HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciTivo safely and effectively. See full prescribing information for LuciTivo.

INDICATIONS AND USAGE

LuciTivo is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

DOSAGE AND ADMINISTRATION

• Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity.

• Dose interruptions and/or dose reduction may be needed to manage adverse reactions.

• For patients with moderate hepatic impairment, reduce the dose to 0.89 mgfor 21 days on treatment followed by 7 days off treatment (28-day cycle).

DOSAGE FORMS AND STRENGTHS

Capsules: 1.34mg×21 capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating LuciTivo. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the LuciTivo dose.

• Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with LuciTivo.

• Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue LuciTivo for severe arterial thromboembolic events, such as myocardial infarction and stroke.

• Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue LuciTivo for severe venous thromboembolic events.

• Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

• Proteinuria: Monitor throughout treatment with LuciTivo. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with LuciTivo.

• Thyroid Dysfunction: Monitor before initiation and throughout treatment with LuciTivo.

• Risk of Impaired Wound Healing: Withhold LuciTivo for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of LuciTivo after resolution of wound healing complications has not been established.

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue LuciTivo if signs or symptoms of RPLS occur.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

CYP3A Inducers: Avoid concomitant use of strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

• Females and Males of Reproductive Potential: Can impair fertility.

• Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.