INTRODUCTION ABOUT SYNDYMA 400MG INJECTION

SYNDYMA 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.

SYNDYMA 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. SYNDYMA 400MG INJECTION is not recommended for use in patients allergic to Bevacizumab, Chinese hamster ovary (CHO) cell products, and/or other recombinant human or humanized antibodies. It is also not recommended for use in patients who have recently undergone major operations or surgery.

Before receiving SYNDYMA 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).

SYNDYMA 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.

SYNDYMA 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 SYNDYMA 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 SYNDYMA 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 SYNDYMA 400MG INJECTION WORKS

SYNDYMA 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

SYNDYMA 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 SYNDYMA 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 SYNDYMA 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 accompanied by fever), low platelet counts leading to bleeding (including in the lungs), or blocking of veins by blood clots
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

Contraindicated

SYNDYMA 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 contraceptives during and after stopping management with medicine for the next 6 months to manage accidental pregnancy. If pregnancy occurs during management with SYNDYMA 400MG INJECTION, then you should inform your doctor immediately. Consult your doctor before receiving the medicine.

BREASTFEEDING

Contraindicated

SYNDYMA 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 Caution

Do not drive or operate machines if you experience sleepiness or fainting after receiving the medicine.

ALLERGY

Contraindicated

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

HEART DISEASE

Use with Caution

SYNDYMA 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

Contraindicated

SYNDYMA 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 Caution

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

OTHERS

SYNDYMA 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 SYNDYMA 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 SYNDYMA 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:

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

FAQs ABOUT SYNDYMA 400MG INJECTION

Q: What is SYNDYMA 400MG INJECTION used for?

A: SYNDYMA 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 SYNDYMA 400MG INJECTION work?

A: SYNDYMA 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 SYNDYMA 400MG INJECTION?

A: The most common side effects of receiving SYNDYMA 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 SYNDYMA 400MG INJECTION administered?

A: SYNDYMA 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 SYNDYMA 400MG INJECTION be administered to pregnant and breastfeeding women?

A: No, SYNDYMA 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] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3228024/

3. Pfizer Ireland Pharmaceuticals. Electronic Medicines Compendium (EMC). [Revised in January 2023] [Accessed on 30thJanuary 2023] https://www.medicines.org.uk/emc/files/pil.13267.pdf

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

AUTHOR DETAILS

Written By Dr. N. Sai Swaroop - Pharm.D

Last updated on 27 Nov 2023 | 04:42 PM(IST)

SYNDYMA 400mg Injection 16ml

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