Decision

Lutetium (177Lu) vipivotide tetraxetan: Treatment protocol: Information for patients

Published 5 April 2022

This decision was withdrawn on 4 April 2023

Reason: Granting of marketing authorisation

Introduction

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines (medicines that do not have a marketing authorisation or are used outside their licence) to UK patients that have a high unmet clinical need. The medicines included in the scheme are those that are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options. Read more information about the scheme

The information below is intended for you, the patient, and is provided by the pharmaceutical company (called scientific opinion holder) that manufactures the EAMS medicine. This medicine, which does not yet have a drug licence or is used outside its licence, may also be used in combination with other medicines. Read more information about medicines licensing

This medicine can be prescribed for individual patients to meet specific needs provided they are given sufficient information about the medicine to make an informed decision. The prescribing doctor will be responsible for giving you all the information you need to make this decision and for obtaining informed consent from you prior to treatment. You will be asked to sign a form to confirm that you are providing informed consent to receiving the EAMS treatment. Read more information on consent.

The information below is provided to help you decide with the prescribing doctor on whether to use the EAMS medicine and helps explain how to use it in accordance with the pharmaceutical company’s instructions for safe and proper use. The information below may change during the time you are using the medicine if more data become available. The prescribing doctor will highlight to you any changes that you need to be aware of.

Whilst you are using this medicine, data will be collected on the use and safety profile of the medicine, to ensure that the benefits of taking the medicine continue to outweigh any potential risks. The prescribing doctor will answer all your questions during and after the treatment and will provide you with contact details that you should use in case of any events or problems.

Each patient enrolled in the scheme will continue to receive the EAMS product until the end of the treatment in line with prescribing and NHS guidance and as long as benefit is seen. In rare cases where the EAMS treatment may not be available anymore, your prescribing doctor will discuss other options with you.   ##Information for the patient

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan 1000 MBq/mL solution for injection/infusion

Read all this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What lutetium (¹⁷⁷Lu) vipivotide tetraxetan is and what it is used for

What lutetium (¹⁷⁷Lu) vipivotide tetraxetan is

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan (otherwise known as [¹⁷⁷Lu]Lu-PSMA-617) is a radiopharmaceutical product for therapy only.

What lutetium (¹⁷⁷Lu) vipivotide tetraxetan is used for

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is used to treat adults with a certain type of advanced prostate cancer (called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer [PSMA-positive mCRPC]) (otherwise known as metastatic hormone-refractory prostate cancer [mHRPC])” that has spread to other parts of the body (metastatic) and that has already been treated with other anti-cancer treatments.

How lutetium (¹⁷⁷Lu) vipivotide tetraxetan works

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan binds to a protein called PSMA (known as prostate specific membrane antigen) that is found on the surface of prostate cancer cells. Once bound, radiation is emitted from the ¹⁷⁷Lu causing prostate cancer cells to die.

Tests will be performed to see if PSMA is present on the surface of the cancer cells. Your cancer is likely to respond to treatment with lutetium (¹⁷⁷Lu) vipivotide tetraxetan if the test result is positive.

The use of lutetium (¹⁷⁷Lu) vipivotide tetraxetan involves exposure to radioactivity. Your doctors have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

If you have any questions about how lutetium (¹⁷⁷Lu) vipivotide tetraxetan works or why this medicine has been prescribed for you, ask your doctor.

What you need to know before lutetium (¹⁷⁷Lu) vipivotide tetraxetan is used

Follow all instructions given by your nuclear medicine doctor or oncologist carefully. They may differ from the general information contained in this leaflet.

Your doctor must not give you lutetium (¹⁷⁷Lu) vipivotide tetraxetan if you are allergic to lutetium (¹⁷⁷Lu) vipivotide tetraxetan or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If any of these apply to you, tell your nuclear medicine doctor or oncologist before receiving lutetium (¹⁷⁷Lu) vipivotide tetraxetan:

• If you have a low level of blood cell counts (haemoglobin, white blood cell count, absolute neutrophil count, platelet count)
• If you have or have had tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding, or frequent infections with signs such as fever, chills, sore throat or mouth ulcers
• If you have or have had kidney problems
• If you have or have had any other type of cancer or treatment for that cancer, as lutetium (¹⁷⁷Lu) vipivotide tetraxetan contributes to your overall long-term cumulative radiation exposure

Before administration of lutetium (¹⁷⁷Lu) vipivotide tetraxetan you should

• Drink plenty of water in order to urinate as often as possible during the first hours after administration

Children and adolescents

This medicine is not intended for children and adolescents. Therefore, the safety and efficacy of this medicine have not been established in this age group.

