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pms-Bortezomib

pms-Bortezomib Side Effects

bortezomib

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious.
If the patient is given PMS-BORTEZOMIB for multiple myeloma, they must be advised to inform the doctor straight away if they notice any of the following symptoms: muscle cramping, muscle weakness; confusion, visual loss or disturbances, blindness, seizures, headaches; shortness of breath, swelling of the feet or changes in the heart beat, high blood pressure, tiredness, fainting; coughing and breathing difficulties or tightness in the chest.
Treatment with PMS-BORTEZOMIB can very commonly cause a decrease in the numbers of red and white blood cells and platelets in the blood. Therefore, the patient will have to take regular blood tests before and during the treatment with PMS-BORTEZOMIB, to check the blood cell counts regularly. The patient may experience a reduction in the number of: platelets, which may make the patient be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from the bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver); red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness; white blood cells may make the patient more prone to infections or flu-like symptoms.
If the patient is given PMS-BORTEZOMIB for the treatment of multiple myeloma, the side effects the patient may get are listed as follows: Very common side effects (may affect more than 1 in 10 people): Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage; Reduction in the number of red blood cells and or white blood cells (see previously mentioned); Fever; Feeling sick (nausea) or vomiting, loss of appetite; Constipation with or without bloating (can be severe); Diarrhoea (If this happens, it is important that the patient drinks more water than usual. Another medicine may be given to control diarrhoea.); Tiredness (fatigue), feeling weak; Muscle pain, bone pain.
Common side effects (may affect up to 1 in 10 people): Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting; High blood pressure; Reduced functioning of the kidneys; Headache; General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness; Shivering; Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness; Shingles (localized including around the eyes or spread across the body); Chest pains or shortness of breath with exercise; Different types of rash; Itching of the skin, lumps on the skin or dry skin; Facial blushing or tiny broken capillaries; Redness of the skin; Dehydration; Heartburn, bloating, belching, wind, stomach pain, bleeding from the bowels or stomach; Alteration of liver functioning; A sore mouth or lip, dry mouth, mouth ulcers or throat pain; Weight loss, loss of taste; Muscle cramps, muscle spasms, muscle weakness, pain in the limbs; Blurred vision; Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis); Nose bleeds; Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood, restlessness or agitation, changes in the mental status, disorientation; Swelling of body, to include around eyes and other parts of the body.
Uncommon side effects (may affect up to 1 in 100 people): Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate; Failing of the kidneys; Inflammation of a vein, blood clots in the veins and lungs; Problems with blood clotting; Insufficient circulation; Inflammation of the lining around the heart or fluid around the heart; Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis; Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina; Cerebrovascular disorders; Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation (feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching; Arthritis, including inflammation of the joints in the fingers, toes, and the jaw; Disorders that affect the lungs, preventing the body from getting enough oxygen (some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that becomes shallow, difficult or stops, wheezing); Hiccups, speech disorders; Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention; Altered levels of consciousness, confusion, memory impairment or loss; Hypersensitivity; Hearing loss, deafness or ringing in the ears, ear discomfort; Hormone abnormality which may affect salt and water absorption; Overactive thyroid gland; Inability to produce enough insulin or resistance to normal levels of insulin; Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye; Swelling of the lymph glands; Joint or muscle stiffness, sense of heaviness, pain in the groin; Hair loss and abnormal hair texture; Allergic reactions; Redness or pain at the injection site; Mouth pain; Infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines, sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood; Skin infections; Bacterial and viral infections; Tooth infection; Inflammation of the pancreas, obstruction of the bile duct; Genital pain, problem having an erection; Weight increase; Thirst; Hepatitis; Injection site or injection device related disorders; Skin reactions and disorders (which may be severe and life threatening), skin ulcers; Bruises, falls and injuries; Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots (usually on the legs) to large bruise-like patches under the skin or tissue; Benign cysts; A severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.
Rare side effects (may affect up to 1 in 1,000 people): Heart problems to include heart attack, angina; Serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barré syndrome); Flushing; Discoloration of the veins; Inflammation of the spinal nerve; Problems with the ear, bleeding from the ear; Underactivity of the thyroid gland; Bleeding in the brain; Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins); Changes in or abnormal bowel function; Yellow discoloration of eyes and skin (jaundice); Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse; Breast disorders; Vaginal tears; Genital swelling; Inability to tolerate alcohol consumption; Wasting, or loss of body mass; Increased appetite; Fistula; Joint effusion; Cysts in the lining of joints (synovial cysts); Fracture; Breakdown of muscle fibers leading to other complications; Swelling of the liver, bleeding from the liver; Cancer of the kidney; Psoriasis like skin condition; Cancer of the skin; Paleness of the skin; Increase of platelets or plasma cells (a type of white cell) in the blood; Blood clot in small blood vessels (thrombotic microangiopathy); Abnormal reaction to blood transfusions; Partial or total loss of vision; Decreased sex drive; Drooling; Bulging eyes; Sensitivity to light; Rapid breathing; Rectal pain; Gallstones; Hernia; Injuries; Brittle or weak nails; Abnormal protein deposits in the vital organs; Coma; Intestinal ulcers; Multi-organ failure; Death.
Reporting: If the patient gets any side effects, the patient must be advised to talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Reporting side effects can help provide more information on the safety of this medicine.
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