Lunsumio (mosunetuzumab) for Follicular Lymphoma

Lunsumio is used to treat adults who have a blood cancer called follicular lymphoma (FL). Lunsumio is given to patients who have tried at least two previous treatments for FL when either cancer has not responded to them, or it has come back again.

Lunsumio contains the active substance, mosunetuzumab, which is a monoclonal antibody, a type of protein that attaches to specific targets in the body. In this case, mosunetuzumab attaches to a target substance found on B cells, including the cancerous B cells, and another target found on ‘T cells, a different type of white blood cell. T cells are another part of the body’s defenses that can destroy invading cells. By attaching the two cells together like a bridge, Lunsumio encourages the T cells to destroy the cancerous B cells. This helps control the FL and prevent its spread.

You must not be given Lunsumio if you are allergic to mosunetuzumab or any of the other ingredients of this medicine.

Talk to your doctor or nurse before you are given Lunsumio if any of the following apply to you:

• you have ever had heart, lung, or kidney problems

• you have an infection or had an infection, or if it keeps coming back

• if you received a vaccine or planning to receive a vaccine.

• Are pregnant, or planning to become pregnant. Lunsumio may affect your unborn baby.

• Are breastfeeding or planning to breastfeed. You must not breastfeed during and for at least 3 months after your last treatment. It is not known if Lunsumio can pass into your breast milk.

Lunsumio will be given to you by a doctor experienced in giving such treatments.

• It is given into a vein, as a drip.

• It is given over 4 hours during the first cycle. Each cycle is 21 days and in the first cycle, you will be given the 4-hour infusion on day 1, day 8, and day 15.

• If side effects are not severe, the dose may be given over 2 hours during the following cycles.

Lunsumio is normally given in cycles of 21 days. The recommended treatment duration is at least 8 treatment cycles. However, depending on side effects and how the disease responds to treatment, you may be given up to 17 cycles.

• Day 1: 1 mg
• Day 8: 2 mg
• Day 15: 60 mg

• Day 1: 60 mg

• Day 1: 30 mg

You may be given other medicines 30 to 60 minutes before you are given Lunsumio. This is to help prevent infusion reactions and fever. These other medicines may include:

• Corticosteroids – such as dexamethasone or methylprednisolone

• Paracetamol

• An antihistamine – such as diphenhydramine

• Rash

• Itchy skin

• Dry skin

• Diarrhea

• Headache

• Fever

• Chills

• Cytokine release syndrome

• Shown in blood tests:
  • Low levels of some white blood cells (neutropenia)
  • Low number of red blood cells
  • Low platelet count
  • Low levels of phosphate, potassium, or magnesium
  • High levels of alanine aminotransferase in the blood

• Lung infection

• infection of nose, throat, sinuses

• Urinary tract infection

• Fever due to low levels of neutrophils (a type of white blood cell)

• Tumor flare

• Shown in blood tests:
  • Increased levels of liver enzymes, which may be a sign of liver problems

• A rapid breakdown of tumor cells results in chemical changes in the blood and damage to organs, including the kidneys, heart, and liver (tumor lysis syndrome).

• Cytokine release syndrome: a condition associated with medicines that stimulate T-cells. Before each infusion, you may be given medicines, which will help to reduce possible side effects of cytokine release syndrome. Tell your doctor if you experience any of the following symptoms:
  • Symptoms can include:
  • high fever
  • chills or shaking chills
  • cold or pale clammy skin
  • difficulty breathing
  • feeling dizzy or lightheaded
  • fast or uneven heartbeat
  • confusion
  • feeling very tired or weak
  • fainting
  • blurred vision
  • headache.

• Tumor lysis syndrome: some people may get unusual levels of salts in the blood caused by the fast breakdown of cancer cells during treatment. Your doctor will do blood tests to check for this condition. Make sure to be well-hydrated before each infusion and you may be given medicines that can help reduce high levels of uric acid and thus reduce possible side effects of tumor lysis syndrome. Tell your doctor if you experience any of the following symptoms:
  • fever
  • chills
  • feeling or being sick (nausea and vomiting)
  • confusion
  • being short of breath
  • fits (seizures)
  • uneven heartbeat
  • dark or cloudy urine
  • unusual tiredness
  • muscle or joint pain
  • increase in potassium, phosphate, or uric acid.

• Tumor flare: as your cancer is destroyed, it may react and appear to get worse – this is called ‘tumor flare reaction’. Symptoms can include:
  • tender swollen lymph nodes
  • chest pain
  • cough or difficulty breathing easily
  • pain at the site of the tumor.

• Infections: you may get signs of infection, which can vary depending on where in the body the infection is.

• Keep Lunsumio out of the reach of children.

• Do not use Lunsumio after the expiry date.

• Store in a refrigerator (2°C – 8°C).

• Do not freeze.

• The diluted solution should not be kept for more than 24 hours at 2°C – 8°C and 24 hours at ambient temperature (9°C – 30°C).

• Keep the container in the outer carton in order to protect it from light.

The active substance is mosunetuzumab. The other ingredients are L-methionine, acetic acid, L-histidine, sucrose, polysorbate 20 (E432), and water for injections.