AVASTIMAB 400mg Injection 16ml

INTRODUCTION ABOUT AVASTIMAB 400MG INJECTION

AVASTIMAB 400MG INJECTION contains Bevacizumab, which belongs to the group of
medicines called Antineoplastic agents. It is used in adult patients with
fluoropyrimidine (a chemotherapy medicine) to manage metastatic cancer in the
large bowel (colon or rectum). It is also used with Paclitaxel or Capecitabine
(chemotherapy medicine) to manage metastatic breast cancer in adult patients.

AVASTIMAB 400MG INJECTION is used with a chemotherapy regimen containing
platinum to manage advanced non-small cell lung cancer without epidermal growth
factor receptor (a mutated protein responsible for causing cancer in a cell) and
with Erlotinib (a chemotherapy medicine) to manage metastatic non-small cell
lung cancer with epidermal growth factor receptor (in cancer cells) in adult
patients.

This medicine is indicated for use to manage metastatic kidney cancer along with
interferon (chemotherapy medicine), which is also indicated for use with
carboplatin, gemcitabine, and/or carboplatin and Paclitaxel
(chemotherapy medicine) to manage recurrent advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer in adult patients.

This medicine is also used to manage persistent, recurrent, or metastatic
cervical cancer with or without Paclitaxel, Cisplatin, or Paclitaxel and
Topotecan in adult patients. AVASTIMAB 400MG INJECTION is not recommended for
use in patients allergic to Bevacizumab, Chinese hamster ovary (CHO) cell
products, and/or other recombinant human or hum
recommended for use in patients who have recently undergone major operations or
surgery.

Before receiving AVASTIMAB 400MG INJECTION, inform your doctor if you are
scheduled for an invasive dental management or surgery and/or suffer from
conditions such as inflammation inside the abdomen, uncontrolled high blood
pressure, dental problems, kidney problems, and liver problems (such as hepatic
injury).

AVASTIMAB 400MG INJECTION is not recommended for use in pregnant women or in
women planning for pregnancy since it may cause harm to the unborn baby. It is
also not recommended for use by breast-feeding women since it may interfere with
the growth and development of the baby.

AVASTIMAB 400MG INJECTION is not recommended for use in children and adolescents
(aged below 18 years) since the safety and efficacy of the medicine are not
established in this age group. It is advised to be used with caution in elderly
patients (aged 65 years and older) after consulting the doctor.

The most common side effects of receiving AVASTIMAB 400MG INJECTION are
constipation, loss of appetite, fever, eye problems (such as an increase in the
production of tears), changes in speech or sense of taste, runny nose, and/or
loss of body weight. Consult your doctor if any of these symptoms worsen.

USES OF AVASTIMAB 400MG INJECTION

To manage:

• Metastatic cancer in the large bowel (colon/rectum), breast, and kidney
• Advanced non-small cell lung cancer
• Recurrent advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
• persistent, recurrent, or metastatic cervical cancer

HOW AVASTIMAB 400MG INJECTION WORKS

AVASTIMAB 400MG INJECTION works by reducing microvascular growth of tumour blood
vessels which leads to reduced blood flow to the tumour cells resulting in its
death thus managing the disease and managing its spread to other parts of the
body in affected individuals.

DIRECTIONS FOR USE

AVASTIMAB 400MG INJECTION will be given to you only by a doctor or a nurse into
a vein as an intravenous infusion. Your doctor will determine the correct dose
and duration for you based upon your age, body weight, and disease condition.

SIDE EFFECTS OF AVASTIMAB 400MG INJECTION

COMMON

• constipation, loss of appetite
• fever
• eye problems (such as an increase in the production of tears)
• changes in speech or sense of taste
• runny nose
• dry skin, flaking, skin inflammation, and skin colour changes
• loss of body weight
• nose bleeds.
• voice changes and hoarseness

RARE

Stop receiving AVASTIMAB 400MG INJECTION and contact your doctor immediately if
you experience any of the following side effects:

