Xospata

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/2/2021
Xospata Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xospata?

Xospata (gilteritinib) is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

What Are Side Effects of Xospata?

Common side effects of Xospata include:

Dosage for Xospata

The dose of Xospata is 120 mg orally once daily.

What Drugs, Substances, or Supplements Interact with Xospata?

Xospata may interact with combined P-gp and strong CYP3A inducers, strong CYP3A inhibitors, escitalopram, fluoxetine, and sertraline. Tell your doctor all medications and supplements you use.

Xospata During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xospata; it may harm a fetus. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with Xospata and for 2 months after the last dose.

Additional Information

Our Xospata (gilteritinib) Tablets, for Oral Use 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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Xospata Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Gilteritinib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 2 days to 3 months after you start taking gilteritinib.

Seek medical help right away if you have symptoms of differentiation syndrome:

  • fever, cough, trouble breathing;
  • bone pain;
  • rapid weight gain; or
  • swelling in your arms, legs, underarms, groin, or neck.

Call your doctor at once if you have:

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • fever, chills, cough with mucus, chest pain;
  • flu symptoms, mouth and throat ulcers;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • a light-headed feeling, like you might pass out; or
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

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

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation;
  • pain or sores in the mouth or throat;
  • cough, shortness of breath;
  • headache, dizziness;
  • eye problems;
  • muscle or joint pain;
  • low blood pressure;
  • swelling of your arms or legs;
  • fever, tiredness;
  • decreased urination;
  • rash; or
  • abnormal liver function tests.

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 Xospata (Gilteritinib Tablets)

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Xospata Professional Information

SIDE EFFECTS

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

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.

The safety profile of XOSPATA is based on 319 patients with relapsed or refractory AML treated with gilteritinib 120 mg daily in three clinical trials. The median duration of exposure to XOSPATA was 3.6 months (range 0.1 to 43.4 months).

Fatal adverse reactions occurred in 2% of patients receiving XOSPATA. These included cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%).

Of the 319 patients, 91 (29%) required a dose interruption due to an adverse reaction; the most common adverse reactions leading to dose interruption were aspartate aminotransferase increased (6%), alanine aminotransferase increased (6%) and fever (4%). Twenty patients (6%) required a dose reduction due to an adverse reaction. Twenty-two (7%) discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%).

Overall, for the 319 patients, the most frequent (≥10%) all-grade nonhematological adverse reactions reported in patients were transaminase increased (51%), myalgia/arthralgia (50%), fatigue/malaise (44%), fever (41%), mucositis (41%), edema (40%), rash (36%), noninfectious diarrhea (35%), dyspnea (35%), nausea (30%), cough (28%), constipation (28%), eye disorders (25%), headache (24%), dizziness (22%), hypotension (22%), vomiting (21%), renal impairment (21%), abdominal pain (18%), neuropathy (18%), insomnia (15%) and dysgeusia (11%). The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%). Shifts to grades 3-4 nonhematologic laboratory abnormalities included phosphate decreased 42/309 (14%), alanine aminotransferase increased 41/317 (13%), sodium decreased 37/314 (12%), aspartate aminotransferase increased 33/317 (10%), calcium decreased 19/312 (6%), creatine kinase increased 20/317 (6%), triglycerides increased 18/310 (6%), creatinine increased 10/316 (3%), and alkaline phosphatase increased 5/317 (2%).

Adverse reactions reported in the first 30 days of therapy on the ADMIRAL Study [see Clinical Studies] are shown in Tables 2 and 3, according to whether patients were preselected for high intensity or low intensity chemotherapy.

Table 2: Adverse Reactions Reported in ≥10% (Any Grade) or ≥5% (Grade 3-5)* of Patients with Relapsed or Refractory AML in the Pre-selected High Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial

Adverse Reaction Any Grade n (%) Grade ≥3 n (%)
XOSPATA (120 mg daily)
n=149
Chemotherapy
n=68
XOSPATA (120 mg daily)
n=149
Chemotherapy
n=68
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia† 56 (38) 20 (29) 1 (1) 3 (4)
Investigations
Transaminase increased‡ 46 (31) 11 (16) 15 (10) 5 (7)
General disorders and administration site conditions
Fatigue/malaise§ 36 (24) 9 (13) 1 (1) 2 (3)
Fever 25 (17) 21 (31) 2 (1) 4 (6)
Edema¶ 20 (13) 13 (19) 0 0
Gastrointestinal disorders
Constipation 29 (20) 10 (15) 0 0
Mucositis# 18 (12) 30 (44) 0 5 (7)
Nausea 23 (15) 26 (38) 0 0
Abdominal painÞ 16 (11) 16 (24) 0 0
Blood and lymphatic system disorder
Febrile neutropenia 26 (17) 30 (44) 26 (17) 30 (44)
Skin and subcutaneous tissue disorders
Rashβ 23 (15) 21 (31) 1 (1) 2 (3)
Respiratory, thoracic and mediastinal disorders
Dyspneaa 20 (13) 9 (13) 1 (1) 6 (9)
Cough 18 (12) 5 (7) 1 (1) 0
Nervous system disorders
Neuropathye 19 (13) 0 0 0
Dizziness ∂ 17 (11) 2 (3) 0 0
Headache 17 (11) 12 (18) 0 0
*Grade 3-5 includes serious, life-threatening and fatal adverse reactions
†Grouped terms: arthralgia, back pain, bone pain, flank pain, limb discomfort, medial tibial stress syndrome, myalgia, muscle twitching, musculoskeletal discomfort, musculoskeletal pain, muscle spasms, neck pain, non-cardiac chest pain, pain and pain in extremity
‡Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hepatoxicity, liver function test increased and transaminases increased
§Grouped terms: asthenia, fatigue, lethargy and malaise
¶Grouped terms: edema, edema peripheral, face edema, fluid overload, generalized edema, hypervolemia, localized edema, periorbital edema and swelling face
#Grouped terms: aphthous ulcer, colitis, enteritis, esophageal pain, gingival pain, large intestinal ulcer, laryngeal inflammation, lip blister, lip ulceration, mouth hemorrhage, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, proctalgia, stomatitis, swollen tongue, tongue discomfort and tongue ulceration
ÞGrouped terms: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper and gastrointestinal pain
βGrouped terms: acne, dermatitis bullous, dermatitis contact, drug eruption, eczema asteatotic, erythema, hyperkeratosis, lichenoid keratosis, palmar-plantar erythrodysesthesia syndrome, rash, rash maculo-papular, rash papular, skin exfoliation, skin lesion and skin hyperpigmentation
aGrouped terms: acute respiratory distress syndrome, dyspnea, dyspnea exertional, hypoxia, pulmonary edema, respiratory failure, tachypnea and wheezing
eGrouped terms: hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, peripheral sensory neuropathy and paresthesia
∂Grouped terms: coordination abnormal and dizziness

