrowth spectrum

Sponsor

  • Novartis Pharmaceuticals CorporationOne Health PlazaEast Hanover, New Jersey 07936

Safety and efficacy not established

Patients aged ≥65 years had higher incidence of grade 3-4 hyperglycemia compared with patients aged <65 years

Patients aged ≥75 years: Insufficient number of patients to assess differences in safety and efficacy

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Interactions

Interaction Checker

and alpelisib

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              Serious - Use Alternative (58)

              • abametapir

                abametapir will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • acalabrutinib

                acalabrutinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • amobarbital

                amobarbital will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • apalutamide

                apalutamide will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • atazanavir

                atazanavir will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • bosentan

                bosentan will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • butabarbital

                butabarbital will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • butalbital

                butalbital will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • carbamazepine

                carbamazepine will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • cobicistat

                cobicistat will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

                cobicistat will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • cyclosporine

                cyclosporine will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • dabrafenib

                dabrafenib will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

                dabrafenib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • darolutamide

                darolutamide will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • dipyridamole

                dipyridamole will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • efavirenz

                efavirenz will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • eltrombopag

                eltrombopag will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • eluxadoline

                eluxadoline will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • enzalutamide

                enzalutamide will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • erdafitinib

                alpelisib will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If coadministration of a strong CYP2C9 inhibitors is unavoidable, closely monitor adverse reactions and modify dose of erdafitinib accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.

              • etravirine

                etravirine will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • fexinidazole

                fexinidazole will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • gefitinib

                gefitinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • imatinib

                imatinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • ivosidenib

                ivosidenib will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • ketoconazole

                ketoconazole will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • lapatinib

                lapatinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • lasmiditan

                lasmiditan increases levels of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

              • lonafarnib

                lonafarnib will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • lopinavir

                lopinavir will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lorlatinib

                lorlatinib will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • lumacaftor/ivacaftor

                lumacaftor/ivacaftor will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • mitotane

                mitotane will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • nafcillin

                nafcillin will decrease the level or effect of alpelisib by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • osimertinib

                osimertinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • pantoprazole

                pantoprazole will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • pentobarbital

                pentobarbital will decrease the level or effect of alpelisib by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • phenobarbital

                phenobarbital will decrease the level or effect of alpelisib by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

                phenobarbital will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • phenytoin

                phenytoin will decrease the level or effect of alpelisib by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

                phenytoin will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • ponatinib

                ponatinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • primidone

                primidone will decrease the level or effect of alpelisib by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

                primidone will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • regorafenib

                regorafenib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • rifabutin

                rifabutin will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • rifampin

                rifampin will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • rifapentine

                rifapentine will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • rolapitant

                rolapitant will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • safinamide

                safinamide will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • secobarbital

                secobarbital will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • St John's Wort

                St John's Wort will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of alpelisib (CYP3A4 substrate) with strong CYP3A4 inducers.

              • stiripentol

                stiripentol will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • sunitinib

                sunitinib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • tacrolimus

                tacrolimus will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • tafamidis

                tafamidis will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • vandetanib

                vandetanib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • velpatasvir

                velpatasvir will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • vemurafenib

                vemurafenib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.

              • voxelotor

                voxelotor will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (49)

              • armodafinil

                armodafinil will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belzutifan

                belzutifan will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

              • bexarotene

                bexarotene will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • bosentan

                alpelisib will decrease the level or effect of bosentan by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • brigatinib

                brigatinib will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • celecoxib

                alpelisib will decrease the level or effect of celecoxib by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • cenobamate

                cenobamate will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • chlorpropamide

                alpelisib will decrease the level or effect of chlorpropamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • diclofenac

                alpelisib will decrease the level or effect of diclofenac by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • dronabinol

                alpelisib will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • elagolix

                elagolix will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • encorafenib

                encorafenib will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • etravirine

                alpelisib will decrease the level or effect of etravirine by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • fedratinib

                fedratinib will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fluoxetine

                alpelisib will decrease the level or effect of fluoxetine by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • fluvastatin

                alpelisib will decrease the level or effect of fluvastatin by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely.

