Axitinib

Name: Axitinib

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • dizziness
  • seizures
  • coughing up blood

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to axitinib. Your doctor will also check your blood pressure regularly during your treatment with axitinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Axitinib Side Effects

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

Some people taking axitinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Also call your doctor at once if you have:

  • any unexpected pain or swelling, any wound that will not heal;
  • a light-headed feeling, like you might pass out;
  • chest pain or pressure, pain spreading to your jaw or shoulder, trouble breathing;
  • shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • sudden vision loss, headache, confusion, thinking problems, seizure (convulsions);
  • easy bruising, unusual bleeding (nosebleeds, bleeding gums), heavy menstrual bleeding, or any other bleeding that will not stop;
  • signs of stomach bleeding--severe stomach pain, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • symptoms of a blood clot--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;
  • signs of a thyroid problem--sudden weight gain or loss, feeling very weak or tired, muscle pain, feeling hot or cold, hair loss, changes in your menstrual periods, hoarse or deepened voice; or
  • dangerously high blood pressure-severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath, uneven heartbeats.

Common side effects may include:

  • nausea, vomiting, diarrhea, constipation;
  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
  • increased blood pressure;
  • weakness, tired feeling;
  • decreased appetite, weight loss; or
  • hoarse voice.

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.

How supplied

Dosage Forms And Strengths

1 mg tablets of INLYTA: red, film-coated, oval tablets, debossed with “Pfizer” on one side and “1 XNB” on the other side.

5 mg tablets of INLYTA: red, film-coated, triangular tablets, debossed with “Pfizer” on one side and “5 XNB” on the other side.

Storage And Handling

INLYTA tablets are supplied as follows:

1 mg tablets are red film-coated, oval tablets debossed with “Pfizer” on one side and “1 XNB” on the other; available in bottles of 180: NDC 0069-0145-01.

5 mg tablets are red film-coated, triangular tablets debossed with “Pfizer” on one side and “5 XNB” on the other; available in bottles of 60: NDC 0069-0151-11.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Aug 2014

Clinical pharmacology

Mechanism Of Action

Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

Pharmacodynamics

The effect of a single oral dose of INLYTA (5 mg) in the absence and presence of 400 mg ketoconazole on the QTc interval was evaluated in a randomized, single-blinded, two-way crossover study in 35 healthy subjects. No large changes in mean QTc interval (i.e., > 20 ms) from placebo were detected up to 3 hours post-dose. However, small increases in mean QTc interval (i.e., < 10 ms) cannot be ruled out.

Pharmacokinetics

The population pharmacokinetic analysis pooled data from 17 trials in healthy subjects and patients with cancer. A two-compartment disposition model with first-order absorption and lag-time adequately describes the axitinib concentration-time profile.

Absorption and Distribution

Following single oral 5-mg dose administration, the median Tmax ranged from 2.5 to 4.1 hours. Based on the plasma half-life, steady state is expected within 2 to 3 days of dosing. Dosing of axitinib at 5 mg twice daily resulted in approximately 1.4-fold accumulation compared to administration of a single dose. At steady state, axitinib exhibits approximately linear pharmacokinetics within the 1-mg to 20-mg dose range. The mean absolute bioavailability of axitinib after an oral 5 mg dose is 58%.

Compared to overnight fasting, administration of INLYTA with a moderate fat meal resulted in 10% lower AUC and a high fat, high-calorie meal resulted in 19% higher AUC. INLYTA can be administered with or without food [see DOSAGE AND ADMINISTRATION].

Axitinib is highly bound ( > 99%) to human plasma proteins with preferential binding to albumin and moderate binding to α1-acid glycoprotein. In patients with advanced RCC (n=20), at the 5 mg twice daily dose in the fed state, the geometric mean (CV%) C max and AUC 0-24 were 27.8 (79%) ng/mL and 265 (77%) ng.h/mL, respectively. The geometric mean (CV%) clearance and apparent volume of distribution were 38 (80%) L/h and 160 (105%) L, respectively.

