Blinatumomab (Intravenous route)
- Powder for Solution
Warnings:Intravenous route(Powder for Solution)
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving blinatumomab. Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving blinatumomab. Interrupt or discontinue blinatumomab as recommended .
Monoclonal Antibody Fragment
Uses of This Medicine:
Blinatumomab injection is used to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) that has come back or after other medicines did not work well. 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.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of blinatumomab injection in children.
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, encephalopathy, infections) in patients which may require caution in patients receiving blinatumomab injection.
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.
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.
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 of This Medicine:
A nurse or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.
Hospitalization is recommended for the first 9 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 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.
You may receive steroid medicines (eg, dexamethasone) before injection with blinatumomab to help prevent unwanted reactions to the injection.
Precautions While Using This Medicine:
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. 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 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 or your child have any of the following symptoms: a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.
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 the 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 a 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 youdizzy, confused, or less alert than youare 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.
Some preparations of this medicine may contain benzyl alcohol which may cause serious reactions (including gasping syndrome) to newborn or premature infants.
Side Effects of This Medicine:
- More common
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain
- cough or hoarseness
- fever or chills
- 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
- sore throat
- stiff neck
- tightness in the chest
- tingling of the hands or feet
- troubled breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- Incidence not known
- Cloudy urine
- darkened urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extremely high fever or body temperature
- eye pain
- feeling sad or empty
- general feeling of illness
- lack or loss of strength
- loss of interest or pleasure
- mood or mental changes
- 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
- slow or fast heartbeat
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- yellow eyes or skin
- More common
- Bone, joint, or muscle pain
- change in urination
- decreased appetite
- 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
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:
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:
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.
Last Updated: 9/4/2017