Gazyva

The recommended adult dose of Gazyva (Obinutuzumab) is 1000 mg, given by intravenous infusion (into a vein), into a site specially prepared for giving Gazyva (Obinutuzumab). Gazyva (Obinutuzumab) is given as a series of 6 cycles, each lasting 28 days.

For the first cycle, 100 mg of Gazyva (Obinutuzumab) is given on Day 1, and the remaining 900 mg is given on Day 2. A dose of 1000 mg is given on Days 8 and 15. For the remaining cycles, a dose of 1000 mg is given on Day 1 of each cycle only.

Very careful handling of Gazyva (Obinutuzumab) is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation of the medication and facilities to treat medical emergencies, such as infusion reactions.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

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

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

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.

Each vial of sterile, preservative free, non-pyrogenic, clear, colourless-to-slightly-brownish liquid contains 1000 mg of Gazyva (Obinutuzumab). Nonmedicinal ingredients: L-histidine/L-histidine hydrochloride poloxamer 188, trehalose and water for injection.

Do not take Gazyva (Obinutuzumab) if you are allergic to Gazyva (Obinutuzumab) or any ingredients of the medication.

There may be an interaction between Gazyva (Obinutuzumab) and any of the following:

• acetylsalicylic acid (Asa)
• alpha agonists (e.g., Clonidine, methyldopa)
• amifostine
• Amiodarone
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• anti-psychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• BCG vaccine
• Belimumab
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Bortezomib
• brimonidine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Clopidogrel
• dabigatran
• Deferiprone
• diazoxide
• Dipyridamole
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• echinacea
• Fingolimod
• Heparin
• Hydralazine
• Leflunomide
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Natalizumab
• nitrates (isosorbide dinitrate, Nitroglycerin)
• Nivolumab
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Pentoxifylline
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pimecrolimus
• Prasugrel
• quinine
• Rivaroxaban
• Roflumilast
• sacubitril
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• Tacrolimus
• Ticagrelor
• Ticlopidine
• Tofacitinib
• Trastuzumab
• vaccines
• Warfarin

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 Gazyva (Obinutuzumab). 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 Gazyva (Obinutuzumab).

Birth control: Gazyva (Obinutuzumab) may cause infants to be born without B-cells if Gazyva (Obinutuzumab) is used by the mother during pregnancy. Women of childbearing age who are taking Gazyva (Obinutuzumab) should use an effective method of birth control such as condoms during treatment and for 18 months after stopping the medication.

Bleeding: Gazyva (Obinutuzumab) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Heart disease: Gazyva (Obinutuzumab) may cause severe cardiovascular reactions, such as heart attack, irregular heartbeat, Angina or Stroke. People who already have heart disease, may find that Gazyva (Obinutuzumab) makes their symptoms of heart disease worse. If you have any form of heart disease, discuss with your doctor how Gazyva (Obinutuzumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gazyva (Obinutuzumab), and whether any special monitoring is needed.

Hepatitis B virus (HBV) reactivation: People who have had hepatitis B infections may find that this infection returns with the use of Gazyva (Obinutuzumab). Gazyva (Obinutuzumab) works by reducing the number of infection-fighting white blood cells. By doing so, the hepatitis B virus may be reactivated, causing liver damage.

Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Infection: Gazyva (Obinutuzumab) is intended to reduce the number of B-cells, which are specific types of cells that fight infection in the body. This reduces your body's ability to fight infections. If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Infusion reactions: Gazyva (Obinutuzumab) can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, itchiness, Hives, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately.

Kidney function: Kidney Disease or reduced kidney function may cause Gazyva (Obinutuzumab) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Gazyva (Obinutuzumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Gazyva (Obinutuzumab), and whether any special monitoring is needed.

Progressive multifocal leukoencephalopathy (PML):There have been reports of PML after using Gazyva (Obinutuzumab). 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: Gazyva (Obinutuzumab), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, notice cloudy urine or joint pain or muscle spasms. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Vaccines: Vaccines (e.g., yellow fever, BCG, Cholera, typhoid, varicella, meningococcal, diphtheria) should not be given while you are taking Gazyva (Obinutuzumab). Vaccinations should be postponed until recovery from treatment with Gazyva (Obinutuzumab) is complete.

Pregnancy: Gazyva (Obinutuzumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Gazyva (Obinutuzumab), contact your doctor immediately.

Breast-feeding: Gazyva (Obinutuzumab) may pass into breast milk. If you are a breast-feeding mother and are receiving Gazyva (Obinutuzumab), it may affect your baby. Because the potential for harm to an infant is not known, you should stop breast-feeding if you are receiving Gazyva (Obinutuzumab).

Women who have used Gazyva (Obinutuzumab) in the past should not breast-feed for at least 18 months after stopping Gazyva (Obinutuzumab).

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

Seniors: It is likely that people over the age of 75 will experience more side effects and more severe side effects. If you are over age 75, you should report any unusual effects to your doctor as soon as possible.