Lutetium (177Lu) vipivotide tetraxetan - Intravenous

Lutetium (177Lu) vipivotide tetraxetan is used together with other medicines to treat a specific cancer of the prostate that has spread to other parts of the body.

It is used for those who have already been treated with other medicines and whose cancer cells have a protein on their surface called prostate-specific membrane antigen.

Lutetium (177Lu) vipivotide tetraxetan is to be given intravenously (into the vein). It is delivered directly into the bloodstream via the blood vessel.

Your doctor or nurse will administer the injection for you.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the course of treatment depending on your response to the medication.

Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Lutetium (177Lu) vipivotide tetraxetan.

If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.

Inform your doctor if you have mild to moderate kidney disease.

Avoid sexual activity for 7 days after administration of Lutetium (177Lu) vipivotide tetraxetan. Men should not father a child while being treated with this medicine. Men with female partners who can become pregnant should use a condom during sexual intercourse throughout treatment and for 14 weeks after the last dose.

This medicine is not indicated for use in women.

Drink plenty of water and pass urine as often as possible after administration of this medicine.

Lutetium (177Lu) vipivotide tetraxetan is radioactive, follow the instructions below to minimise radiation exposure to others unless otherwise instructed by your doctor:

• Limit close contact (less than 1 metre) with others in your household for 2 days and with pregnant women and children for 7 days.
• Sleep in a separate bedroom from others in your household for 3 days, from pregnant women for 15 days and children for 7 days.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Routine tests (e.g. liver and kidney function, complete blood count) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs or symptoms of blood problems and infection may also be needed.

Lutetium (177Lu) vipivotide tetraxetan may cause any of the following side effects: headache, dizziness, nausea, vomiting, diarrhoea, constipation, change in taste, dry mouth, stomach pain, dry eye, dizziness with sensations of spinning, loss of appetite, tiredness, and weight loss.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience pain or difficulty in passing urine, change in how much urine is passed, or blood in the urine.

This medicine will cause the level of your red blood cells, white blood cells and platelets to drop.

Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.

White blood cells help your body to fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Alert your doctor if you have a fever, cough, or flu that does not go away.

Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Alert your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in a cool, dry place away from the reach of children. Do not allow to freeze.

Keep in the original container to protect from ionising radiation.

Medicines must not be used past the expiry date.

As Lutetium (177Lu) vipivotide tetraxetan is a radiopharmaceutical, national guidelines must be followed when receiving, handling, and disposing this medicine.