Tositumomab Side Effects

Applies to tositumomab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions.

Prolonged and severe cytopenias occur in most patients.

Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3).

The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals.

Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff.

Intravenous route (solution)

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions.

Prolonged and severe cytopenias occur in most patients.

Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3).

The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals.

Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff.

Serious side effects of tositumomab

Along with its needed effects, tositumomab 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 tositumomab:

More common

• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• bone pain
• chest pain
• chills
• confusion
• constipation
• cough
• coughing up blood
• depressed mood
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry skin and hair
• fast heartbeat
• feeling cold
• fever or chills
• hair loss
• headache
• hives
• hoarseness or husky voice
• increased menstrual flow or vaginal bleeding
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• muscle cramps and stiffness
• noisy breathing
• nosebleeds
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red or black, tarry stools
• red or dark brown urine
• shortness of breath
• skin rash
• slowed heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• tightness in the chest
• tingling of the hands or feet
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• wheezing

Less common

• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck

Other side effects of tositumomab

Some side effects of tositumomab 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

• acid or sour stomach
• back pain
• belching
• body aches or pain
• congestion
• diarrhea or increased bowel movements
• difficult or labored breathing
• difficulty with moving
• dryness or soreness of the throat
• heartburn
• indigestion
• itching skin
• joint pain
• lack or loss of strength
• loose or liquid stools
• loss of appetite
• muscle aches or pains
• nausea or feeling of upset stomach or feeling like you may vomit
• neck pain
• runny nose
• stomach discomfort, upset, or pain
• sudden sweating
• swelling of the hands, ankles, feet, or lower legs
• swollen joints
• tender, swollen glands in the neck
• trouble with swallowing
• voice changes
• vomiting
• weight loss

Less common

• sleepiness or unusual drowsiness

For healthcare professionals

Applies to tositumomab: intravenous kit.

Cardiovascular

• Common (1% to 10%): Hypotension, vasodilation^[Ref]

Dermatologic

• Very common (10% or more): Rash, pruritus
• Common (1% to 10%): Sweating^[Ref]

Endocrine

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

Gastrointestinal

• Very common (10% or more): Abdominal pain, nausea, vomiting, diarrhea, anorexia
• Common (1% to 10%): Constipation, dyspepsia^[Ref]

Hematologic

• Very common (10% or more): Neutropenia, thrombocytopenia, anemia^[Ref]

Hypersensitivity

• Common (1% to 10%): Allergic (hypersensitivity) reactions (allergic reaction, facial edema, injection site hypersensitivity, anaphylactic reaction, laryngismus, serum sickness)
• Postmarketing reports: Hypersensitivity reactions including fatal anaphylaxis^[Ref]

Immunologic

• Very common (10% or more): Positive serology for human anti-mouse antibodies (HAMA)^[Ref]

Local

• Frequency not reported: Infusion reactions^[Ref]

Metabolic

• Common (1% to 10%): Peripheral edema, weight loss^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia, arthralgia
• Common (1% to 10%): Back pain, neck pain^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, somnolence
• Postmarketing reports: Axonal neuropathy leading to quadriparesis^[Ref]

Oncologic

• Common (1% to 10%): Secondary malignancies (non-melanoma skin, colorectal, head and neck, breast, lung, bladder, melanoma, gastric)
• Frequency not reported: Secondary leukemia, myelodysplastic syndrome^[Ref]

Other

• Very common (10% or more): Asthenia, fever, infections, pain, chills, headache
• Common (1% to 10%): Chest pain, serious infections (pneumonia, bacteremia, septicemia, bronchitis, skin infections)^[Ref]

Respiratory

• Very common (10% or more): Cough, pharyngitis, dyspnea, rhinitis
• Common (1% to 10%): Pneumonia^[Ref]

Further information

Tositumomab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer