Lunsumio

Generic name: Mosunetuzumab-axgb
Dosage form: injection, for intravenous infusion
Drug class: Miscellaneous antineoplastics

Usage of Lunsumio

Lunsumio is a prescription medicine used to treat adults with follicular lymphoma, a cancer of the lymphatic system in which B lymphocytes (B cells) become cancerous and accumulate in 'follicles' in the lymph nodes. It the most common slow-growing form of non-Hodgkin’s lymphoma.

Lunsumio contains mosunetuzumab, a first-in-class bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. It works by activating and redirecting the T cells to engage and eliminate the target B cells.

Lunsumio side effects

Lunsumio may cause serious side effects, including:

See Important information

Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment, including:

headache

numbness and tingling of the arms, legs, hands, or feet

dizziness

confusion and disorientation

difficulty paying attention or understanding things

forgetting things or forgetting who or where you are

trouble speaking, reading, or writing

sleepiness or trouble sleeping

tremors

loss of consciousness

seizures

muscle problems or muscle weakness

loss of balance or trouble walking

Serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment, including:

fever of 100.4°F (38°C) or higher

cough

chest pain

tiredness

shortness of breath

painful rash

sore throat

pain during urination

feeling weak or generally unwell

Low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be severe. Your healthcare provider will check your blood cell counts during treatment. Lunsumio may cause the following low blood cell counts:

low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.

low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.

low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.

Growth in your tumor or worsening of tumor related problems (Tumor flare). Lunsumio may cause serious or severe worsening of your tumor.

Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at the site of the tumor.

Your healthcare provider may temporarily stop or permanently stop treatment if you develop severe side effects.

The most common side effects of Lunsumio include tiredness, rash, fever, and headache.

The most common severe abnormal lab test results with Lunsumio include decreased phosphate, increased glucose, and increased uric acid levels.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Lunsumio

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving Lunsumio.

have an infection or have had an infection in the past which lasted a long time or keeps coming back.

have or had Epstein-Barr Virus.

are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment. Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment.

you should use an effective method of birth control during your treatment and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose.

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How to use Lunsumio

Usual Adult Dose for Follicular Lymphoma

A treatment cycle is 21 days.

Day of Treatment Dose Rate of Infusion Cycle 1 Day 1 1 mg Administer over a minimum of 4 hours. Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg Administer over 2 hours if infusions from Cycle 1 were well-tolerated. Cycles 3+ Day 1 30 mg

Comment: Premedicate to reduce risk of cytokine release syndrome and infusion-related reactions. Administer only as an intravenous infusion. Administer for 8 cycles, unless patients experience unacceptable toxicity or disease progression.

Use: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Warnings

Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher

chills

low blood pressure

fast or irregular heartbeat

tiredness or weakness

difficulty breathing

headache

confusion

feeling anxious

dizziness or light-headedness

nausea

vomiting

Due to the risk of CRS, you will receive Lunsumio on a "step-up dosing schedule".

The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment.

You will receive a higher dose on Day 15 of your first cycle of treatment.

If your dose is delayed for any reason, you may need to repeat the "step-up dosing schedule."

Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS.

See How will I receive Lunsumio? for more information.

Your healthcare provider will check you for CRS during treatment, and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment if you have severe side effects.

See Lunsumio side effects for more information about side effects.

What other drugs will affect Lunsumio

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Disclaimer

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