Gilotrif Side Effects

Generic Name: afatinib

Note: This page contains information about the side effects of afatinib. Some of the dosage forms included on this document may not apply to the brand name Gilotrif.

In Summary

Common side effects of Gilotrif include: diarrhea, skin rash, abnormal hepatic function tests, acneiform eruption, and erythema. Other side effects include: renal insufficiency, and palmar-plantar erythrodysesthesia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to afatinib: oral tablet

In addition to its needed effects, some unwanted effects may be caused by afatinib (the active ingredient contained in Gilotrif). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking afatinib:

• Bloody or cloudy urine
• burning, dry, or itching eyes
• diarrhea
• difficult, burning, or painful urination
• discharge or excessive tearing
• fever
• frequent urge to urinate
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• tingling of the hands and feet
• ulceration of the skin

• Cough
• difficult breathing
• shortness of breath

If any of the following symptoms of overdose occur while taking afatinib, get emergency help immediately:

• Abdominal or stomach pain
• dizziness
• headache
• lack or loss of strength
• nausea
• vomiting

Minor Side Effects

Some of the side effects that can occur with afatinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Blemishes on the skin
• canker sores
• chapped, red, or swollen lips
• decreased appetite
• decreased weight
• dry skin
• itching skin
• loosening of the fingernails
• nosebleeds
• pimples
• rash
• redness or soreness around the fingernails
• runny nose
• scaling, redness, burning, pain, or other signs of inflammation of the lips
• sores, ulcers, or white spots on the lips or tongue or inside the mouth

For Healthcare Professionals

Applies to afatinib: oral tablet

General

The most frequent serious adverse reactions reported were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).

Dose reductions due to adverse reactions were required in 57% of patients. The most frequent adverse reactions that led to dose reduction were diarrhea (20%), rash/acne (19%), paronychia (14%), and stomatitis (10%).

Discontinuation of therapy for adverse reactions was 14.0%. The most frequent adverse reactions that led to discontinuation were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%).^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (96%), stomatitis (71%), cheilitis (12%)^[Ref]

Dermatologic

Very common (10% or more): Acneiform rash/dermatitis (90%), paronychia (58%), dry skin (31%), pruritus (21%)^[Ref]

Genitourinary

Very common (10% or more): Cystitis (13%)^[Ref]

Hepatic

Very common (10% or more): Alanine aminotransferase increased (11%)
Common (1% to 10%): Aspartate aminotransferase increased (8%)^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (29%), weight decreased (17%)^[Ref]

Ocular

Very common (10% or more): Conjunctivitis (11%)^[Ref]

Other

Very common (10% or more): Pyrexia (12%)^[Ref]

Respiratory

Very common (10% or more): Epistaxis (17%), rhinorrhea (11%)^[Ref]

Not all side effects for Gilotrif may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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