              • fosphenytoin

                alpelisib will decrease the level or effect of fosphenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • fostemsavir

                fostemsavir will increase the level or effect of alpelisib by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • glimepiride

                alpelisib will decrease the level or effect of glimepiride by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • glipizide

                alpelisib will decrease the level or effect of glipizide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • glyburide

                alpelisib will decrease the level or effect of glyburide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • imatinib

                alpelisib will decrease the level or effect of imatinib by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • istradefylline

                istradefylline will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • ketamine

                alpelisib will decrease the level or effect of ketamine by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • lacosamide

                alpelisib will decrease the level or effect of lacosamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • lesinurad

                alpelisib will decrease the level or effect of lesinurad by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • losartan

                alpelisib will decrease the level or effect of losartan by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • mestranol

                alpelisib will decrease the level or effect of mestranol by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • miconazole oral

                alpelisib will decrease the level or effect of miconazole oral by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • modafinil

                modafinil will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • montelukast

                alpelisib will decrease the level or effect of montelukast by pharmacodynamic synergism. Modify Therapy/Monitor Closely.

              • nateglinide

                alpelisib will decrease the level or effect of nateglinide by pharmacodynamic synergism. Modify Therapy/Monitor Closely.

              • ospemifene

                alpelisib will decrease the level or effect of ospemifene by pharmacodynamic synergism. Modify Therapy/Monitor Closely.

              • phenytoin

                alpelisib will decrease the level or effect of phenytoin by pharmacodynamic synergism. Modify Therapy/Monitor Closely.

              • propofol

                alpelisib will decrease the level or effect of propofol by pharmacodynamic synergism. Modify Therapy/Monitor Closely.

              • rucaparib

                rucaparib will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • siponimod

                alpelisib will decrease the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • sulfadiazine

                alpelisib will decrease the level or effect of sulfadiazine by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • sulfisoxazole

                alpelisib will decrease the level or effect of sulfisoxazole by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • tamoxifen

                alpelisib will decrease the level or effect of tamoxifen by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • tazemetostat

                tazemetostat will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • telotristat ethyl

                telotristat ethyl will decrease the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tolbutamide

                alpelisib will decrease the level or effect of tolbutamide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • torsemide

                alpelisib will decrease the level or effect of torsemide by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • trimethoprim

                alpelisib will decrease the level or effect of trimethoprim by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • voriconazole

                alpelisib will decrease the level or effect of voriconazole by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • warfarin

                warfarin will increase the level or effect of alpelisib by affecting hepatic enzyme CYP2C19 metabolism. Modify Therapy/Monitor Closely.

                alpelisib will decrease the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              • zafirlukast

                alpelisib will decrease the level or effect of zafirlukast by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.

              Minor (2)

              • dapsone

                alpelisib will decrease the level or effect of dapsone by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.

              • ribociclib

                ribociclib will increase the level or effect of alpelisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10% (In Combination with Fulvestrant)

              Glucose increased (79%)

              Creatinine increased (67%)

              Diarrhea (58%)

              Rash (52%)

              Lymphocyte count decreased (52%)

              GGT increased (52%)

              Nausea (45%)

              ALT increased (44%)

              Fatigue (42%)

              Hemoglobin decreased (42%)

              Lipase increased (42%)

              Glucose increased, grade 3-4 (39%)

              Decreased appetite (36%)

              Stomatitis (30%)

              Vomiting (27%)

              Decreased weight (27%)

              Calcium (corrected) decreased (27%)

              Glucose decreased (26%)

              aPTT prolonged (21%)

              Alopecia (20%)

              Rash, grade 3-4 (20%)

              Mucosal inflammation (19%)

              Pruritus (18%)

              Dry skin (18%)

              Dysgeusia (18%)

              Headache (18%)

              Abdominal pain (17%)

              Peripheral edema (15%)

              Pyrexia (14%)

              Platelet count decreased (14%)

              Potassium decreased (14%)

              Albumin decreased (14%)

              Mucosal dryness (12%)

              Dyspepsia (11%)

              Magnesium decreased (11%)

