INTRODUCTION
VERSAVO 400MG INJECTION contains Bevacizumab which belongs to the group of medicines called Antineoplastic agents. It is used in adult patients with Fluoropyrimidine (chemotherapy medicine) to treat metastatic cancer in large bowel (colon or rectum). It is also used with Paclitaxel/ Capecitabine (chemotherapy medicine) to treat metastatic breast cancer in adult patients.
VERSAVO 400MG INJECTION is used with chemotherapy regimen containing Platinum to treat advanced non-small cell lung cancer without epidermal growth factor receptor (mutated protein responsible to cause cancer in a cell) and with Erlotinib (chemotherapy medicine) to treat metastatic non-small cell lung cancer with epidermal growth factor receptor (in cancer cells) in adult patients. The medicine is indicated for use to treat metastatic kidney cancer along with interferon (chemotherapy medicine) which is also indicated for use with Carboplatin, Gemcitabine, and/or with Carboplatin and Paclitaxel (chemotherapy medicine) to treat recurrent advanced epithelial ovarian, fallopian tube/primary peritoneal cancer in adult patients. The medicine is also used to treat persistent, recurrent or metastatic cervical cancer with/without Paclitaxel and Cisplatin/ Paclitaxel and Topotecan in adult patients.
VERSAVO 400MG INJECTION is not recommended for use if in patients allergic to Bevacizumab, Chinese hamster ovary (CHO) cell products, and/or other recombinant human/humanised antibodies. It is also not recommended for use in patients who had recently undergone major operation/surgery.
Before receiving VERSAVO 400MG INJECTION, inform your doctor if you are scheduled for an invasive dental treatment/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).
VERSAVO 400MG INJECTION is not recommended for use in pregnant women and in women planning for pregnancy since it may cause harm to the unborn baby. It is also not recommended for use in breast-feeding women since it may interfere with the growth and development of the baby.
VERSAVO 400MG INJECTION is not recommended for use in children and adolescents (aged below 18 years) since safety and efficacy of the medicine is not established in this age group. It is advised to be used with caution in elderly patients (aged 65 years and above) after consulting the doctor.
The most common side effects of receiving VERSAVO 400MG INJECTION are constipation, loss of appetite, fever, eye problems (such as increase in production of tears), changes in speech/sense of taste, runny nose, and/or loss of body weight. Consult your doctor if any of these symptoms worsens.
USES OF VERSAVO 400MG INJECTION
Treats:
- Metastatic cancer in large bowel (colon/rectum), breast, and kidney
- Advanced non-small cell lung cancer
- Recurrent advanced epithelial ovarian, fallopian tube/primary peritoneal cancer
- Persistent/recurrent/metastatic cervical cancer
HOW VERSAVO 400MG INJECTION WORKS
VERSAVO 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 treating the disease and preventing its spread to other parts of the body in affected individuals.
DIRECTIONS FOR USE
VERSAVO 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 VERSAVO 400MG INJECTION
COMMON
- constipation, loss of appetite
- fever
- eye problems (such as increase in production of tears)
- changes in speech/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 VERSAVO 400MG INJECTION and contact your doctor immediately if you experience any of the following side effects:
- high blood pressure
- feeling of numbness/tingling in hands/feet
- low white blood cell count leading to infection (which may be accompanied by fever) / low platelet count leading to bleeding (including in lungs)/ blocking of veins by blood clot
- severe weakness/tiredness
- severe abdominal pain, perforation of the gut, diarrhoea, nausea, and/or vomiting
- heart failure, problems with wound healing after surgery
- redness, peeling, tenderness, pain, and/or blistering on fingers/feet
- severe low red cell count in blood
- severe lack of energy
- stomach and intestinal disorder
- severe muscle and joint pain/muscular weakness
- dry mouth in combination with thirst and/or reduced/darkened urine
- inflammation of moist lining of mouth and gut, lungs and air passages, reproductive, and urinary tracts
- painful sores in 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
- localised collection of pus
- severe infection (particularly in blood/bladder, skin)/nosebleed
- stroke
- high heart rate
- blockage in gut/bowel
- shortness of breath/low levels of oxygen in blood
- fistula (abnormal tube-like connection between internal organs and skin or other tissues)
- signs of allergic reactions such as breathing difficulty, facial redness, rash, low/high blood pressure, low oxygen (in your blood), chest pain, and/or nausea/vomiting
- sign of anaphylactic shock such as sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, and/or loss of consciousness
- serious infections of skin/deeper layers under the skin (especially if you had holes in the gut wall/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 nostrils of the nose
- hole in the stomach/intestines
- an open sore/hole in the lining of stomach/small intestine associated with signs such as abdominal pain, bloating, black tarry stools, and/or blood in stools (faeces)/blood in vomit
- bleeding from lower part of the large bowel
- lesions in the gums with an exposed jawbone that does not heal and may be associated with pain/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 have had pain in the mouth, teeth/jaw, swelling/sores inside the mouth, numbness/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, fresh fruit, and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments 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 moisture, 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
ContraindicatedVERSAVO 400MG INJECTION is not recommended for use in pregnant women and in women planning for pregnancy since it may cause harm to the unborn baby. Women of child bearing potential should use effective contraceptives during and after stopping treatment with medicine for next 6 months to prevent accidental pregnancy. If pregnancy occurs during treatment with VERSAVO 400MG INJECTION, then it should be informed to your doctor immediately. Consult your doctor before receiving the medicine.
