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

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

Fulvestrant Glenmark 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 Glenmark 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 Glenmark 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 Glenmark 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 Glenmark

Do not use Fulvestrant Glenmark

  • 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

If any of the following applies to you, talk to your doctor, pharmacist, or nurse before using Fulvestrant Glenmark:

  • 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 Glenmark is not intended for use in children and adolescents below 18 years.

Other medicines and Fulvestrant Glenmark

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 Glenmark if you are pregnant. If you can get pregnant, you should use an effective contraceptive during treatment with Fulvestrant Glenmark and for 2 years after the last dose.

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

Driving and using machines

Fulvestrant Glenmark 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 Glenmark contains excipients

Fulvestrant Glenmark contains 500 mg alcohol ( ethanol )  per injection equivalent to 100 mg / ml (10% w / v). The amount in each injection of this medicine corresponds to 13 ml of beer or 5 ml of wine.

The amount of alcohol in this medicine is unlikely to have any effects on adults and adolescents.

The alcohol in this medicine may affect the effects of other medicines. Tell your doctor or pharmacist if you are taking any other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are or have been addicted to alcohol, consult your doctor or pharmacist before using this medicine.

Fulvestrant Glenmark contains benzyl alcohol

This medicine contains 500 mg of benzyl alcohol per pre-filled syringe, equivalent to 100 mg/ml. Benzyl alcohol can cause allergic reactions.

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

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

3. How to use Fulvestrant Glenmark

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 injections of 250 mg / 5 ml) once a month, with an additional dose of 500 mg two weeks after the first dose.

Your doctor or nurse will give you Fulvestrant Glenmark 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.

If you use more Fulvestrant Glenmark then you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

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 side effect are (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 Glenmark can not be assessed on

due to the underlying disease.

5. How to store Fulvestrant Glenmark

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 on the 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. 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 should return immediately to the recommended storage conditions (stored and transported cold, 2 ° C-8 ° C) Temperature deviations have a cumulative effect on product quality and the 28-day time period must not be exceeded during the entire 2-year shelf life of Fulvestrant Glenmark. ° C does not damage the product, provided it is not stored below -20 ° C.

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

Healthcare professionals are responsible for the proper storage, use and disposal of Fulvestrant Glenmark.

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 percent), benzyl alcohol (E 1519), benzyl benzoate and castor oil (refined).

What the medicine looks like and contents of the pack

Fulvestrant Glenmark is a clear, colorless to yellow, viscous solution in a pre-filled syringe containing 5 ml solution for injection . Two syringes must be administered to reach the recommended monthly dose of 500 mg.

Fulvestrant Glenmark is available in three pack sizes, one pack containing 1 pre-filled syringe , one pack containing 2 pre-filled syringes and one pack containing 6 pre-filled syringes. 1, 2 or 6 protected needles (BD SafetyGlide) to connect to each syringe are also included.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Laboralios Farmalán, SA

Calle La Vallina s / n, Edificio 2,

Polígono Industrial Navatejera,

24193, Villaquilambre, Leon,

Muhammad Nadeem

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