Rituximab (Rituxan)

What Is Rituximab?

Rituximab (pronounced [ri TUK si mab]) is also known by the brand name, Rituxin. Rituximab is a type of chemotherapy, and it is an antineoplastic (anti-cancer) drug that belongs to a class called anti-CD20 monoclonal antibodies. 

Pe baza Rituxan, au fost produse mai multe biosimilare diferite, inclusiv Riabni, Ruxience și Truxima. 

Rituxan este, de asemenea, considerat un imunosupresor, deoarece are un rol în suprimarea sistemului imunitar. Rituximab atacă celulele țintă, iar unele dintre celulele sănătoase sunt, de asemenea, afectate în acest proces. 

Deși este chimioterapie, nu este considerată un agent periculos.

Ce este chimioterapia?

Chimioterapia este un tratament pentru cancer în care anumite medicamente sunt utilizate pentru a ucide celulele canceroase. Medicamente pentru chimioterapie sunt de obicei citotoxic substanțe chimice toxice pentru celule, care le restricționează creșterea, împiedică diviziunea și, în cele din urmă, distrug celulele.

Cum se utilizează Rituxan?

Rituxan a fost aprobat de Administrația pentru Alimente și Medicamente (FDA) ca agent de primă linie pentru tratarea mai multor indicații canceroase și necancerigene, inclusiv leucemie limfocitară cronică (LLC)Limfom non-Hodgkin (LNH), poliangeită, pemfigus vulgarși artrita reumatoidă. De asemenea, este utilizat în mod obișnuit pentru alte câteva indicații.

Rituxan poate fi utilizat în combinație cu alte medicamente, inclusiv agenți chimioterapeutici.

Formulări disponibile

Rituxan este disponibil numai sub formă de injecție intravenoasă. Soluția din flacon trebuie să fie limpede/incoloră.

Instrucțiuni de utilizare

Rituximab se administrează de obicei pe parcursul a câteva ore (între 3 și 8 ore), dar poate fi administrat și într-un timp mai scurt dacă este bine tolerat. Acest medicament se administrează de obicei o dată pe săptămână. Durata și frecvența perfuziei depind de indicația de utilizare și de severitate. Asigurați-vă că verificați doza și frecvența corecte cu medicul dumneavoastră. 

The typical rate for the initial infusion is 50 mg/hr and can be increased to a maximum rate of 400 mg/hr. Dilute Rituxan in an infusion bag with normal saline or 5% dextroză în apă. Gently invert to mix and do not shake. Do not mix or dilute with any other medications. Any unused portion left in the vial must be discarded.

Premedicație

Premedicația este insistent recomandată înainte de perfuzia cu Rituxan pentru a reduce simptomele perfuziei. Premedicația trebuie administrată cu aproximativ 30 de minute înainte de perfuzie. Opțiunile de premedicație pot include un analgezic (cum ar fi acetaminofen/Tylenol), un antihistaminic (cum ar fi difenhidramină/Benadryl) și un steroid (cum ar fi metilprednisolon).

Doză omisă

Dacă ați ratat o programare pentru o perfuzie cu Rituxan, consultați imediat medicul pentru a o reprograma.

Depozitare

Rituxan vials must be stored in the refrigerator. Once diluted, it can be stored in the refrigerator for up to 24 hours and then at room temperature for an additional 24 hours (refrigeration is preferred). Do not freeze and do not shake. Keep the vials protected from light by keeping them stored in their original containers.

Ce trebuie evitat în timp ce luați Rituxan?

În timpul terapiei cu Rituxan, trebuie să respectați câteva precauții. Informați întotdeauna medicul despre orice medicament pe care îl luați deja. Nu luați niciun medicament (chiar și medicamente din plante medicinale sau fără prescripție medicală) fără consimțământul prealabil al medicului sau farmacistului, deoarece acestea pot interacționa cu Rituxan..

Evitați orice fel de imunizare sau vaccinare fără acordul prealabil al medicului dumneavoastră. Evitați consumul de alcool, deoarece acesta poate amplifica efectele secundare ale tratamentului. Un efect secundar frecvent în timpul și imediat după tratament este amețeala; prin urmare, evitați conducerea vehiculelor sau orice sarcină care ar putea necesita concentrare.

Pregnancy and Rituxan

Females of childbearing age must use effective contraception during treatment and for 12 months after the last dose. Since Rituxan can be present in breast milk and may cause fetal harm, it is not recommended for women who are breastfeeding.

However, there are certain cases where the benefits outweigh the risks, and in such cases, the physician may decide in favor of administering Rituxan during pregnancy or while breastfeeding.

Efecte secundare

Although it is generally well-tolerated, you may encounter many side effects while taking Rituxan. A few things to keep in mind are: 

• Este posibil să nu aveți toate reacțiile adverse enumerate mai jos. Multe persoane pot prezenta reacții adverse puține sau deloc.
• Severitatea efectelor secundare poate varia de la o persoană la alta, așa că nu comparați efectele secundare cu experiențele altor persoane.
• Majoritatea efectelor secundare se vor ameliora odată cu întreruperea tratamentului.
• These side effects are easily manageable most of the time, either by readjusting the dose of Rituxan or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore the available options.
• Do not hide any symptoms; when you feel any discomfort, do not hesitate to tell your physician or pharmacist about it. 

NotaAceasta nu este o listă completă a tuturor reacțiilor adverse. Discutați cu medicul dumneavoastră dacă aveți întrebări.

Some of the more serious side effects of Rituxan are:

Tumor Lysis Syndrome (TLS)

TLS is caused by the fast breakdown of cancer cells (bursting of the cells). TLS can cause you to have kidney failure and the need for dialysis. It may also cause an abnormal heart rhythm. TLS can happen within 12 to 24 hours after an infusion of Rituxan. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy.

Serious Infections

There may be a high chance of acquiring an infection while on Rituxan therapy. Infections may include fungal, bacterial (like pneumonia), or viral infections (like hepatitis B). If a patient previously had hepatitis B, Rituxan may lead to the reactivation of the viral infection even several months after its discontinuation. Signs of hepatitis B include yellowing of the skin and eyes or excessive tiredness. In order to minimize the risk for infection, it is important to avoid crowds, unhygienic street foods, certain vaccines, etc. Early symptoms of infection may include cough, chills, fever, flu, or trouble breathing. Premedication with a steroid and antihistamine may help reduce any symptoms. If you acquire an infection, immediately seek advice from your physician. 

Heart Complications

Rituxan may cause chest pain, irregular heartbeats, and a heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan if you have symptoms of heart problems or a history of heart problems. Tell your healthcare provider right away if you have chest pains or irregular heartbeats during treatment with Rituxan.

Stomach and Serious Bowel Problems

Bowel problems, including blockage or tears in the bowel, can occur, especially in those taking Rituxan in combination with other chemotherapy agents. Tell your healthcare provider right away if you have any stomach pain during treatment with Rituxan.

Bone/Joint Pain

Another common side effect includes bone, muscle, joint, or even back pain. Adequate rest and hydration may help reduce potential bone, joint, or back pain. Over-the-counter acetaminophen (Tylenol) may be a good option to relieve some of these pains. Consult your physician if these pains become intolerable or are affecting your normal daily functions. 

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare, serious brain infection caused by a virus, and is more common in those who have a weakened immune system. It causes an imbalance of electrolytes (like calcium, potassium, phosphate, etc.) in the body. In the worst cases, PML can result in severe disability or death. There is no known treatment, prevention, or cure for PML. Contact your physician immediately if you are experiencing any of the following symptoms: confusion, dizziness or loss of balance, difficulty walking or talking, decreased strength or weakness on one side of your body, or vision problems like blurred vision or loss of vision.

Kidney Complications

Rituxan can cause severe kidney problems, especially if you are receiving Rituxan for Non–Hodgkin’s lymphoma (NHL). Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine, brown-colored urine, or if you notice you urinate less than usual. This complication may also be a result of PML.

Severe Skin and Mouth Reactions

Severe skin and mouth reactions are also known as mucocutaneous reactions, and they can include paraneoplastic pemphigus, Sindromul Stevens-Johnson (SJS), lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis (TEN). Some of these reactions may be life-threatening. Tell your healthcare provider or get medical help right away if you experience any of these symptoms at any time during treatment: painful sores or ulcers on the skin, lips, or mouth; blisters; peeling skin; rash; or pustules. 