• high blood pressure
• feeling of numbness or tingling in the hands or feet
• low white blood cell counts leading to infection (which may be accomp
• severe weakness/tiredness
• severe abdominal pain, perforation of the gut, diarrhea, nausea, and/or vomiting
• heart failure, problems with wound healing after surgery
• redness, peeling, tenderness, pain, and/or blistering on fingers or feet
• severe low red cell counts in the blood
• severe lack of energy
• stomach and intestinal disorders
• severe muscle and joint pain/muscular weakness
• dry mouth in combination with thirst and/or reduced or darkened urine
• inflammation of the moist lining of the mouth and gut, lungs and air passages, reproductive, and urinary tracts
• painful sores in the mouth and tube from mouth to stomach, which may cause difficulty while swallowing
• severe headache, back pain, and pain in the pelvis and anal regions
• localized collection of pus
• severe infection (particularly in the blood, bladder, or skin) or nosebleed
• stroke
• high heart rate
• blockage in the gut or bowel
• shortness of breath or low levels of oxygen in the blood
• fistula (an abnormal tube-like connection between internal organs and skin or other tissues)
• signs of allergic reactions such as breathing difficulty, facial redness, rash, low or high blood pressure, low oxygen (in your blood), chest pain, and/or nausea or vomiting
• sign of anaphylactic shock, such as a sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, a fast heartbeat, sweating, and/or loss of consciousness
• serious infections of the skin or deeper layers under the skin (especially if you had holes in the gut wall or problems with wound healing)
• brain condition with symptoms such as seizures (fits), headache, confusion, and/or changes in vision
• symptoms that suggest changes in normal brain function, such as headaches, vision changes, confusion, seizures, and/or high blood pressure
• aneurysms and artery dissections (enlarged and weakened blood vessel wall/tear in a blood vessel wall)
• clogging of a very small blood vessel(s) in the kidney
• abnormally high blood pressure in the blood vessels of the lungs, which makes the right side of the heart pump harder than normal.
• hole in the cartilage wall separating the nostrils of the nose.
• hole in the stomach or intestines
• an open sore or hole in the lining of the stomach or small intestine associated with signs such as abdominal pain, bloating, black tarry stools, and/or blood in stools (faeces) or vomit
• bleeding from the lower part of the large bowel
• lesions in the gums with an exposed jawbone that do not heal and may be associated with pain or inflammation of the surrounding tissue
• hole in the gall bladder with associated signs and symptoms such as abdominal pain, fever, nausea, and/or vomiting
• have/ever had pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or feeling of heaviness in the jaw; or loosening of a tooth

HOW TO MANAGE SIDE EFFECTS

!### Constipation

Try to eat high-fiber foods such as vegetables, cereals, and fresh fruit, and
drink plenty of water. Involve yourself in regular exercise (going for a daily
walk or run), and if this does not help, consult and inform your doctor about
receiving alternate managements for constipation.

!### Dry Skin

Try moisturizing your skin with an ointment, cream, or lotion 2 or 3 times a
day, or as often as needed. Moisturizers help to keep the area moist, so they
work best on damp skin. After you bathe, pat your skin dry, then apply your
moisturizer. Try to avoid using skin care products and soaps that contain
alcohol, fragrances, dyes, or other chemicals.

WARNING & PRECAUTIONS

!### PREGNANCY

ContraindicatedAVASTIMAB 400MG INJECTION is not recommended for use in pregnant women or in
women planning for pregnancy since it may cause harm to the unborn baby. Women
of childbearing potential should use effective contrace
stopping management with medicine for the next 6 months to manage accidental
pregnancy. If pregnancy occurs during management with AVASTIMAB 400MG INJECTION,
then you should inform your doctor immediately. Consult your doctor before
receiving the medicine.

!### BREASTFEEDING

ContraindicatedAVASTIMAB 400MG INJECTION is not recommended for use in breast-feeding women
during and for the next 6 months of therapy after stopping the medicine since it
may interfere with the growth and development of your baby. Consult your doctor
before receiving the medicine.

!### DRIVING AND USING MACHINES

Use with CautionDo not drive or operate machines if you experience sleepiness or fainting after
receiving the medicine.

!### ALLERGY

ContraindicatedDo not receive AVASTIMAB 400MG INJECTION if you are allergic to Bevacizumab,
Chinese hamster ovary (CHO) cell products, other recombinant human or hum
antibodies, and/or any other ingredients of this medicine.

!### HEART DISEASE

Use with CautionAVASTIMAB 400MG INJECTION should be used with caution in patients with heart
problems such as heart attack and stroke. Consult your doctor before receiving
the medicine.

!### USE IN PEDIATRICS

ContraindicatedAVASTIMAB 400MG INJECTION is not recommended for use in children and adolescents
(aged below 18 years) since the safety and efficacy of the use of medicine are
not established in this age group. Consult your doctor before receiving the
medicine.

!### USE IN GERIATRICS

Use with CautionAVASTIMAB 400MG INJECTION should be used with caution in elderly patients (aged
65 years and above). Consult your doctor before receiving the medicine.

