• Rituxan Hycela is a brand (trade) name for rituximab which may be used to treat follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
• Rituxan Hycela works by targeting a specific protein, called CD20, that exists on the surface of immature and mature B-lymphocytes. B lymphocytes are a type of white blood cell that are thought to contribute to the development of certain inflammatory conditions that affect B-cells. When Rituxan Hycela binds to this protein, it causes B-cells to self-destruct or disintegrate. NHL and CLL are blood cancers that affect B-cells. CD20 is an antigen that is displayed on certain B-cells, providing a target for Rituxan Hycela to latch onto. However, the exact way Rituxan Hycela works is not completely clear. Studies suggest that Rituxan Hycela may recruit macrophages, which are also a type of white blood cell, to ‘eat’ the B-cells via a process called antibody-dependent phagocytosis. It may also bring about antibody-dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity.
• Rituxan Hycela belongs to the class of medicines called CD20 monoclonal antibodies. It may also be called a targeted treatment, a biologic, or a monoclonal antibody.

• May be used to treat adults with relapsed or refractory follicular lymphoma as a sole agent.
• May be used to treat previously untreated follicular lymphoma in combination with first-line chemotherapy. In those who achieve a complete or partial response, it may be continued as single-agent maintenance therapy.
• For non-progressing (including stable disease) follicular lymphoma it may be given as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
• For previously untreated DLBCL, Rituxan Hycela may be given in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), or other anthracycline-based chemotherapy regimens.
• May be given to adults with previously untreated or previously treated chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide.
• Rituxan Hycela contains rituximab, the same active ingredient as in Rituxan. But it has been formulated with hyaluronidase, which is an enzyme that allows the active ingredient rituximab to be given over 5-7 minutes via subcutaneous injection. However, Rituxan is approved to treat some non-cancer conditions such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis), microscopic polyangiitis (MPA), and Pemphigus Vulgaris.
• Research has indicated that people prefer Rituxan Hycela because it can be given over 5 to 7 minutes, rather than 3 to 6 hours, like Rituxan.
• Available in two strengths: 1,400mg/23,400 units providing 1,400 mg rituximab and 23,400 units hyaluronidase human per 11.7 mL, and 1,600 mg/26,800 units providing 1,600 mg rituximab and 26,800 units hyaluronidase human per 13.4 mL
• Rituxan Hycela is not chemotherapy, it is a targeted treatment that works by binding to a protein called CD20 that is present on the surface of B-lymphocytes, which are a type of white blood cell. When Rituxan Hycela binds to this protein, it causes B-cells to self-destruct or disintegrate.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea, fatigue, fever, lack of energy, infections, neutropenia, anemia, joint pains, paresthesia (burning or prickling sensations), headache, fever, constipation, diarrhea, abdominal pain, vomiting, and injection site redness and pain are the most common side effects reported. Hair loss (alopecia), itch, rash, insomnia, shortness of breath, and some other side effects may also occur.
• Severe skin reactions can occur, including injection site reactions. Symptoms include pain, swelling, hemorrhage, redness, itch, and rash. Mucocutaneous reactions, some fatal, such as paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis have occurred in people treated with Rituxan Hycela. Discontinue treatment.
• Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving Rituxan Hycela. Perform cardiac monitoring during and after all infusions of Rituxan Hycela for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina and discontinue infusions for serious or life-threatening cardiac arrhythmias.
• Severe, including fatal, renal toxicity can occur after Rituxan Hycela administration.
• Abdominal pain, bowel obstruction, and perforation, in some cases leading to death, can occur in patients receiving Rituxan Hycela in combination with chemotherapy. The average time to onset was 6 days (range 1–77) days.
• People can only receive Rituxan Hycela AFTER they have received at least 1 full dose of a rituximab product by IV infusion.
• Rituxan Hycela cannot be used to treat medical conditions, such as rheumatoid arthritis, that are not cancers.
• Even though it is given subcutaneously (under the skin) it still needs to be administered by a healthcare professional.
• Patients need to be premedicated with acetaminophen and an antihistamine before each infusion to lower the risk of infusion-related reactions. Premedication with a glucocorticoid should also be considered. Observe patients for at least 15 minutes following Rituxan Hycela.
• Patients with CLL have a higher risk of developing herpes virus infections and Pneumocystis jirovecii pneumonia (PCP) during treatment and for 12 months following treatment with Rituxan Hycela and should be provided with prophylactic treatment for both these infections.
• Reactivation of hepatitis B has been reported in people who have a current or prior hepatitis B virus (HBV) infection before initiating treatment with Rituxan Hycela. In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. All patients should be screened for current or prior hepatitis B virus (HBV) infection by measuring HBsAg and anti-HBc before initiating treatment with Rituxan Hycela.
• A complete blood count (CBC) including platelets is also needed before the first dose. Depending on the condition being treated, CBCs with differential and platelets may be needed before every infusion, at weekly or monthly intervals, and more frequently in those who develop cytopenias. Continue to monitor for cytopenias after the final dose and until resolution.
• Rituxan Hycela should be injected subcutaneously into the abdomen over approximately 5 to 7 minutes. Do not inject into areas of skin that are red, bruised, tender, or hard, or where there are moles or scars.
• Serious infections, including sepsis, have occurred in people receiving Rituxan Hycela and Rituxan. The incidence of infections was 56% with Rituxan Hycela and 49% with Rituxan in patients with CLL and 46% and 41% in those with FL/DLBCL in combination with chemotherapy.
• Rituxan Hycela will suppress the immune system and will reduce a person's ability to fight infection. This ability will be further compromised if the person is also taking other drugs that suppress the immune system, such as chemotherapy agents, immune-modulating therapies, or other immunosuppressants. This immune-suppressing effect will persist for a few months after stopping Rituxan Hycela treatment. Review all other immune-suppressing medications before initiating Rituxan Hycela, and be aware of those with a long half-life whose effects may persist for weeks after discontinuation, such as natalizumab, teriflunomide, or mitoxantrone. Life-threatening and fatal infections have occurred in association with Rituxan Hycela.
• Rituxan Hycela will also reduce the immune response to live vaccines, such as MMR and varicella vaccines. All vaccines should be up to date before Rituxan Hycela is even started. Administer all live or live-attenuated vaccines at least 4 weeks before initiating Rituxan Hycela, and non-live vaccines at least 2 weeks before.
• Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients with hematologic malignancies or with autoimmune diseases who have received Rituxan Hycela. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that often leads to death or severe disability. Posterior reversible encephalopathy syndrome (PRES), tumor lysis syndrome (TLS), and respiratory effects have also been reported.
• Store Rituxan Hycela in the refrigerator at 2°C to 8°C (36°F to 46°F) and leave it in the original carton to protect it from light. Do not freeze.
• Can cause fetal harm if administered to pregnant women and those of childbearing potential should use effective contraception while receiving Rituxan Hycela and for 12 months after the last dose. If a woman becomes inadvertently pregnant she should advise her doctor immediately. Women should not breastfeed during treatment with Rituxan Hycela and for 6 months after the last dose.
• Not available as a generic.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before starting treatment with Rituxan Hycela, and during treatment with Rituxan Hycela, tell your health care provider if you think you have an infection or have symptoms of an infection such as a fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. Also, let them know if you have infections that keep coming back.
• Some vaccinations may need to be avoided during treatment with Rituxan Hycela and for a few months after stopping it. Take care to avoid people who are unwell and protect yourself from injury.
• Your doctor will also obtain a complete blood count including platelets and screen you for hepatitis B virus (HBV) infection before starting Rituxan Hycela. This is because treating HCV may reactivate an underlying hepatitis B infection (HBV). Any underlying HBV infection should be treated before Rituxan Hycela is started.
• Rituxan Hycela is given via subcutaneous injection - an injection under the skin - in the stomach area. It is administered by a healthcare professional and should only be administered after at least one full dose of a rituximab product has been administered via intravenous (IV) infusion because of the potential for hypersensitivity reactions and other side effects during the initial administration of rituximab products.
• Before you receive Rituxan Hycela, an antihistamine and acetaminophen, and possibly a glucocorticoid medication, will be administered to help prevent side effects. After your injection, you’ll be monitored for at least 15 minutes.
• Infusion reactions, some serious, may occur while you are having a Rituxan Hycela infusion. Symptoms may include itchy skin, a rash, hives, skin redness, bronchospasm, throat irritation, oropharyngeal pain, shortness of breath, throat edema, flushing, low blood pressure, fever, fatigue, headache, dizziness, nausea, a fast heartbeat, and anaphylaxis.
• Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding before being administered Rituxan Hycela as it is not suitable during pregnancy and breastfeeding. Use effective contraception while receiving Rituxan Hycela and for 12 months after the last infusion. If you inadvertently become pregnant, see your doctor immediately.

