Talvey 40 mg/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 Talvey is and what it is used for
2. What you need to know before you are given Talvey
3. How Talvey is given
4. Possible side effects
5. How to store Talvey
6. Contents of the pack and other information

• if you are allergic to talquetamab or any of the other ingredients of this medicine (listed in section 6).

Do not use Talvey if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given Talvey.

Talk to your doctor or nurse before you are given Talvey.

Serious side effects

There are serious side effects that may occur after you start taking Talvey. You need to tell your doctor or nurse straight away if these occur, as they may require that you get immediate medical attention.

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

• signs of a condition known as ‘cytokine release syndrome’ (CRS). CRS is a serious immune reaction with symptoms such as fever, low blood pressure, chills, difficulty breathing, fatigue, headache, fast heart beat and increased level of liver enzymes in the blood.
• effects on your nervous system. Symptoms include feeling confused, feeling disoriented, feeling sleepy, feeling less alert, slow or difficulty thinking, altered thinking or decreased conciousness, confusion, difficulty speaking and understanding speech. Some of these may be signs of a serious immune reaction called ‘immune effector cell-associated neurotoxicity syndrome’ (ICANS).
• problems with the mouth, such as a loss of taste, dry mouth, difficulty swallowing and inflammation of the lining of the mouth.
• skin problems such as rash, redness and nail problems.
• feeling warm, fever, chills or shivering, sore throat or mouth ulcers may be signs of an infection.

Talvey and vaccines

Talk to your doctor or nurse before you are given Talvey if you have had a recent vaccination or are going to have a vaccination. Your immune system (the body’s natural defences) may not respond as well to vaccination when you are taking this medicine.

You should not receive live vaccines, a specific type of vaccine, from at least 4 weeks before starting your treatment with Talvey until at least 4 weeks after you have taken your last dose.

Tests and checks

Before you are given Talvey your doctor will check your blood to look at the levels of different blood cells and to test for signs of infection. Infections will be treated before you start taking this medicine.

After you have Talvey your doctor will monitor you for side effects. They will also regularly check your blood counts, as the number of blood cells and other blood components may decrease when you use this medicine.

Talvey should not be used in children or young people below 18 years of age, because the medicine has not been studied in this age group and 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.

Pregnancy and contraception

Talvey has the potential to be transmitted from the mother to the developing foetus. The effects of Talvey on the developing foetus are unknown and a risk to newborns/infants cannot be excluded.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before you are given this medicine.

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

If you could become pregnant, you must use effective contraception during treatment and for 3 months after stopping treatment with Talvey. Your doctor will check if you are pregnant before starting treatment.

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

If you have taken this medicine during pregnancy, your newborn baby should not be given any live vaccines until he or she is at least four weeks old.

Breast-feeding

It is not known if Talvey passes into breast milk. There may be a risk to breastfed newborns/infants. Ask your doctor for advice before starting this medicine. 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 3 months after stopping treatment.

Fertility

There are no data on the effect of talquetamab on fertility. Effects of talquetamab on male and female fertility have not been evaluated in animal studies

Some people may feel tired, dizzy, or confused while taking Talvey. Do not drive, use tools or machines from recieving your first dose until at least 48 hours after receiving your first treatment dose of Talvey or as instructed by your doctor.

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

Talvey will be given to you under supervision by a doctor experienced in treating patients with multiple myeloma. Your doctor will decide how much Talvey you are given. The dose of Talvey will depend on your body weight.

Talvey is given either once a week or once every 2 weeks, depending on the dose, as follows:

0.4 mg/kg once a week:

• For your first dose, you will receive 0.01 mg per kilogram of bodyweight.
• For your second dose, which will be given 2-4 days later, you will receive 0.06 mg per kilogram of bodyweight.
• For your third dose, you will receive a ‘Treatment dose’ of 0.4 mg per kilogram of bodyweight 2-4 days after your second dose.
• After your third dose, you will then receive a ‘Treatment dose’ once a week thereafter.
• Treatment will continue for as long as you benefit from having Talvey.

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 each of the first three doses in case you have side effects.

If you experience side effects after any of your first two doses, your doctor may decide to wait up to 7 days before giving you your next dose.