Metabolism and Elimination

The plasma half life of INLYTA ranges from 2.5 to 6.1 hours. Axitinib is metabolized primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1. Following oral administration of a 5-mg radioactive dose of axitinib, approximately 41% of the radioactivity was recovered in feces and approximately 23% was recovered in urine. Unchanged axitinib, accounting for 12% of the dose, was the major component identified in feces. Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine. In plasma, the N-glucuronide metabolite represented the predominant radioactive component (50% of circulating radioactivity) and unchanged axitinib and the sulfoxide metabolite each accounted for approximately 20% of the circulating radioactivity.

The sulfoxide and N-glucuronide metabolites show approximately ≥ 400-fold less in vitro potency against VEGFR-2 compared to axitinib.

Drug-Drug Interactions

Effects of Other Drugs on INLYTA: Axitinib is metabolized primarily in the liver by CYP3A4/5. Additionally, the aqueous solubility of axitinib is pH dependent, with higher pH resulting in lower solubility. The effects of a strong CYP3A4/5 inhibitor, a strong CYP3A4/5 inducer, and an antacid on the pharmacokinetics of axitinib are presented in Figure 1 [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS].

Figure 1 : Impact of Co-administered Drugs and Hepatic Impairment on Axitinib Pharmacokinetics

AUC: Area under the curve. Cmax: Maximum concentration. See DOSAGE AND ADMINISTRATION.

Effects of INLYTA on Other Drugs: In vitro studies demonstrated that axitinib has the potential to inhibit CYP1A2 and CYP2C8. However, co-administration of axitinib with paclitaxel, a CYP2C8 substrate, did not increase plasma concentrations of paclitaxel in patients.

In vitro studies indicated that axitinib does not inhibit CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, or UGT1A1 at therapeutic plasma concentrations. In vitro studies in human hepatocytes indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.

Axitinib is an inhibitor of the efflux transporter P-glycoprotein (P-gp) in vitro. However, INLYTA is not expected to inhibit P-gp at therapeutic plasma concentrations.

Pharmacokinetics in Specific Populations

Pediatric Use: INLYTA has not been studied in patients < 18 years of age.

Hepatic Impairment: The effects of hepatic impairment on the pharmacokinetics of axitinib are presented in Figure 1 [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and Use in Specific Populations].

Renal Impairment: Population pharmacokinetic analysis (based on pre-existing renal function) was carried out in 590 healthy volunteers and patients, including five with severe renal impairment (15 mL/min ≤ CLcr < 29 mL/min), 64 with moderate renal impairment (30 mL/min ≤ CLcr < 59 mL/min), and 139 with mild renal impairment (60 mL/min ≤ CLcr < 89 mL/min). Mild to severe renal impairment did not have meaningful effects on the pharmacokinetics of axitinib. Data from only one patient with end-stage renal disease are available [see Use in Specific Populations].

Other Intrinsic Factors: Population pharmacokinetic analyses indicate that there are no clinically relevant effects of age, gender, race, body weight, body surface area, UGT1A1 genotype, or CYP2C19 genotype on the clearance of axitinib.

Clinical Studies

The safety and efficacy of INLYTA were evaluated in a randomized, open-label, multicenter Phase 3 study. Patients (N=723) with advanced RCC whose disease had progressed on or after treatment with 1 prior systemic therapy, including sunitinib-, bevacizumab-, temsirolimus-, or cytokine-containing regimens were randomized (1:1) to receive INLYTA (N=361) or sorafenib (N=362). Progression-free survival (PFS) was assessed by a blinded independent central review committee. Other endpoints included objective response rate (ORR) and overall survival (OS).

Of the patients enrolled in this study, 389 patients (54%) had received 1 prior sunitinib-based therapy, 251 patients (35%) had received 1 prior cytokine-based therapy (interleukin-2 or interferon-alfa), 59 patients (8%) had received 1 prior bevacizumab-based therapy, and 24 patients (3%) had received 1 prior temsirolimus-based therapy. The baseline demographic and disease characteristics were similar between the INLYTA and sorafenib groups with regard to age (median 61 years), gender (72% male), race (75% white, 21% Asian), Eastern Cooperative Oncology Group (ECOG) performance status (55% 0, 45% 1), and histology (99% clear cell).

