Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Lunsumio

Descriptions


Mosunetuzumab-axgb injection is used to treat follicular lymphoma that has come back or did not respond to treatment in patients who have received at least 2 previous treatments.

Mosunetuzumab-axgb is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mosunetuzumab-axgb injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mosunetuzumab-axgb injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Serious infections (eg, Epstein-Barr virus), history of—Use with caution. May make this condition worse.
  • Infection, active—Should not be used in patients with this condition.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

You will receive this medicine on a "step-up dosing schedule" on Day 1 and 8 of your first cycle. You will receive a higher dose on Day 15 of your first cycle treatment. After cycle 1, you will receive this medicine every 21 days.

Your doctor may also give you other medicines (eg, allergy medicine, fever medicine, steroids) 30 to 60 minutes before starting treatment with this medicine to help prevent unwanted side effects from the injection.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and infusion reactions. This may be life-threatening and requires immediate attention. Tell your doctor right away if you have a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause serious infections (eg, pneumonia, sepsis, upper respiratory tract infection). Check with your doctor right away if you have chest pain or tightness, fever or chills, confusion, cough or hoarseness, dizziness, fainting, fast heartbeat, lightheadedness, lower back or side pain, painful or difficult urination, sneezing, sore throat, or trouble breathing.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause dizziness, confusion, tremors, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have chest pain, cough, pain or swelling at the site of the tumor, tender or swollen lymph nodes, or trouble breathing. These may be symptoms of serious or worsening of tumor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Abnormal or decreased touch sensation
  2. agitation
  3. back pain
  4. blue lips and fingernails
  5. blurred vision
  6. body aches or pain
  7. bone pain
  8. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  9. burning, numbness, tingling, or painful sensations
  10. chest pain or tightness
  11. chills
  12. confusion as to time, place, or person
  13. cough
  14. coughing that sometimes produce a pink frothy sputum
  15. decrease in amount of urine
  16. difficulty in moving
  17. dizziness
  18. drowsiness
  19. ear congestion
  20. fast, noisy breathing
  21. fever
  22. frequent or painful urination
  23. hallucinations
  24. headache
  25. holding false beliefs that cannot be changed by fact
  26. increased sweating
  27. irritability
  28. joint pain
  29. loss of voice
  30. mental depression or anxiety
  31. muscle aches, cramps, pain, or stiffness
  32. neck pain
  33. nerve pain
  34. nightmares or unusually vivid dreams
  35. pain or tenderness around the eyes and cheekbones
  36. pale skin
  37. rapid or irregular heartbeat
  38. seizures
  39. sneezing
  40. sore throat
  41. stiff neck
  42. stomach pain
  43. stuffy or runny nose
  44. swelling
  45. swelling of the hands, ankles, feet, or lower legs
  46. swollen joints
  47. trembling and shaking of the hands
  48. trouble breathing
  49. trouble performing routine tasks
  50. trouble sleeping
  51. unsteadiness or awkwardness
  52. unusual excitement, nervousness, or restlessness
  53. unusual tiredness or weakness
  54. vomiting
  55. weakness in the arms, hands, legs, or feet
  56. weight gain

Incidence not known

  1. Black, tarry stools
  2. bleeding gums
  3. blood in the urine or stools
  4. lower back or side pain
  5. painful or difficult urination
  6. pinpoint red spots on the skin
  7. ulcers, sores, or white spots in the mouth
  8. unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Diarrhea
  2. dry skin
  3. itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.