Acellbia Adverse Reactions

Most side effects are mild to moderate but some may be serious and require treatment.
Rarely, some of these reactions have been fatal.
Infusion reactions: During or within the first 2 hours of the first infusion, patient may develop fever, chills, and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness, tiredness, headache, breathing difficulties, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack, or low number of platelets. If the patient has heart disease or angina, these reactions might get worse. Inform the person giving the infusion immediately if the patient develops any of these symptoms, as the infusion may need to be slowed down or stopped. Patient may require additional treatment such as an antihistamine or paracetamol. When these symptoms go away or improve, the infusion can be continued. These reactions are less likely to happen after the second infusion. The doctor may decide to stop Rituximab treatment if these reactions are serious.
Infections: Inform the doctor immediately if the patient gets signs of an infection including: Fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell; memory loss, trouble thinking, difficulty walking, or sight loss may be due to a very rare, serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or PML). The patient might get infections more easily during treatment with Rituximab.
Skin Reactions: Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas, or the eyelids, and fever may be present.
Other side effects include: If the patient is being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukemia: Very common side effects (may affect more than 1 in 10 people): Bacterial or viral infections, bronchitis; low number of white blood cells, with or without fever or low blood platelet count; feeling sick (nausea); bald spots on the scalp, chills, headache; lower immunity: because of lower levels of antibodies called "immunoglobulins" (IgG) in the blood which help protect against infection.
Common side effects (may affect up to 1 in 10 people): Infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B; low number of red blood cells (anemia), low number of white blood cells, allergic reactions (hypersensitivity); high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme "LDH" in the blood, low calcium levels in the blood; unusual feelings of the skin: such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch; feeling restless, problems falling asleep; becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels; feeling dizzy or anxious; producing more tears, tear duct problems, inflamed eye (conjunctivitis); ringing sound in the ears, ear pain; heart problems: such as heart attack, uneven or fast heart rate; high or low blood pressure (low blood pressure especially when standing upright); tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat, or sinuses, shortness of breath, runny nose; being sick (vomiting), diarrhea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion; eating disorders, not eating enough, leading to weight loss; hives, increased sweating, night sweats; muscle problems: such as tight muscles, joint or muscle pain, back and neck pain; general discomfort or feeling uneasy or tired, shaking, signs of flu; multiple-organ failure.
Uncommon side effects (may affect up to 1 in 100 people): Blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic hemolytic anemia), swollen or enlarged lymph nodes; low mood and loss of interest or enjoyment in doing things, feeling nervous; taste problems: such as changes in the way things taste; swelling of the stomach.
Very rare side effects (may affect up to 1 in 10, 000 people): Short-term increase in the amount of some types of antibodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells; nerve damage in arms and legs, paralyzed face; heart failure; inflammation of blood vessels including those leading to skin symptoms; respiratory failure; damage to the intestinal wall (perforation); severe skin problems causing blisters that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas, or the eyelids, and fever may be present.
Not known (it is not known how often these side effects happen): A reduction in white blood cells which does not happen straight away; reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases; hearing loss, loss of other senses.
If the patient is being treated for rheumatoid arthritis: Very common side effects (may affect more than 1 in 10 people): Infections such as pneumonia (bacterial); pain on passing water (urinary tract infection); allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion; changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness; headache; changes in laboratory tests carried out by the doctor. These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Common side effects (may affect up to 1 in 10 people): Infections such as bronchial tube inflammation (bronchitis); a feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems; fungal foot infection (athlete's foot); high cholesterol levels in the blood; abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica, migraine, dizziness; loss of hair; anxiety, depression; indigestion, diarrhoea, acid reflux, irritation and/or ulceration of the throat and the mouth; pain in the tummy, back, muscles and/or joints.
Uncommon side effects (may affect up to 1 in 100 people): Excess fluid retention in the face and body; inflammation, irritation and/or tightness of the lungs, and throat, coughing; skin reactions including hives, itching and rash; allergic reactions including wheezing or shortness of breath, swelling of the face and tongue, collapse.
Very rare side effects (may affect up to 1 in 10, 000 people): A complex of symptoms occurring within a few weeks of an infusion of Rituximab including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever; severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Other rarely reported side-effects due to Rituximab include a decreased number of white cells in the blood (neutrophils) that help to fight against infection. Some infections may be severe.
If the patient is being treated for granulomatosis with polyangiitis or microscopic polyangiitis: Very common side effects (may affect more than 1 in 10 people): Infections, such as chest infections, urinary tract infections (pain on passing water), colds and herpes infections allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion; diarrhea; coughing or shortness of breath; nose bleeds; raised blood pressure; painful joints or back; muscle twitches or shakiness; feeling dizzy; tremors (shakiness, often in the hands); difficulty sleeping (insomnia); swelling of the hands or ankles.
Common side effects (may affect up to 1 in 10 people): Indigestion; constipation; skin rashes, including acne or spots; flushing or redness of the skin; blocked nose; tight or painful muscles; pain in the muscles or in the hands or feet; low number of red blood cells (anemia); low numbers of platelets in the blood; an increase in the amount of potassium in the blood; changes in the rhythm of the heart, or the heart beating faster than normal.
Very rare side effects (may affect up to 1 in 10, 000 people): Severe blistering skin conditions that can be life-threatening. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present; recurrence of a previous Hepatitis B infection.
Rituximab may also cause changes in laboratory tests carried out.
If the patient is having Rituximab with other medicines, some of the side effects that they may get may be due to the other medicines.