FIELD OF APPLICATIONDETAILS
Generic Name
Rituximab and hyaluronidase human
Active Ingredient
Rituximab, Hyaluronidase
US Brand Names
RITUXAN HYCELA
Drug Category
Oncology, Hematology
Drug Class
CD20-Directed Cytolytic Antibody and Endoglycosidase
Route of Administration
Subcutaneous Injection
FDA Approval Status
Approved by the FDA (June 2017)
Approved

Rituximab and Hyaluronidase Overview

Rituximab and hyaluronidase is a specialized prescription medication used to treat certain types of blood cancer. The original version of rituximab is given as a slow intravenous drip. This modern combination is given as a quick shot under the skin. It is approved by the FDA under the brand name Rituxan Hycela.

This medication combines a powerful biologic drug with a special enzyme that helps it absorb quickly. While traditional rituximab is used across rheumatology to treat autoimmune diseases, this fast-acting formulation is strictly approved for adult patients with specific types of lymphoma and leukemia. It offers patients the same powerful treatment, but saves them hours of time at the clinic.

What Is Rituximab and Hyaluronidase and How Does It Work

This medication is a fixed-dose combination of two different active ingredients that work together to make treatment faster.

First, rituximab is a type of protein called a monoclonal antibody. It is designed to hunt down and attach to a specific marker called CD20. This marker is found on the surface of B-cells, a type of white blood cell. In lymphoma and leukemia, these B-cells become cancerous and multiply out of control. When rituximab attaches to the CD20 marker, it acts like a target. It signals your body’s immune system to attack and destroy the cancerous cells.

Second, hyaluronidase is a natural enzyme. Your skin contains a gel-like substance called hyaluronan that normally prevents large amounts of liquid from being injected. Hyaluronidase temporarily breaks down this gel, creating a space under the skin. This allows a large dose of rituximab to be injected quickly and absorbed directly into your bloodstream over a few hours. The skin tissue completely repairs itself within 24 to 48 hours.

Is Rituximab and Hyaluronidase FDA Approved

Yes, this combination drug is officially approved by the United States Food and Drug Administration. It was approved on June 22, 2017, as a faster alternative to traditional rituximab IV infusions.

What Is Rituximab and Hyaluronidase Used For

  • It is approved to treat Follicular Lymphoma, a slow-growing type of non-Hodgkin lymphoma.
  • It is approved for Diffuse Large B-cell Lymphoma, an aggressive type of non-Hodgkin lymphoma.
  • It is approved to treat Chronic Lymphocytic Leukemia, a cancer of the blood and bone marrow.
  • Note: Patients must first receive at least one full, successful dose of standard rituximab through an IV drip before they are allowed to switch to this injection.

Before Taking Rituximab and Hyaluronidase Contraindications and Precautions

Because this medicine powerfully suppresses your immune system, it is not safe for everyone. Your doctor will carefully screen you before starting treatment.

Who Should Not Take Rituximab and Hyaluronidase

  • Anyone who has had a severe allergic reaction to rituximab, hyaluronidase, or any other ingredients in the shot.
  • Patients who currently have an active, severe infection, such as pneumonia.
  • People who have an active Hepatitis B virus infection, as this drug can cause the virus to reactivate and permanently damage the liver.

Pregnancy and Fertility Warnings

  • Pregnancy: This medication can cause severe harm to an unborn baby. Women who are able to get pregnant must use highly effective birth control during treatment and for at least 12 months after the last dose.
  • Breastfeeding: It is not known if this specific medication passes into human breast milk. Because of the potential for serious harm, women must not breastfeed during treatment and for at least 6 months after the final dose.

Tell Your Doctor Before Taking This Medicine

  • Tell your doctor if you have a history of heart disease, irregular heartbeats, or chest pain.
  • Share any history of lung disease or breathing problems.
  • Inform your doctor if you have ever had Hepatitis B or Hepatitis C.
  • Provide a complete list of your current medications, especially blood pressure pills.

Dosage and Administration

This medication is not a pill you take at home. It is administered entirely by a healthcare professional in a clinic or hospital setting.

Standard Dosing

  • The exact dose depends on the type of cancer being treated.
  • The medication comes in two different strengths. One is used for non-Hodgkin lymphoma, and a larger dose is used for Chronic Lymphocytic Leukemia.
  • Treatment cycles vary. It may be given once a week, or once every few weeks, depending on your exact chemotherapy plan.
  • Important Safety Rule: You can only receive this quick injection after you have successfully completed at least one full dose of the standard rituximab IV drip without having a severe allergic reaction.

How It Is Administered

  • A nurse or doctor will inject the medicine directly into the fatty tissue of your stomach area.
  • The injection usually takes about 5 to 7 minutes to complete. This is much faster than the IV version, which takes several hours.
  • You will be monitored in the clinic for at least 15 minutes after the injection to ensure you do not have an allergic reaction.
  • Never inject it into skin that is red, bruised, tender, or hard.

Clinical Efficacy and Research

Clinical trials have proven that Rituxan Hycela is just as effective as the traditional IV version of rituximab. In large studies involving patients with Follicular Lymphoma and Chronic Lymphocytic Leukemia, blood tests showed that the fast under-the-skin injection provided the exact same level of medicine in the bloodstream as the IV drip. The overall survival rates and tumor shrinkage were identical. Furthermore, patient surveys showed that the vast majority of people strongly preferred the quick 7-minute injection.

Side Effects and Safety Profile

BLACK BOX WARNING

This medication carries a strict FDA Black Box Warning for four severe risks.