BREASTFEEDING
ContraindicatedVERSAVO 400MG INJECTION is not recommended for use in breast-feeding women during and for 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/fainting after receiving the medicine.
KIDNEY
Use with CautionVERSAVO 400MG INJECTION should be used with caution in patients with kidney problems. Consult your doctor before receiving the medicine.
LIVER
Use with CautionVERSAVO 400MG INJECTION should be used with caution in patients with liver problems such as hepatic injury. Consult your doctor before receiving the medicine.
ALLERGY
ContraindicatedDo not receive VERSAVO 400MG INJECTION if you are allergic to Bevacizumab, Chinese hamster ovary (CHO) cell products, other recombinant human/humanised antibodies, and/or any other ingredients of this medicine.
LUNGS
Use with CautionVERSAVO 400MG INJECTION should be used with caution in patients with a history of risk of bleeding in lungs. Consult your doctor before receiving the medicine.
HEART DISEASE
Use with CautionVERSAVO 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.
OTHERS
VERSAVO 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 a surgery
Before receiving VERSAVO 400MG INJECTION, inform your doctor if you:
- have conditions causing inflammation inside the abdomen such as diverticulitis, stomach ulcers, colitis associated with chemotherapy
- have uncontrolled high blood pressure
- you need to undergo an invasive dental treatment/dental surgery
- have dental problem
Use in Paediatrics:
VERSAVO 400MG INJECTION is not recommended for use in children and adolescents (aged below 18 years) since safety and efficacy of the use of medicine is not established in in this age group. Consult your doctor before receiving the medicine.
Use in Geriatrics:
VERSAVO 400MG INJECTION should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before receiving the medicine.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving VERSAVO 400MG INJECTION, inform your doctor if you are receiving any of the following medicine:
- sunitinib malate (prescribed for renal and gastrointestinal cancer)
- Platinum/taxane-based therapies such as carboplatin and paclitaxel (medicines used to treat non-small cell lung cancer and metastatic breast cancer)
- Radiotherapy
Overdosage:
VERSAVO 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 large bowel (colon/rectum), breast, kidney, Advanced non-small cell lung cancer (with/without epidermal growth factor receptor), Recurrent advanced epithelial ovarian, fallopian tube/primary peritoneal cancer, Persistent/recurrent/metastatic cervical cancer |
| Dosage Forms | : | Injection |
MORE INFORMATION
- Keep VERSAVO 400MG INJECTION out of the sight and reach of children
- Store VERSAVO 400MG INJECTION in a refrigerator between 2-8°C
FAQs ABOUT VERSAVO 400MG INJECTION
Q. What is VERSAVO 400MG INJECTION used for?
A. VERSAVO 400MG INJECTION is used in adult patients to treat metastatic cancer in large bowel (colon/rectum), breast, kidney, and lungs. It is also used to treat recurrent advanced epithelial ovarian, fallopian tube/primary peritoneal cancer, and/or persistent/recurrent/metastatic cervical cancer in affected individuals.
Q. How VERSAVO 400MG INJECTION works?
A. VERSAVO 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 treating the disease and preventing its spread to other parts of the body in affected individuals.
Q. What are the common side effects of receiving VERSAVO 400MG INJECTION?
A. The most common side effects of receiving VERSAVO 400MG INJECTION are constipation, loss of appetite, fever, eye problems (such as increase in production of tears), changes in speech/sense of taste, runny nose, and/or loss of body weight. Consult your doctor if any of these symptoms worsens.
Q. How VERSAVO 400MG INJECTION is administered?
A. VERSAVO 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 VERSAVO 400MG INJECTION be administered in pregnant and breastfeeding women?
A. No, VERSAVO 400MG INJECTION is not recommended for use in pregnant women and in women planning for pregnancy since it may cause harm to the unborn baby. It is also not recommended for use in 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] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228024/
3. Pfizer Ireland Pharmaceuticals. Electronic Medicines Compendium (EMC). [Revised in January 2023] [Accessed on 30th January 2023] https://www.medicines.org.uk/emc/files/pil.13267.pdf
USEFUL DIAGNOSTIC TESTS
- Mammogram
- CT scan
- MRI Scan
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