Precautions for Axitinib Use
Axitinib is an oral, highly selective tyrosine kinase inhibitor developed by Pfizer, primarily used to treat advanced renal cell carcinoma.
Precautions for Axitinib Use
1. Hypertension and Hypertensive Crisis
Blood pressure should be well controlled before starting axitinib treatment. Monitor blood pressure during treatment and use standard antihypertensive therapy as needed.
Depending on the severity of hypertension, temporarily interrupt axitinib treatment, then reduce the dose or permanently discontinue treatment.
2. Arterial Thromboembolic Events
Patients who have experienced an arterial thromboembolic event within the past 12 months have not been evaluated. Caution should be exercised when using axitinib in patients at risk of arterial thromboembolic events or with a relevant history of such events.
If an arterial thromboembolic event occurs, permanently discontinue use.
3. Venous Thromboembolic Events
Monitor patients for signs and symptoms of VTE and pulmonary embolism. If symptoms occur, temporarily interrupt treatment and then resume administration at the same dose or permanently discontinue depending on the severity of the event.
4. Bleeding
Grade 3 or 4 bleeding events include cerebral hemorrhage, hematuria, hemoptysis, lower gastrointestinal bleeding, and melena.
Do not evaluate in patients with evidence of untreated brain metastases or recent active gastrointestinal bleeding; avoid use in such patients. If a bleeding event occurs, suspend axitinib treatment and then reduce the dose or discontinue depending on the severity and duration of the bleeding.
5. Heart Failure
Monitor for signs or symptoms of heart failure. Dose reduction, treatment interruption, or permanent discontinuation of axitinib may be necessary.
6. Gastrointestinal Perforation and Fistula Formation
Use with caution in patients at risk of gastrointestinal perforation or fistula formation. Monitor regularly for symptoms of gastrointestinal perforation or fistula formation during treatment.
7. Thyroid Dysfunction
Assess baseline thyroid function before starting treatment and monitor regularly during treatment. Treat hypothyroidism and hyperthyroidism according to standard medical practice to maintain normal thyroid function.
8. Wound Healing Complications
Axitinib may impair wound healing. Discontinue use at least 2 days before elective surgery and at least 2 weeks after major surgery. The decision to resume treatment postoperatively should be based on a clinical assessment of wound healing adequacy.
Resumption of administration at a reduced dose or discontinuation may be made depending on the severity and persistence of impaired wound healing. The safety of resuming axitinib after the resolution of wound healing complications has not been established.
9. Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
It may manifest as headache, seizures, somnolence, confusion, blindness, and other visual and neurological disturbances. Mild to severe hypertension may also occur. Magnetic resonance imaging (MRI) is required to confirm the diagnosis.
Permanent discontinuation of axitinib is recommended for patients with signs or symptoms of RPLS. The safety of resuming axitinib in patients with a history of RPLS is unknown.
10. Proteinuria
Monitor proteinuria regularly before initiating treatment and during treatment. For moderate to severe proteinuria, discontinue treatment and then reduce the dose.
11. Hepatotoxicity
For elevated liver enzymes, interrupt or permanently discontinue axitinib and avirumab or pembrolizumab, and administer corticosteroids as needed.
Axitinib in combination with avirumab or pembrolizumab can cause hepatotoxicity, with a higher-than-expected incidence of grade 3 or 4 ALT or AST elevations.
12. Major Adverse Cardiovascular Events (MACE)
Cardiovascular events, sometimes serious and fatal, have been reported when used in combination with avirumab.
Consider assessing LVEF at baseline and periodically. Monitor for signs and symptoms of cardiovascular events and optimize the management of cardiovascular risk factors such as hypertension, diabetes, and dyslipidemia. If a grade 3 or 4 cardiovascular event occurs, permanently discontinue axitinib and avirumab.
13. Fetal/Neonatal Morbidity and Death
Axitinib may cause fetal harm and has been shown to be teratogenic, embryotoxic, and fetal toxic in animals.
Pregnancy should be avoided during treatment. If used during pregnancy or if the patient is pregnant, the potential fetal risks should be explained.
14. Combination Therapy
When axitinib is used in combination with avirumab or pembrolizumab, in addition to the precautions associated with axitinib, the usual precautions, precautions, and contraindications associated with avirumab and pembrolizumab should be considered.
Special Considerations for Axitinib Use in Special Populations
1. Patients with Hepatic Impairment
(1) Mild Hepatic Impairment (Child-Pugh A): No dose adjustment is required.
(2) Moderate Hepatic Impairment (Child-Pugh B): The starting dose should be halved.
(3) Severe Hepatic Impairment (Child-Pugh C): Inexperience with this treatment is insufficient; its use should be avoided.
2. Patients with Renal Impairment
(1) No dose adjustment is required for patients with mild to severe renal impairment.
(2) Use with caution in patients with end-stage renal disease.
3. Elderly Patients
No dose adjustment is required solely based on age, but close monitoring is necessary as their tolerance to adverse reactions may be lower.
4. Pregnant and Lactating Women
Axitinib is embryotoxic and contraindicated in pregnant women. Women of childbearing age should use effective contraception during treatment and for one week after discontinuation. Breastfeeding women should discontinue breastfeeding.
Precautions During Axitinib Use
1. If long-term use of this medication is required, regular follow-up visits are necessary to monitor progress. Blood and urine tests may be required to monitor for adverse effects.
2. During use of this medication, your doctor will check your blood pressure regularly. If you experience severe headache, dizziness, or changes in vision, please inform your doctor immediately.
3. If you experience severe heartburn, cramps, or pain in your stomach; bloody or tarry stools; difficulty breathing; heartburn; indigestion; nausea; or vomiting coffee-ground-like material, seek immediate medical attention. These may be symptoms of a serious intestinal problem.
4. This medication may cause a serious skin problem called hand-foot syndrome. If you develop a rash or any redness, pain, swelling, or blisters on your palms or soles, seek immediate medical attention.
