Rituximab and hyaluronidase human, recombinant (Subcutaneous)

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

Rituximab and hyaluronidase human, recombinant combination injection is an antineoplastic agent (cancer medicine). It affects 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.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be necessary to look for unwanted effects.

Serious skin reactions can happen with this medicine. Contact your doctor immediately if you experience 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 while using this medicine.

This medicine may reactivate hepatitis B infection. Discuss any concerns with your doctor.

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

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Inform your doctor right away if you experience 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. Contact 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 immediately if you notice 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.

Contact your doctor right away if you develop 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 could be signs of an infection.

This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Contact 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, trouble breathing, or weight gain. You might also feel dizzy or faint, or experience a fast, pounding, or uneven heartbeat.

Contact your doctor right away if you notice bloody urine, a decrease in the 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, trouble 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. Contact your doctor right away if you experience severe stomach pain or ongoing vomiting.

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

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

Allergies

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

Pediatric

There have not been appropriate studies on how rituximab and hyaluronidase human, recombinant combination injection affects children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of rituximab and hyaluronidase human, recombinant combination injection in this age group. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies on women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose, or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Abatacept
• Adenovirus Vaccine
• 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 increase the 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 medicines.

• Influenza Virus Vaccine (Subvirion)
• Pneumococcal Vaccine Polyvalent

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Electrolyte or fluid imbalance or
• Hypogammaglobulinemia (deficiency with antibodies) or
• Kidney disease—May worsen side effects.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may require 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 changes 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.

In the U.S.

• Rituxan Hycela

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Find detailed information on biosimilars for this medication.

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.