Pregnancy, breast-feeding and fertility

This medicine is not intended for females. Therefore, the safety and efficacy of lutetium (¹⁷⁷Lu) vipivotide tetraxetan have not been established in females.

Before you receive lutetium (¹⁷⁷Lu) vipivotide tetraxetan, it is important to tell your nuclear medicine doctor or oncologist if you are sexually active, this is because:

• All radiopharmaceuticals, including lutetium (¹⁷⁷Lu) vipivotide tetraxetan, have the potential to cause harm to an unborn baby.
• You should use a condom for intercourse during treatment with lutetium (¹⁷⁷Lu) vipivotide tetraxetan and for 14 weeks after your last dose.
• Lutetium (¹⁷⁷Lu) vipivotide tetraxetan may cause infertility.

You must not donate sperm for 6 months after administration of lutetium (¹⁷⁷Lu) vipivotide tetraxetan.

Driving and using machines

It is considered unlikely that lutetium (¹⁷⁷Lu) vipivotide tetraxetan will affect your ability to drive or to use machines.

Urinary incontinence and/or use of urinary catheter bags

Patients with uncontrolled urinary incontinence and/or patients that use urinary catheter bags should not participate in the lutetium (¹⁷⁷Lu) vipivotide tetraxetan EAMS study.

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan contains sodium

This medicine contains up to 88.75 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.

How lutetium (¹⁷⁷Lu) vipivotide tetraxetan is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Lutetium (¹⁷⁷Lu) vipivotide tetraxetan will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely.

The recommended dose is 7400 MBq (megabecquerel, the unit used to express radioactivity). Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is given approximately every 6 weeks for up to a total of 6 doses.

Administration of lutetium (¹⁷⁷Lu) vipivotide tetraxetan and conduct of the procedure Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is administered directly into a vein.

Due to the radiation emitted by this medicine, during the administration procedure, you should be isolated from other patients who are not receiving the same treatment. The doctor will inform you when you can leave the controlled area or the hospital.

Duration of the procedure

Your nuclear medicine doctor or oncologist will inform you about the usual duration of the procedure.

If you have questions about how long you will receive lutetium (¹⁷⁷Lu) vipivotide tetraxetan, talk to your nuclear medicine doctor or oncologist.

Treatment monitoring

Your nuclear medicine doctor will do blood tests before and during treatment to check your condition and to detect any side effects as early as possible. It is possible that based on the results, your nuclear medicine doctor or oncologist may decide to delay, modify or stop your treatment with lutetium (¹⁷⁷Lu) vipivotide tetraxetan if necessary.

After administration of lutetium (¹⁷⁷Lu) vipivotide tetraxetan, you should:

• Remain hydrated and urinate frequently in order to eliminate the product from your body
• Limit close contact (less than 1 meter) with others in your household for 2 days or with children and pregnant women for 7 days
• Sleep in a separate bedroom from others in your household for 3 days, from children for 7 days, or from pregnant women for 15 days

The nuclear medicine doctor or oncologist will inform you if you need to take any special precautions after receiving this medicine. This may include special precautions for you or your caregiver with regard to contact with children and/or pregnant women, contact with spouse and other family members, toilet/bathroom use, showering, laundry, waste disposal, emergency medical assistance, unplanned hospitalisation or travelling. Contact your nuclear medicine doctor if you have any questions.

If you have been given more lutetium (¹⁷⁷Lu) vipivotide tetraxetan than you should:

An overdose is unlikely. However, in the case of an overdose, you will receive the appropriate treatment.

If you forget to receive lutetium (¹⁷⁷Lu) vipivotide tetraxetan

If you miss an appointment for an administration, contact your nuclear medicine doctor or oncologist as soon as possible to reschedule.

Should you have any further questions on the use of lutetium (¹⁷⁷Lu) vipivotide tetraxetan, please ask the nuclear medicine doctor or oncologist who supervises the procedure.

Possible side effects

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

Some side effects could be serious

If you experience any of the following serious side effects, tell your nuclear medicine doctor or oncologist right away.

