Pronunciation:

blin-a-TOOM-oh-mab

Brand Names:

• Blincyto

Dosage Forms:

• Powder for Solution

Warnings:

Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving blinatumomab; interrupt or discontinue blinatumomab and treat with corticosteroids as recommended. Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be severe, life-threatening, or fatal, occurred in patients receiving blinatumomab. Interrupt or discontinue blinatumomab as recommended .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Bispecific Antibody

Uses of This Medicine:

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. 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:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of blinatumomab injection in children.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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.

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. 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 of This Medicine:

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.