              GGT increased, grade 3-4 (11%)

              1-10% (In Combination with Fulvestrant)

              Urinary tract infection (10%)

              Lymphocyte count decreased, grade 3-4 (8%)

              Diarrhea, grade 3-4 (7%)

              Lipase increased, grade 3-4 (7%)

              Potassium decreased, grade 3-4 (2.1%)

              Fatigue, grade 3-4 (5%)

              Hemoglobin decreased, grade 3-4 (4.2%)

              Decreased weight, grade 3-4 (3.9%)

              ALT increased, grade 3-4 (3.5%)

              Creatinine increased, grade 3-4 (2.8%)

              Nausea, grade 3-4 (2.5%)

              Stomatitis, grade 3-4 (2.5%)

              Mucosal inflammation, grade 3-4 (2.1%)

              Calcium (corrected) decreased (2.1%)

              Abdominal pain, grade 3-4 (1.4%)

              Platelet count decreased, grade 3-4 (1.1%)

              >1% (In Combination with Fulvestrant)

              Pruritus, grade 3-4 (0.7%)

              Urinary tract infection, grade 3-4 (0.7%)

              Headache, grade 3-4 (0.7%)

              Decreased appetite, grade 3-4 (0.7%)

              Vomiting, grade 3-4 (0.7%)

              aPTT prolonged, grade 3-4 (0.7%)

              Dry skin, grade 3-4 (0.4%)

              Dysgeusia, grade 3-4 (0.4%)

              Mucosal dryness, grade 3-4 (0.4%)

              Glucose decreased, grade 3-4 (0.4%)

              Magnesium decreased, grade 3-4 (0.4%)

              Postmarketing Reports

              Skin and subcutaneous tissue disorders: Drug reaction with eosinophilia and systemic symptoms (DRESS)

              Metabolism and nutrition disorders: Hyperglycemic hyperosmolar nonketotic syndrome (HHNKS)

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              Warnings

              Contraindications

              Hypersensitivity to alpelisib or any of its components

              Cautions

              Severe hypersensitivity reactions (eg, anaphylaxis, anaphylactic shock) reported; reactions manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia

              Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, reported; consider noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms (eg, hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic examinations) and in whom infectious, neoplastic, and other causes have been excluded; permanently discontinue therapy in all patients with confirmed pneumonitis; advise patients to immediately report new or worsening respiratory symptoms

              Severe diarrhea, including dehydration and acute kidney injury, occurred; based on severity of diarrhea, therapy may require dose interruption, reduction, or discontinuation; advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs

              Based on findings in animals and its mechanism of action, fetal harm may occur when administered to pregnant women

              The safety of therapy in patients with Type 1 and uncontrolled Type 2 diabetes has not been established

              Severe cutaneous adverse reactions

              • Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) reported
              • Do not initiate with history of SJS, EM, or toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)
              • If signs or symptoms of cutaneous reactions occur, interrupt therapy until etiology of reaction determined
              • If SJS, TEN, or EM confirmed, permanently discontinue; do not reintroduce in patients who have experienced previous severe cutaneous reactions during treatment
              • If cutaneous reactions not confirmed, therapy may require dose modifications, topical corticosteroids, or oral antihistamine treatment

              Severe hyperglycemia

              • Closely monitor patients with diabetes
              • Based on severity of hyperglycemia, therapy may require dose interruption, reduction, or discontinuation
              • In some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis; some fatal cases of ketoacidosis have occurred in the post marketing setting
              • Before initiating treatment, test FPG and HbA1c, and optimize blood glucose
              • After initiation, monitor fasting glucose more frequently for the first few weeks during treatment in patients with risk factors for hyperglycemia such as obesity (BMI greater than or equal to 30), elevated FPG, HbA1c at the upper limit of normal or above, use of concomitant systemic corticosteroids, or age greater than or equal to 75
              • Monitor blood glucose and/or FPG at least qWeek for the first 2 weeks, then at least q4Weeks, and as clinically indicated; monitor HbA1c every 3 months and as clinically indicated
              • During treatment with antidiabetic medication, continue monitoring blood glucose or FPG at least once a week for 8 weeks, followed by once q2Weeks and as clinically indicated
              • Advise patients of signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss)

