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BORTEZOM 2mg Injection 1's
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INTRODUCTION
BORTEZOM 2MG INJECTION contains Bortezomib which belongs to the group of medicines called Antineoplastic agents. It is used in adult patients alone or with pegylated liposomal doxorubicin/dexamethasone to treat progressive multiple myeloma when anticancer therapy or hematopoietic stem cell transplantation becomes unsuitable to treat the disease.
BORTEZOM 2MG INJECTION is also used in adult patients with rituximab, cyclophosphamide, doxorubicin and prednisone to treat untreated mantle cell lymphoma when hematopoietic stem cell transplantation becomes unsuitable to treat the disease.
Multiple myeloma is a type of cancer that occurs in plasma cells (white blood cells) which are generally characterized by symptoms such as bone pain, nausea, constipation and loss of appetite. Mantle Cell Lymphoma is a rare form of cancer that affects the lymphatic system, generally characterized by symptoms such as loss of appetite, fever, nausea and/or vomiting.
Your doctor may advise you to do regular blood tests to check your blood counts before and during treatment with BORTEZOM 2MG INJECTION. It is not recommended for use in patients with severe lung or heart disease.
BORTEZOM 2MG INJECTION is not recommended for use in pregnant and breastfeeding women. BORTEZOM 2MG INJECTION is also not indicated for use in children and adolescents (below 18 years of age).
The most common side effects of receiving BORTEZOM 2MG INJECTION are dizziness, increased heartbeat, sweating, abnormal vision, paresthesia (burning or pickling sensation), muscle pain and headache. Inform your doctor if any of the symptoms worsen during or after treatment with BORTEZOM 2MG INJECTION.
USES OF BORTEZOM 2MG INJECTION
Used in adults:
- To treat progressive multiple myeloma when anticancer therapy or hematopoietic stem cell transplantation becomes unsuitable to treat the disease (alone or in combination with pegylated liposomal doxorubicin/dexamethasone)
- To treat untreated mantle cell lymphoma (with rituximab, cyclophosphamide, doxorubicin and prednisone when hematopoietic stem cell transplantation becomes unsuitable to treat the disease)
HOW BORTEZOM 2MG INJECTION WORKS
BORTEZOM 2MG INJECTION works by inhibiting proteasomes (enzymes responsible for breaking down proteins into smaller compounds for cells) which leads to an imbalance in the cancer cell thus resulting in its destruction and thereby treating multiple myeloma and mantle cell lymphoma in affected individuals.
DIRECTIONS FOR USE
BORTEZOM 2MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous infusion or into skin as a subcutaneous injection. Your doctor will decide the correct dose and duration of BORTEZOM 2MG INJECTION for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF BORTEZOM 2MG INJECTION
COMMON
- fluid retention
- difficulty or problems in sleeping
- altered level of consciousness, confusion
- dizziness, abnormal vision
- chest discomfort, sweating
- cough, hiccups
- ringing in the ears, ear discomfort
- difficulty swallowing
- infection or inflammation of the stomach and intestine
- throat pain, decreased appetite
- infection of the urinary tract
- pain in limbs, numbness, fever
- burning or pickling sensation
- nausea or vomiting
- constipation with or without bloating (can be severe)
- diarrhoea
- tiredness, weakness
- muscle or bone pain
- low or high blood pressure
- sudden fall of blood pressure on standing which may lead to fainting
- headache
- general ill feeling, pain
- vertigo (spinning sensation), light-headedness
- shivering
- chest pain or shortness of breath with exercise
- 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 your bowels or stomach
- sore mouth or lip, dry mouth, mouth ulcers
- weight loss
- loss of taste
- muscle cramps, muscle spasms, muscle weakness, pain in your limbs
- blurred vision
- nose bleeds
- hair loss and abnormal hair texture
UNCOMMON
- inflammation of a vein, blood clots in your veins and lungs
- problems with blood clotting
- insufficient circulation
- inflammation of the lining around your heart or fluid around your heart
- bloody stools or bleeding from mucosal membranes such as mouth, vagina
- cerebrovascular disorders
- speech disorders
- memory impairment or loss
- hearing loss, deafness or ringing in the ears, ear discomfort
- hormone abnormality which may affect salt and water absorption
- overactive thyroid gland
- swelling of your lymph glands
- joint or muscle stiffness, sense of heaviness, pain in your groin
- redness or pain at the injection site
- mouth pain
- skin or tooth infection
- genital pain, problem in having an erection
- weight increase, thirst
- hepatitis, sepsis
- skin reactions and disorders (which may be severe and life-threatening), skin ulcers
- bruises, falls and injuries
RARE
- serious nerve inflammation, which may cause paralysis and difficulty breathing
- flushing
- discolouration of the veins
- inflammation of the spinal nerve
- ear problems such as bleeding from the ear
- underactive thyroid gland
- abnormal bowel function
- signs of bleeding in the brain such as headache, confusion
- yellow discolouration of eyes and skin (jaundice)
- breast disorders
- vaginal tears
- loss of body mass, fistula
- joint effusion, fracture
- kidney cancer
- skin conditions such as psoriasis (itching), skin cancer
- abnormal reaction to blood transfusions
- partial/total loss of vision, drooling
- decreased sex drive
- bulging eyes
- hernia, gallstones, rectal pain
