Bortecad 2.5Mg Injection 1's

Introduction About BORTECAD 2.5MG INJECTION

BORTECAD 2.5MG 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 manage progressive
multiple myeloma when anticancer therapy or hematopoietic stem cell
transplantation becomes unsuitable to manage the disease.

BORTECAD 2.5MG INJECTION is also used in adult patients with rituximab,
cyclophosphamide, doxorubicin, and prednisone to manage unmanageed mantle cell
lymphoma when hematopoietic stem cell transplantation becomes unsuitable to
manage the disease.

Multiple myeloma is a type of cancer that occurs in plasma cells (white blood
cells) and is 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 and is 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 management with BORTECAD 2.5MG INJECTION. It is not
recommended for use in patients with severe lung or heart disease.

Before receiving BORTECAD 2.5MG INJECTION, inform your doctor if you have
bleeding problems, diarrhea, constipation, nausea or vomiting, shortness of
breath or cough, seizures, congestive heart failure, mild or moderate renal
impairment, and/or moderate or severe liver impairment.

BORTECAD 2.5MG INJECTION is not recommended for use by pregnant and
breastfeeding women. BORTECAD 2.5MG INJECTION is also not indicated for use in
children and adolescents (below 18 years of age).

The most common side effects of receiving BORTECAD 2.5MG 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 management with BORTECAD 2.5MG INJECTION.

Uses Of BORTECAD 2.5MG INJECTION

Used in adults:

• To manage progressive multiple myeloma when anticancer therapy or hematopoietic stem cell transplantation becomes unsuitable to manage the disease (alone or in combination with pegylated liposomal doxorubicin/dexamethasone)
• To manage unmanageed mantle cell lymphoma (with rituximab, cyclophosphamide, doxorubicin, and prednisone when hematopoietic stem cell transplantation becomes unsuitable to manage the disease)

How BORTECAD 2.5MG INJECTION Works

BORTECAD 2.5MG INJECTION works by inhibiting proteasomes (enzymes responsible
for breaking down proteins into smaller compounds for cells), which leads to
imbalance in the cancer cell, thus resulting in its destruction and thereby
managing multiple myeloma and mantle cell lymphoma in affected individuals.

How to use BORTECAD 2.5MG INJECTION

BORTECAD 2.5MG INJECTION will be given to you only by a doctor or a nurse into a
vein as an intravenous infusion or into the skin as a subcutaneous injection.
Your doctor will decide the correct dose and duration of BORTECAD 2.5MG
INJECTION for you depending upon your age, body weight, and disease condition.

Side Effects Of BORTECAD 2.5MG INJECTION

Common

• fluid retention
• difficulty or problems sleeping
• altered level of consciousness, confusion
• dizziness, abnormal vision
• chest discomfort and 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)
• diarrhea
• tiredness, weakness
• muscle or bone pain
• low or high blood pressure
• sudden fall of blood pressure while 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, and pain in your limbs
• blurred vision
• nose bleeds
• hair loss and abnormal hair texture

Uncommon

• inflammation of a vein and 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 the mouth or vagina
• cerebrovascular disorders
• speech disorders
• memory impairment or loss
• hearing loss, deafness or ringing in the ears, ear discomfort
• hormone abnormality that may affect salt and water absor
• 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 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
• discoloration of the veins
• inflammation of the spinal nerve
• ear problems such as bleeding from the ear
• underactivity of the thyroid gland
• abnormal bowel function
• signs of bleeding in the brain, such as headache and confusion
• yellow discoloration of the eyes and skin (jaundice)
• breast disorders
• vaginal tears
• loss of body mass, fistula
• joint effusion, fracture
• kidney cancer
• skin conditions such as psoriasis (itching) and skin cancer
• abnormal reaction to blood transfusions
• partial or total loss of vision, drooling
• decreased sex drive
• bulging eyes
• hernia, gallstones, rectal pain
• brittle/weak nails
• intestinal ulcers
• multi-organ failure

Stop receiving BORTECAD 2.5MG 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 (a 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 tumor lysis syndrome (a condition that occurs when tumor 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 (type of high blood pressure that affects arteries in the lungs and in the heart) such as blue lips and skin, chest pressure or 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 a serum-sickness-type reaction
• signs of polyarthritis (a type of joint disease that involves at least five joints) such as pain, stiffness, swelling or redness in the affected area, or rash
• signs of auto-immune disorders such as proliferative glomerulonephritis

How To Manage Side Effects

!### Constipation

Eat more fiber-rich foods, especially soluble fibers. Keep yourself hydrated.
Inform your doctor if the symptoms do not improve.

!### Diarrhea

Drink a lot of fluids, such as water or fruit juices, to keep yourself hydrated.
Inform your doctor if the symptoms do not improve.

Headache

Rest and relax. Drink plenty of fluids, such as water or electrolytes. Apply a
pain-relieving balm to the head if required. Do not consume alcohol. Inform your
doctor if the symptoms do not improve.

!### Nausea And Vomiting

Stick to simple meals. Avoid eating oil-rich or spicy foods. Inform your doctor
if the symptoms do not improve.

!### Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller and more
frequent meals. Keep a heat pad on your stomach. If the symptoms do not improve,
contact your doctor.

Warning & Precautions

!### Pregnancy

Consult your doctorBORTECAD 2.5MG INJECTION is not recommended for use during pregnancy or by women
planning for pregnancy. It should be used with caution in women with
childbearing potential who should use effective contrace
receiving BORTECAD 2.5MG INJECTION.