• Clinical studies showed Rituxan Hycela delivered similar blood levels and effectiveness to rituximab; however, the majority (77 percent) of patients preferred Rituxan Hycela over IV Rituxan due to less time spent in the clinic.
• Research has shown that Rituxan Hycela is non-inferior to Rituxan with similar response rates reported (an overall response rate of 85% with Rituxan compared to 84% with Rituxan Hycela.
• Studies of Rituxan in non-Hodgkin’s lymphoma show it starts working rapidly in patients. An initial clinical trial showed CD20+ B-cells were rapidly depleted in the peripheral blood of patients 24-72 hours after they received Rituxan. Tumor biopsies taken 2 weeks after treatment with Rituxan revealed that the drug had attached itself to tumor cells and the number of B-cells had decreased. Further investigation also confirmed that B-cells were depleted within the first 3 weeks.
• In addition to these immediate effects of Rituxan on the body, researchers have investigated how long it takes for the drug to cause signs of cancer to decrease and disappear. In a key clinical trial conducted in 166 patients with NHL, the median time to onset of response was 50 days in the 48% of patients who responded to therapy.
• Rituxan Hycela also works in the same way to cause a rapid depletion of B-cells in patients with CLL.

Medicines that interact with Rituxan Hycela may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Rituxan Hycela. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Rituxan Hycela include:

• antineoplastics, such as capecitabine or cyclophosphamide
• antipsychotics, such as clozapine
• biologics, such as adalimumab, etanercept, golimumab, or infliximab
• fingolimod or golimumab
• HIV medications, such as zidovudine
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, Covid-19 vaccines, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Rituxan Hycela reduces the immune response to vaccination. Administer live or live-attenuated vaccines at least 4 weeks before Rituxan Hycela initiation, and non-live vaccines at least 2 weeks before)
• probiotics, such as bifidobacterium or lactobacillus
• zinc.

Rituxan Hycela may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Take this into account when switching from drugs with prolonged immune effects.

Note that this list is not all-inclusive and includes only common medications that may interact with Rituxan Hycela. You should refer to the prescribing information for Rituxan Hycela for a complete list of interactions.