- brittle/weak nails
- intestinal ulcers
- multi-organ failure
Stop receiving BORTEZOM 2MG INJECTION and contact your doctor immediately if you experience any of the following side effects:
- meningitis, epstein-barr virus infection, genital herpes
- tonsillitis, mastoiditis
- post-viral fatigue syndrome
- grade 4 neuropathy (life-threatening damage or dysfunction of one or more nerves) and/or severe autonomic neuropathy (nerve damage that controls automatic body functions)
- signs of progressive multifocal leukoencephalopathy (neurological disorder) such as clumsiness or loss of coordination, difficulty walking and facial drooping
- signs of posterior reversible encephalopathy syndrome (rare rapidly evolving neurological disorder) such as seizure, hypertension, headache, lethargy, confusion, blindness
- signs of peripheral neuropathy (nerve damage that occurs in hands and feet) such as gradual onset of numbness, prickling or tingling in feet or hands, sharp, jabbing, throbbing or burning pain, and extreme sensitivity to touch
- cardiac failure
- signs of tumour lysis syndrome (condition that occurs when tumour cells release their contents into the bloodstream) such as nausea with or without vomiting, lack of appetite, weakness, and dark urine.
- signs of pulmonary hypertension (a type of high blood pressure that affects arteries in the lungs and in the heart) such as blue lips & skin, chest pressure/pain, and dizziness
- acute diffuse infiltrative pulmonary disorders (group of lung disorders) such as shortness of breath, coughing (typically nonproductive), decreased exercise tolerance, and weakness.
- signs of Guillain-Barre syndrome (serious nerve inflammation) such as paralysis and difficulty breathing
- signs of allergy such as serum-sickness-type reaction
- signs of polyarthritis (type of joint disease that involves at least 5 joints) such as pain, stiffness, swelling/redness in the affected area, and or rash.
- signs of auto immune disorders such as proliferative glomerulonephritis
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Inform your doctor if the symptom did not improve.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Inform your doctor if the symptom did not improve.
Nausea:
Stick to simple meals. Avoid eating oil-rich or spicy foods. Inform your doctor if the symptom did not improve.
Stomach Pain:
Try to rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heating pad on your stomach. If the symptom does not improve, contact your doctor.
Constipation:
Eat more fibre foods, especially soluble fibres. Keep yourself hydrated. Inform your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
Consult your doctorBORTEZOM 2MG INJECTION is not recommended for use during pregnancy and in women planning for pregnancy. It should be used with caution in women with childbearing potential who should use effective contraceptive measures before receiving BORTEZOM 2MG INJECTION.
BREASTFEEDING
ContraindicatedBORTEZOM 2MG INJECTION is not recommended for use in breastfeeding women. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any machines if you feel dizzy, tired, syncope (fainting), and/or blurred vision after receiving BORTEZOM 2MG INJECTION.
KIDNEY
Use with CautionBORTEZOM 2MG INJECTION should be used with caution in patients with kidney problems such as mild to moderate renal impairment. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
LIVER
Use with CautionBORTEZOM 2MG INJECTION should be used with caution in patients with moderate or severe liver problems such as hepatic impairment. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
ALLERGY
Consult your doctorDo not receive BORTEZOM 2MG INJECTION if you are allergic to bortezomib, boron or any other ingredients of this medicine. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
LUNGS
Consult your doctorBORTEZOM 2MG INJECTION is not recommended for use in patients with severe lung problems. It should be used with caution in patients with hepatitis B virus disease. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
HEART DISEASE
Consult your doctorBORTEZOM 2MG INJECTION is not recommended for use if you have severe heart problems. BORTEZOM 2MG INJECTION should be used with caution in patients suffering from heart problems such as congestive heart failure. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
OTHERS
Before receiving BORTEZOM 2MG INJECTION, inform your doctor if you have:
- low red or white blood cell count
- bleeding problems and/or low number of platelets in your blood
- diarrhoea, constipation, nausea or vomiting
- fainting, dizziness or light-headedness in the past
- numbness, tingling or pain in the hands or feet (neuropathy) in the past
- blood pressure problems
- shortness of breath or cough
- seizures
- shingles (viral infection that cause swelling around the eyes or spread across the body)
- symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath
- signs of a serious brain infection such as memory loss, trouble thinking, difficulty with walking or loss of vision
- muscle cramping, muscle weakness
- confusion, visual loss or disturbances, blindness, seizures, headaches
- shortness of breath, swelling of your feet or changes in your heartbeat, high blood pressure, tiredness, fainting
- coughing and breathing difficulties or tightness in the chest
Use in Pediatrics:
BORTEZOM 2MG INJECTION is generally not recommended for use in children and adolescents (aged below 18 years). Consult your child’s doctor for advice before administration of BORTEZOM 2MG INJECTION to your child.
