250 mg solution for injection, pre-filled syringe
fulvestrant
1. What Fulvestrant SUN is and what it is used for
Fulvestrant SUN 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 SUN 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 SUN 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 SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask doctors, pharmacists, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Fulvestrant SUN
Do not use Fulvestrant SUN
– 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
– if you have severe liver problems.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant SUN 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 SUN is not intended for use in children and adolescents below 18 years.
Other medicines and Fulvestrant SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor about
- your use of anticoagulants (medicines that prevent blood clots).
Pregnancy, breastfeeding, and fertility
You must not use Fulvestrant SUN if you are pregnant. If you can get pregnant, use an effective contraceptive when you are being treated with Fulvestrant SUN.
You must not breast-feed while being treated with Fulvestrant SUN.
Driving and using machines
Fulvestrant SUN 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 SUN contains excipients
Fulvestrant SUN contains 10% w / v ethanol (alcohol), ie up to 1 g per dose, equivalent to 20 ml beer, or 8 ml wine per dose. Harmful to those who suffer from alcoholism.
Attention should be paid to pregnant or lactating women and high-risk groups such as patients with liver disease or epilepsy.
Fulvestrant SUN contains castor oil, which can cause severe allergic reactions.
Fulvestrant SUN contains benzyl alcohol
This medicine contains 1 g of benzyl alcohol per dose, equivalent to 100 mg/ml. Benzyl alcohol can cause allergic reactions.
If you are pregnant or breast-feeding or have impaired liver or kidney function, consult 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 ).
3. How to use Fulvestrant SUN
Your doctor or nurse will give you Fulvestrant SUN as a slow intramuscular injection, one in each buttock.
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.
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.
Serious side effects are
If you get any of the following side effects, tell your doctor immediately :
- allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat (very common side effect ) which may be a sign of anaphylactic reactions
- thromboembolism (increased risk of blood clots) * (common side effect ). Symptoms may include pain, deep pain and swelling in the affected area (especially in one leg), difficulty breathing, and chest pain (if a blood clot is transported to the lungs)
- liver inflammation ( hepatitis ) (less common side effect ). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching, or chills
- liver failure (less common side effect ). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes).
Other side effects ar
Tell your doctor, pharmacist, or nurse if you get any of the following side effects:
Very common side effects (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.
Common side effects (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)
- 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 side effects (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
- numbness, tingling, and pain
- anaphylactic reactions.
* Includes side effects for which the exact effect of Fulvestant SUN cannot be assessed due to the underlying disease.
Reporting of side effects ar
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 via
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
By reporting side effects, you can help increase drug safety information.
5. How to store Fulvestrant SUN
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 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 o C and not exceeding a period of 28 days during which
the average storage temperature for 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 the product quality and the time period of 28 days must not be exceeded during the entire shelf life of Fulvestrant SUN. 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 SUN.
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 (E1519), benzyl benzoate, and castor oil (refined).
What the medicine looks like and the contents of the pack
Fulvestrant SUN is a clear, colorless to yellow, viscous solution in a pre-filled syringe fitted with a safety closure containing 5 ml solution for injection. Two syringes must be administered to reach the recommended monthly dose of 500 mg.
Fulvestrant SUN is available in four-pack sizes, consisting of packs containing 1, 2, 4, or 6 pre-filled syringes. One, 2, 4, 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
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
This medicinal product is authorized under the European Economic Area under the names:
Germany Fulvestrant SUN
France Fulvestrant SUN
Italy Fulvestrant SUN
Netherlands Fulvestrant SUN
Poland Fulvestrant SUN
Romania Fulvestrant SUN
Spain Fulvestrant SUN
United Kingdom Fulvestrant SUN