250 mg solution for injection in a pre-filled syringe
fulvestrant
1. What Fulvestrant Teva is and what it is used for
Fulvestrant Teva 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 Teva 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 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 Teva 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.
What you need to know before using Fulvestrant Teva
DO NOT use Fulvestrant Teva
- if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- if you have severe liver problems
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant Teva 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 problems (see section “Fulvestrant Teva contains 96% ethanol (alcohol)”).
The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical internal disease.
Children and young people
Fulvestrant Teva is NOT intended for children and adolescents under 18 years of age.
Other medicines and Fulvestrant Teva
Tell your doctor, pharmacist, or nurse 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 Teva if you are pregnant. If you could become pregnant, use an effective contraceptive when you are being treated with Fulvestrant Teva.
You must NOT breast-feed while being treated with Fulvestrant Teva.
Driving and using machines
Fulvestrant Teva is unlikely to affect your ability to drive or use machines, but if you feel tired after treatment, DO NOT drive or use 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 Teva contains ethanol and benzyl alcohol
Fulvestrant Teva contains 96% ethanol (alcohol), equivalent to about 1,000 mg per dose, to be equated with 20 ml of beer or 8 ml of wine per dose.
Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.
Fulvestrant Teva contains benzyl alcohol, the amount of benzyl alcohol per dose is 500 mg per 5 ml (100 mg per 1 ml), which may cause allergic reactions.
3. How to use Fulvestrant Teva
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
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 Teva 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) *
- liver inflammation ( hepatitis )
- liver failure.
Tell your doctor, pharmacist, or nurse if you get any of the following side effects:
Side effects reported for people treated with Fulvestrant Teva as monotherapy:
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 users
- 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 Teva cannot be assessed due to the underlying disease.
Side effects reported for people treated with Fulvestrant Teva as combination therapy with palbociclib:
Very common: may affect more than one in 10 users
- reduction in neutrophils ( neutropenia )
- decrease in white blood cell count ( leukopenia )
- infection is
- fatigue
- nausea
- reduction of red blood cells ( anemia )
- inflammation or sores in the mouth
- diarrhea
- decreased platelet count ( thrombocytopenia )
- vomiting
- hair loss
- rash
- loss of appetite
- fever
Common: may affect up to 1 in 10 users
- weakness
- the increased amount of liver enzyme
- loss of taste
- nosebleeds
- excessively wet eyes
- dry skin
- dimsyn
- dry eyes
Uncommon: may affect up to 1 in 100 people
- fever with other signs of infection (febrile neutropenia )
5. How to store Fulvestrant Teva
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.
Do not use this medicine if you see particles or discoloration before administration.
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 25 ° 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 cold, 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 Teva. 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 Fulvestrant Teva.
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 contains 250 mg fulvestrant. Each ml of solution contains 50 mg of fulvestrant.
- The other ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate, and castor oil, refined.
What the medicine looks like and the contents of the pack
Fulvestrant Teva is a clear, colorless to yellow, viscous solution in a pre-filled syringe fitted with a Luer-Lock connector, containing 5 ml solution for injection. Two syringes must be administered to reach the recommended monthly dose of 500 mg.
Fulvestrant Teva is available in two pack sizes,
- 1 pack containing 1 pre-filled syringe and 1 protected needle to connect the syringe.
- 1 pack containing 2 pre-filled syringes and 2 protected needles to connect to each syringe is also included.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Teva AB
Box 1070
251 10 Helsingborg
Manufacturer
PLIVA Hrvatska doo (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25,
Zagreb 10000
Croatia
This medicinal product is authorized under the European Economic Area under the names:
| Belgium: | Fulvestrant Teva 250 mg solution for injection / solution injectable / Injektionslösung |
| Bulgaria: | Fully Western Teva 250mg Coated Injection Mouthpieces |
| Denmark: | Fulvestrant Teva |
| Estonia: | Fulvestrant Teva |
| Finland: | Fulvestrant ratiopharm 250 mg injection, liuos, esitäytetty ruisku |
| France: | Fulvestrant Teva 250 mg solution injectable in pre-sample Zeringue |
| Ireland: | Fulvestrant Teva 250 mg Solution for Injection in Pre-filled Syringe |
| Iceland: | Fulvestrant Teva 250 mg solution for injection in a pre-filled syringe |
| Italy: | Fulvestrant Teva |
| Croatia: | Fulvestrant Pliva 250 mg utopian for injection in nasal congestion |
| Latvia: | Fulvestrant Teva 250 mg weight loss pills |
| Lithuania: | Fulvestrant Teva 250mg Injection Tyroline Treatment |
| Luxembourg: | Fulvestrant Teva 250 mg solution for injection / solution injectable / Injektionslösung |
| Netherlands: | Fulvestrant Teva 250 mg, pre-filled syringe solution for injection |
| Poland: | Fulvestrant Teva |
| Portugal: | Fulvestrant Teva |
| Romania: | Fulvestrant Teva 250 mg injectable solution in premature ejaculation |
| Slovakia: | Fulvestrant Teva |
| Slovenia: | Fulvestrant Teva 250 mg injection for injection in Naples injection syringe |
| Spain: | Fulvestrant Teva 250mg injectable solution in EFG pre-loaded ring |
| UK: | Fulvestrant Teva 250mg solution for injection into the pre-filled syringe |
| Germany: | Fulvestrant Teva 250 mg solution for injection in a syringe |
| Hungary: | Fulvestrant Teva 250 mg / 5 ml oldatos injekció előretöltött fecskendőben |
| Austria: | Fulvestrant ratiopharm 250 mg solution for injection in a ready-made syringe |