Rituximab and hyaluronidase human

What is Rituximab and hyaluronidase human?

• Rituximab and hyaluronidase human (Rituxan Hycela) is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase used alone or with other drugs to treat:
• Chronic lymphocytic leukemia
• Diffuse large B-cell lymphoma
• Follicular lymphoma

• Rituximab and hyaluronidase human is a form of rituximab that is given as a subcutaneous injection.
• This form can be given in less time than rituximab, which is given as an infusion.
• The subcutaneous form is used only after patients have received one full dose of rituximab by infusion.

Rituximab

Hyaluronidase 1 2PE4

What are the uses of this medicine?

Rituximab and hyaluronidase human (Rituxan Hycela) is a prescription medicine used to treat adults with:

• Follicular Lymphoma (FL): alone or with certain chemotherapy medicines.
• Diffuse Large B-Cell Lymphoma (DLBCL): with certain other chemotherapy medicines in people who have not had previous treatment for their DLBCL.
• Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.

Limitations of Use:

• Initiate treatment with Rituxan Hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion.
• It is not known if Rituxan Hycela is safe and effective in children.

How does this medicine work?

Rituximab mechanisms of action

• A combination preparation of rituximab, a genetically engineered chimeric murine/human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against the CD20 antigen, and the recombinant form of the human enzyme hyaluronidase, with antineoplastic activity.
• Upon subcutaneous administration of rituximab and hyaluronidase human, the hyaluronidase reversibly depolymerizes the polysaccharide hyaluronan in the subcutaneous tissue.
• This increases the permeability of the subcutaneous tissue and enhances the absorption of rituximab into the systemic circulation.
• In turn, rituximab targets and binds to CD20 expressed on tumor cells, and induces tumor cell lysis primarily through the induction of complement dependent cytotoxicity (CDC) and antibody-dependent cell mediated cytotoxicity (ADCC).
• When administered subcutaneously, hyaluronidase, an endoglycosidase, increases the dispersion and absorption of co-administered drugs.
• CD20 is expressed on the surface of pre-B and mature Blymphocytes, and is overexpressed in a variety of B-cell malignancies.
• Hyaluronidase human has been shown to increase the absorption rate of a rituximab product into the systemic circulation.

Who Should Not Use this medicine ?

Limitations of Use:

• Initiate treatment with Rituxan Hycela only after patients have received at least one full dose of a rituximab product by intravenous infusion.
• It is not known if Rituxan Hycela is safe and effective in children.

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention any of the following:

• adalimumab (Humira)
• certolizumab (Cimzia)
• etanercept (Enbrel)
• golimumab (Simponi)
• infliximab (Remicade)
• other medications for rheumatoid arthritis
• medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune, Torisel), and tacrolimus (Envarsus, Prograf)

Is this medicine FDA approved?

• Initial U.S. Approval: 2017

How should this medicine be used?

• Premedicate with acetaminophen and antihistamine before each dose; in addition, consider premedication with glucocorticoids.

Recommended dosage:

• Follicular Lymphoma (FL)/Diffuse large B-cell lymphoma: Administer 1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously according to recommended schedule.
• Chronic Lymphocytic Leukemia (CLL): Administer 1,600 mg/26,800 Units (1,600 mg rituximab and 26,800 Units hyaluronidase human) subcutaneously according to recommended schedule.

Administration:

• Rituxan Hycela is given as an injection under the skin, in the stomach-area (abdomen).
• Rituxan Hycela is injected over 5 or 7 minutes.
• Your healthcare provider will prescribe medicines before the injection of Rituxan Hycela to help reduce side effects such as fever and chills.
• Your healthcare provider should monitor you for side effects for at least 15 minutes after you receive an injection of Rituxan Hycela.
• If you have CLL, your healthcare provider should prescribe medicines to help prevent certain infections during treatment and for up to 12 months following treatment with Rituxan Hycela.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL (120 mg/2,000 Units per mL) solution in a single-dose vial
• 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL (120 mg/2,000 Units per mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Rituxan Hycela

What side effects can this medication cause?

• The most common side effects of Rituxan Hycela in people with Follicular Lymphoma (FL) include: infections, low white blood cell count, nausea, constipation, cough, and tiredness.
• The most common side effects of Rituxan Hycela in people with Diffuse Large B-cell Lymphoma (DLBCL) include: infections, low white blood cell count, loss of hair, nausea, and low red blood cell count.
• The most common side effects of Rituxan Hycela in people with Chronic Lymphocytic Leukemia (CLL) include: infections, low white blood cell count, nausea, low platelet count, fever, vomiting, and injection site redness.

Rituxan Hycela can cause serious side effects, including:

• Severe skin and mouth reactions
• Hepatitis B virus (HBV) reactivation
• Progressive Multifocal Leukoencephalopathy (PML)
• Serious allergic reactions and other severe reactions
• Tumor Lysis Syndrome (TLS)
• Serious infections
• Heart problems
• Kidney problems
• Stomach and serious bowel problems

What special precautions should I follow?

• Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab-containing products, including Rituxan Hycela. The safety of re-administration of a rituximab-containing product, including Rituxan Hycela, to patients with severe mucocutaneous reactions has not been determined.
• Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab-containing products. In patients who develop reactivation of HBV while on Rituxan Hycela, immediately discontinue treatment and any concomitant chemotherapy, and institute appropriate treatment.
• JC virus infection resulting in PML and death has been observed in patients receiving rituximab-containing products, including Rituxan Hycela. Discontinue Rituxan Hycela and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.
• Local cutaneous reactions may occur more than 24 hours after administration. Interrupt injection if severe reaction develops. Premedicate before injection.
• TLS can occur within 12–24 hours after administration of a rituximab-containing product, including Rituxan Hycela. Administer aggressive intravenous hydration, anti hyperuricemic agents, monitor renal function.
• 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. Withhold and institute appropriate anti-infective therapy.
• Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur with rituximab-containing products, including Rituxan Hycela. Discontinue in case of serious or life-threatening events.
• Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including Rituxan Hycela. Discontinue in patients with rising serum creatinine or oliguria.
• 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. Consider and evaluate for abdominal pain, vomiting, or related symptoms.
• Live virus vaccinations prior to or during treatment not recommended.
• Rituxan Hycela can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on human data, rituximab-containing products can cause fetal harm.
• There are no available data on Rituxan Hycela use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of Rituxan Hycela in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: rituximab and hyaluronidase human.
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, α,α-trehalose dihydrate, and Water for Injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA
• Rituxan Hycela® is a registered trademark of Biogen.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Rituximab and hyaluronidase human
• FDA Rituximab and hyaluronidase human

Rituximab and hyaluronidase human Resources
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