Stivarga Side Effects

Generic name: regorafenib

Note: This document contains side effect information about regorafenib. Some of the dosage forms listed on this page may not apply to the brand name Stivarga.

Some side effects of Stivarga may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to regorafenib: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking regorafenib (the active ingredient contained in Stivarga) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using regorafenib and call your doctor at once if you have:

• fever, chills, flu symptoms, mouth sores, severe or ongoing vomiting or diarrhea;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;

• heavy menstrual periods or abnormal vaginal bleeding;

• any bleeding that will not stop;

• chest pain and severe dizziness, fainting, feeling short of breath;

• headache, confusion, change in mental status, vision loss, seizure (convulsions);

• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• dangerously high blood pressure (blurred vision, buzzing in your ears, anxiety, uneven heartbeats);

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;

• any wound that won't heal; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• diarrhea, stomach pain, weight loss;

• hoarse voice; or

• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to regorafenib: oral tablet

General

The most common side effect resulting in discontinuation was skin toxicity (HFSR/PPE or rash).
The most frequently observed adverse drug reactions (greater than or equal to 30%) were asthenia/fatigue, decreased appetite and food intake, HFSR/PPE, diarrhea, mucositis, weight loss, infection, hypertension and dysphonia.
The most serious adverse drug reactions were hepatotoxicity, hemorrhage, and gastrointestinal perforation.

Cardiovascular

Very common (10% or more): Hypertension (30%)

Dermatologic

Very common (10% or more): HFSR/PPE (45%), rash (26%)
Common (1% to 10%): Alopecia (7.6%)

Endocrine

Very common (10% or more): Increased lipase (46%), increased amylase (26%)
Common (1% to 10%): Hypothyroidism (4.2%)

Gastrointestinal

Very common (10% or more): Diarrhea (43%), mucositis (33%)
Common (1% to 10%): Taste disorder (7.6%), dry mouth (4.8%), gastroesophageal reflux (1.4%)
Uncommon (0.1% to 1%): Gastrointestinal fistula (0.8%)

Hematologic

Very common (10% or more): Anemia (79%), lymphopenia (54%), thrombocytopenia (41%), increased INR (24%), hemorrhage (21%)
Common (1% to 10%): Neutropenia (3%)

Hepatic

Very common (10% or more): Increased AST (65%), increased ALT (45%), hyperbilirubinemia (45%)

Immunologic

Very common (10% or more): Infection (31%)

Metabolic

Very common (10% or more): Hypocalcemia (59%), hypophosphatemia (57%), decreased appetite and food intake (47%), weight loss (32%), hyponatremia (30%), hypokalemia (26%)

Musculoskeletal

Common (1% to 10%): Musculoskeletal stiffness (6.0%)

Nervous system

Very common (10% or more): Pain (29%), headache (10%)
Common (1% to 10%): Tremor (2%)

Oncologic

Rare (less than 0.1%): Keratoacanthoma/squamous cell carcinoma of the skin (0.09%)

Other

Very common (10% or more): Asthenia/fatigue (64%), fever (28%)

Renal

Very common (10% or more): Proteinuria (60%)

Respiratory

Very common (10% or more): Dysphonia (30%)

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