Drug Ingredient Information
BORTEZOMIB-2MG
BORTEZOMIB
| Information for
patients
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| Drug Information |
BORTEZOMIB contains the active substance bortezomib, a so-called „proteasome inhibitor?. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells. BORTEZOMIB is used for the treatment of multiple myeloma (a cancer of the bone marrow) in adults:
-in combination with other medicines containing melphalan and prednisone, for patients who have not been previously treated for multiple myeloma and are unsuitable for high-dose chemotherapy with bone marrow transplant.
-alone (monotherapy) for patients whose disease is worsening (progressive) after receiving at lea |
| Drug Alert |
| Alert |
-if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of BORTEZOMIB
-if you have certain severe pulmonary or heart problems. |
| Before Consuming
the Medicine
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| Avoid Drug |
-if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of BORTEZOMIB
-if you have certain severe pulmonary or heart problems. |
| Drug Special Care |
You should tell your doctor if you have any of the following:
low numbers of red or white blood cells
bleeding problems and/or low number of platelets in your blood
diarrhoea, constipation, nausea or vomiting
fainting, dizziness or light-headedness in the past.
kidney problems
moderate to severe hepatic impairment (liver problems).
numbness, tingling, or pain in the hands or feet (neuropathy) in the past.
heart or blood pressure problems.
shortness of breath or cough
You will have to take regular blood tests before and during your treatment with BORTEZOMIB, to check your blood cell counts regularly. |
| Drug Drug Interactions |
Please tell your doctor, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.In particular, tell you doctor if you are using medicines containing any of the following active substances:
-ketoconazole, used to treat fungal infections
-rifampicin, an antibiotic used to treat bacterial infections
-carbamazepine, phenytoin or phenobarbital used to treat epilepsy
-St. John?s Wort used for depression or other conditions
-oral antidiabetics |
| Drug Pregnancy Interaction |
You should not use BORTEZOMIB if you are pregnant, unless clearly necessary. Both men and women receiving BORTEZOMIB must use effective contraception during and for up to 3 months after treatment. If, despite these measures, pregnancy occurs, tell your doctor immediately. |
| Drug Breast feeding Interaction |
You should not breastfeed while using BORTEZOMIB. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment. |
| Drug Machinery Interaction |
BORTEZOMIB might cause tiredness, dizziness, fainting, or blurred vision. Do not drive or operate any dangerous tools or machines if you experience such side effects; even if you do not, you should still be cautious |
| Drug More Information |
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| How to take the
Medicine
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| Consumption Info |
Your doctor will work out your dose of BORTEZOMIB according to your height and weight (body surface area). The usual starting dose is 1.3 mg/m2 body surface area.
Your doctor may change the dose and total number of cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions |
| Drug quanitty |
Monotherapy
When BORTEZOMIB is given alone, one cycle of treatment with BORTEZOMIB consists of a total of 4 doses. Doses are given on days 1, 4, 8 and 11, followed by a 10-day „rest period? without treatment. Therefore, the duration of a treatment cycle is 21 days (3 weeks).
Combination therapy
If you have not been treated before for multiple myeloma, you will receive BORTEZOMIB together with two other medicines containing melphalan and prednisone.
In this case, the duration of a cycle is 6 weeks. The treatment consists of a total of 9 cycles (54 weeks).
?In Cycles 1-4, BORTEZOMIB is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32).
?In Cycles 5-9, BORTEZOMIB is administered once weekly (days 1, 8, 22 and 29).
Melphalan and prednisone are both given orally on days 1, 2, 3 and 4 of the first week of each cycle. 3 |
| Drug Dose |
You will receive BORTEZOMIB in a specialised medical unit, under the supervision of a health care professional experienced in the use of cytotoxic medicinal products. BORTEZOMIB powder has to be dissolved before administration. This will be done by a healthcare professional. The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds. |
| Excess Drug Consumption |
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| Forgot Drug Consumption |
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| Stop Drug Consumption |
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| Possible Side
Effects
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| General Information |
Like all medicines, BORTEZOMIB can cause side effects, although not everybody gets them. Some of these effects may be serious.Treatment with BORTEZOMIB can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with BORTEZOMIB, to check your blood cell counts regularly. You may experience a reduction in the number of
-platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your 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 you more prone to infections or flu-like symptoms.
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 above)
Fever, shivering fits
Shortness of breath without exercise
Feeling sick (nausea) or vomiting, loss of appetite
Constipation with or without bloating (can be severe),
Diarrhoea: if this happens, it is important that you drink more water than usual. Your doctor may give you another medicine to control diarrhoea .
Muscle pain
Tiredness
Headache
Herpes zoster infection (including disseminated) |
| Common Drug Side Effects |
Sudden fall of blood pressure on standing which may lead to fainting
Depression which may be severe, confusion
Swelling around the eyes or face (which may rarely be due to a serious allergic reaction), or swelling in the ankles, wrists, arms or legs.
General ill feeling, dizziness, light-headedness, or a feeling of weakness
Changes in potassium in your blood, too much sugar in your blood
Chest pains or coughing with phlegm, shortness of breath with exercise
Different types of rash and/or itching, lumps on the skin or dry skin
Redness of the skin or redness and pain at the injection site
Dehydration
Heartburn, bloating, belching, wind or stomach pain
A sore mouth or lip, dry mouth, mouth ulcers or throat pain
Weight loss, loss of taste
Muscle cramps, bone pain, pain in your limbs or back
Blurred vision
Nose bleeds
Difficulty in sleeping, sweating, anxiety
Overtiredness (fatigue) |
| Rare Drug Side Effects |
Inflammation of the lining around your heart
Inflammation of the blood vessels that can appear as small red or purple dots (usually on the legs) to bruise-like patches on the skin. |
| Very Rare Drug Side Effects |
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| Drug Side Effects Symptoms |
Palpitations (sensation of rapid or irregular heart beat), changes in heart beat, heart failure, heart attack, chest pain, chest discomfort or decreased ability of the heart to work
Bleeding from your bowels or stomach, bloody stools, bleeding in the brain, bleeding from the liver or bleeding from mucosal membranes, e.g., mouth
Paralysis, seizures
Breathing becomes shallow, difficult or stops, wheezing, difficulty in breathing, cough that produces frothy sputum that may be tinged with blood or coughing blood
Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine
Yellow discolouration of eyes and skin (jaundice)
Loss of attention, restlessness or agitation, changes in your mental status, mood swings
Facial blushing or tiny broken capillaries
Hearing loss, deafness or ringing in the ears
Changes in calcium, sodium, magnesium, and phosphates in your blood, too little sugar in your blood
Hormone abnormality affecting salt and water absorption
Irritated eyes, excessively wet or dry eyes, discharge from the eyes, abnormal vision, eye infections (including herpes zoster), bleeding of the eye or sensitivity to light
Swelling of your lymph nodes
Joint or muscle stiffness, muscle spasms or twitching, pain in your bottom
Hair loss
Allergic reactions
Mouth pain, retching
Abdominal pain
Weight increase
Severe skin reactions, which may have blisters and involve the mouth, throat, eyes and genitals, that can be life-threatening (Stevens Johnson Syndrome and toxic epidermal necrolysis).
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems. |
| How to Store the
Medicine
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| How to Store the Medicine |
Keep out of the reach and sight of children. Do not store above 30C. Keep the vial in the outer carton in order to protect from light. Do not use after the expiry date stated on the vial and the carton after EXP. The reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25 °C in the original vial and/or a syringe prior to administration, with a maximum of 8 hours in the syringe. |
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