There was a statistically significant advantage for INLYTA over sorafenib for the endpoint of PFS (see Table 3 and Figure 2). There was no statistically significant difference between the arms in OS.

Table 3: Efficacy Results

Endpoint/Study Population INLYTA Sorafenib HR (95% CI) P-value
Overall ITT N= 361 N = 362    
Median PFSa,b in months (95% CI) 6.7 (6.3, 8.6) 4.7 (4.6, 5.6) 0.67 (0.54, 0.81) < 0.0001c
Median OS in months (95% CI) 20.1 (16.7, 23.4) 19.2 (17.5, 22.3) 0.97 (0.80, 1.17) NS
ORR % (95% CI) 19.4 (15.4, 23.9) 9.4 (6.6, 12.9) 2.06d (1.41, 3.00) -e
PFS by prior treatment
Sunitinib-refractory subgroup N=194 N=195    
  Median, months (95% CI) 4.8 (4.5, 6.4) 3.4 (2.8, 4.7) 0.74 (0.57, 0.96) -e
Cytokine-refractory subgroup N=126 N=125    
  Median, months (95% CI) 12.1 (10.1, 13.9) 6.5 (6.3, 8.3) 0.46 (0.32, 0.68) -e
CI: Confidence interval; HR: Hazard ratio (INLYTA/sorafenib); ITT: Intent to treat; ORR: Objective response rate; NS: Not significant; OS: Overall survival; PFS: Progression-free survival
aTime from randomization to progression or death due to any cause, whichever occurs first.
bAssessed by independent radiology review according to RECIST.
cOne-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy (comparison is considered statistically significant if the one-sided p-value is < 0.023).
dRisk ratio is used for ORR. A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm.
eP-value not included since it was not adjusted for multiple testing.

Figure 2: Kaplan-Meier Curve for Progression Free Survival by Independent Assessment (Intent-to-Treat Population)

Axitinib Drug Class

Axitinib is part of the drug class:

  • Protein kinase inhibitors

Axitinib Food Interactions

Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of axitinib in your blood.

Patient Handout

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Axitinib dosing information

Usual Adult Dose for Renal Cell Carcinoma:

Initial dose: 5 mg orally twice a day
Maintenance dose: Increase or decrease dose based on individual safety and tolerability
Dose range: 2 to 10 mg twice a day

Comments: Doses should be taken approximately 12 hours apart.

Use: For the treatment of advanced renal cell carcinoma after the failure of 1 prior systemic therapy.

Introduction

Antineoplastic agent; a second-generation tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3.1 2 8 9 10 16

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Axitinib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

1 mg

Inlyta

Pfizer

5 mg

Inlyta

Pfizer

Commonly used brand name(s)

In the U.S.

  • Inlyta

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Proper Use of axitinib

Take axitinib exactly as directed by your doctor, even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

axitinib comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take axitinib with or without food.

Swallow the tablet whole with a glass of water. Do not break, crush, or chew it.

Do not eat grapefruit or drink grapefruit juice while you are using axitinib. Grapefruit and grapefruit juice may change the amount that is absorbed in the body.

Dosing

The dose of axitinib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of axitinib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For kidney cancer:
      • Adults—At first, 5 milligrams (mg) two times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of axitinib, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

