Zydelig

Last reviewed on RxList: 11/6/2020
Zydelig Side Effects Center

What Is Zydelig?

Zydelig (idelalisib) is an inhibitor of phosphatidylinositol 3-kinase used in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is also used to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

What Are Side Effects of Zydelig?

Common side effects of Zydelig include:

Dosage for Zydelig

The recommended maximum starting dose of Zydelig is 150 mg administered orally twice daily.

What Drugs, Substances, or Supplements Interact with Zydelig?

Zydelig may interact with CYP3A inducers including rifampin, phenytoin, St. John's wort, or carbamazepine, CYP3A inhibitors, and CYP3A substrates. Tell your doctor all medications and supplements you use.

Zydelig During Pregnancy and Breastfeeding

Zydelig is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this drug passes into breast milk. Zydelig is not recommended for use while breastfeeding.

Additional Information

Our Zydelig (idelalisib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Zydelig Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Idelalisib can cause serious harm to your liver, lungs, or intestines. You may have severe or life-threatening diarrhea, or a perforation (a hole or tear) in your intestines. Some of these conditions may lead to fatal complications.

Call your doctor at once if you have:

  • severe diarrhea, increased number of stools per day;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • intestinal problems--worsening stomach pain, fever, chills, vomiting;
  • liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • lung problems--worsening cough, wheezing, cough with mucus, or shortness of breath;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, stomach pain, diarrhea;
  • fever, cough, lung problems;
  • low white blood cells;
  • abnormal liver function tests;
  • rash; or
  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zydelig (Idelalisib Tablets)

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Zydelig Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling.

  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Severe Diarrhea or Colitis [see WARNINGS AND PRECAUTIONS]
  • Pneumonitis [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Intestinal Perforation [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Neutropenia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Summary Of Clinical Trials In Chronic Lymphocytic Leukemia

The safety data reflect exposure to Zydelig from two randomized, double-blind clinical trials (Studies 312-0116 and 312-0115) in 634 patients with relapsed CLL [see Clinical Studies] and one randomized, open-label trial in 259 patients with relapsed CLL (Study 312-0119).

Zydelig with Rituximab (Study 312-0116)

Patients with relapsed CLL received up to 8 doses of rituximab (R) with or without Zydelig 150 mg twice daily. The median duration of exposure to Zydelig was 8 months.

Serious adverse reactions were reported in 65 (59%) patients treated with Zydelig + R The most frequent serious adverse reactions reported for patients treated with Zydelig + R were pneumonia (23%), diarrhea (10%), pyrexia (9%), sepsis (8%), and febrile neutropenia (5%).

Adverse reactions that led to discontinuation of Zydelig occurred in 19 (17%) patients.

The most common adverse reactions that led to treatment discontinuations were hepatotoxicity and diarrhea/colitis.

Forty-two (38%) patients had dose interruptions and sixteen (15%) patients had dose reductions due to adverse reactions or laboratory abnormalities. The most common reasons for dose interruptions or reductions were pneumonia, diarrhea or colitis, rash, and elevated transaminases.

Table 2 and Table 3 summarize common adverse reactions and laboratory abnormalities reported for Zydelig + R and placebo + R arms.

Table 2: Adverse Reactions Reported in ≥5% of Patients with CLL and Occurred at ≥2% Higher Incidence in Patients Receiving Zydelig in Study 312-0116

Adverse ReactionZydelig + R
N=110 (%)
Placebo + R
N=108 (%)
Any GGrade ≥3radeGrade ≥3Any GradeGrade ≥3
General disorders and administration site conditions
  pyrexia44 (40)3 (3)20 (19)1 (1)
  chills27 (25)2 (2)17 (16)0
  pain8 (7)01 (1)0
Gastrointestinal disorders
  diarrhea (a)35 (32)12 (11)20 (19)0
  nausea30 (27)1 (1)25 (23)0
  abdominal pain (b)20 (18)1 (1)17 (16)2 (2)
  vomiting17 (15)09 (8)0
  gastroesophageal reflux disease11 (10)1 (1)00
  stomatitis7 (6)2 (2)1 (1)0
Respiratory, thoracic, and mediastinal disorders
  pneumonia (c)33 (30)23 (21)20 (19)14 (13)
Skin and subcutaneous tissue disorders
  rash (d)27 (25)4 (4)7 (6)1 (1)
Metabolism and Nutrition Disorders
  decreased appetite18 (16)2 (2)12 (11)2 (2)
  dehydration7 (6)3 (3)00
Infections and infestations
  sepsis (e)10 (9)10 (9)4 (4)4 (4)
  sinusitis9 (8)06 (6)0
  urinary tract infection9 (8)1 (1)4 (4)2 (2)
  bronchitis8 (7)1 (1)5 (5)1 (1)
  oral herpes6 (5)1 (1)3 (3)0
Psychiatric disorders
  insomnia10 (9)07 (6)0
Musculoskeletal and connective tissue disorders
  arthralgia9 (8)1 (1)4 (4)0
Nervous system disorders
  lethargy6 (5)02 (2)0
(a) Diarrhea includes the following preferred terms: diarrhea, colitis.
(b) Abdominal pain includes the following preferred terms: abdominal pain, abdominal pain upper, abdominal pain lower.
(c) Pneumonia includes the terms: pneumonia, pneumonitis, lung infection, lung infiltration, pneumocystis jiroveci pneumonia, pneumonia legionella, lung infection pseudomonal, pneumonia fungal, respiratory tract infection, lower respiratory tract infection, and lower respiratory tract infection bacterial.
(d) Rash includes the following preferred terms: dermatitis exfoliative, drug eruption, rash, rash erythematous, rash generalized, rash macular, rash maculo-papular, rash papular, rash pruritic, rash morbilliform, and exfoliative rash.
(e) Sepsis includes the terms: sepsis, septic shock, neutropenic sepsis, and sepsis syndrome