Use in Geriatrics:
BORTEZOM 2MG INJECTION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving BORTEZOM 2MG INJECTION.
INTERACTIONS
A. Drug - Drug interactions:
Before taking BORTEZOM 2MG INJECTION, inform your doctor if you are taking any of the following medicines:
- ketoconazole (used to treat fungal infections)
- omeprazole (used to treat indigestion and heartburn)
- dexamethasone (used to treat inflammation and severe allergies)
- melphalan, prednisone (used to treat multiple myeloma)
- ritonavir (used to treat HIV infection)
- rifampicin (an antibiotic used to treat bacterial infections)
- carbamazepine, phenytoin or phenobarbital (used to treat epilepsy)
- st. john’s wort (herbal medicine used to treat depression)
- oral antidiabetics (used to treat diabetes) Ex. metformin, glimiperide
- adalimumab (used to reduce pain and swelling due to arthritis)
- lomitapide (used to lower cholesterol)
Overdosage:
BORTEZOM 2MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor if you experience any unusual symptoms of BORTEZOM 2MG INJECTION such as acute onset of symptomatic hypotension (low blood pressure while standing up from lying position) and thrombocytopenia (condition marked with low platelet count).
SYNOPSIS
| Drug | : | Bortezomib |
| Pharmacological Category | : | Anti-neoplastic agent |
| Therapeutic Indication | : | Multiple myeloma, Mantle cell lymphoma |
| Dosage Forms | : | Injection |
MORE INFORMATION
- Store BORTEZOM 2MG INJECTION in a refrigerator at 2-8°C
FAQs ABOUT BORTEZOM 2MG INJECTION
How is BORTEZOM 2MG INJECTION administered?
BORTEZOM 2MG INJECTION will be given to you only by a doctor or a nurse into a vein as an intravenous infusion or into skin as a subcutaneous injection. Your doctor will decide the correct dose and duration of BORTEZOM 2MG INJECTION for you depending upon your age, body weight and disease condition.
Can BORTEZOM 2MG INJECTION be used during pregnancy?
BORTEZOM 2MG INJECTION is not recommended for use during pregnancy and in women planning for pregnancy. It should be used with caution in women with childbearing potential who should use effective contraceptive measures before receiving BORTEZOM 2MG INJECTION.
Who should avoid receiving BORTEZOM 2MG INJECTION?
BORTEZOM 2MG INJECTION is not recommended for use in patients with severe lung and liver problems which is also not recommended for use in pregnant and breastfeeding women. BORTEZOM 2MG INJECTION is also not indicated for use in children and adolescents (below 18 years of age). Consult your doctor before receiving BORTEZOM 2MG INJECTION.
Can I drive after receiving BORTEZOM 2MG INJECTION?
Do not drive after receiving BORTEZOM 2MG INJECTION since it may cause dizziness, tiredness, syncope (fainting) and/or blurred vision which may affect your ability/concentration to drive. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
Can BORTEZOM 2MG INJECTION be used in patients with liver problems?
BORTEZOM 2MG INJECTION should be used with caution in patients with moderate or severe liver problems such as hepatic impairment. Consult your doctor before receiving BORTEZOM 2MG INJECTION.
REFERENCES
1. Lawrence. L. Brunton. John S. Lazo, Keith L.Parker. Chemotherapy of Neoplastic drugs. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 2018 Page 1372.
2. Antonia Field-Smith, Gareth J Morgan, and Faith E Davies. Bortezomib (Velcade) in the Treatment of Multiple Myeloma. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. September 2006. [Accessed on 4th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936263/
3. Dana-Farber Cancer Institute. Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in June 2019] [Accessed on 4th May 2022] https://www.clinicaltrials.gov/ct2/show/NCT00153920
4. Accord Healthcare B.V. European Medical Agency (EMA). [Revised July 2021] [Accessed on 4th May 2022] https://www.ema.europa.eu/en/documents/product-information/bortezomib-accord-epar-product-information_en.pdf
5. Arecher Healthcare LLP. Bortezomib Injection. [Accessed on 4th May 2022] https://www.arechar.in/blog/bortecine-bortezomib-injection
USEFUL DIAGNOSTIC TESTS
- Albumin/Globulin Ratio, Serum
- Complete Blood Count
- Kidney Function Test
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 16 Aug 2023 | 05:51 PM(IST)
PRODUCT DETAILS
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