axitinib Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain
  • bleeding gums
  • bloody nose
  • blurred vision
  • cloudy urine
  • confusion
  • constipation
  • coughing up blood
  • decreased urination
  • depressed mood
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • dry skin and hair
  • fainting
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • incoherent speech
  • increased menstrual flow or vaginal bleeding
  • increased urination
  • lightheadedness
  • loss of appetite
  • metallic taste
  • muscle cramps and stiffness
  • muscle weakness
  • nausea
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • rapid breathing
  • red or black, tarry stools
  • red or dark brown urine
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • slow or fast heartbeat
  • sunken eyes
  • thirst
  • tightness in the chest
  • tingling of the hands and feet
  • ulceration of the skin
  • unusual tiredness or weakness
  • vomiting
  • weight gain or loss
  • wrinkled skin
Less common
  • Anxiety
  • bleeding from the gums or nose
  • bleeding from the rectum
  • bloody, black or tarry stools
  • change in vision
  • chest pain or discomfort
  • extreme drowsiness
  • eye pain
  • heartburn
  • inability to speak
  • indigestion
  • numbness or tingling in the face, arms, hands, or legs
  • pain in the chest, groin, or legs
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, or swelling in the arm or leg
  • pale skin
  • ringing in the ears
  • seizures
  • sensitivity to heat
  • severe headaches of sudden onset
  • severe stomach pain, cramping, or burning
  • slurred speech
  • sudden loss of coordination
  • sudden onset of slurred speech
  • sudden shortness of breath or troubled breathing
  • sudden vision changes
  • sweating
  • temporary blindness
  • trouble sleeping
  • trouble speaking, thinking, or walking
  • troubled breathing with exertion
  • uncomfortable swelling around the anus
  • unusual bleeding or bruising
  • vomiting of material that looks like coffee grounds
  • weakness in the arm or leg on one side of the body

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Belching
  • change in taste
  • cough
  • cracked lips
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • itching skin or rash
  • joint pain
  • lack or loss of strength
  • loss of taste
  • muscle aches or pain
  • pain in the arms or legs
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach discomfort or upset
  • swelling or inflammation of the mouth
  • swollen joints
  • upper stomach pain
  • voice changes
Less common
  • Burning sensation of the tongue
  • continuous ringing or buzzing or other unexplained noise in the ears
  • flushing or redness of the skin
  • hearing loss
  • thinning of the hair
  • unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How is this medicine (Axitinib) best taken?

Use axitinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Swallow whole with a full glass of water.
  • If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosing Renal Impairment

Mild to severe renal impairment (CrCl 15 to <89 mL/minute): No initial dosage adjustment necessary.

End-stage renal disease (ESRD): There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing Adjustment for Toxicity

Adverse events: May require temporary interruption, dose decreases (reduce dose from 5 mg twice daily to 3 mg twice daily; further reduce to 2 mg twice daily) or discontinuation

Cardiac failure: May require permanent discontinuation

Hypertension: Treat with standard antihypertensive therapy.

Persistent hypertension: May require dose reduction

Severe, persistent (despite antihypertensives and dose reduction), or evidence of hypertensive crisis: Discontinue treatment

Hemorrhage: Any bleeding requiring medical intervention: Temporarily interrupt treatment.

Proteinuria (moderate-to-severe): Reduce dose or temporarily interrupt treatment.

Extemporaneously Prepared

For patients unable to swallow tablets whole, a suspension may be prepared for nasogastric tube administration (for doses of 2 to 10 mg). Place a 20 mL tightly capped amber syringe in a small drinking glass, with the open end of the syringe pointing up. Place the appropriate axitinib dose in the open syringe barrel; add 15 mL of USP grade water (do not use tap water or bottled water) to the syringe. Allow at least 10 minutes to dissolve the tablets; avoid direct light. Place the plunger of the syringe into the barrel, invert the syringe so the tip is pointing upward and remove the cap. Expel excess air; replace the cap until ready for use (keep syringe tip facing up). Prior to administration, gently invert the syringe several times to ensure a uniform suspension. Flush the nasogastric feeding tube with 15 mL of USP grade water before administration. After administering the dose, draw up 10 mL of USP grade water (into the same syringe which contained the dose) and flush the feeding tube; repeat this step 5 additional times to ensure the entire dose has been administered. Lastly, flush the feeding tube with a separate syringe containing 15 mL of USP grade water. Administer within 15 minutes of preparation.

Borst DL, Arruda LS, MacLean E, Pithavala YK, Morgado JE. Common questions regarding clinical use of axitinib in advanced renal cell carcinoma. Am J Health Syst Pharm. 2014;71(13):1092-1096.