Table 3: Hematologic and Hepatic Laboratory Abnormalities Reported in ≥10% of Patients with CLL and Occurred at ≥5% Higher Incidence in Patients Receiving Zydelig in Study 312-0116

Laboratory ParameterZydelig + R
N=110 (%)
Placebo + R
N=108 (%)
Any GradeGrade 3–4Any GradeGrade 3–4
Hematology abnormalities
  neutropenia71 (65)46 (42)61 (56)33 (31)
  leukopenia34 (31)9 (8)25 (23)9 (8)
  lymphocytopenia23 (21)11 (10)13 (12)4 (4)
Serum chemistry abnormalities
  ALT increased43 (39)10 (9)13 (12)1 (1)
  AST increased31 (28)6 (5)16 (15)0

After closure of Study 312-0116, 71 patients continued treatment with Zydelig on an extension study (Study 312-0117). The median duration of exposure was 18 months. Serious adverse reactions occurred in 48 (68%) patients. The most frequent serious adverse reactions reported were pneumonia (30%), diarrhea (15%), and pyrexia (11%).

The most frequent adverse reactions were pneumonia (51%), pyrexia (46%), and cough (45%). The most frequent Grade 3 or greater adverse reactions were pneumonia (30%), diarrhea (15%), and sepsis (10%).

Zydelig with Ofatumumab (Study 312-0119)

In Study 312-0119, 259 patients with relapsed CLL received up to 12 doses of ofatumumab with or without Zydelig 150 mg orally twice daily. The median duration of exposure to Zydelig was 13.9 months.

Serious adverse reactions were reported in 133 (77%) patients treated with Zydelig + ofatumumab. The most frequent serious adverse reactions reported were pneumonia (14%), pyrexia (13%), and diarrhea (12%).

Adverse reactions that led to discontinuation of Zydelig occurred in 71 (41%) patients.

One hundred and ten (64%) patients had dose interruptions and 42 (24%) patients had dose reductions due to adverse reactions or laboratory abnormalities. The most common reasons for dose discontinuations, reductions, or interruptions were diarrhea and colitis.

The most common adverse reactions were diarrhea (55%), pyrexia (38%), nausea (34%), and fatigue (34%).

Zydelig with Bendamustine and Rituximab (Study 312-0115)

In Study 312-0115, patients with relapsed CLL received up to 6 cycles of bendamustine and rituximab (BR) with or without Zydelig 150 mg orally twice daily. The median duration of exposure to Zydelig was 18.2 months.

Serious adverse reactions were reported in 147 (71%) patients treated with Zydelig + BR. The most frequent serious adverse reactions reported for patients treated with Zydelig + BR were febrile neutropenia (21%), pneumonia (17%), pyrexia (12%), and diarrhea (6%).

Adverse reactions that led to discontinuation of Zydelig occurred in 68 (33%) patients. The most common adverse reactions that led to treatment discontinuations were pneumonia, diarrhea, and pyrexia.

One hundred twenty-two (59%) patients treated with Zydelig + BR had dose interruptions and 34 (16%) patients had dose reductions due to adverse reactions. The most common reasons for dose interruptions or reductions were increased ALT and diarrhea.

The most common adverse reactions were neutropenia (64%), pyrexia (43%), and diarrhea (41%).

