250 mg solution for injection in a pre-filled syringe
fulvestrant

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

Fulvestrant Stada 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 Stada is used either:

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

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

2. What you need to know before using Fulvestrant STADA

Do not use Fulvestrant STADA

  • 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 Stada 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 Stada is not intended for children and adolescents under 18 years of age.

Other medicines and Fulvestrant STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important that you tell your doctor if you are taking anticoagulants (medicines that prevent blood clots).

Pregnancy, breastfeeding and fertility

Pregnancy

You must not use Fulvestrant Stada if you are pregnant. If you could become pregnant, use an effective contraceptive when you are being treated with Fulvestrant Stada and for 2 years after your last dose .

Breast-feeding

You must not breast-feed while being treated with Fulvestrant Stada.

Driving and using machines

Fulvestrant Stada 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 STADA contains ethanol, benzyl alcohol and benzyl benzoate

Fulvestrant Stada contains benzyl alcohol

Fulvestrant Stada contains 1,000 mg of benzyl alcohol per 500 mg of fulvestrant.

Benzyl alcohol can cause allergic reactions.

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 Stada contains benzyl benzoate

Fulvestrant Stada contains 1,500 mg of benzyl benzoate per 500 mg of fulvestrant.

3. How to use Fulvestrant STADA

Always use 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 / 5 ml injection s) once per month, with an additional dose at 500 mg two weeks after the initial dose a .

Your doctor or nurse will give you Fulvestrant Stada 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 reactions
  • Thromboembolism (increased risk of blood clots) *
  • Inflammation of the liver ( hepatitis )
  • Liver failure.

Tell your doctor, pharmacist or nurse if you get any of the following side effects:

Very common (may affect more than 1 user 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
  • hot flashes
  • rash
  • allergic (hypersensitivity) reaction, including swelling of the face, lips, tongue and / or throat.

Other side effects:

Common (may affect up to 1 in 10 people)

  • headache
  • vomiting, diarrhea, or decreased appetite *
  • urinary tract infection
  • back pain *
  • increase in 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 maintaining balance ( peripheral neuropathy ).

Uncommon (may affect up to 1 in 100 people)

  • 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
  • liver inflammation ( hepatitis )
  • liver failure
  • numbness, tingling and pain
  • anaphylactic reactions.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Fulvestrant STADA

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

Store and transport in a refrigerator (2 ° C-8 ° C).

Store the pre-filled syringe in the original package. Sensitive to light.

Deviations outside the temperature range 2 ° C – 8 ° C must be limited. This includes avoiding storage at temperatures exceeding 30 ° C and not exceeding a period of 28 days where the average storage temperature of the product is below 25 ° C (but above 2 ° C-8 ° C). After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported in a refrigerator, 2 ° C-8 ° C). Temperature deviations have a cumulative effect on product quality and the time period of 28 days must not be exceeded during the entire shelf life of 4 years for Fulvestrant Stada. Exposure to temperatures below 2 ° C does not damage the product, provided it is not stored below -20 ° C.

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

The medical staff is responsible for the correct storage, use and disposal of Fulvestrant Stada.

This medicine may pose a risk to the aquatic environment. 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 (5 ml) contains 250 mg fulvestrant. Each ml of solution contains 50 mg of fulvestrant.
  • The other ingredients are ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil (refined).

What the medicine looks like and contents of the pack

Fulvestrant Stada is a clear, colorless to yellow, practically free from visible particle, oily and viscous solution, in a pre-filled syringe of glass. Each syringe contains 5 ml solution for injection .

Fulvestrant Stada is available in two pack sizes:

– Carton with a blister with a pre-filled syringe , a protected, sterile needle (BD SafetyGlide) and a package leaflet.

Or

– Cardboard with two blisters, each with a pre-filled syringe , two protected sterile needles (BD SafetyGlide) and a package leaflet.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

STADAPHARM, GmbH

Feodor-Lynen-Str. 35

30625 Hanover

Germany

SC Rompharm Company SRL

St. Eroilor, no. 1A

075100 OTOPENI, ILFOV

Romania

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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