Applies to ibritumomab: intravenous solution.

Serious side effects of Ibritumomab

Along with its needed effects, ibritumomab 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 ibritumomab:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough or hoarseness
• coughing up blood
• difficulty with breathing or swallowing
• dizziness
• fever or chills
• headache
• increased menstrual flow or vaginal bleeding
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• noisy breathing
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or dark brown urine
• red stools
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing

Less common

• Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes
• bluish lips or skin
• chest pain or discomfort
• confusion
• diarrhea
• fainting
• fast heartbeat
• hives
• itching
• lightheadedness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• skin rash
• small red or purple spots on the skin
• unusual vaginal bleeding
• vomiting blood or material that looks like coffee grounds

Rare

• Agitation
• anxiety
• back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
• blurred vision
• coma
• drowsiness
• fast, pounding, or irregular heartbeat or pulse
• hallucinations
• inability to speak
• irritability
• mood or mental changes
• nausea
• redness of the skin
• seizures
• severe headache
• slurred speech
• stiff neck
• temporary blindness
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe
• welts

Incidence not known

• Blistering, peeling, or loosening of the skin
• cracks in the skin
• joint or muscle pain
• loss of heat from the body
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• skin blisters

Other side effects of Ibritumomab

Some side effects of ibritumomab 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:

More common

• Abdominal or stomach pain
• bruising
• constipation
• difficult or labored breathing
• difficulty with moving
• faintness or lightheadedness when getting up from a lying or sitting position
• fear
• feeling of warmth
• full or bloated feeling or pressure in the stomach
• joint pain
• lack or loss of strength
• large, flat, blue or purplish patches in the skin
• loss of appetite
• muscle aching or cramping
• muscle pain or stiffness
• nervousness
• pain
• rash
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• sleeplessness
• sneezing
• stuffy nose
• sudden or increased sweating
• swelling of the abdominal or stomach area
• swelling of the hands, ankles, feet, or lower legs
• swollen joints
• throat irritation
• trouble with sleeping
• unable to sleep
• weight loss

Less common

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

• Bleeding gums
• bone pain
• headache, sudden and severe
• inability to speak
• increased menstrual flow or vaginal bleeding
• red or black, tarry stools
• red or dark brown urine
• temporary blindness

For Healthcare Professionals

Applies to ibritumomab: intravenous kit.

Cardiovascular

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

Dermatologic

Common (1% to 10%): Night sweats, petechiae, pruritus, rash

Postmarketing reports: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, exfoliative dermatitis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea, abdominal pain, diarrhea^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia, neutropenia, anemia, leukopenia, lymphopenia

Common (1% to 10%): Ecchymosis

Frequency not reported: Cytopenias^[Ref]

Local

Postmarketing reports: Infusion site erythema, ulceration following extravasation^[Ref]

Metabolic

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

Musculoskeletal

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

Nervous system

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

Oncologic

Frequency not reported: Secondary malignancy^[Ref]

Other

Very common (10% or more): Fatigue, asthenia, pyrexia, serious and life threatening infections

Common (1% to 10%): Influenza-like illness

Uncommon (0.1% to 1%): Antibody formation

Postmarketing reports: Radiation injury^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (19%), cough (11%)

Common (1% to 10%): Pharyngolaryngeal pain, epistaxis, bronchitis, rhinitis, sinusitis^[Ref]