Summary Of Clinical Trials In Indolent Non-Hodgkin Lymphoma

The safety data reflect exposure to Zydelig from three open-label clinical trials (Studies 101-09, 101-02, and 101-10 in 146 patients with indolent non-Hodgkin lymphoma (iNHL) treated with Zydelig 150 mg orally twice daily [see Clinical Studies]. The median duration of exposure was 6.1 months (range 0.3 to 26.4 months).

Serious adverse reactions were reported in 73 (50%) patients. The most frequent serious adverse reactions that occurred were pneumonia (15%), diarrhea (11%), and pyrexia (9%).

Adverse reactions resulted in interruption or discontinuation for 78 (53%) patients. The most common reasons for interruption or discontinuations were diarrhea (11%), pneumonia (11%), and elevated transaminases (10%).

Table 4 provides the adverse reactions occurring in at least 10% of patients receiving Zydelig monotherapy and Table 5 provides the hematologic and hepatic laboratory abnormalities.

Table 4: Adverse Reactions Reported in ≥ 10% of Patients with Indolent NHL Treated with Zydelig

Adverse ReactionZydelig Monotherapy
N=146 (%)
Any GradeGrade ≥3
Gastrointestinal disorders
  diarrhea (a)68 (47)20 (14)
  nausea42 (29)2 (1)
  abdominal pain (b)38 (26)3 (2)
  vomiting22 (15)2 (1)
General disorders and administration site conditions
  fatigue44 (30)2 (1)
  pyrexia41 (28)3 (2)
  asthenia17 (12)3 (2)
  peripheral edema15 (10)3 (2)
Respiratory, thoracic, and mediastinal disorders
  cough42 (29)1 (1)
  pneumonia (c)37 (25)23 (16)
  dyspnea25 (17)6 (4)
Skin and subcutaneous disorders
  rash (d)31 (21)4 (3)
  night sweats18 (12)0
Metabolism and nutrition disorders
  decreased appetite24 (16)1 (1)
Infections and infestations
  upper respiratory tract infection18 (12)0
Psychiatric disorders
  insomnia17 (12)0
Nervous system disorders
  headache16 (11)1 (1)
(a) Diarrhea includes the following preferred terms: diarrhea, colitis, enterocolitis, and gastrointestinal inflammation.
(b) Abdominal pain includes the following preferred terms: abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort.
(c) Pneumonia includes the terms: pneumonia, pneumonitis, interstitial lung disease, lung infiltration, pneumonia aspiration, respiratory tract infection, atypical pneumonia, lung infection, pneumocystis jiroveci pneumonia, bronchopneumonia, pneumonia necrotizing, lower respiratory tract infection, pneumonia pneumococcal, pneumonia staphylococcal, pneumonia streptococcal, pneumonia cytomegaloviral, and respiratory syncytial virus infection.
(d) Rash includes the following preferred terms: dermatitis exfoliative, rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, and exfoliative rash.

Table 5: Hematologic and Hepatic Laboratory Abnormalities in Patients with Indolent non-Hodgkin Lymphoma Treated with Zydelig

Zydelig Monotherapy
N=146 (%)
Laboratory AbnormalityAny GradeGrade 3Grade 4
Serum chemistry abnormalities
  ALT increased73 (50)20 (14)7 (5)
  AST increased60 (41)12 (8)6 (4)
Hematology abnormalities
  neutrophils decreased78 (53)20 (14)16 (11)
  hemoglobin decreased41 (28)3 (2)0
  platelets decreased38 (26)4 (3)5 (3)
Grades were obtained per CTCAE version 4.03.

Summary Of Discontinued Clinical Trials In First-Line Cll And Early Line iNHL

Safety data described below reflect exposure to Zydelig in three randomized, doubleblind clinical trials (Studies 312-0123, 313-0124, and 313-0125) in patients with CLL and iNHL.

In Study 312-0123 (NCT01980888), 311 patients with previously untreated CLL received up to 6 cycles of BR with or without Zydelig 150 mg twice daily.

In Study 313-0124 (NCT01732913), 295 patients with previously treated iNHL received 8 doses of R with or without Zydelig 150 mg twice daily. Patients had a median of one prior therapy.

In Study 313-0125 (NCT01732926), 475 patients with previously treated iNHL received up to 6 cycles of BR with or without Zydelig 150 mg twice daily. Patients had a median of two prior therapies.

These three studies were terminated early due to a higher incidence of fatal and/or serious adverse reactions observed in patients treated with Zydelig in combination with R or BR. The most frequent serious adverse reactions were in the system organ classes of infections and infestations, blood and lymphatic system disorders, and gastrointestinal disorders.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Zydelig. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Disorders - Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS)

Read the entire FDA prescribing information for Zydelig (Idelalisib Tablets)

© Zydelig Patient Information is supplied by Cerner Multum, Inc. and Zydelig Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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