Stivarga Generic Name & Formulations
Legal Class
Rx
General Description
Regorafenib 40mg; tabs.
Pharmacological Class
Kinase inhibitor.
How Supplied
Tabs—84 (4 x 21)
Manufacturer
Generic Availability
NO
Stivarga Indications
Indications
Metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy. Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) in patients who have been previously treated with imatinib mesylate or sunitinib malate. Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
Stivarga Dosage and Administration
Adult
Swallow whole with water after a low-fat meal (contains <600 calories and <30% fat). 160mg once daily for the first 21 days of each 28-day cycle; until disease progression or unacceptable toxicity. Dose modifications: reduce by 40mg increments (see full labeling).
Children
<18yrs: not established.
Stivarga Contraindications
Not Applicable
Stivarga Boxed Warnings
Boxed Warning
Hepatotoxicity.
Stivarga Warnings/Precautions
Warnings/Precautions
Risk of severe liver injury (may be fatal). Obtain LFTs before initiation, at least every 2 weeks during first 2 months of treatment, and monthly or more frequently thereafter as indicated. Interrupt, reduce or discontinue if persistent hepatotoxicity or hepatocellular necrosis occurs. Severe hepatic impairment: not recommended. Increased risk of infections; withhold if Grade 3/4 occurs or infection of any grade worsens; resume when resolved. Permanently discontinue if severe or life-threatening hemorrhage occurs. Interrupt and reduce or permanently discontinue if dermatological toxicity occurs (eg, hand-foot skin reaction [a.k.a. palmar-plantar erythrodysesthesia], rash). Ensure BP is controlled before starting; monitor weekly for the first 6 weeks then every cycle or as clinically indicated; withhold if severe or uncontrolled. Increased risk of myocardial ischemia/infarction: withhold if new or acute onset develops; resume when resolved. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) or GI perforation/fistula develops. Impaired wound healing: withhold for ≥2 weeks prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Asian patients (monitor). Dialysis. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during treatment and up to 2 months after completion. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Stivarga Pharmacokinetics
See Literature
Stivarga Interactions
Interactions
Potentiated by strong CYP3A4 inhibitors (eg, clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, voriconazole); avoid. Antagonized by strong CYP3A4 inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital, St. John’s Wort); avoid. Potentiates BCRP substrates (eg, methotrexate, fluvastatin, atorvastatin); monitor closely. Monitor INR levels with concomitant warfarin.
Stivarga Adverse Reactions
Adverse Reactions
Asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction, diarrhea, mucositis, weight loss, infection, hypertension, dysphonia, hyperbilirubinemia, GI and abdominal pain, rash, fever, nausea; hepatotoxicity, hemorrhage, GI perforation, cardiac ischemia/infarction, RPLS.
Stivarga Clinical Trials
See Literature
Stivarga Note
Not Applicable
Stivarga Patient Counseling
See Literature
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