Ambiful contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.

Ambiful 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 to treat women with a type of breast cancer called hormone receptor- positive, human epidermal growth factor receptor 2-negative breast cancer, that 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 medicine called a luteinizing hormone releasing hormone (LHRH) agonist.

When Ambiful is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please ask your doctor.

1. Do not use Ambiful:

   – if you are allergic to fulvestrant or to 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 precautions

   Talk to your doctor, pharmacist or nurse before using Ambiful if any of these apply to you: – kidney or liver problems
   – low numbers of platelets (which help blood clotting) or bleeding disorders
   – previous problems with blood clots

   – osteoporosis (loss of bone density) – alcoholism

   Children and adolescents

   Ambiful is not indicated in children and adolescents under 18 years.

   Other medicines and Ambiful

   Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

   Pregnancy and breast-feeding

   You must not use Ambiful if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with Ambiful.

   You must not breast-feed while on treatment with Ambiful.

   Driving and using machines

   Ambiful is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment do not drive or use machines.

   Ambiful contains ethanol

   Ambiful contains 10 vol % ethanol (alcohol), i.e. up to 500 mg per syringe, equivalent to 10 ml beer or 4 ml wine per syringe.
   Harmful for those suffering from alcoholism.
   To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

   Ambiful contains benzyl alcohol

   Ambiful contains 500 mg benzyl alcohol in each syringe which is equivalent to 100 mg/ml.
   Benzyl alcohol may cause allergic reactions. Increased risk in young children.
   Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

   Ambiful contains benzyl benzoate

   Ambiful contains 750 mg benzyl benzoate in each syringe which is equivalent to 150 mg/ml.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month with an additional 500 mg dose given 2 weeks after the initial dose.

Your doctor will give you Ambiful as a slow intramuscular injection, one into each of your buttocks. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

1. Like all medicines, this medicine can cause side effects, although not everybody gets them.

   You may need immediate medical treatment if you experience any of the following side effects:

   • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that 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 notice any of the following side effects:

     Very common side effects (may affect more than 1 in 10 people) • Injection site reactions, such as pain and/or inflammation
     • Abnormal levels of liver enzymes (in blood tests) *
     • Nausea (feeling sick)

     • Weakness, tiredness*

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 labels after EXP. The expiry date refers to the last day of that month.

Store below 25 °C. Store the pre-filled syringe in the original package in order to protect from light.

Your healthcare professional will be responsible for the correct storage, use and disposal of Ambiful.

This medicine may pose a risk to the aquatic environment.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.