Pronunciation:

ri-TUX-i-mab, hye-al-ure-ON-i-dase HUE-man, ree-KOM-bi-nant

Brand Names:

• Rituxan Hycela

Dosage Forms:

• Solution

Warnings:

Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including rituximab and hyaluronidase human, recombinant. Hepatitis B Virus (HBV) reactivation can occur in patients treated with rituximab-containing products, including rituximab and hyaluronidase human, recombinant, 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 rituximab and hyaluronidase human, recombinant. Discontinue rituximab and hyaluronidase human, recombinant and concomitant medications in the event of HBV reactivation. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including rituximab and hyaluronidase human, recombinant .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Rituximab and hyaluronidase human, recombinant combination injection is used alone or together with other cancer medicines to treat follicular lymphoma and chronic lymphocytic leukemia (CLL). It is also used together with other medicines to treat diffuse large B-cell lymphoma (DLBCL) in people who have not received previous treatment.

Rituximab and hyaluronidase human, recombinant combination injection is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rituximab and hyaluronidase human, recombinant combination injection in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab and hyaluronidase human, recombinant combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine, Live
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Belimumab
• Benzocaine
• Bupivacaine
• Bupivacaine Liposome
• Butacaine
• Chloroprocaine
• Cholera Vaccine, Live
• Cisplatin
• Cocaine
• Dengue Tetravalent Vaccine, Live
• Dibucaine
• Ebola Zaire Vaccine, Live
• Etidocaine
• Infliximab
• Influenza Virus Vaccine, Live
• Lidocaine
• Measles Virus Vaccine, Live
• Mepivacaine
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Prilocaine
• Procaine
• Proparacaine
• Propoxycaine
• Ropivacaine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer)
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tetracaine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Influenza Virus Vaccine (Subvirion)
• Pneumococcal Vaccine Polyvalent

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain), history of or
• Heart disease or
• Heart rhythm problem (eg, arrhythmia), history of or
• Hepatitis B, history of or
• Kidney problems or
• Lung problems (including lung tumor)—May make these conditions worse.

• Electrolyte or fluid imbalance or
• Hypogammaglobulinemia (deficiency with antibodies) or
• Kidney disease—May cause side effects to become worse.

• Infection (eg, cytomegalovirus, herpes simplex virus, hepatits B and C, parvovirus B19, varicella zoster virus, West Nile virus)—May decrease your body's ability to fight an infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot under your skin in the stomach area.

Before receiving this medicine, your doctor will give you at least 1 full dose of a rituximab product by IV infusion.

You may also receive medicines (eg, acetaminophen, antihistamine, steroid medicine) before each dose of rituximab and hyaluronidase human, recombinant combination to help prevent unwanted side effects from the injection.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

This medicine may reactivate hepatitis B infection. Talk to your doctor if you have concerns about this.

This medicine may increase your risk of developing a serious and rare brain infection, called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause a serious reaction, called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have an infection.

This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine can cause bowel problems, including bowel blockage, tears, or holes. Check with your doctor right away if you have severe stomach pain or continuing vomiting.

Do not have any live vaccines (immunizations) while you are being treated with rituximab and hyaluronidase human, recombinant combination injection. Check with your doctor before having any vaccines.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

body aches or pain

bone pain

chest pain

chills

cough

cough producing mucus

difficult or labored breathing

difficult, burning, or painful urination

difficulty in moving

dizziness

ear congestion

fever or chills

frequent urge to urinate

headache

joint pain

loss of voice

lower back or side pain

muscle aches or cramps

muscle pain or stiffness

muscle spasm

nasal congestion

nervousness

pale skin

pounding in the ears

rapid weight gain

severe pain

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

stuffy or runny nose

swelling or inflammation of the mouth

swollen glands

swollen joints

tightness in the chest

tingling of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Less common

Cracked lips

difficulty in swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

general feeling of discomfort or illness

hoarseness

loss of appetite

nausea

shivering

sweating

trouble sleeping

upper stomach pain

vomiting

Incidence not known

Bloody, black, or tarry stools

blurred vision or other change in vision

dilated neck veins

extreme fatigue

eye pain

feeling of discomfort

high fever

inflammation of the joints

irregular breathing

irregular heartbeat

itching

rash

redness of the eye

sensitivity of the eye to light

severe stomach pain

severe vomiting, sometimes with blood

tearing

unexplained bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Belching

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

hair loss

heartburn

indigestion

lack or loss of strength

pain in the mouth and throat

pain or tenderness around the eyes and cheekbones

stomach discomfort, upset, or pain

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Less common

Burning, dry, or itching of the eyes

discharge, excessive tearing

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.