Because this drug kills B-cells, it severely weakens your immune system. You and your doctor must watch closely for side effects.

First, it can cause severe, sometimes fatal skin reactions.

Second, it can reactivate the Hepatitis B virus, which can lead to fatal liver failure.

Third, it can cause a rare, deadly brain infection called Progressive Multifocal Leukoencephalopathy.

Fourth, it can cause severe, life-threatening allergic reactions during the administration of the dose.

Common Side Effects

  • Infections, such as the common cold, sinus infections, or urinary tract infections.
  • Low white blood cell counts, which makes you more prone to getting sick.
  • Nausea, vomiting, or stomach pain.
  • Feeling very tired or weak.
  • Injection site reactions, including redness, pain, and swelling on your stomach.

Serious Adverse Events

  • Severe Heart Problems: It can cause irregular heartbeats, chest pain, or heart attacks.
  • Kidney Damage: Rapid breakdown of cancer cells can overload your kidneys.
  • Severe Infections: Pneumonia or severe blood infections that require hospitalization.
  • Bowel Problems: Rarely, it can cause a tear or blockage in your stomach or intestines.

Managing Side Effects

To help prevent stomach upset, your doctor may give you anti-nausea medicine before your injection. If you develop a fever, chills, or a cough, call your doctor immediately. If your injection site hurts, a cold compress can help relieve the swelling. Always attend your scheduled blood tests.

Interactions and What to Avoid

Certain vaccines and medications can interact with this drug, causing serious health risks.

Drug Interactions

  • Live Vaccines: You must never receive a live vaccine while taking this medicine. The vaccine can give you a severe infection.
  • Blood Pressure Medicines: This drug can occasionally cause your blood pressure to drop during the injection. Your doctor may ask you to stop taking your blood pressure pills for 12 hours before your appointment.
  • Other Immune Drugs: Taking this medicine with other strong immunosuppressants greatly increases your risk of catching a severe infection.

Food and Alcohol

  • There are no specific foods you must avoid while taking this medication.
  • It is best to avoid alcohol, as it can worsen side effects like nausea and fatigue, and put extra stress on your liver.

Missed Dose Overdose and Storage

Because this medication is handled and given entirely by healthcare professionals, the risks of missed doses or overdose are tightly managed by your clinic.

Missed Dose

If you miss your scheduled appointment for an injection, call your doctor’s office immediately to reschedule. Staying on your exact treatment schedule is critical for keeping the cancer under control.

Overdose and Emergency

Overdoses are extremely rare because the medicine is pre-packaged in exact doses and administered by a nurse. If an overdose occurs, it would be managed immediately by the medical staff.

How to Store It

  • As a patient, you will not handle or store this medication at home.
  • The pharmacy stores the vials in a refrigerator between 36 and 46 degrees Fahrenheit.
  • The vials must remain in their original carton to protect them from direct light.
  • The medication must never be frozen or shaken.

Patient Management and Monitoring

Your healthcare team will monitor you very strictly before, during, and after your treatment course.

Tests Before Starting Treatment

  • A mandatory blood test to check for Hepatitis B virus.
  • A complete blood count to check your red cells, white cells, and platelets.
  • Heart function tests, especially if you have a history of heart problems.

Monitoring During Treatment

  • You will have frequent blood draws to ensure your white blood cells do not drop to dangerously low levels.
  • Your doctor will monitor you for signs of infections or liver stress at every visit.
  • Nurses will monitor your blood pressure and breathing during and right after your injection.

Dos and Donts

  • Do use highly effective birth control during treatment and for a full year afterward.
  • Do wash your hands frequently and avoid crowds.
  • Don’t get any vaccines without getting permission from your oncologist first.
  • Don’t ignore a fever, even a mild one. Call your doctor right away.

Frequently Asked Questions

Why do I have to get an IV dose first before I can get the quick shot?

The first time a patient receives rituximab, there is a high risk of a severe allergic reaction. The IV drip allows the nurse to give the medicine very slowly and stop it instantly if you react poorly. Once your body proves it can tolerate the drug safely, you can switch to the fast under-the-skin shot.

Does the injection hurt?

You may feel a pinch when the needle goes in, and some pressure or mild stinging as the liquid is pushed under your skin. Because it is a larger amount of liquid than a typical shot, your stomach may feel a little full or tender for a day or two.

Will this medication make my hair fall out?

Rituximab itself does not typically cause severe hair loss. However, it is often given in combination with other chemotherapy drugs that do cause hair loss.

How long will my immune system be weak?

Because this drug destroys B-cells, your immune system will remain weakened for several months, and sometimes up to a year, after your very last injection. You must remain cautious about infections during this entire recovery period.

What is Progressive Multifocal Leukoencephalopathy?

It is a very rare but severe brain infection caused by a common virus. When your immune system is heavily suppressed, the virus can wake up and attack the brain, causing confusion, vision loss, or difficulty walking. It is a medical emergency.

Can I drive myself home after the injection?

Most people can drive themselves home after the 15-minute observation period. However, if your doctor gives you strong anti-nausea or anti-allergy medications right before the shot, those pills will make you drowsy, and you will need a driver.

Is Rituxan Hycela used for rheumatoid arthritis?

No. While standard IV rituximab is frequently used to treat rheumatoid arthritis, this specific fast-acting combination is only FDA-approved for certain blood cancers.

References

  • U.S. FDA Rituxan Hycela prescribing information.
  • U.S. FDA Drugs@FDA Rituxan Hycela approval details.

The information provided in this clinical reference is for educational purposes only and does not constitute medical advice. Consult a qualified healthcare provider before starting or stopping any medication.