50mg solution for injection in a pre-filled syringe
fulvestrant

What Fulvestrant Mylan is and what it is used for

Fulvestrant Mylan 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 Mylan 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 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.

What you need to know before using Fulvestrant Mylan

Do not use Fulvestrant Mylan

  • 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 Mylan if any of the following apply to you:

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

Children and young people

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

Other medicines and Fulvestrant Mylan

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 and breastfeeding

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

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

Driving and using machines

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

Fulvestrant Mylan contains excipients

Fulvestrant Mylan contains 10% w / v ethanol (alcohol), ie 500 mg per 5 ml, equivalent to 25 ml beer or 10 ml wine per treatment dose (ie two syringes). The small amount of alcohol in this medicine has no noticeable effects.

Fulvestrant Mylan contains benzyl alcohol

This medicine contains benzyl alcohol 500 mg per 5 ml, which is equivalent to 100 mg/ml (10% w / v). Benzyl alcohol can cause allergic reactions.

Fulvestrant Mylan contains benzyl benzoate

This medicine contains benzyl benzoate 750 mg per 5 ml, equivalent to 150 mg / ml (15% w / v).

3. How to use Fulvestrant Mylan

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 injections ) once a month, with an additional dose of 500 mg two weeks after the initial dose.

Your doctor or nurse will give you Fulvestrant Mylan 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:

The very common  side effect is (may affect more than one 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 are (may affect up to 1 in 10)

  • 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 )

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 Mylan cannot be assessed due to the underlying disease.

5. How to store Fulvestrant Mylan

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 and syringe label after “EXP”. The expiration date is the last day of the specified month.

Store and transport cold (2 ° C – 8 ° C). Deviations outside the temperature range 2 ° C-8 ° C must be limited and a period of 28 days where the average storage temperature of the product is below 25 ° C (but above 2 ° C-8 ° C) must not be exceeded. After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported cold, 2 ° C – 8 ° C). Temperature deviations have a cumulative effect on the product quality and the time period of 28 days must not be exceeded during the entire shelf life of Fulvestrant Mylan. 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 medical staff is responsible for the correct storage, use, and disposal of Fulvestrant Mylan.

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 benzyl benzoate (see section 2 “Fulvestrant Mylan contains benzyl benzoate”), benzyl alcohol (see section 2 “Fulvestrant Mylan contains benzyl alcohol”), anhydrous ethanol (see section 2 “Fulvestrant Mylan contains 10% w / v ethanol (alcohol ) ”), And refined castor oil.

What the medicine looks like and the contents of the pack

Fulvestrant Mylan is a clear, colorless to yellow, viscous solution in a pre-filled syringe fitted with a safety closure containing 5 ml solution for injection.

Fulvestrant Mylan is available in four-pack sizes, either a pack containing 1 pre-filled glass syringe or a pack containing 2 pre-filled glass syringes or a pack containing 4 pre-filled glass syringes or a pack containing 6 pre-filled glass syringes. Protected needles (BD SafetyGlide) to attach to each syringe are also included.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

MYLAN SAS

117 Allée des Parcs

69800 SAINT PRIEST FRANCE

Manufacturer

MYLAN THEORY

Inverin

Co. Galway

IRELAND

Muhammad Nadeem

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