Rituximab and hyaluronidase (human recombinant)
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Boxed warning
WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Severe mucocutaneous reactions, some with fatal outcomes ( 5.1 ). Hepatitis B virus reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.2 ). Progressive multifocal leukoencephalopathy resulting in death ( 5.3 ).
Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.1) ]. Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.2) ] .
Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ].
CD20-directed Cytolytic Antibody, Endoglycosidase
Dosing in kidney impairment
4 CONTRAINDICATIONS None None. 5 WARNINGS AND PRECAUTIONS Hypersensitivity and other administration reactions: Local cutaneous reactions may occur more than 24 hours after administration. Interrupt injection if severe reaction develops. Premedicate before injection. Tumor lysis syndrome: Administer aggressive intravenous hydration, anti hyperuricemic agents, monitor renal function.
Infections: Withhold and institute appropriate anti-infective therapy. Cardiac adverse reactions: Discontinue in case of serious or life-threatening events. Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria. Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms.
A high number of circulating malignant cells (≥ 25,000/mm 3 ) or high tumor burden confers a greater risk of TLS. Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated [see Warnings and Precautions ] . 5.6 Infections Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy with rituximab-containing products, including RITUXAN HYCELA.
Discontinue RITUXAN HYCELA for serious or life threatening cardiac arrhythmias. Perform cardiac monitoring during and after all administrations of RITUXAN HYCELA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina [see Adverse Reactions ] . 5.8 Renal Toxicity Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA .
Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and RITUXAN HYCELA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue RITUXAN HYCELA in patients with a rising serum creatinine or oliguria [see Warnings and Precautions ] . 5.9 Bowel Obstruction and Perforation Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA , in combination with chemotherapy.
Preparation and administration
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Preparation and Administration To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is RITUXAN HYCELA for subcutaneous use. Do not administer RITUXAN HYCELA intravenously . RITUXAN HYCELA is ready to use. Preparation Use a sterile needle and syringe to prepare RITUXAN HYCELA.
RITUXAN HYCELA is compatible with polypropylene and polycarbonate syringe material and stainless steel transfer and injection needles. Using a 20 mL syringe, withdraw the required volume from the vial with a narrow (e.g., 25–30 gauge) needle of any length. Label the syringe with the provided peel-off label. Change the needle to a 1/2" to 5/8" long, narrow gauge needle (e.g., 25–30 gauge) immediately prior to subcutaneous administration to avoid needle clogging.
Visually inspect for particulate matter and discoloration prior to administration. RITUXAN HYCELA should be a clear to opalescent and colorless to yellowish liquid. Do not use if particulates or discoloration is present. Administration Inject RITUXAN HYCELA into the subcutaneous tissue of the abdomen over approximately 5–7 minutes.
Never inject into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars. No data are available on performing the injection at other sites of the body. Inject 11.7 mL of RITUXAN HYCELA 1,400 mg/23,400 Units vial (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously into the abdomen over approximately 5 minutes.
Inject 13.4 mL of RITUXAN HYCELA 1,600 mg/26,800 Units vial (1,600 mg rituximab and 26,800 Units hyaluronidase human) subcutaneously into the abdomen over approximately 7 minutes. If administration of RITUXAN HYCELA is interrupted, continue administering at the same site, or at a different site, but restricted to the abdomen.
Observe patients for at least 15 minutes following RITUXAN HYCELA administration [see Warnings and Precautions ]. During treatment with RITUXAN HYCELA, do not administer other medications for subcutaneous use at the same sites as RITUXAN HYCELA. Storage Use immediately. If not used immediately store refrigerated at 2°C to 8°C (36°F to 46°F) up to 48 hours and subsequently for 8 hours at room temperature up to 30°C (86°F) in diffuse light.
Drug interactions
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- Rituximab and hyaluronidase (human recombinant)
Label text (1 paragraph)
Renal toxicity when used in combination with cisplatin. ( 5.8 )
Contraindications
None None.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for rituximab and hyaluronidase (human recombinant). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero (see Clinical Considerations ) . There are no available data on RITUXAN HYCELA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, intravenous administration of a rituximab product to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans.
Reduced fetal weight and increased fetal lethality were observed following subcutaneous administration of hyaluronidase human in mice at a dose > 2700 times higher than the human dose. Comparable systemic exposure levels could occur in a pregnant patient following accidental intravenous administration of an entire vial of RITUXAN HYCELA (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk in the U.S.
general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Observe newborns and infants for signs of infection and manage accordingly. Data Human Data Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to rituximab in-utero. Rituximab was detected postnatally in the serum of infants exposed in-utero. Animal Data RITUXAN HYCELA for subcutaneous injection contains rituximab and hyaluronidase human [see Description (11) ] .
Rituximab Product: An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received rituximab via the intravenous route during early gestation (organogenesis period; post coitum days 20 through 50). Rituximab was administered as loading doses on post coitum (PC) Days 20, 21 and 22, at 15, 37.5 or 75 mg/kg/day, and then weekly on PC Days 29, 36, 43 and 50, at 20, 50 or 100 mg/kg/week. The 100 mg/kg/week dose resulted in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Rituximab crosses the monkey placenta. Exposed offspring did not exhibit any teratogenic effects but did…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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