Frexivo ® 250 mg Solution

FREXIVO is used to treat breast cancer in postmenopausal women. FREXIVO is a medicine that stops some of the actions of oestrogen (female sex hormone) within the body, which has an effect on the growth of breast cancer.

Do not use FREXIVO

• If you are hypersensitive (allergic) to fulvestrant or any of the other ingredients of FREXIVO (listed in section 6).
• If you have severe liver problems.
• If you are pregnant or breastfeeding an infant
• FREXIVO should not be given to children or men.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you have any problems with your liver or kidneys.
• If you have been told you have a low blood platelet count, a bleeding disorder or if you use anticoagulants (medicine to prevent blood clots).
• If you have osteoporosis (loss of bone density)
• If you have ever been dependent on alcohol

Hypersensitivity (allergic) reactions:

Hypersensitivity (allergy), including swelling of the face, lips, tongue and/or throat (angioedema) and itchy rash, weals and swelling of the skin (urticaria) has been commonly reported and can be serious. If you have any of these symptoms, you may have had a serious allergic reaction to FREXIVO and may need urgent medical attention or hospitalisation. FREXIVO contains alcohol which may cause allergic reactions.

Other medicines and FREXIVO

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy and breastfeeding

Do not receive FREXIVO if you are pregnant or breastfeeding your infant.

If you can become pregnant, you should use effective contraception while you are being treated with FREXIVO and for 2 years after your last dose

If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or health care professional for advice.

Driving and using machines

FREXIVO is not expected to affect your ability to drive or use machines. However, some patients may occasionally feel tired. If this happens to you, ask your doctor, pharmacist or other health care professional for advice.

FREXIVO contains FREXIVO contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per Injection. FREXIVO contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml. FREXIVO contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.

Your doctor or nurse will give you the FREXIVO injection. The usual dose is 2 injections given once a month, with an additional 2 injections given two weeks after the initial dose, but your doctor decides the exact dose. FREXIVO will be slowly injected into the muscle of each of your buttocks.

If you take more FREXIVO than you should

Since a health care provider will administer FREXIVO, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

FREXIVO can have side effects. Not all side effects reported for FREXIVO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FREXIVO, please consult your health care provider for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity is a common side effect, and can be serious.
• Hypersensitivity (allergy) can include swelling of the face, lips, tongue and/or throat (angioedema) with difficult breathing and itchy rash, weals and swelling of the skin (urticaria). If you have any of these symptoms, you may have had a serious allergic reaction to FREXIVO. You may need urgent medical attention or hospitalisation.

Tell your doctor if you experience any of the following side effects:

Frequent:

• Injection site reactions, such as pain and/or inflammation.
• Weakness
• Nausea
• Joint and musculoskeletal pain
• Hot flushes
• Headache
• Gastro - intestinal symptoms (symptoms from the stomach or the bowels), such as, vomiting, diarrhoea or loss of appetite
• Skin rash
• Urinary tract infections (bladder infections)
• Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes), liver pain or liver swelling.

The following side effects can also occur with FREXIVO, and they are seen when a blood test is taken:

Frequent:

• Increased level of bilirubin (yellow pigmented chemical produced by the liver).
• Decreased levels of platelets (thrombocytopenia).

Less frequent:

• Increased levels of enzymes produced in the liver (called AST, ALT, ALP, and Gamma GT).

If you notice any side effects not mentioned in this leaflet, please inform your doctor, pharmacist or other health care professional.

Reporting of side effects

If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects you can help provide more information on the safety of FREXIVO.

The injections will normally be stored for you by your doctor or the hospital. The staff are responsible for the correct storage, use and disposal of FREXIVO. Store between 2 °C and 8 °C (in a refrigerator). Do not freeze. Keep the injections in the original pack and do not break the seal, in order to protect from light. The injections should not be used after the expiry date on the pack. Store all medicines out of reach of children.