FULVIRA Prefilled Syringe(Pfs) 2x5ml
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Introduction About FULVIRA PREFILLED SYRINGE(PFS)
FULVIRA PREFILLED SYRINGE(PFS) contains Fulvestrant which belongs to the group of Estrogen blockers. It is used for a type of breast cancer called estrogen receptor positive breast cancer in postmenopausal women that is locally advanced or has spread to other parts of the body (metastatic). This medicine is also used with combination with palbociclib for women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be managed with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist.
FULVIRA PREFILLED SYRINGE(PFS) is not recommended to use in patients with severe liver problems. Before receiving FULVIRA PREFILLED SYRINGE(PFS), inform your doctor if you have or ever had kidney problems, liver problems, osteoporosis, low number of platelets, bleeding problems, or previous problems with blood clots.
Avoid consumption of alcohol while receiving FULVIRA PREFILLED SYRINGE(PFS), as it may lead to unwanted side effects. FULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in pregnant and breastfeeding women. The most common side effects of receiving FULVIRA PREFILLED SYRINGE(PFS) are headache, vomiting, diarrhea, loss of appetite, urinary tract infection, back pain, vaginal bleeding, and thromboembolism. Consult your physician if any of the symptoms worsen or persists for a longer duration.
Uses Of FULVIRA PREFILLED SYRINGE(PFS)
It is used for:
- a type of breast cancer called estrogen receptor positive breast cancer (in postmenopausal women)
- a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (in combination with other medicines)
How FULVIRA PREFILLED SYRINGE(PFS) Works
FULVIRA PREFILLED SYRINGE(PFS) blocks the action of estrogen on breast cancer cells which lowers the growth of some breast cancer cells that need estrogen to grow.
How to use FULVIRA PREFILLED SYRINGE(PFS)
FULVIRA PREFILLED SYRINGE(PFS) will be administered by your doctor or nurse. The correct dose and duration will be decided by your doctor depending on your age, body weight, and disease condition.
Side Effects Of FULVIRA PREFILLED SYRINGE(PFS)
Serious
Stop receiving FULVIRA PREFILLED SYRINGE(PFS) and contact your physician immediately if you experience any of the following side effects:
- injection site reactions, such as pain or inflammation
- elevated levels of liver enzymes
- weakness, tiredness
- joint and musculoskeletal pain
- hot flushes
- skin rash
- allergic reactions (symptoms like swelling of the face, lips, tongue, and/or throat)
Common
- headache
- vomiting
- diarrhea
- loss of appetite
- urinary tract infections
- back pain
- increase in bilirubin
- thromboembolism (increased risk of blood clots)
- decreased levels of platelets (thrombocytopenia)
- vaginal bleeding
- lower back pain irradiating to leg on one side (sciatica)
- peripheral neuropathy (sudden weakness, tingling, numbness, or loss of movement in the leg, especially on only one side of the body, sudden problems with walking or balance)
Uncommon
- infection of the vagina symptoms like thick, whitish vaginal discharge and candidiasis
- bruising and bleeding at the site of injection
- hepatitis (inflammation of the liver)
- liver failure
- numbness, tingling, and pain
- anaphylactic reactions
How To Manage Side Effects
Diarrhea
Drink more fluids like water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your physician.
Nausea And Vomiting
Take this medicine with, or just after meals. Stick to simple meals. Avoid eating oily-rich or spicy foods.
Warning & Precautions
Pregnancy
ContraindicatedFULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in pregnant women. Consult your doctor for advice.
Breastfeeding
ContraindicatedFULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in breastfeeding women as it may pass through breast milk. Consult your doctor for advice.
Driving and Using Machines
Use with CautionDo not drive or operate any machines if you feel tired after receiving FULVIRA PREFILLED SYRINGE(PFS).
Alcohol
Consult your doctorAvoid consumption of alcohol while receiving FULVIRA PREFILLED SYRINGE(PFS). Consult your doctor for advice.
Kidney
Use with CautionFULVIRA PREFILLED SYRINGE(PFS) should be used with caution in patients with kidney disease. Consult your doctor before receiving.
Liver
Consult your doctorFULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in patients with serious liver problems and can be used with caution in patients with mild to moderate liver problems. Consult your doctor before receiving.
