TECVAYLI 90mg/ml solution for injection

• 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.

1. What TECVAYLI is and what it is used for
2. What you need to know before you are given TECVAYLI
3. How TECVAYLI is given
4. Possible side effects
5. How to store TECVAYLI
6. Contents of the pack and other information

TECVAYLI is an antibody, a type of protein which has been designed to recognise and attach to specific targets in your body. TECVAYLI targets B cell maturation antigen (BCMA), which is found on multiple myeloma cancer cells, and cluster of differentiation 3 (CD3), which is found on so-called T cells of your immune system. This medicine works by attaching to these cells and bringing them together, so that your immune system can destroy the multiple myeloma cancer cells.

Talk to your doctor or nurse before you are given TECVAYLI if you

• have had a stroke or seizure within the past 6 months.
• have ever had or might now have a hepatitis B infection. This is because TECVAYLI could cause hepatitis B virus to become active again. Your doctor will check you for signs of this infection before, during and for some time after treatment with TECVAYLI. Tell your doctor or nurse if you get worsening tiredness, or yellowing of your skin or white part of your eyes.

At any time during or after your treatment, tell your doctor or nurse immediately if you

• notice any new or worsening symptoms of Progressive Multifocal Leukoencephalopathy (PML). PML is a serious and potentially fatal brain infection. Symptoms may include, but are not limited to, blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.

Talk to your doctor or nurse before you are given TECVAYLI if you have had a recent vaccination or are going to have a vaccination.

You should not receive live vaccines from four weeks before until four weeks after you are treated with TECVAYLI.

Before you are given TECVAYLI, your doctor will check your blood counts for signs of infection. If you have any infection, it will be treated before you start TECVAYLI. Your doctor will also check if you are pregnant or breast-feeding.

During treatment with TECVAYLI, your doctor will monitor you for side effects. Your doctor will regularly check your blood counts, as the number of blood cells and other blood components may decrease.

Look out for serious side effects.

Tell your doctor or nurse right away if you experience any of the following:

• Signs of a condition known as ‘cytokine release syndrome’ (CRS). Cytokine release syndrome is a serious immune reaction with symptoms such as fever, chills, nausea, headache, fast heartbeat, feeling dizzy, and difficulty breathing.
• Effects on your nervous system. Symptoms include feeling confused, feeling less alert, sleepy, or having difficulty writing and/or speaking. Some of these may be signs of a serious immune reaction called ‘immune effector cell-associated neurotoxicity syndrome’ (ICANS).
• Signs and symptoms of an infection.

Tell your doctor or nurse if you notice any signs of the above.

Do not give TECVAYLI to children or young people below 18 years of age, because it is not known how this medicine will affect them.

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

This includes medicines you can get without a prescription and herbal medicines.

It is not known if TECVAYLI affects an unborn baby or if it passes into breast milk.

Pregnancy-information for women

Tell your doctor or nurse before you are given TECVAYLI if you are pregnant, think you might be pregnant or are planning to have a baby.

If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.

Pregnancy-information for men

If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away.

Contraception – information for women who could become pregnant

If you could become pregnant, you must use effective contraception during treatment and for 5 months after stopping treatment with TECVAYLI.

Contraception – information for men

If your partner could become pregnant, you must use effective contraception during treatment and for 3 months after stopping treatment with TECVAYLI.

Breast-feeding

You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby. If you and your doctor decide to stop taking this medicine, you should not breast-feed for 5 months after stopping treatment.

Some people may feel tired, dizzy, or confused while taking TECVAYLI. Do not drive, use tools, operate heavy machinery, or do things that could pose a danger to yourself until at least 48 hours after receiving your third dose of TECVAYLI, or as instructed by your doctor.

TECVAYLI contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Your doctor will determine your dose of TECVAYLI. The dose will depend on your body weight. The first two doses will be lower.

TECVAYLI is given as follows:

• You will receive 0.06 mg for each kilogram of bodyweight for your first dose.
• You will receive 0.3 mg per kilogram of bodyweight as your second dose 2-7 days later.
• You will then receive a ‘Maintenance dose’ of 1.5 mg per kilogram of bodyweight 2-7 days after your second dose.
• You will then continue receiving a ‘Maintenance dose’ once a week as long as you are getting benefit from TECVAYLI.

If you are continuing to receive benefit from TECVAYLI after 6 months, your doctor may decide that you will receive a ‘Maintenance dose’ every two weeks.

Your doctor will monitor you for side effects after each of your first three doses. They will do this for 2 days after each dose.

You should stay close to a healthcare facility after the first three doses in case you have side effects.

TECVAYLI will be given to you by a doctor or nurse as an injection under your skin (‘subcutaneous’ injection). It is given in the stomach area (abdomen) or thigh.

You will be given medicines 1-3 hours before each of your first three doses of TECVAYLI, which help to lower the chance of side effects, such as cytokine release syndrome. These may include:

• medicines to reduce the risk of an allergic reaction (antihistamines)
• medicines to reduce the risk of inflammation (corticosteroids)
• medicines to reduce the risk of fever (such as paracetamol)

You may also be given these medicines for later doses of TECVAYLI based on any symptoms you have.