              Drug interactions overview

              • Alpelisib: CYP3A4 and BCRP substrate; CYP2C9 inducer
              • CYP3A4 inducers
                • Strong CYP3A4 inducers may decrease alpelisib concentration and/or activity
                • Avoid coadministration with strong CYP3A4 inducers
              • BCRP inhibitors
                • Coadministration with BCRP inhibitors may increase alpelisib concentration and/or risk of toxicities
                • Avoid coadministration with BCRP inhibitors; if unable to avoid or use alternant drugs, closely monitor for increased adverse effects of alpelisib
              • CYP2C9 substrates
                • Coadministration of alpelisib with CYP2C9 substrates (eg, warfarin) may reduce plasma concentration of CYP2C9 substrates
                • Closely monitor when used in combination with CYP2C9 substrates for potential reduced activity of these drugs
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              Pregnancy & Lactation

              Pregnancy

              Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant women

              No data available in pregnant women to inform the drug-associated risk

              Advise pregnant women and females of reproductive potential of fetal risk

              Verify pregnancy status in females of reproductive potential before initiating

              Animal data

              • In animal reproduction studies, oral administration to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryofetal mortality (postimplantation loss), reduced fetal weights, and increased incidences of fetal malformations at maternal exposures ≥0.8 times the exposure in humans based on AUC at the recommended dose of 300 mg/day

              Contraception

              • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the last dose
              • Male patients with female partners of reproductive potential: Use condoms and effective contraception during treatment and for 1 week after the last dose

              Infertility

              • Based on findings from animal studies, fertility in males and females of reproductive potential may be impaired

              Lactation

              There are no data on the presence of alpelisib in human milk, its effects on milk production, or the breastfed child

              Because of potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment and for 1 week after the last dose

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against PI3K-alpha

              In breast cancer, alpelisib inhibits the phosphorylation of PI3K downstream targets and has shown activity in cell lines possessing a PIK3CA mutation

              PI3K inhibition has been shown to induce an increase in ER transcription in breast cancer cells

              Combination with fulvestrant demonstrates an increase in antitumor activity compared with either treatment alone

              Absorption

              Peak plasma concentration at steady-state: 2480 ng/mL

              Peak plasma time: 2-4 hr

              AUC: 33,224 ng·hr/mL

              Steady-state reached within 3 days

              Effects of food following a single dose

              • High-fat, high-calorie meal (985 calories with 58.1 grams of fat) increased AUC by 73% and peak plasma concentration by 84%
              • Low-fat, low-calorie meal (334 calories with 8.7 grams of fat) increased AUC by 77% and peak plasma concentration by 145%

              Distribution

              Vd: 114 L

              Protein bound: 89%

              Metabolism

              Primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite, BZG791

              Metabolized to a lesser extent by CYP3A4

              Elimination

              Half-life: 8-9 hr

              Clearance: 9.2 L/hr

              Excretion

              • Feces: 81% (36% unchanged, 32% BZG791)
              • Urine: 14% (2% unchanged, 7.1 BZG791)
              • CYP3A4-mediated metabolites accounted for 12% of the dose
              • Glucuronides accounted for ~15% of the dose
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              Administration

              Oral Administration

              Take orally with food

              Administer dose at approximately same time each day

              Swallow tablet whole (do not chew, crush, or split)

              Do not ingest if tablet is broken, cracked, or otherwise not intact

              Missed dose

              • Missed dose ≤9 hr of scheduled time: Take dose
              • Missed dose >9 hr of scheduled time: Skip dose for that day; the next day, take dose at usual time
              • If dose is vomited, advise not to take an additional dose on that day; resume dosing schedule the next day at the usual time

              Storage

              Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Piqray oral
              -
              250 mg/day (200 mg x1-50 mg x1) tablet
              Piqray oral
              -
              300 mg/day (150 mg x 2) tablet
              Piqray oral
              -
              200 mg/day (200 mg x 1) tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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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.

              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.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.