Axita 5mg

Pregnancy Category D. Axitinib can cause fetal harm when administered to a pregnant woman based on its mechanism of action. There are no adequate and well-controlled studies in pregnant women using Axitinib. In developmental toxicity studies in mice, axitinib was teratogenic, embryotoxic and fetotoxic at maternal exposures that were lower than human exposures at the recommended clinical dose.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving Axitinib. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus

Nursing Mothers: It is not known whether axitinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Axitinib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Hypertension including hypertensive crisis has been observed. Blood pressure should be well-controlled prior to initiating Axita. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the Axita dose.

Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for these events.

Hemorrhagic events, including fatal events, have been reported. Axita has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients.

Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with Axita.

Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula.

Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment with Axita.

Stop Axita at least 24 hours prior to scheduled surgery.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. Permanently discontinue Axita if signs or symptoms of RPLS occur.

Monitor for proteinuria before initiation of, and periodically throughout, treatment with Axita. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with Axita.

Liver enzyme elevation has been observed during treatment with Axita. Monitor ALT, AST and bilirubin before initiation of, and periodically throughout, treatment with Axita.

The starting dose of Axita should be decreased if used in patients with moderate hepatic impairment. Axita has not been studied in patients with severe hepatic impairment.

Axita can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant while receiving Axita.

Strong CYP3A4/5 Inhibitors: The concomitant use of strong CYP3A4/5 inhibitors should be avoided (e.g., Ketoconazole, Itraconazole, Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, and Voriconazole). Selection of an alternate concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. Although Axita dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of Axita by approximately half is recommended, as this dose reduction is predicted to adjust the Axita area under the plasma concentration vs time curve (AUC) to the range observed without inhibitors. The subsequent doses can be increased or decreased based on individual safety and tolerability. If co-administration of the strong inhibitor is discontinued, the Axita dose should be returned (after 3-5 half-lives of the inhibitor) to that used prior to initiation of the strong CYP3A4/5 inhibitor.

Hepatic Impairment: No starting dose adjustment is required when administering Axita to patients with mild hepatic impairment (Child-Pugh class A). Based on the pharmacokinetic data, the Axita starting dose should be reduced by approximately half in patients with baseline moderate hepatic impairment (Child Pugh class B). The subsequent doses can be increased or decreased based on individual safety and tolerability. Axita has not been studied in patients with severe hepatic impairment (Child-Pugh class C).

There is no specific treatment for Axita overdose. In a controlled clinical study with Axita for the treatment of patients with RCC, 1 patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1). In a clinical dose finding study with Axita, subjects who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal hemoptysis. In cases of suspected overdose, Axita should be withheld and supportive care instituted.

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