Rituxan

Rituxan (Rituximab) IV:

Rituxan (Rituximab) should only be given by health care professionals that are experienced treating the conditions that Rituxan (Rituximab) is used for.

For non-Hodgkin's lymphoma and chronic lymphocytic leukemia, the recommended dose and dosing schedule of Rituxan (Rituximab) varies according to body size, the condition being treated, and other medications that are being used.

It is injected intravenously (into a vein) by a health care professional, usually in a clinical setting such as a hospital clinic, over a period of time. This process is called an intravenous infusion.

For rheumatoid arthritis, the recommended dose is 1,000 mg for the first dose, followed 2 weeks later by a second dose of 1,000 mg. The medication is injected into a vein (IV) over a period of time in by a health care professional, usually in a clinic setting.

For Wegener's granulomatosis, the recommended dose is 375 mg/m² of body surface area, given once weekly for 4 weeks.

Very careful handling of Rituxan (Rituximab) is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important to receive Rituxan (Rituximab) exactly as recommended by your doctor. If you miss an appointment to receive Rituxan (Rituximab), contact your doctor as soon as possible to reschedule your appointment.

Many things can affect the dose and schedule of medication that a person needs, such as body size, other medical conditions, and other medications. Your doctor may choose a schedule different from the one above.

Rituxan (Rituximab) is stored in the refrigerator at 2°C to 8°C and protected from light.

Rituxan (Rituximab) SC:

Rituxan (Rituximab) SC is used only after the first dose of Rituxan (Rituximab) has been given by intravenous infusion and is tolerated. The recommended adult dose of Rituxan (Rituximab) SC is 1400 mg injected subcutaneously (under the skin) of the stomach on day 1 of each cycle of chemotherapy after the first cycle has been completed.

Very careful handling of Rituxan (Rituximab) is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important to receive Rituxan (Rituximab) exactly as recommended by your doctor. If you miss an appointment to receive Rituxan (Rituximab), contact your doctor as soon as possible to reschedule your appointment.

Many things can affect the dose and schedule of medication that a person needs, such as body size, other medical conditions, and other medications. Your doctor may choose a schedule different from the one above.

Rituxan (Rituximab) should be stored in the refrigerator at 2°C to 8°C and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

10 mg/mL solution for intravenous infusion

Each mL of sterile, clear, colourless liquid concentrate for IV (intravenous) administration contains 10 mg of Rituxan (Rituximab). Nonmedicinal ingredients: hydrochloric acid, polysorbate 80, sodium chloride, sodium citrate, sodium hydroxide, and sterile water for injection. Rituxan (Rituximab) does not contain preservatives.

120 mg/mL solution for subcutaneous injection

Each 1 mL of colorless-to-yellowish, clear-to-opalescent solution supplied in sterile, preservative-free, non-pyrogenic single-dose vial, contains 120 mg of Rituxan (Rituximab). Nonmedicinal ingredients: recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dehydrate, L-methionine, polysorbate 80, water for injection.

Do not receive Rituxan (Rituximab) if you:

• are allergic to Rituxan (Rituximab) or any ingredients of Rituxan (Rituximab)
• are allergic to proteins of similar origin
• have a severe infection
• have or have had progressive multifocal leukoencephalopathy (PML), a rare disorder associated with nerve damage in the brain

There may be an interaction between Rituxan (Rituximab) and any of the following:

• Abatacept
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• alpha agonists (e.g., Clonidine, methyldopa)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• bacillus Calmette-Guérin (BCG) (intravesical)
• Belimumab
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Certolizumab Pegol
• Clozapine
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• echinacea
• Fingolimod
• Leflunomide
• Natalizumab
• Nivolumab
• Pimecrolimus
• Roflumilast
• Tacrolimus
• tofacititinb
• Trastuzumab
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Rituxan (Rituximab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Rituxan (Rituximab).

Allergic reactions: In rare cases, some people may develop a serious allergic reaction to Rituxan (Rituximab). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, get immediate medical attention.

Blood clotting: Rituxan (Rituximab) can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily.

Tell your doctor about any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Drowsiness and dizziness: Because Rituxan (Rituximab) can cause drowsiness and dizziness, you should arrange to have someone drive you home after you receive Rituxan (Rituximab).

Heart problems: Serious and potentially life-threatening heart problems have occurred in people who were using Rituxan (Rituximab). If you have a heart problem (e.g., arrhythmia, Angina, heart failure), you will be monitored closely by your doctor during the infusion and immediately after the infusion is finished.

If you are taking medication for high blood pressure, you may need to temporarily stop the medication while receiving Rituxan (Rituximab). Talk to your doctor for more information.

Hepatitis B infection: There have been rare reports of the recurrence of hepatitis B infection in people receiving Rituxan (Rituximab) (often in combination with chemotherapy) who had previously been infected with the virus.

If you are at risk of hepatitis B infection, you should have a blood test before starting therapy to check if you carry the virus. Talk to your doctor if you are unsure whether you are at risk.

If you are a carrier of hepatitis B virus, had a previous infection, or are at risk of infection, your doctor will monitor you closely during Rituxan (Rituximab) therapy and for up to one year after finishing it for signs and symptoms of hepatitis B infection. These include abdominal or joint pain, loss of appetite, feeling of sickness, and yellowing of the skin and eyes (jaundice). If you experience these symptoms, contact your doctor immediately.

Infection: Rituxan (Rituximab) can reduce the number of cells that fight infection in the body (white blood cells), increasing the risk of developing an infection or reactivating an inactive infection (e.g., herpes, shingles). Avoid contact with people with contagious infections.

If you notice signs of an infection such as fever, chills, pain, redness and swelling, pus, cough, or difficult or painful urination, contact your doctor as soon as possible.

Rituxan (Rituximab) should also not be started while you have an active infection or a weakened immune system. While you are taking Rituxan (Rituximab), your doctor will monitor you for signs of infection.

Infusion-related reactions: There have been reports of severe infusion-related reactions, sometimes resulting in death, in people with who were given Rituxan (Rituximab) intravenously. Your health care provider will closely monitor you during and after the infusion. These reactions usually occur within 30 minutes to 2 hours of starting the infusion.

If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, flushing, chest pain, stomach upset, rash, or a dramatic drop in blood pressure tell your health care provider immediately.

It is important to take the medication(s) recommended by your doctor before your infusion of Rituxan (Rituximab). If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Rituxan (Rituximab). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Tumour lysis syndrome (TLS): Rituxan (Rituximab) may cause TLS, a potentially fatal condition that causes sudden kidney failure and abnormal heart rhythms. In the early stage of TLS, you may not have any symptoms, but your doctor will monitor for this condition with blood tests.

If you experience symptoms of TLS (e.g., a pounding, fast, or irregular heartbeat; vomiting; fatigue or weakness; difficulty concentrating; swelling, numbness or tingling in hands, face, or feet; back pain; muscle cramps; fainting; or trouble breathing), contact your doctor immediately.

Vaccines: Vaccines should not be given when you are receiving Rituxan (Rituximab). Talk to your doctor if you need any vaccinations while taking Rituxan (Rituximab).

Pregnancy: Rituxan (Rituximab) is not recommended for use during pregnancy. If you may become pregnant, use an effective method of birth control while you are using Rituxan (Rituximab), and for at least 12 months after the last treatment. Tell your doctor immediately if you become pregnant.

Breast-feeding: It is not known if Rituxan (Rituximab) passes into breast milk. If you are a breast-feeding mother and are taking Rituxan (Rituximab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Rituxan (Rituximab) have not been established for children.