Drug Notebook

FDA Alerts

    Fatal Infusion-related Reactions
  • Death has occurred within 24 hours of administration following the occurrence of severe infusion-related effects (i.e., hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, VF, and/or cardiogenic shock).
  • Approximately 80% of fatal reactions have occurred with the first dose.
  • If severe infusion-related effects occur, discontinue rituximab infusion and institute appropriate treatment. (See Infusion-related Effects under Cautions.)
    Tumor Lysis Syndrome
  • Acute renal failure requiring dialysis (sometimes fatal) reported in patients with non-Hodgkin’s lymphoma who experience tumor lysis syndrome. (See Tumor Lysis Syndrome under Cautions.)
    Severe Mucocutaneous Reactions
  • Severe, sometimes fatal, mucocutaneous reactions reported. (See Mucocutaneous Reactions under Cautions.)
    Progressive Multifocal Leukoencephalopathy (PML)
  • JC virus infection resulting in PML and death reported. (See Progressive Multifocal Leukoencephalopathy [PML] under Cautions.)

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rituximab
(ri TUK si mab)

Before receiving rituximab, tell your doctor if you are also being treated with any of the following drugs:

  • cisplatin (Platinol);

  • adalimumab (Humira);

  • azathioprine (Imuran);

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • etanercept (Enbrel);

  • infliximab (Remicade);

  • leflunomide (Arava);

  • minocycline (Dynacin, Minocin, Vectrin);

  • sulfasalazine (Azulfidine);

  • blood pressure medications;

  • gold salts such as auranofin (Ridaura), aurothioglucose (Solganal); or

  • medication to treat malaria, such as chloroquine (Aralen) or hydroxychloroquine (Plaquenil, Quineprox).

This is not a complete list and there may be other drugs that can affect rituximab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

  • sudden numbness or weakness, especially on one side of the body;

  • confusion, dizziness, loss of balance, blurred vision, and problems with speech or walking; or

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • uneven heartbeats, wheezing or trouble breathing;

  • urinating more or less than usual;

  • fever, chills, cough, body aches, flu symptoms;

  • easy bruising or bleeding;

  • a red, raised, blistering, scaly, itchy, or peeling skin rash;

  • severe constipation or stomach pain;

  • black, bloody, or tarry stools; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • pain where the IV needle is placed;

  • headache, back pain;

  • mild stomach pain, nausea, or diarrhea;

  • swelling in your hands or feet;

  • muscle or joint pain;

  • runny or stuffy nose; or

  • night sweats.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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