!### Breastfeeding

ContraindicatedBORTECAD 2.5MG INJECTION is not recommended for use by breastfeeding women.
Consult your doctor before receiving BORTECAD 2.5MG 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 BORTECAD 2.5MG INJECTION.

!### Kidney

Use with CautionBORTECAD 2.5MG INJECTION should be used with caution in patients with kidney
problems such as mild to moderate renal impairment. Consult your doctor before
receiving BORTECAD 2.5MG INJECTION.

!### Liver

Use with CautionBORTECAD 2.5MG INJECTION should be used with caution in patients with moderate
or severe liver problems, such as hepatic impairment. Consult your doctor before
receiving BORTECAD 2.5MG INJECTION.

!### Allergy

ContraindicatedDo not receive BORTECAD 2.5MG INJECTION if you are allergic to bortezomib,
boron, or any other ingredients of this medicine. Consult your doctor before
receiving BORTECAD 2.5MG INJECTION.

!### Lungs

Consult your doctorBORTECAD 2.5MG 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 BORTECAD 2.5MG INJECTION.

!### Heart Disease

Consult your doctorBORTECAD 2.5MG INJECTION is not recommended for use if you have severe heart
problems. BORTECAD 2.5MG INJECTION should be used with caution in patients
suffering from heart problems such as congestive heart failure. Consult your
doctor before receiving BORTECAD 2.5MG INJECTION.

!### Use In Pediatrics

ContraindicatedBORTECAD 2.5MG INJECTION is generally not recommended for use in children and
adolescents (aged below 18 years). Consult your child’s doctor for advice before
administering BORTECAD 2.5MG INJECTION to your child.

!### Use In Geriatrics

Use with CautionBORTECAD 2.5MG INJECTION should be used with caution in elderly patients (aged
65 years and above). Consult your doctor before receiving BORTECAD 2.5MG
INJECTION.

Others

Before receiving BORTECAD 2.5MG INJECTION, inform your doctor if you have:

• low red or white blood cell count
• bleeding problems and/or a low number of platelets in your blood
• diarrhea, 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 (a viral infection that causes swelling around the eyes or spreads 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 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, or fainting
• coughing and breathing difficulties or tightness in the chest

Interactions

A. Drug-Drug interactions:

Before taking BORTECAD 2.5MG INJECTION, inform your doctor if you are taking any
of the following medicines:

• ketoconazole (used to manage fungal infections)
• omeprazole (used to manage indigestion and heartburn)
• dexamethasone (used to manage inflammation and severe allergies)
• melphalan, prednisone (used to manage multiple myeloma)
• ritonavir (used to manage HIV infection)
• rifampicin (an antibiotic used to manage bacterial infections)
• carbamazepine, phenytoin, or phenobarbital (used to manage epilepsy)
• St. John’s wort (herbal medicine used to manage depression)
• oral antidiabetics (used to manage diabetes) Ex. metformin, glimepiride
• adalimumab (used to manage pain and swelling due to arthritis)
• lomitapide (used to manage cholesterol levels)

Overdosage:

BORTECAD 2.5MG INJECTION will be administered to you only by a doctor or a nurse
in a hospital, and so you are unlikely to receive an overdose. However, consult
your doctor if you experience any unusual symptoms of BORTECAD 2.5MG INJECTION,
such as the acute onset of symptomatic hypotension (low blood pressure while
standing up from a lying position) and thrombocytopenia (a condition marked by a
low platelet count).

Synopsis

Drug	:	Bortezomib
Pharmacological Category	:	Anti-neoplastic agent
Therapeutic Indication	:	Multiple myeloma, Mantle cell Lymphoma
Dosage Forms	:	Injection

More Information

• Store BORTECAD 2.5MG INJECTION in a refrigerator at 2-8°C

FAQs About BORTECAD 2.5MG INJECTION

Q: How is BORTECAD 2.5MG INJECTION administered?

A: BORTECAD 2.5MG INJECTION will be given to you only by a doctor or a nurse
into a vein as an intravenous infusion or into the skin as a subcutaneous
injection. Your doctor will decide the correct dose and duration of BORTECAD
2.5MG INJECTION for you depending upon your age, body weight, and disease
condition.

Q: Can BORTECAD 2.5MG INJECTION be used during pregnancy?

A: BORTECAD 2.5MG INJECTION is not recommended for use during pregnancy or by
women planning for pregnancy. It should be used with caution in women with
childbearing potential who should use effective contrace
receiving BORTECAD 2.5MG INJECTION.

Q: Who should avoid receiving BORTECAD 2.5MG INJECTION?

A: BORTECAD 2.5MG INJECTION is not recommended for use in patients with severe
lung and liver problems, and it is also not recommended for use in pregnant and
breastfeeding women. BORTECAD 2.5MG INJECTION is also not indicated for use in
children and adolescents (below 18 years of age). Consult your doctor before
receiving BORTECAD 2.5MG INJECTION.

Q: Can I drive after receiving BORTECAD 2.5MG INJECTION?

A: Do not drive after receiving BORTECAD 2.5MG INJECTION since it may cause
dizziness, tiredness, syncope (fainting), and/or blurred vision, which may
affect your ability or concentration to drive. Consult your doctor before
receiving BORTECAD 2.5MG INJECTION.

Q: Can BORTECAD 2.5MG INJECTION be used in patients with liver problems?

A: BORTECAD 2.5MG INJECTION should be used with caution in patients with
moderate or severe liver problems, such as hepatic impairment. Consult your
doctor before receiving BORTECAD 2.5MG INJECTION.

Useful Diagnostic Tests

• Albumin/Globulin Ratio, Serum
• Complete Blood Count
• Kidney Function Test