250 mg soaking liquid, solution in pre-filled syringe
fulvestrant

1. What Fulvestrant Sandoz is and what it is used for

Fulvestrant Sandoz contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogen er, a type of female sex hormone may in some cases be involved in the growth of breast cancer.

Fulvestrant Sandoz is used antigenically:

  • alone to treat postmenopausal women with a type of breast cancer called estrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
  • in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a drug called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Sandoz is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. Ask your doctor if you have any questions about palbociclib.

Fulvestrant contained in Fulvestrant Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fulvestrant Sandoz

Do not use Fulvestrant Sandoz

  • if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or breastfeeding
  • if you have severe liver problems.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Fulvestrant Sandoz if any of the following apply to you:

  • kidney or liver problems
  • low platelet count (contributes to blood clotting), bleeding disorder
  • previous problems with blood clots
  • problems with bone mineral loss ( osteoporosis )
  • alcohol problem.

Children and young people

Fulvestrant Sandoz is not intended for use in children and adolescents below 18 years.

Other drugs and Fulvestrant Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, nor might take any other medicines.

You must tell your doctor if you are taking anticoagulants (medicines that prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant,t or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not use Fulvestrant Sandoz if you are pregnant or breast-feeding. If you can get pregnant, use an effective contraceptive when you are treated with Fulvestrant Sandoz.

You must not breast-feed when you are being treated with Fulvestrant Sandoz.

Driving and using machines

Fulvestrant Sandoz is unlikely to affect your ability to drive or use machines, but if you feel tired after treatment, avoid driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fulvestrant Sandoz contains excipients

Fulvestrant Sandoz contains ethanol .

This medicine contains 12% by volume of ethanol (alcohol), ie up to 1000 mg per dose, equivalent to 20 ml of beer or 8 ml of wine per dose.

Harmful to those who suffer from alcoholism.

To be considered for pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.

Fulvestrant Sandoz contains benzyl alcohol.

This medicine contains 100 mg of benzyl alcohol per ml.

Benzyl alcohol can cause allergic reactions. 

Benzyl alcohol is associated with the risk of serious side effects such as breathing difficulties (“gasping syndrome”) in young children.

Do not give this medicine to newborns (up to 4 weeks of age) unless your doctor tells you to.

Do not use this medicine for more than 1 week in young children (younger than 3 years) unless your doctor or pharmacist has recommended it.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ). 

If you have had liver or kidney problems, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Fulvestrant Sandoz contains benzyl benzoate.

This medicine contains 150 mg of benzyl benzoate per ml.

Benzyl benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).

3. How to use Fulvestrant Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 500 mg fulvestrant (two 250 mg injection s) once per month, with an additional dose at 500 mg two weeks after the first dose one.

Your doctor or nurse will give you Fulvestrant Sandoz as a slow intramuscular injection, one in each buttock.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may need immediate medical attention if you get any of the following side effects:

  • Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat which may be signs of anaphylactic reaction
  • Thromboembolism (increased risk of blood clots) *
  • Inflammation of the liver ( hepatitis )
  • Liver failure.

Tell your doctor or pharmacist if you experience the following side effects:  

Very common side effects are (may affect more than 1 in 10)

  • Injection site reactions, such as pain and/or inflammation
  • Changes in liver enzyme values ​​(shown by blood tests) *
  • Nausea
  • Weakness, fatigue *
  • Joint and musculoskeletal pain
  • Hemorrhoids
  • Rash
  • Allergic (hypersensitivity) reaction, including swelling of the face, lips, tongue, and/or throat.

Other side effects:

Common side effects  (may affect up to 1 in 10 people)

  • Headache
  • Vomiting, diarrhea, or decreased appetite *
  • Urinary tract infection
  • Back pain *
  • Elevation of bilirubin (a bile pigment produced by the liver)
  • Thromboembolism (Increased risk of blood clots)
  • Decreased platelet count ( thrombocytopenia )
  • Vaginal bleeding
  • Pain in the lower back that radiates to the leg on one side (sciatica)
  • Sudden weakness, numbness, tingling, or loss of mobility in the leg, especially only on one side of the body, sudden difficulty walking or keeping balance ( peripheral neuropathy ).

Less common side effects are (may affect up to 1 in 100)

  • Thick, whitish vaginal discharge and fungal infection
  • Bruising and bleeding at the injection site
  • Increase in gamma-GT, a liver enzyme seen in a blood test
  • Inflammation of the liver ( hepatitis )
  • Liver failure
  • Numbness, tingling, and pain
  • Anaphylactic reactions.

* Includes side effects for which the exact effect of Fulvestrant Sandoz cannot be assessed due to the underlying disease.

5. How to store Fulvestrant Sandoz

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C).

Store the prefilled syringe in the original package. Sensitive to light.

The medical staff is responsible for the proper storage, use, and disposal of Fulvestrant Sandoz.

Do not use this medicine after the expiry date which is stated on the carton or syringe label after EXP. The expiration date is the last day of the specified month.

Do not use this medicine if you notice that the syringe or its contents have deteriorated in any way, such as damage to the syringe, if the solution is cloudy or contains liquid particles, or if the color of the solution has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fulvestrant. Each pre-filled syringe contains 250 mg fulvestrant in 5 ml solution (50 mg / ml).
  • Other excipients are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and castor oil.

What the medicine looks like and the contents of the pack

Fulvestrant Sandoz is a clear, colorless to yellow, viscous solution for injection into a pre-filled syringe.

Fulvestrant Sandoz is supplied in a pack containing 1 or 2 pre-filled syringes.

The packages also contain sterile needles.

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or

Ebewe Pharma Ges.mbH Nfg.KG, Mondseestrasse 11, 4866 Unterach am Attersee, Austria

Muhammad Nadeem

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