0.8 mg/kg once every 2 weeks:

• For your first dose, you will receive 0.01 mg for each kilogram of bodyweight.
• For your second dose, which will be given 2-4 days later, you will receive 0.06 mg per kilogram of bodyweight.
• For your third dose, which will be given 2-4 days later, you will receive 0.4 mg per kilogram of bodyweight
• For your fourth dose, you will then receive a ‘Treatment dose’ of 0.8 mg per kilogram of bodyweight 2-4 days after your third dose.
• After your fourth dose, you will then receive a ‘Treatment dose’ once every 2 weeks thereafter.
• Treatment will continue for as long as you benefit from having Talvey.

Your doctor will monitor you for side effects after each of your first four doses. They will do this for 2 days after each dose. You should stay close to a healthcare facility after each of the first four doses in case you have side effects.

If you experience side effects after any of your first three doses, your doctor may decide to wait up to 7 days before giving you your next dose.

The decision to use either the 0.4 mg/kg once weekly or 0.8 mg/kg every two weeks should be made in consultation with your doctor.

Talvey 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.

Medicines given during treatment with Talvey

Before the first three doses (if you are given 0.4 mg/kg bodyweight) or the first four doses (if you are given 0.8 mg/kg bodyweight) of Talvey, you will be given medicines which help to lower the chance of side effects. These may include:

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

You may also be given these medicines for when you take later doses of Talvey 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. 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 to make sure your treatment works. 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):

• Immune effector cell-associated neurotoxicity syndrome (ICANS), a serious immune reaction that may affect your nervous system. Some of the symptoms are:
  • feeling confused
  • being less alert or aware
  • feeling disoriented
  • feeling sleepy
  • low energy
  • slow and difficulty thinking.
• Cytokine release syndrome (CRS), a serious immune reaction. CRS may cause symptoms such as:
  • fever
  • low blood pressure
  • chills
  • low level of oxygen in the blood
  • headache
  • fast heart beat
  • increased level of liver enzymes in the blood
• low levels of neutrophils (neutropenia), a type of white blood cell that helps fight infection
• low number of blood platelets (thrombocytopenia), which help blood to clot

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):

• nail problems
• pain in the muscles and bones (musculoskeletal pain)
• low number of red blood cells (anaemia)
• feeling tired
• chills
• weight loss
• abnormally dry skin or membranes such as the mouth and eyes (xerosis)
• low number of lymphocytes (lymphopenia), a type of white blood cell
• problem being able to produce or control movement (motor dysfunction)
• feeling dizzy
• nerve damage that may cause tingling, numbness, pain or loss of pain sensation (sensory neuropathy)
• damage or disease affecting brain function (encephalopathy)
• diarrhoea
• nausea
• constipation
• stomach pain
• vomiting
• infected nose, sinuses or throat (upper respiratory tract infection)
• itching (pruritus)
• decreased appetite
• pain
• low number of white blood cells (leukopenia)
• low levels of potassium in the blood (hypokalaemia)
• low levels of phosphate in the blood (hypophosphataemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• low level of immunoglobulins, a type of antibody in the blood (hypogammaglobulinaemia), which may make infections more likely
• swelling caused by fluid build up in the body (oedema)
• irritation or pain where the injection is given
• increased level of liver enzymes in the blood
• COVID-19 infection
• blood tests may show it takes longer for blood to clot (fibrinogen decreased, INR increased and PTT prolongation)
• bacterial infection
• mouth pain
• fungal infection
• fever (pyrexia)
• headache
• shortness of breath (dyspnoea)
• cough
• problems with the mouth and swallowing, such as change in sense of taste (dysgeusia), dry mouth, difficulty swallowing (dysphagia), and inflammation of the lining of the mouth (stomatitis)
• skin problems, including skin rash

Common (may affect up to 1 in 10 people)

• hair loss
• bleeding, which can be severe (haemorrhage)
• infection of the lungs (pneumonia)
• viral infection
• blood poisoning (sepsis)
• low number of a type of white blood cell (neutrophils), with a fever
• redness, swelling, tingling or burning sensation with cracking of the skin on the palms of hands and/or soles of feet (hand-foot syndrome)

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 the Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ 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 talquetamab. Talvey comes in two different strengths:
  • 2 mg/mL – one 1.5 mL vial contains 3 mg talquetamab
  • 40 mg/mL – one 1 mL vial contains 40 mg talquetamab
• The other ingredients are EDTA disodium salt dihydrate (E385), glacial acetic acid (E260), polysorbate 20 (E432), sodium acetate trihydrate, sucrose, water for injection (see “Talvey contains sodium” in section 2).

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

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