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Description of product
What is Stivarga and how is it used?
Stivarga is a prescription medicine used to treat the symptoms of Colorectal Cancer, Gastrointestinal Stromal Tumors, and Hepatocellular Carcinoma. Stivarga may be used alone or with other medications.
Stivarga belongs to a class of drugs called Antineoplastics, Tyrosine Kinase Inhibitor; Antineoplastics, Angiogenesis Inhibitor.
It is not known if Stivarga is safe and effective in children.
What are the possible side effects of Stivarga?
Stivarga may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- fever,
- sore throat,
- burning eyes,
- skin pain,
- red or purple skin rash with blistering and peeling,
- nausea,
- vomiting,
- sleep problems,
- dark urine,
- yellowing of the skin or eyes (jaundice),
- headache,
- confusion,
- change in mental status,
- vision,
- seizure,
- pain, blisters, bleeding, or severe rash in the pals of your hands or the soles of your feet,
- chest pain,
- shortness of breath,
- lightheadedness,
- severe headache,
- blurred vision,
- pounding in your neck or ears,
- chills,
- severe stomach pain or swelling,
- nausea,
- vomiting,
- increase thirst,
- decreased urination,
- bruising,
- nosebleeds,
- heavy menstrual periods,
- blood in your urine,
- bloody or tarry stools,
- coughing up blood,
- bleeding that will not stop,
- sore throat,
- cough with or without mucus,
- vaginal itching,
- vaginal discharge,
- pain or burning when you urinate, and
- redness and swelling
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Stivarga include:
- diarrhea,
- nausea,
- stomach pain,
- loss of appetite,
- weight loss,
- increased blood pressure,
- fever,
- infection,
- abnormal liver function test,
- pain or redness in your mouth or throat,
- hoarse voice,
- weakness, and
- tiredness,
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Stivarga. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
DESCRIPTION
STIVARGA (regorafenib) is amultikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl] carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula:
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Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3 • H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone.
STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with "BAYER" on one side and "40" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
INDICATIONS
Colorectal Cancer
STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) 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.
Gastrointestinal Stromal Tumors
STIVARGA is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
Hepatocellular Carcinoma
STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
DOSAGE AND ADMINISTRATION
Recommended Dose
The recommended dose is 160 mg STIVARGA (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.
Take STIVARGA at the same time each day. Swallow tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat [see CLINICAL PHARMACOLOGY]. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day.
Dose Modifications
If dose modifications are required, reduce the dose in 40 mg (one tablet) increments; the lowest recommended daily dose of STIVARGA is 80 mg daily.
Interrupt STIVARGA for the following:
- Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia syndrome (PPES)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR
- Symptomatic Grade 2 hypertension
- Any Grade 3 or 4 adverse reaction
- Worsening infection of any grade
Reduce the dose of STIVARGA to 120 mg:
- For the first occurrence of Grade 2 HFSR of any duration
- After recovery of any Grade 3 or 4 adverse reaction except infection
- For Grade 3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation, only resume if the potential benefit outweighs the risk of hepatotoxicity
Reduce the dose of STIVARGA to 80 mg:
- For re-occurrence of Grade 2 HFSR at the 120 mg dose
- After recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity or infection)
Discontinue STIVARGA permanently for the following:
- Failure to tolerate 80 mg dose
- Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN)
- Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN
- Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg
- For any Grade 4 adverse reaction; only resume if the potential benefit outweighs the risks
HOW SUPPLIED
Dosage Forms And Strengths
STIVARGA is a 40 mg, light pink, oval-shaped, film-coated tablet, debossed with ‘BAYER’ on one side and ‘40’ on the other side.
Tablets are supplied in the following:
Packages containing three bottles, with each bottle containing 28 tablets, for a total of 84 tablets per package
(NDC 50419-171-03).
Packages containing four bottles, with each bottle containing 21 tablets, for a total of 84 tablets per package
(NDC 50419-171-06).
Storage And Handling
Store STIVARGA at 25°C (77°F); excursions are permitted from 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Store tablets in the original bottle and do not remove the desiccant. Keep the bottle tightly closed after first opening.
Discard any unused tablets 7 weeks after opening the bottle. Dispose of unused tablets in accordance with local requirements.