Reacții legate de perfuzie

Infusion-related reactions are very common side effects of Rituxan treatment and most commonly occur during treatment or within 24 hours after infusion. This side effect is the main reason premedication is necessary. Infusion-related reactions can present as hives (red itchy welts) or rash; itching; swelling of your lips, tongue, throat, or face; sudden cough; shortness of breath; difficulty breathing, or wheezing; weakness; dizziness or feeling faint; palpitations (feeling like your heart is racing or fluttering); or chest pain.

Reacții alergice

Allergic reactions are another rare side effect of Rituxan. A mild allergic reaction can include a rash on the skin, skin becoming itchy, etc. Severe side effects may include swelling under the eyes, lips, or hands, and throat or tongue swelling with disturbed breathing. Immediately contact your physician if any signs of an allergic reaction are present. 

Alte reacții adverse frecvente pot include:

• creștere în greutate
• Durere de cap
• Febră sau frisoane
• Durere de stomac
• Diaree
• Arsuri la stomac
• Spălare
• Transpirații nocturne
• Slăbiciune sau oboseală
• Nas înfundat/curgător
• Anxietate
• Depresie

Precauții

Unless approved by your physician, Rituximab is generally not recommended for: 

• Patients with a history of cardiac complications like heart attacks or cardiac arrhythmias or who experience this during therapy.
  • Blood pressure should be monitored regularly while on therapy.
  • If cardiac arrhythmia occurs during therapy, discontinuation of rituximab is highly recommended.
• Patients who develop PML during therapy. If PML develops during therapy, discontinuation of rituximab is highly recommended.
• Patients who develop severe mucocutaneous reactions like SJS or TEN. If a severe mucocutaneous reaction occurs, discontinuation of rituximab is recommended.
• Patients with severe kidney impairment. If severe kidney damage occurs during therapy, permanent discontinuation is recommended.
• Patients with active hepatitis B, hepatitis C, HIV, tuberculosis, or other severe infection or who have a reactivated hepatitis B infection.
  • For patients who have active viral infections, the physician may decide against using Rituxan and may choose a different medication, depending on the situation.
  • If reactivation of the hepatitis B virus occurs during therapy, immediate discontinuation of therapy is recommended.
• Patients who have a severe infusion-related reaction during therapy.
  • If a non-severe reaction occurs, stop the infusion or slow the infusion rate.
  • If a severe reaction occurs, discontinuation of Rituxan is recommended.

What To Expect Post-infusion With Rituxan

Rituxan infusions may feel a little draining, especially if it is the first infusion. The infusion may make you feel sick and unwell for a few days. Keep this in mind before scheduling your infusion, because in some cases, you may need to schedule time off work after the infusion.

Rituxan affects different people in different ways, and many of these effects usually occur within hours of receiving the infusion or the following day. They may also require a few days to subside. The more common post-infusion side effects can include:

• Fever (high temperature) or chills
• Greață sau vărsături
• Muscle aches or spasms
• Bone, joint, or muscle pain
• Dureri de cap
• Weakness or tiredness
• Vânătăi sau sângerări
• Nose bleeds or bleeding gums

Premedication is typically administered 30 minutes before the infusion, which can help reduce the chance and severity of all these side effects. Even though these are typical side effects post-infusion, it is essential to communicate any side effects you experience throughout your treatment to your physician. There may be other medications that could be taken to reduce any severe symptoms you may experience.

Întrebări frecvente

Is Rituxan a chemo agent?

Chemo drugs are those that are used in the management of various cancers. Rituxan kills cancer cells and is thus a chemo agent. It is used as a treatment option for various cancer patients.

How long will it take to recover after each infusion?

It is very typical to feel unwell following an infusion of Rituxan. The symptoms usually appear within hours after the infusion, and some begin to appear the following day. These symptoms can take a few days to a week to subside, depending on the body and post-infusion care.

How is Rituxan taken?

Rituxan is only available in the form of an intravenous injection, and is typically given over a few hours and dosed once per week. The length of the infusion and frequency depends on the indication and severity. Verify the correct dose and frequency with your provider.

What should my health care provider know?

It is important to inform them of the following: 

• Any previous reaction to Rituxan or any other rituximab product.
• Any serious infections like hepatita B, hepatitis C, HIV, or tuberculosis.
• Any vaccines you recently received.
• Any medications that you are currently taking including over-the-counter medications, vitamins, or herbal supplements.
• Any side effects you have experienced while being treated with Rituxan.