You may also be given additional medicines based on any symptoms you experience or your medical history.

This medicine will be given by your doctor or nurse, and it is unlikely that you will receive too much. In the event that you are given too much (an overdose), your doctor will check you for side effects.

It is very important to go to all your appointments. If you miss an appointment, make another one as soon as possible.

Get medical help straight away if you get any of the following serious side effects, which may be severe and can be fatal.

Very common (may affect more than 1 in 10 people):

• serious immune reaction (‘cytokine release syndrome’) that may cause fever, chills, nausea, headache, fast heart beat, feeling dizzy, and difficulty breathing
• low level of antibodies called ‘immunoglobulins’ in the blood (hypogammaglobulinaemia), which may make infections more likely
• low levels of a type of white blood cells (neutropenia)
• infection, which may include fever, chills, shivering, cough, shortness of breath, rapid breathing and rapid pulse

Common (may affect up to 1 in 10 people):

• Effects on your nervous system. These may be signs of a serious immune reaction called ‘immune effector cell-associated neurotoxicity syndrome’ (ICANS). Some of the symptoms are:
  • feeling confused
  • feeling less alert
  • having difficulty writing
  • having difficulty speaking
  • sleepiness
  • loss of ability to carry out skilled movement and gestures (despite having the physical ability and desire to perform them)

Uncommon (may affect up to 1 in 100 people):

• A serious and potentially fatal brain infection called Progressive Multifocal Leukoencephalopathy (PML). Some of the symptoms are:
  • blurred, loss of or double vision
  • difficulty speaking
  • weakness in an arm or a leg
  • a change in the way you walk or problems with your balance
  • persistent numbness
  • decreased sensation or loss of sensation
  • memory loss or confusion

Tell your doctor right away if you notice any of the above-listed serious side effects.

Other side effects are listed below. Tell your doctor or nurse if you get any of these side effects.

Very common (may affect more than 1 in 10 people):

• lung infection (pneumonia)
• COVID-19 infection caused by a virus called coronavirus (SARS-CoV-2)
• infected nose, sinuses or throat (upper respiratory tract infection)
• urinary tract infection
• low levels of red blood cells (anaemia)
• low levels of blood platelets (cells that help blood to clot; thrombocytopaenia)
• low number of white blood cells (leukopenia)
• low levels of a type of white blood cells (lymphopenia)
• low level of ‘phosphate’, ‘magnesium’ or ‘potassium’ in the blood (hypophosphataemia, hypomagnesaemia or hypokalaemia)
• increased level of ‘calcium’ (hypercalcaemia)
• increased ‘alkaline phosphatase’ in the blood
• decreased appetite
• feeling sick (nausea), diarrhoea, constipation, vomiting, stomach pain (abdominal pain)
• headache
• nerve damage that may cause tingling, numbness, pain or loss of pain sensation
• muscle spasms
• high blood pressure (hypertension)
• bleeding, which can be severe (haemorrhage)
• low blood pressure (hypotension)
• cough
• being short of breath (dyspnoea)
• fever
• feeling very tired
• pain or muscle aches
• swollen hands, ankles or feet (oedema)
• skin reactions at or near the injection site, including redness of the skin, itching, swelling, pain, bruising, rash, bleeding

Common (may affect up to 1 in 10 people):

• severe infection throughout the body (sepsis)
• skin infection causing redness (cellulitis)
• low number of a type of white blood cell with a fever (febrile neutropenia)
• low levels of ‘fibrinogen,’ a type of protein in the blood, making it more difficult to form clots
• change in brain function (encephalopathy)
• low level of ‘calcium’ or ‘sodium’ in the blood (hypocalcaemia or hyponatraemia)
• high level of ‘potassium’ in the blood (hyperkalaemia)
• low level of ‘albumin’ in the blood (hypoalbuminaemia)
• low level of sugar in the blood (hypoglycaemia)
• low level of oxygen in the blood (hypoxia)
• increased level of ‘gamma-glutamyltransferase’ in the blood
• increased level of liver enzymes 'transaminases' in the blood
• increased level of ‘creatinine’ in the blood
• increased level of ‘amylase’ in the blood (hyperamylasaemia)
• increased level of ‘lipase’ in the blood (hyperlipasaemia)
• blood tests may show it takes longer for blood to clot (INR increased and PTT prolongation)

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is teclistamab. TECVAYLI comes in two different strengths:
  • 10 mg/mL - one 3 mL vial contains 30 mg teclistamab
  • 90 mg/mL - one 1.7 mL vial contains 153 mg teclistamab
• The other ingredients are EDTA disodium salt dihydrate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, water for injections (see “TECVAYLI contains sodium” in section 2).

TECVAYLI is a solution for injection (injection) and is a colourless to light yellow liquid.

TECVAYLI is supplied as a carton pack containing 1 glass vial.