Table 3: Adverse Reactions Reported in ≥10% (Any Grade) or ≥5% (Grade 3-5)* of Patients with Relapsed or Refractory AML in the Pre-selected Low Intensity Chemotherapy Subgroup in the First 30 Days of the ADMIRAL Trial

Adverse Reaction Any Grade n (%) Grade ≥3 n (%)
XOSPATA (120 mg daily)
n=97
Chemotherapy
n=41
XOSPATA (120 mg daily)
n=97
Chemotherapy
n=41
Investigations
Transaminase increased† 35 (36) 6 (15) 9 (9) 1 (2)
Blood and lymphatic system disorder
Febrile neutropenia 26 (27) 5 (12) 25 (26) 5 (12)
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia‡ 21 (22) 7 (17) 2 (2) 0
General disorders and administration site conditions
Fatigue/malaise§ 20 (21) 9 (22) 4 (4) 1 (2)
Edema¶ 19 (20) 5 (12) 1 (1) 0
Fever 11 (11) 7 (17) 0 0
Gastrointestinal disorders
Mucositis# 19 (20) 7 (17) 1 (1) 1 (2)
Constipation 13 (13) 5 (12) 1 (1) 0
Diarrhea 12 (12) 2 (5) 0 0
Nausea 10 (10) 7 (17) 0 0
Respiratory, thoracic and mediastinal disorders
DyspneaÞ 11 (11) 2 (5) 3 (3) 2 (5)
Skin and subcutaneous tissue disorders
Rashβ 10 (10) 2 (5) 2 (2) 0
*Grade 3-5 includes serious, life-threatening and fatal adverse reactions
†Grouped terms: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased and transaminases increased
‡Grouped terms: arthralgia, arthritis, back pain, limb discomfort, myalgia, muscle contracture, muscle spasms, myositis, non-cardiac chest pain, pain, pain in extremity and polyarthritis
§Grouped terms: asthenia, fatigue and malaise
¶Grouped terms: edema, face edema, localized edema, edema peripheral, peripheral swelling, periorbital edema, scrotal edema and swelling face
#Grouped terms: colitis, mouth hemorrhage, mouth ulceration, mucosal inflammation, oropharyngeal pain, proctalgia, stomatitis, tongue discomfort and tongue ulceration
ÞGrouped terms: acute respiratory failure, dyspnea, hypoxia and respiratory failure
βGrouped terms: dermatitis acneiform, dermatitis bullous, dermatitis exfoliative, erythema, rash, rash maculo-papular, rash papular, rosacea and skin ulcer
Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity (8%), pancreatitis* (5%), cardiac failure* (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis* (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%).
*Grouped terms: cardiac failure (cardiac failure, cardiac failure congestive, cardiomegaly, cardiomyopathy, chronic left ventricular failure, and ejection fraction decreased), hypersensitivity (anaphylactic reaction, angioedema, dermatitis allergic, drug hypersensitivity, erythema multiforme, hypersensitivity, and urticaria), pancreatitis (amylase increased, lipase increased, pancreatitis, pancreatitis acute), pericarditis/myocarditis (myocarditis, pericardial hemorrhage, pericardial rub, and pericarditis).

Selected post-baseline laboratory values that were observed in patients with relapsed or refractory AML are shown in Table 4.

Table 4: Shifts to Grade 3-4 Laboratory Abnormalities in Patients with Relapsed or Refractory AML by Pre-selected High Intensity and Low Intensity Chemotherapy in the First 30 Days of the ADMIRAL Trial

  Pre-selected High Intensity Chemotherapy Subgroup Pre-selected Low Intensity Chemotherapy Subgroup
XOSPATA (120 mg daily) Chemotherapy XOSPATA (120 mg daily) Chemotherapy
Alanine aminotransferase increased 7/149 (5%) 1/66 (2%) 7/95 (7%) 1/41 (2%)
Alkaline phosphatase increased 1/149 (1%) 0 0 0
Aspartate aminotransferase increased 8/149 (5%) 2/65 (3%) 5/95 (5%) 0
Calcium decreased 2/149 (1%) 3/65 (5%) 3/94 (3%) 0
Creatine kinase increased 1/149 (1%) 0 1/95 (1%) 0
Phosphatase decreased 4/144 (3%) 6/65 (9%) 4/93 (4%) 3/38 (8%)
Sodium decreased 7/148 (5%) 5/65 (8%) 6/93 (6%) 2/41 (5%)
Triglycerides increased 1/146 (1%) 0 2/94 (2%) 0

Read the entire FDA prescribing information for Xospata (Gilteritinib Tablets)

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

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