Allergy
Use with CautionDo not receive FULVIRA PREFILLED SYRINGE(PFS) if you are allergic to Fulvestrant or any of the other ingredients of the medicine.
Use In Pediatrics
ContraindicatedFULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in children and adolescents (below the age of 18 years). Consult your doctor for advice.
Use In Geriatrics
Use with CautionFULVIRA PREFILLED SYRINGE(PFS) should be used with caution in elder patients. Consult your doctor for advice.
Others
Before receiving FULVIRA PREFILLED SYRINGE(PFS), inform your doctor if you:
- Have previous problems with blood clots or bleeding disorders
- Have osteoporosis (loss of bone density)
Interactions
A. Drug-Drug interactions:
Before receiving FULVIRA PREFILLED SYRINGE(PFS), inform your doctor if you are taking any of the following medicine:
- Anticoagulants (a medicine used to thin the blood clots) (Ex. warfarin)
Overdosage:
FULVIRA PREFILLED SYRINGE(PFS) will be administered to you only by a doctor or nurse in a hospital, so it is unlikely to receive an overdose. However, consult your physician or health care professionals if you experience any unusual symptoms.
Synopsis
| Drug | : | Fulvestrant |
| Pharmacological Category | : | Estrogen receptor antagonists |
| Therapeutic Indication | : | Breast cancer |
| Dosage Forms | : | Injection |
More Information
- Keep FULVIRA PREFILLED SYRINGE(PFS) out of reach of children
- Store at 2 to 8°C
FAQs About FULVIRA PREFILLED SYRINGE(PFS)
Q: How is FULVIRA PREFILLED SYRINGE(PFS) administered?
A: FULVIRA PREFILLED SYRINGE(PFS) will be given to you only by a doctor or nurse as a slow intramuscular administration. The correct dose and duration of FULVIRA PREFILLED SYRINGE(PFS) will be decided by your doctor depending on your age, body weight, and disease condition.
Q: Does FULVIRA PREFILLED SYRINGE(PFS) causes tiredness?
A: Tiredness is one of the most common side effects of FULVIRA PREFILLED SYRINGE(PFS). However, it does not affect every individual. Consult your doctor immediately if you experience any unusual symptoms that occur after receiving FULVIRA PREFILLED SYRINGE(PFS).
Q: Who should avoid administering FULVIRA PREFILLED SYRINGE(PFS)?
A: FULVIRA PREFILLED SYRINGE(PFS) is not recommended for patients having severe kidney problems, liver problems, bleeding disorders, osteoporosis, or previous problems with blood clots. Consult your doctor before receiving FULVIRA PREFILLED SYRINGE(PFS).
Q: Is it safe to use FULVIRA PREFILLED SYRINGE(PFS) in pregnancy?
A: FULVIRA PREFILLED SYRINGE(PFS) is not recommended for use in pregnant women. Consult your doctor before receiving the medicine.
Q: Is there any food restriction before receiving FULVIRA PREFILLED SYRINGE(PFS)?
A: As such, there is no food restriction. Consult your doctor before receiving FULVIRA PREFILLED SYRINGE(PFS).
References
1. Claudine Isaacs, Anton Wellstein, and Anna T. Riegel. Hormones and Related Agents in Therapy of Cancer. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018 Page – 1237-1247.
2. Mark R. Nathan and Peter Schmid. A Review of Fulvestrant in Breast Cancer. Journal of Oncology and Therapy. May 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488136/
3. I. Blancas, C. Olier, V. Conde, J. L. Bayo, C. Herrero, I. Zarcos-Pedrinaci, F. Carabantes, J. M. Baena-Cañada, J. Cruz & M. Ruiz-Borrego. Real-world data of fulvestrant first-line treatment of postmenopausal women with estrogen receptor-positive metastatic breast cancer. Journal of Nature. February 2021 https://www.nature.com/articles/s41598-021-83622-1
4. Katalin Boer. Fulvestrant in advanced breast cancer: evidence date and place in therapy. Journal of Therapeutic advances in medical oncology. June 2017 https://journals.sagepub.com/doi/10.1177/1758834017711097
5. AstraZeneca UK Limited. Electronic Medicines Compendium (EMC). [Revised in December 2020] [Accessed on 17th May] https://www.medicines.org.uk/emc/files/pil.68.pdf
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