OTHERS

AVASTIMAB 400MG INJECTION is not recommended for use if you:

• have an operation or had major surgery (within the last 28 days), or if you still have an unhealed wound followed by surgery

Before receiving AVASTIMAB 400MG INJECTION, inform your doctor if you:

• have conditions causing inflammation inside the abdomen, such as diverticulitis, stomach ulcers, and colitis associated with chemotherapy
• have uncontrolled high blood pressure
• you need to undergo invasive dental management or dental surgery
• have dental problem

INTERACTIONS

A. Drug-Drug interactions:

Before receiving AVASTIMAB 400MG INJECTION, inform your doctor if you are
receiving any of the following medicines:

• sunitinib malate (prescribed for renal and gastrointestinal cancer)
• platinum/taxane-based therapies such as carboplatin and paclitaxel (medicines used to manage non-small cell lung cancer and metastatic breast cancer)

Overdosage:

AVASTIMAB 400MG 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 or nurse if you experience any unusual symptoms.

SYNOPSIS

Drug	:	Bevacizumab
Pharmacological Category	:	Antineoplastics
Therapeutic Indication	:	Metastatic cancer in the large bowel (colon/rectum), breast, and kidney, Advanced non-small cell lung cancer, Recurrent advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer and Persistent, recurrent, or metastatic cervical cancer
Dosage Forms	:	Injection

MORE INFORMATION

• Keep AVASTIMAB 400MG INJECTION out of the sight and reach of children
• Store AVASTIMAB 400MG INJECTION in a refrigerator between 2-8°C

FAQs ABOUT AVASTIMAB 400MG INJECTION

Q: What is AVASTIMAB 400MG INJECTION used for?

A: AVASTIMAB 400MG INJECTION is used in adult patients to manage metastatic
cancer in the large bowel (colon/rectum), breast, kidney, and lungs. It is also
used to manage recurrent advanced epithelial ovarian, fallopian tube/primary
peritoneal cancer, and/or persistent, recurrent, or metastatic cervical cancer
in affected individuals.

Q: How does AVASTIMAB 400MG INJECTION work?

A:AVASTIMAB 400MG INJECTION works by reducing microvascular growth of tumour
blood vessels which leads to reduced blood flow to the tumour cells resulting in
its death thus managing the disease and managing its spread to other parts of
the body in affected individuals.

Q: What are the common side effects of receiving AVASTIMAB 400MG INJECTION?

A: The most common side effects of receiving AVASTIMAB 400MG INJECTION are
constipation, loss of appetite, fever, eye problems (such as an increase in the
production of tears), changes in speech or sense of taste, runny nose, and/or
loss of body weight. Consult your doctor if any of these symptoms worsen.

Q: How is AVASTIMAB 400MG INJECTION administered?

A: AVASTIMAB 400MG INJECTION will be given to you only by a doctor or a nurse
into a vein as an intravenous infusion. Your doctor will determine the correct
dose and duration for you based upon your age, body weight, and disease
condition.

Q: Can AVASTIMAB 400MG INJECTION be administered to pregnant and breastfeeding
women?

A: No, AVASTIMAB 400MG INJECTION is not recommended for use in pregnant women or
in women planning for pregnancy since it may cause harm to the unborn baby. It
is also not recommended for use by breast-feeding women since it may interfere
with the growth and development of the baby. Consult your doctor before
receiving the medicine.

REFERENCES

1. KD Tripathi MD. Anticancer Drugs. Essentials of Medical Pharmacology 8th
   edition. 2019. Page- 930.

2. Filis Kazazi-Hyseni, Jos H. Beijnen, Jan H. M. Schellen. Bevacizumab. NIH
   National Library of Medicine. National Center for Biotechnology Information. PMC
   PubMed Central. August 2010. [Accessed on 30th January
   2023]

3. Pfizer Ireland Pharmaceuticals. Electronic Medicines Compendium (EMC).
   [Revised in January 2023] [Accessed on 30thJanuary
   2023]

USEFUL DIAGNOSTIC TESTS

• Breast Carcinoma Prognosis Profile
• Breast Carcinoma Prognosis Panel
• Fish, Her-2 Neu Oncogene Amplification, Breast Cancer
• Cyfra - Lung Cancer Marker
• Cyfra 21 (Lung Cancer Marker) Blood Culture (Bd Bactec) Blood Culture (Bd Bactec)
• Biopsy - Uterus With Both Tubes & Ovaries