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Inlyta

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Inlyta

Inlyta

Inlyta Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Inlyta (axitinib) is a prescription medication indicated for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy for this type of cancer. The most common side effects observed in greater than 20 percent of patients were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal.

Inlyta comes in 1 mg and 5 mg strengths. The starting dose is 5 mg taken orally twice daily, approximately 12 hours, with a full glass or water, with or without food.

Inlyta can be harmful to unborn children causing severe birth defects or death. Women who can become pregnant should evaluate the risks of using Erivedge with their doctors.. It is not known if Inlyta passes into breast milk. The patient and the doctor should decide whether or not to take Inlyta. Nursing mothers should not do both.

Our Inlyta 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Inlyta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 clinical practice.

The safety of INLYTA has been evaluated in 715 patients in monotherapy studies, which included 537 patients with advanced RCC. The data described reflect exposure to INLYTA in 359 patients with advanced RCC who participated in a randomized clinical study versus sorafenib [see Clinical Studies].

The following risks, including appropriate action to be taken, are discussed in greater detail in other sections of the label [see WARNINGS AND PRECAUTIONS]: hypertension, arterial thromboembolic events, venous thromboembolic events, hemorrhage, gastrointestinal perforation and fistula formation, thyroid dysfunction, wound healing complications, RPLS, proteinuria, elevation of liver enzymes, and fetal development.

Clinical Trials Experience

The median duration of treatment was 6.4 months (range 0.03 to 22.0) for patients who received INLYTA and 5.0 months (range 0.03 to 20.1) for patients who received sorafenib. Dose modifications or temporary delay of treatment due to an adverse reaction occurred in 199/359 patients (55%) receiving INLYTA and 220/355 patients (62%) receiving sorafenib. Permanent discontinuation due to an adverse reaction occurred in 34/359 patients (9%) receiving INLYTA and 46/355 patients (13%) receiving sorafenib.

The most common ( ≥ 20%) adverse reactions observed following treatment with INLYTA were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Table 1 presents adverse reactions reported in ≥ 10% patients who received INLYTA or sorafenib.

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients Who Received INLYTA or Sorafenib

Adverse Reactiona INLYTA
(N=359)
Sorafenib
(N=355)
All Gradesb % Grade 3/4 % All Gradesb % Grade 3/4 %
Diarrhea 55 11 53 7
Hypertension 40 16 29 11
Fatigue 39 11 32 5
Decreased appetite 34 5 29 4
Nausea 32 3 22 1
Dysphonia 31 0 14 0
Palmar-plantar erythrodysesthesia syndrome 27 5 51 16
Weight decreased 25 2 21 1
Vomiting 24 3 17 1
Asthenia 21 5 14 3
Constipation 20 1 20 1
Hypothyroidism 19 < 1 8 0
Cough 15 1 17 1
Mucosal inflammation 15 1 12 1
Arthralgia 15 2 11 1
Stomatitis 15 1 12 < 1
Dyspnea 15 3 12 3
Abdominal pain 14 2 11 1
Headache 14 1 11 0
Pain in extremity 13 1 14 1
Rash 13 < 1 32 4
Proteinuria 11 3 7 2
Dysgeusia 11 0 8 0
Dry skin 10 0 11 0
Dyspepsia 10 0 2 0
Pruritus 7 0 12 0
Alopecia 4 0 32 0
Erythema 2 0 10 < 1
aPercentages are treatment-emergent, all-causality events
bNational Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0

Selected adverse reactions (all grades) that were reported in < 10% of patients treated with INLYTA included dizziness (9%), upper abdominal pain (8%), myalgia (7%), dehydration (6%), epistaxis (6%), anemia (4%), hemorrhoids (4%), hematuria (3%), tinnitus (3%), lipase increased (3%), glossodynia (3%), pulmonary embolism (2%), rectal hemorrhage (2%), hemoptysis (2%), deep vein thrombosis (1%), retinal-vein occlusion/thrombosis (1%), polycythemia (1%), and transient ischemic attack (1%).

Table 2 presents the most common laboratory abnormalities reported in ≥ 10% patients who received INLYTA or sorafenib.

Table 2: Laboratory Abnormalities Occurring in ≥ 10% of Patients Who Received INLYTA or Sorafenib

Laboratory Abnormality N INLYTA N Sorafenib
All Gradesa % Grade 3/4 % All Gradesa % Grade 3/4 %
Hematology
Hemoglobin decreased 320 35 < 1 316 52 4
Lymphocytes (absolute) decreased 317 33 3 309 36 4
Platelets decreased 312 15 < 1 310 14 0
White blood cells decreased 320 11 0 315 16 < 1
Chemistry
Creatinine increased 336 55 0 318 41 < 1
Bicarbonate decreased 314 44 < 1 291 43 0
Hypocalcemia 336 39 1 319 59 2
ALP increased 336 30 1 319 34 1
Hyperglycemia 336 28 2 319 23 2
Lipase increased 338 27 5 319 46 15
Amylase increased 338 25 2 319 33 2
ALT increased 331 22 < 1 313 22 2
AST increased 331 20 < 1 311 25 1
Hypernatremia 338 17 1 319 13 1
Hypoalbuminemia 337 15 < 1 319 18 1
Hyperkalemia 333 15 3 314 10 3
Hypoglycemia 336 11 < 1 319 8 < 1
Hyponatremia 338 13 4 319 11 2
Hypophosphatemia 336 13 2 318 49 16
aNational Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0
ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase

Selected laboratory abnormalities (all grades) that were reported in < 10% of patients treated with INLYTA included hemoglobin increased (above the upper limit of normal) (9% for INLYTA versus 1% for sorafenib) and hypercalcemia (6% for INLYTA versus 2% for sorafenib).

Read the entire FDA prescribing information for Inlyta (Axitinib) »

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Additional Inlyta Information

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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