Very common: may affect more than 1 in 10 people

• tiredness, weakness, pale skin or shortness of breath (possible signs of low level of red blood cells) (anaemia)
• bleeding or bruising more easily than normal or difficulty to stop bleeding and frequent infections with signs such as fever, sore throat or mouth ulcers (possible signs of low level of white blood cells) (thrombocytopenia, leukopenia, lymphopenia)

Common: may affect up to 1 in every 10 people

• passing urine less often than usual or passing much smaller amounts of urine than usual (possible sign of kidney problems) (acute kidney injury)
• tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (possible signs of low level of blood cells) (pancytopenia)

Other possible side effects

Other side effects include the following listed below. You should also tell your nuclear medicine doctor or oncologist if you experience any of these side effects.

Very common: may affect more than 1 in 10 people

• tiredness (fatigue)
• dry mouth
• nausea
• loss of appetite
• changes in bowel movements (constipation or diarrhoea)
• vomiting
• urinary tract infection
• abdominal pain
• weight loss

Common: may affect up to 1 in every 10 people

• swollen hands, ankles or feet (peripheral oedema)
• dizziness
• headache
• disturbed sense of taste (dysguesia)
• fever (pyrexia)
• dry eye
• vertigo

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to MHRA via the Yellow Card scheme via www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine. Tell your doctor immediately if you get any side effects. This includes any possible side effects not listed in this leaflet.

How lutetium (¹⁷⁷Lu) vipivotide tetraxetan is stored

You will not have to store this medicine as you will receive this medicine in hospital. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.

The following information is intended for the specialist only.

• Keep this medicine out of the sight and reach of children
• Store below 30°C. Do not freeze
• Store in the original package to protect from ionising radiation (lead shielding)
• Do not use lutetium (¹⁷⁷Lu) vipivotide tetraxetan after the expiry date and time which are stated on the label after EXP

Contents of the pack and other information

What lutetium (¹⁷⁷Lu) vipivotide tetraxetan contains

*The active substance is lutetium (¹⁷⁷Lu) vipivotide tetraxetan. One mL of solution contains 1000 MBq lutetium (¹⁷⁷Lu) vipivotide tetraxetan at the date and time of calibration.

*The other ingredients are: acetic acid, sodium acetate, gentisic acid, sodium ascorbate, pentetic acid, water for injections (see “lutetium (¹⁷⁷Lu) vipivotide tetraxetan contains sodium” in section 2).

What lutetium (¹⁷⁷Lu) vipivotide tetraxetan looks like and contents of the pack

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is a clear, colourless to slightly yellow solution supplied in a clear colourless type 1 glass vial, closed with a bromobutyl rubber stopper and aluminum seal.

Each vial contains a volume varying from 7.5 mL to 12.5 mL of solution, corresponding to a radioactivity of 7400 MBq at the date and time of administration.

The vial is enclosed within a lead container for protective shielding.

Scientific Opinion Holder

Advanced Accelerator Applications UK & Ireland Ltd.
Edison House
223-231 Old Marylebone Road
Marylebone, London
NW1 5QT

Manufacturer

Advanced Accelerator Applications (Italy) S.R.L
Via Ribes 5
10010
Colleretto Giacosa (TO)
Italy

This protocol was revised in March 2022

Additional information

Informed Consent Form

The Early Access to Medicines Scheme will be explained to you by your doctor using the informed consent form. You will be asked to sign this form and a copy will be given to you to keep.

Patient data to be collected

Patient data collected during the scheme are mostly used for safety surveillance and cannot replace a proper clinical trial to support a marketing authorisation. These data are required by the MHRA to help verify that the patient’s condition complies with the EAMS indication and help interpret the side effects and other events occurring during and after the EAMS treatment. These data include patient’s initials. year of birth, gender, diagnosis, height and weight, previous treatments, comorbidities, concomitant medications.

Contact information

Adverse events (side effects) reporting

Patients must contact their treating physician to report any side effects, otherwise known as adverse events. Adverse events may also be reported directly to the MHRA via the Yellow card scheme at www.mhra.gov.uk/yellowcard.

Patients may also contact Novartis at uk.patientsafety@novartis.com (contact number: 0845 601 1387) to report or discuss any adverse events.

Contact details for medical information

Tel: +44 (0)20 7258 5200

Email: infomed@adacap.com