Bortetrust 2mg Injection 1?S Allschoolabs -

Description

INTRODUCTION
BORTETRUST 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.??
BORTETRUST 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 BORTETRUST 2MG INJECTION. It is not recommended for use in patients with severe lung or heart disease.
Your doctor may advise you to do regular blood tests to check your blood counts before and during treatment with BORTETRUST 2MG INJECTION. It is not recommended for use in patients with severe lung or heart disease.
BORTETRUST 2MG INJECTION is not recommended for use in pregnant and breastfeeding women. BORTETRUST 2MG INJECTION is also not indicated for use in children and adolescents (below 18 years of age).
The most common side effects of receiving BORTETRUST 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 BORTETRUST 2MG INJECTION.
USES OF BORTETRUST 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 BORTETRUST 2MG INJECTION WORKS
BORTETRUST 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
BORTETRUST 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 BORTETRUST 2MG INJECTION for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF BORTETRUST 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 BORTETRUST 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
BORTETRUST 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 BORTETRUST 2MG INJECTION.
BREASTFEEDING
BORTETRUST 2MG INJECTION is not recommended for use in breastfeeding women. Consult your doctor before receiving BORTETRUST 2MG INJECTION.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy, tired, syncope (fainting), and/or blurred vision after receiving BORTETRUST 2MG INJECTION.
KIDNEY
BORTETRUST 2MG INJECTION should be used with caution in patients with kidney problems such as mild to moderate renal impairment. Consult your doctor before receiving BORTETRUST 2MG INJECTION.
LIVER
BORTETRUST 2MG INJECTION should be used with caution in patients with moderate or severe liver problems such as hepatic impairment. Consult your doctor before receiving BORTETRUST 2MG INJECTION.
ALLERGY
Do not receive BORTETRUST 2MG INJECTION if you are allergic to bortezomib, boron or any other ingredients of this medicine. Consult your doctor before receiving BORTETRUST 2MG INJECTION.
LUNGS
BORTETRUST 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 BORTETRUST 2MG INJECTION.
HEART DISEASE
BORTETRUST 2MG INJECTION is not recommended for use if you have severe heart problems. BORTETRUST 2MG INJECTION should be used with caution in patients suffering from heart problems such as congestive heart failure. Consult your doctor before receiving BORTETRUST 2MG INJECTION.
OTHERS
Before receiving BORTETRUST 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:
BORTETRUST 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 BORTETRUST 2MG INJECTION to your child.
Use in Geriatrics:
BORTETRUST 2MG INJECTION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving BORTETRUST 2MG INJECTION.
INTERACTIONS
A. Drug ? Drug interactions:
Before taking BORTETRUST 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:
BORTETRUST 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 BORTETRUST 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 BORTETRUST 2MG INJECTION in a refrigerator at 2-8?C

FAQs ABOUT BORTETRUST 2MG INJECTION
How is BORTETRUST 2MG INJECTION administered??
BORTETRUST 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 BORTETRUST 2MG INJECTION for you depending upon your age, body weight and disease condition.
Can BORTETRUST 2MG INJECTION be used during pregnancy?
BORTETRUST 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 BORTETRUST 2MG INJECTION.??
Who should avoid receiving BORTETRUST 2MG INJECTION?
BORTETRUST 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. BORTETRUST 2MG INJECTION is also not indicated for use in children and adolescents (below 18 years of age). Consult your doctor before receiving BORTETRUST 2MG INJECTION.
Can I drive after receiving BORTETRUST 2MG INJECTION?
Do not drive after receiving BORTETRUST 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 BORTETRUST 2MG INJECTION.
Can BORTETRUST 2MG INJECTION be used in patients with liver problems?
BORTETRUST 2MG INJECTION should be used with caution in patients with moderate or severe liver problems such as hepatic impairment. Consult your doctor before receiving BORTETRUST 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