Applies to ziv-aflibercept: intravenous solution.

Serious side effects of Ziv-aflibercept

Along with its needed effects, ziv-aflibercept may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ziv-aflibercept:

More common

• Anxiety
• black, tarry stools
• bladder pain
• bleeding gums
• blood in the urine or stools
• bloody nose
• blurred vision
• chest pain
• confusion
• cough or hoarseness
• decreased urination
• difficult, burning, or painful urination
• dizziness or lightheadedness
• dry mouth
• excessive thirst
• fainting
• fever or chills
• frequent urge to urinate
• headache
• hoarseness
• lower back or side pain
• nervousness
• pain or swelling around the rectum
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sudden shortness of breath or troubled breathing
• sunken eyes
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• wrinkled skin

Less common

• Pains in the chest, groin, or legs, especially calves of the legs
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• troubled breathing

Rare

• Heartburn
• indigestion
• nausea
• severe abdominal or stomach pain, cramping, or burning
• vomiting of material that looks like coffee grounds, severe and continuing

Incidence not known

• Dilated neck veins
• extreme fatigue
• irregular breathing
• irregular heartbeat
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• weight gain

Other side effects of Ziv-aflibercept

Some side effects of ziv-aflibercept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abdominal or stomach pain
• decreased appetite
• diarrhea
• lack or loss of strength
• redness, swelling, or pain of the skin
• runny nose
• scaling of the skin on the hands and feet
• swelling or inflammation of the mouth
• tingling of the hands and feet
• ulceration of the skin

Incidence not known

• Heavy jaw feeling
• loosening of a tooth
• pain, swelling, or numbness in the mouth or jaw

For Healthcare Professionals

Applies to ziv-aflibercept: intravenous solution.

Cardiovascular

Very common (10% or more): Hypertension (41%)

Common (1% to 10%): Arterial thromboembolic events (ATE) (e.g., transient ischemic attack, cerebrovascular accident, angina pectoris)

Postmarketing reports: Cardiac failure, ejection fraction decreased^[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome (11%)

Common (1% to 10%): Skin hyperpigmentation^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (69%), stomatitis (50%), abdominal pain (27%), abdominal pain upper (11%)

Common (1% to 10%): Fistulas (anal, enterovesical, enterocutaneous, colovaginal, intestinal sites), dehydration, oropharyngeal pain, hemorrhoids, rectal hemorrhage, proctalgia

Uncommon (0.1% to 1%): GI hemorrhage, toothache^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Hematologic

Very common (10% or more): Leukopenia (78%), neutropenia (67%), thrombocytopenia (35%), hemorrhage (38%)^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity^[Ref]

Immunologic

Very common (10% or more): Infections (46%)

Common (1% to 10%): Immunogenicity^[Ref]

Metabolic

Very common (10% or more): Anorexia (32%), weight loss (32%)

Postmarketing reports: Osteonecrosis of the jaw^[Ref]

Nervous system

Very common (10% or more): Headache (22%)

Uncommon (0.1% to 1%): Reversible posterior leukoencephalopathy syndrome (RPLS)^[Ref]

Other

Very common (10% or more): Fatigue (48%), dysphonia (25%), asthenia (18%)

Uncommon (0.1% to 1%): Compromised wound healing^[Ref]

Renal

Very common (10% or more): Proteinuria (62%), serum creatinine increased (23%)^[Ref]

Respiratory

Very common (10% or more): Epistaxis (28%), dyspnea (12%)

Common (1% to 10%): Rhinorrhea, nasopharyngitis^[Ref]

Hepatic

Very common (10% or more): AST increased (62%), ALT increased (50%)^[Ref]