Description
Blinatumomab injection is used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in remission with minimal residual disease (MRD). It is also used to treat ALL that has come back or after other medicines did not work well. This medicine is also used to treat Philadelphia chromosome negative precursor ALL in consolidation phase of chemotherapy treatment. Leukemia is a type of cancer where the body makes abnormal white blood cells.
Blinatumomab injection is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by blinatumomab, other side effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.
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:
- Powder for 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 blinatumomab injection in the children younger than 1 month of age. 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 blinatumomab injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, brain problems, infections), which may require caution in patients receiving blinatumomab injection.
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Busulfan
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:
- Encephalopathy or
- Liver disease or
- Neutropenia (low number of white blood cells) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Infections—May decrease your body's ability to fight infections.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.
Your doctor will ask you to stay at the hospital for the first 3 days of the first treatment cycle and for the first 2 days of the second cycle.
This medicine is usually given every day for 4 weeks (28 days) followed by a 2-week treatment free-interval. This is one treatment cycle. After the 2-week break, your doctor will decide if you will be given additional treatment cycles of this medicine.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor may also give you other medicines (eg, steroid medicine) before starting treatment with this medicine.
Your doctor may also give you cancer treatment through an IV that is placed into your spinal cord before and during treatment to prevent ALL from coming back.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure 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 can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment and for at least 48 hours after your treatment ends to keep from getting pregnant. If you think you have become pregnant while receiving this medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS), infusion reactions, and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you or your child have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech.
This medicine can temporarily lower the number of white blood cells in your blood, which increases your chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may cause a serious reaction, called tumor lysis syndrome (TLS). Your doctor may give you medicine to help prevent this. Call your doctor right away if you or your child have a change in how much or how often you urinate, muscle or joint pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may make you dizzy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.
While you are being treated with blinatumomab, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 2 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.
This medicine may contain benzyl alcohol which may cause serious reactions (eg, gasping syndrome) to newborn or premature infants. Talk to your doctor if you have concerns.
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
- Agitation
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or tightness
- chills
- confusion
- cough
- dizziness
- fever
- headache
- hoarseness
- irritability
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid, shallow breathing
- seeing, hearing, or feeling things that are not there
- seizures
- sore throat
- stiff neck
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Incidence not known
- Back pain
- burning, throbbing, or stabbing pain
- cloudy urine
- coma
- darkened urine
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- drowsiness
- extremely high fever or body temperature
- eye pain
- feeling restless
- feeling sad or empty
- general feeling of illness
- hallucinations
- irritability
- jerking movements
- lack or loss of strength
- loss of interest or pleasure
- mood or mental changes
- muscle spasms
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- persistent bleeding or oozing from puncture sites, mouth, or nose
- pounding in the ears
- problems with speech or speaking
- rash
- rigid muscles
- slow or fast heartbeat
- stomach pain
- sweating
- swelling of the hands, ankles, feet, or lower legs
- tremor
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- yellow eyes or skin
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
- Bone, joint, or muscle pain
- change in urination
- decreased appetite
- diarrhea
- difficulty having a bowel movement
- dry mouth
- increased hunger or thirst
- irregular heartbeat
- muscle pain or cramps
- pain in the arms or legs
- shakiness in the legs, arms, hands, or feet
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.
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