FULVIRA Prefilled Syringe(Pfs) 2x5ml

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 consum
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 consum
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).