Rituximab and Hyaluronidase Human Injection
Rituximab and Hyaluronidase Human (Rituxan Hycela) is a subcutaneous injection used to treat certain blood cancers, including follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This medication carries the FDA's most serious warning — a black-box warning — about three life-threatening risks:
- Severe skin reactions: Rituxan Hycela can cause dangerous, even fatal, reactions involving the skin and mucous membranes (the lining of the mouth, eyes, etc.). These include conditions like toxic epidermal necrolysis and Stevens-Johnson syndrome. If you develop a severe rash or blistering, stop treatment and get medical help right away.
- Hepatitis B reactivation: If you carry the hepatitis B virus — even silently — this drug can trigger it to become active again, sometimes causing severe liver failure or death. You must be tested for hepatitis B before starting treatment, and monitored throughout.
- Rare but fatal brain infection (PML): Progressive multifocal leukoencephalopathy is a serious brain infection that can be fatal. Watch for new or worsening symptoms like confusion, trouble walking, vision changes, or weakness, and report them to your doctor immediately.
📖 Rituximab and Hyaluronidase Human Injection: Patient Information Guide
A plain-language walkthrough of Rituximab and Hyaluronidase Human Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Rituxan Hycela treats specific blood cancers in adults. Here are the approved uses:
- Follicular Lymphoma (FL): Used alone for relapsed or refractory FL; with chemotherapy for newly diagnosed FL; and as maintenance therapy in patients who respond to chemotherapy; also as a single agent for stable/non-progressing FL after CVP chemotherapy
- Diffuse Large B-Cell Lymphoma (DLBCL): Used with CHOP or other anthracycline-based chemotherapy for newly diagnosed cases
- Chronic Lymphocytic Leukemia (CLL): Used with fludarabine and cyclophosphamide (FC) for both newly diagnosed and previously treated CLL
It is not approved for non-cancer conditions, and patients must complete at least one full IV dose of a rituximab product before switching to this injection form.
⚙️How it works▾
Rituximab is a monoclonal antibody — a lab-made protein designed to find and attach to a specific target. It binds to a protein called CD20, found on the surface of certain B-cells (immune cells that become cancerous in these blood cancers). Once bound, it triggers the immune system to destroy those cells through two mechanisms: complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity — essentially, it flags the cancer cells for destruction by the body's own defenses.
The second ingredient, hyaluronidase, temporarily breaks down a gel-like substance in the skin called hyaluronan. This loosens the tissue just enough for the medication to absorb quickly under the skin. The effect wears off within 24 to 48 hours, and the tissue returns to normal.
💊How it's taken▾
Rituxan Hycela is injected under the skin (subcutaneously) into the abdomen by a trained healthcare professional — it is never given at home or self-administered. Each injection takes approximately 5 to 7 minutes, and you are observed for at least 15 minutes afterward.
- Before every dose, you'll receive pre-medications — at minimum acetaminophen and an antihistamine — to help reduce reaction risk
- Dose reductions are not recommended; if side effects occur with combination chemotherapy, those drugs are adjusted instead
- Your specific schedule (how often and for how long) depends on which cancer is being treated — follow your care team's plan exactly
🤒Side effects — in detail▾
The most commonly reported side effects (occurring in 20% or more of patients) include:
- Infections of various types
- Neutropenia (low white blood cell count, raising infection risk)
- Nausea
- Fatigue
- Constipation (mainly FL patients)
- Hair loss — alopecia (mainly DLBCL patients)
- Low platelet count — thrombocytopenia (mainly CLL patients)
- Fever and vomiting (mainly CLL patients)
- Injection site redness
Serious reactions — including severe skin blistering, hepatitis B reactivation, heart arrhythmias, kidney problems, and a rare brain infection called PML — require immediate medical attention. Contact your care team right away if anything feels off.
⚠️Warnings & precautions▾
- Severe skin reactions: Life-threatening skin conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis can occur. Stop the medication and seek emergency care immediately if you develop severe rash or blistering.
- Hepatitis B reactivation: The hepatitis B virus can reactivate — even in people who didn't know they carried it — causing liver failure or death. Screening before treatment and monitoring throughout are required.
- Progressive multifocal leukoencephalopathy (PML): This rare but fatal brain infection has been reported. Report any new confusion, vision changes, weakness, or trouble with coordination immediately.
- Tumor lysis syndrome: As cancer cells die rapidly, they release toxins that can stress the kidneys and heart. Your care team will monitor you and may use IV fluids and other treatments to manage this.