Adverse Reactions

>10%:

Cardiovascular: Hypertension (40%; grades 3/4: 16%)

Central nervous system: Fatigue (39%), voice disorder (31%), headache (14%)

Dermatologic: Palmar-plantar erythrodysesthesia (27%; grades 3/4: 5%), skin rash (13%; grades 3/4: <1%)

Endocrine & metabolic: Decreased serum bicarbonate (44%), hypocalcemia (39%), hyperglycemia (28%), weight loss (25%), hypothyroidism (19%; grades 3/4: <1%), hypernatremia (17%), hyperkalemia (15%), hypoalbuminemia (15%), hyponatremia (13%), hypophosphatemia (13%), hypoglycemia (11%)

Gastrointestinal: Diarrhea (55%; grades 3/4: 11%), decreased appetite (34%), nausea (32%; grades 3/4: 3%), increased serum lipase (3% to 27%), increased serum amylase (25%), vomiting (24%; grades 3/4: 3%), constipation (20%), mucosal inflammation (15%), stomatitis (15%), abdominal pain (8% to 14%), dysgeusia (11%)

Genitourinary: Proteinuria (11%; grade 3: 3%)

Hematologic and oncologic: Anemia (4% to 35%; grades 3/4: <1%), lymphocytopenia (33%; grades 3/4: 3%), hemorrhage (16%; grades 3/4 1%), thrombocytopenia (15%; grades 3/4: <1%), leukopenia (11%)

Hepatic: Increased serum alkaline phosphatase (30%), increased serum ALT (22%; grades 3/4: <1%), increased serum AST (20%; grades 3/4: <1%)

Neuromuscular & skeletal: Weakness (21%), arthralgia (15%), limb pain (13%)

Renal: Increased serum creatinine (55%)

Respiratory: Cough (15%), dyspnea (15%)

1% to 10%:

Cardiovascular: Venous thrombosis (grades 3/4: 3%), arterial thrombosis (2%; grade 3/4: 1%), pulmonary embolism (2%) deep vein thrombosis (1%), transient ischemic attack (1%), retinal vein occlusion (≤1%), retinal thrombosis (≤1%)

Central nervous system: Dizziness (9%)

Dermatologic: Xeroderma (10%), pruritus (7%), alopecia (4%), erythema (2%)

Endocrine & metabolic: Dehydration (6%), hyperthyroidism (1%)

Gastrointestinal: Dyspepsia (10%), hemorrhoids (4%), gastrointestinal fistula (1%), gastrointestinal perforation (≤1%)

Genitourinary: Hematuria (3%)

Hematologic and Oncologic: Increased hemoglobin (9%), rectal hemorrhage (2%), polycythemia (1%)

Neuromuscular & skeletal: Myalgia (7%)

Otic: Tinnitus (3%)

Respiratory: Epistaxis (6%), hemoptysis (2%)

<1% (Limited to important or life-threatening): Cardiac failure, cerebral hemorrhage, cerebrovascular accident, fever, hypertensive crisis, neutropenia, reversible posterior leukoencephalopathy syndrome

Renal Dose Adjustments

Mild to severe renal impairment (CrCl 15 mL/min to less than 89 mL/min): No adjustment to starting dose recommended
Severe renal impairment (CrCl less than 15 mL/min): Use with caution

How to Take axitinib (Dosage)

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Advanced kidney cancer

Brand: Inlyta

Form: oral tablet Strengths: 1 mg, 5 mg Adult dosage (ages 18 years and older)
  • Typical starting dosage: 5 mg taken twice per day
  • Dosage increases: If your blood pressure is controlled and you can tolerate the starting dose for least 2 weeks without side effects, your doctor may increase your dose to 7 mg twice per day. If you still have no side effects at that dosage, your doctor may increase your dosage to 10 mg twice per day.
  • Maximum dosage: 10 mg taken twice per day
Child dosage (ages 0–17 years)

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with moderate liver disease should receive half of the typical starting dose, or 2.5 mg taken twice per day.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you. Important considerations for taking Axitinib

Take this drug with a glass of water. You can take it with or without food

Take this drug once every 12 hours

Do not cut or crush the tablet. Swallow it whole

Store this drug carefully

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A prescription for this medication is refillable

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Travel

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Self-management

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Clinical monitoring

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Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Hidden costs

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Insurance

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Are there any alternatives?

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