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Generic Name: obinutuzumab (OH bi nue TOOZ ue mab)

Brand Names: Gazyva

Form: Intravenous solution

Gazyva (obinutuzumab) is a very useful cancer medication that hampers with increase and expansion of cancer cells in body. This medication is used in combination with another cancer medicine known as chlorambucil to heal chronic lymphocytic leukemia. It majorly works on body immune system. It then attacks the blood cells known as B-cell which are the cause of common blood cancers. The medication in combination with chlorambucil chemotherapy aided people suffering from CLL to live longer without any worries of worsening through the disease alone.

Drug Description:

GAZYVA (obinutuzumab) is a tame anti-CD20 derived from a single cell (monoclonal) antitoxin of IgG1 subclass. It identifies a specific epitope of the CD20 molecule which is initiated on B-cells. The molecular mass of the antitoxin is approx. 150 kDa. The medication is highly sterile, clear, and colorless to slightly brown, preservative free fluid concentrate for only intravenous administration. The medication is available at a concentration of 25 mg/mL in 1000 mg single use vials. The product is codified in 240 mM trehalose, 0.02% poloxamer 188, 20 mM L-histidine/L-histidine hydrochloride with pH as 6.0.

Dosage:

Gazyva is recommended for a 28-day treatment phase, and one may only need to be under this medicinal treatment for first 1 to 2 weeks of each cycle. Each dosage is 1000 mg, which is administered intravenously. Exception for dosage of first infusions in cycle 1, is administration on day 1 with 100 mg and day 2 with 900 mg respectively.

Missed Dosage:

If a planned dose is missed due to any case, intake the missed dose as soon as possible and later adjust dosing schedule accordingly. If relevant, patients who do not complete the Day 1 Cycle 1 dose are suggested to proceed to the Day 2 Cycle 1 dose.

Recommended Premedication:

For patients with high tumor burden and/or in case of high circulating; infinite lymphocyte tolls (greater than 25 × 109/L), premeditate with anti-hyperuricemics (e.g., allopurinol) has to be started 12–24 hours before the start of therapy. Ensure enough hydration for prophylaxis of tumor-lysis syndrome in patient before getting treated with this medication.

Preparation and Administration:

Compose the formula for infusion, using aseptic technique as described below:

  • Examine optically for any specific element and discoloration/stains pre administration.
  • Dilute 4 mL (100 mg) of the solution into a 100 mL 0.9% or non-PVC polyolefin immersion bag. Do not use any other diluents such as dextrose (5%). Sodium chloride infusion bag for immediate administration.
  • Dilute the left 36 mL (900 mg) into a 250 mL 0.9% sodium chloride infusion bag at the same time for adoption on Day 2. Store the solution at 2°C to 8°C (36°F to 46°F) for up to 24 hours. After allowing the diluted bag to come to room temperature, use it immediately.
  • Construction of solution for infusion on Day 1 is to be with 100 mg and Day 2 with 900 mg of Cycle 1 respectively.
  • The solution can be executed at a final absorption of 0.4 mg/mL to 4 mg/mL.

Administration:

The solution is to be administered as an intravenous infusion only. The solution is strictly not recommended to administer intravenously by act of pushing or blousing. Do not mix the solution in combination of other drugs. No incompatibilities between the medication and polyvinylchloride (PVC) or non-PVC polyolefin bags are to be practiced.

Storage and Handling:

GAZYVA 1000 mg/40 mL (25 mg/mL) once time use vials encompassing preservative-free solution are found balances at 2°C to 8°C (36°F to 46°F). Do not use the Intravenous solution beyond expiration date stamped on carton. GAZYVA vials should be  strictly kept away from the reach of light. Freezing of the solution is to be avoided. Do not shake the solution vials.

Side Effects:

The most common side effects of seen due to this solution are; infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, and muscle and joint pain. Severe side effects may be any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly so immediately get a medical help in such cases.

Hypotension may occur during getting treated with this intravenous infusion. Consider withholding antihypertensive treatments for 12 hours prior to and throughout infusion for the first hour after administration.

Precautions:

Patients are to be closely monitored during the entire infusion. Reactions due to infusion are usually seen within 24 hours of administration with Gazyva. For patients with already getting treated with cardiac or pulmonary conditions, oversee more usually all over the infusion time and post-infusion period. They may be at higher risk of allowing further more severe reactions. Hypotension may occur as part of infusion reaction. Consider withholding of treatments for 12 hours prior to, during each dosage, and for the first hour post administration until blood pressure is stable. For patients at increased risk of hypertensive crisis, consider the benefits versus the risks of withholding their medication as it is suggested.

Serious bacterial, fungal, and new or reactivated viral infections can occur during or post treatment. Do not administer the solution to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection with reference to this solution.