- Serious infections: Because this drug depletes B-cells, your immune defenses are lowered. Avoid live vaccines during treatment and report any signs of infection promptly.
- Heart problems and kidney damage: Serious cardiac events and kidney toxicity can occur — especially if combined with cisplatin. Tell your doctor about any history of heart or kidney issues.
- Bowel obstruction or perforation: Abdominal pain, vomiting, or other gut symptoms should be evaluated right away.
- Embryo-fetal toxicity: This drug can harm an unborn baby. Women who could become pregnant must use effective contraception and should not breastfeed during treatment.
🔀What it interacts with▾
The label identifies one key drug interaction to be aware of with Rituxan Hycela:
- Cisplatin (a chemotherapy drug): Using Rituxan Hycela together with cisplatin raises the risk of serious kidney damage. Your care team will weigh this carefully if cisplatin is part of your treatment plan.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Hepatitis B carriers: All patients must be screened for hepatitis B before starting — even if you feel fine. The virus can reactivate dangerously during treatment.
- Active or recent infections: Tell your doctor about any current infections before treatment begins.
- Pregnancy: This drug can harm a developing baby, including causing low B-cell counts in newborns. Women of childbearing age must use effective contraception during and after treatment.
- Breastfeeding: Do not breastfeed while receiving this medication.
- Live vaccines: Do not receive live virus vaccines before or during treatment — the lowered immune response makes this unsafe.
- Kidney or liver conditions: The effect of kidney or liver impairment on how your body handles this drug is not fully established — discuss your history with your prescriber.
- Children and adolescents: This medication has not been studied in patients under 18, and dosing guidance does not exist for this age group.
- First dose requirement: You must have successfully completed at least one full IV dose of a rituximab product before receiving this subcutaneous form.
📡Pharmacodynamics — effects in the body▾
Rituxan Hycela works by depleting B-cells — a type of immune cell — throughout the body. B-cell counts drop below normal levels after the first treatment cycle and remain low during the course of therapy. Once treatment stops, B-cells gradually begin to recover, typically starting around 6 months after the last dose, with most patients returning to normal levels within 12 months — though some take longer. In CLL patients, nearly all (96%) were fully B-cell depleted by the sixth treatment cycle.
🔬Pharmacokinetics — how your body processes it▾
Rituxan Hycela is absorbed through the subcutaneous (under-skin) tissue into the bloodstream, with the hyaluronidase component helping to speed that absorption. The bioavailability — the fraction that actually reaches circulation compared to an IV dose — is approximately 63–65%. Rituximab has a long elimination half-life of about 32 to 34 days, meaning it stays active in the body for weeks after each dose. It is cleared from the body through a process that changes over the course of therapy, with both time-dependent and time-independent elimination pathways at work.
📦How to store it▾
Store RITUXAN HYCELA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
📄 Written from Rituximab and Hyaluronidase Human Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Rituximab and Hyaluronidase Human Injection
53 supplements and herbal products have documented interactions with Rituximab and Hyaluronidase Human Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Rituximab and Hyaluronidase Human Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to get an IV infusion first before switching to the injection? ▾
Is the injection something I can do at home? ▾
I used to have hepatitis B years ago. Is that a problem? ▾
What side effects should I actually call the doctor about, versus just riding out? ▾
Can I get my flu shot or other vaccines while on this treatment? ▾
Is it safe to get pregnant or breastfeed during treatment? ▾
Is Rituximab and Hyaluronidase Human Injection available over the counter? ▾
💬 Answers drafted from Rituximab and Hyaluronidase Human Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
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📈 How widely Rituximab and Hyaluronidase Human Injection is used
A general measure of how commonly Rituximab and Hyaluronidase Human Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Rituximab and Hyaluronidase Human Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Rituximab and Hyaluronidase Human Injection prescribed? Of the 1,594 medications we measure, Rituximab and Hyaluronidase Human Injection ranks #1,528 by Medicaid prescriptions — more than 4% of them.
Utilization by Rituximab and Hyaluronidase Human Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
11.7 ML hyaluronidase, human recombinant 2000 UNT/ML / rituximab 120 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1927885
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Rituximab and Hyaluronidase Human Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Rituximab and Hyaluronidase Human Injection NDCs with Medicaid activity.
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Rituximab and Hyaluronidase Human Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Rituximab and Hyaluronidase Human Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Rituximab and Hyaluronidase Human Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Rituximab and Hyaluronidase Human Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
RxNorm drug class
Rituximab and Hyaluronidase Human Injection belongs to the CD20-directed Cytolytic Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.