Mosunetuzumab

Mosunetuzumab is a prescription medicine used for the treatment of follicular lymphoma. 

• Mosunetuzumab is available under the following different brand names: Lunsumio, mosunetuzumab-axgb.

Common side effects of Mosunetuzumab include:

• fever,
• chills,
• tiredness,
• nausea,
• vomiting,
• diarrhea,
• headaches,
• cough,
• low blood pressure,
• fatigue,
• rash, and
• abnormal lab work (decreased lymphocyte, phosphate, neutrophil count, white blood cell, hemoglobin and platelets; increased glucose, and uric acid)

Serious side effects of Mosunetuzumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• low blood pressure,
• fast or irregular heartbeat,
• tiredness,
• weakness,
• headache,
• confusion,
• anxiety,
• dizziness,
• lightheadedness,
• nausea,
• vomiting,
• numbness and tingling,
• difficulty focusing,
• forgetfulness,
• trouble making decisions,
• difficulty following instructions,  
• poor memory,
• trouble reading or writing,
• rambling speech,  
• personality changes,
• drowsiness,
• cough,
• upper respiratory infection,
• sore throat,
• loss of consciousness,
• high fever,
• cold or clammy skin,
• fast heart rate,
• fast or shallow breathing,
• chills,
• sweating,
• abnormal lab work (decreased hemoglobin, platelets, neutrophils)
• sore throat,
• abdominal pain,
• pain or burning when you urinate,
• frequent urination,
• pain near the rectum,
• diarrhea,
• sores in the mouth,
• sores near the rectum,
• chest pain,
• shortness of breath,
• difficulty breathing while laying down, and
• increased difficulty breathing

Rare side effects of Mosunetuzumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 1 mg/mL (single-dose vial)
• 30 mg/30 mL (single-dose vial)

Follicular Lymphoma

Adult dosage

• Each cycle is 21 days
  • Cycle 1 Day 1: 1 mg IV over at least 4 hr
  • Cycle 1 Day 8: 2 mg IV over at least 4 hr
  • Cycle 1 Day 15: 60 mg IV over at least 4 hr
  • Cycle 2 Day 1: 60 mg IV over 2 hr if Cycle 1 infusion was well-tolerated
  • Cycle 3 and subsequent cycles
• Day 1: 30 mg IV over 2 hr if Cycle 1 infusion was well-tolerated
  • Continue for 8 cycles, unless unacceptable toxicity or disease progression
  • Complete response achieved after 8 cycles: No further treatment is required
  • Partial response or stable disease after 8 cycles: Continue treatment for 9 more cycles (17 cycles total) or until unacceptable toxicity or disease progression
• Restarting therapy after dose delay
  • Last dose administered 1 mg (Cycle 1 Day 1)
• Time since the last dose
  • 1-2 weeks: Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule
  • Above 2 weeks: Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule
  • Last dose administered 2 mg (Cycle 1 Day 8)
• Time since last dose
  • 1-2 weeks: Administer 60 mg (Cycle 1 Day 15), then resume planned treatment schedule
  • Above 2 weeks to below 6 weeks: Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule
  • Above 6 weeks: Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule
  • Last dose administered 60 mg (Cycle 1 Day 15)
• Time since last dose
  • 1 week to less than 6 weeks: Administer 60 mg (Cycle 2 Day 1), then resume planned treatment schedule
  • Above 6 weeks: Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1), and then resume planned treatment schedule
  • Last dose administered 60 mg (Cycle 2 Day 1)
• Time since last dose
  • 3 weeks to less than 6 weeks: Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule
  • Above 6 weeks: Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg (Cycle 4 Day 1) and then resume planned treatment schedule
  • *Premedicate for Day 1, Day 8, and Day 15 doses in the next cycle
  • Last dose administered 30 mg (Cycle 3 and subsequent cycles)
• Time since last dose
  • 3 weeks to below 6 weeks: Administer 30 mg, then resume the planned treatment schedule
  • Above 6 weeks: Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15*, followed by 30 mg on Day 1 of subsequent cycles
  • *Premedicate for Day 1, Day 8, and Day 15 doses in the next cycle

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mosunetuzumab has no noted severe interactions with any other drugs.
• Mosunetuzumab has no noted serious interactions with any other drugs.
• Mosunetuzumab has no noted moderate interactions with any other drugs.
• Mosunetuzumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mosunetuzumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mosunetuzumab?”

Cautions

• Based on its mechanism of action, fetal harm may occur when administered to pregnant females
• Can promote serious or fatal infections; monitor for signs and symptoms of infection, including opportunistic infections, and treat as needed
• Serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia reported; monitor complete blood cell counts during treatment
• Tumor flare
  • Serious or severe tumor flare reported; may manifest as new or worsening pleural effusions, localized pain and swelling at sites of lymphoma lesions, and tumor inflammation
  • Closely monitor patients with bulky tumors or diseases located near airways or a vital organ during initial therapy
  • Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor flare
  • If compression or obstruction develops, institute standard treatment of these complications
• CRS
  • CRS reported
    • Median onset time of CRS from the start of Cycle 1 Day 1 was 5 hr, Cycle 1 Day 8 was 28 hr, Cycle 1 Day 15 was 25 hr, and Cycle 2 Day 1 was 46 hr
    • Median duration of CRS was 3 days
    • Clinical signs and symptoms of CRS included fever, chills, hypotension, tachycardia, hypoxia, and headache
    • Premedicate to reduce the risk of CRS, ensure adequate hydration, and monitor following administration accordingly
• Neurotoxicity
  • May cause serious neurologic toxicity, including ICANS
  • Common neurologic toxicities were headache, peripheral neuropathy, dizziness, and mental status changes (including confusional state, disturbance in attention, cognitive disorder, delirium, encephalopathy, and somnolence).
  • Coadministration with drugs that can cause dizziness or mental status changes may increase the risk of neurologic toxicity.
  • Monitor for signs and symptoms of neurologic toxicity during treatment
  • Evaluate patients who experience neurologic toxicity (eg, tremors, dizziness, insomnia, severe neurotoxicity, and other adverse reactions that impair consciousness)
  • Advise patients to avoid driving and operating heavy or potentially dangerous machinery until the resolution

Pregnancy and Lactation

• Based on the mechanism of action, mosunetuzumab may cause fetal harm when administered to pregnant females
• No data are available on use in pregnant females to evaluate drug-associated risk
• No animal reproductive or development toxicity studies were conducted
• Mosunetuzumab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance
• Human immunoglobulin G (IgG) is known to cross the placenta; therefore, mosunetuzumab may potentially transmit from the mother to the developing fetus
• Advise females of the potential risk to the fetus
• Verify the pregnancy status of females of reproductive potential
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 3 months after the final dose
• Lactation
  • There are no data on the presence of mosunetuzumab in human milk, its effects on breastfed children, or its effects on milk production
  • Maternal IgG is known to be present in human milk
  • Advise patients not to breastfeed during treatment and for 3 months after the final dose