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

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

Fulvestrant Accord 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 Accord 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 luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Accord 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 the Fulvestrant Accord 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 Accord

Do not use Fulvestrant Accord

  • 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 Accord if any of the following applies 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 Accord is not intended for children and adolescents under 18 years of age.

Other medicines and Fulvestrant Accord

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

You must tell your doctor if you are taking anticoagulants 

(medicines that prevent blood clots).

Pregnancy, breastfeeding,, and fertility

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

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

Driving and using machines

Fulvestrant Accord is unlikely to affect your ability to drive or use machines, but if you feel tired after the 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 Accord contains ethanol (alcohol), benzyl alcohol, benzyl benzoate

This medicine contains 10% by volume of ethanol (alcohol), ie up to 500 mg per dose, equivalent to 10 ml of beer, or 4 ml of wine per dose. Harmful to people suffering from alcoholism. Attention should be paid to high-risk groups such as patients with liver disease or epilepsy.

Fulvestrant Accord contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.

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 Accord contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant Accord

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 / 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 Accord 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 a sign of anaphylactic reactions
  • 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 are :

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
  • Hemorrhoids
  • Rash
  • Allergic reactions ( hypersensitivity reactions ) 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 *
  • 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 maintaining balance ( peripheral neuropathy )

Uncommon (may affect up to 1 in 100 people)

  • Thick whitish vaginal discharge and fungal infection
  • Anaphylactic reactions
  • 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
  • * Includes side effects for which the exact effect of fulvestrant cannot be assessed due to the underlying disease.

5. How to store the Fulvestrant Accord

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

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.

Store and transport refrigerated (2 ° C ‑ 8 ° C).

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 refrigerated, 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 2 years for Fulvestrant Accord. Exposure to temperatures below 2 ° C does not damage the product, provided it is not stored below -20 ° C.

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

The healthcare staff is responsible for the correct storage, use and disposal of the Fulvestrant Accord.

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.
  • The other ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil, refined.

What the medicine looks like and contents of the pack

Fulvestrant Accord is a clear, colorless to yellow, viscous solution.

Fulvestrant Accord is supplied in a clear type I glass pre-filled syringe with a rubber stopper flask and plunger rod, with safety closure, containing 250 mg fulvestrant in 5 ml solution.

A protected needle (BD SafetyGlide®) is also provided for connection to the syringe.

Fulvestrant Accord is available in a package with two pre-filled syringes for single use.

Marketing Authorization Holder and Manufacturer

In nnehavare Authorization

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Actavis Italy SpA

Via Louis Pasteur 10

Nerviano, MI, 20014

Italy

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

UK

or

Accord Healthcare Polska Sp.z oo

ul. Lutomierska 50

95-200 Pabianice

Poland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000, Malta

or

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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