blinatumomab 35 mcg intravenous kit

Generic name:
Blinatumomab - injection

Pronunciation
(BLIN-a-TOOM-oh-mab)

Brand name(s)
Blincyto

Blinatumomab may cause certain serious (sometimes fatal) side effects, including cytokine release syndrome-CRS and infusion reactions. Symptoms may include fever, chills, headache, nausea, vomiting, stomach/abdominal pain, trouble breathing, skin rash, weakness, or low blood pressure. Blinatumomab can also cause serious brain, spinal cord, and nerve disorders with symptoms such as headache, trouble sleeping, seizures, confusion, loss of consciousness, difficulty with swallowing/facial movements, or speech and balance problems. Tell your doctor right away if you develop any of these symptoms.

You may be given this medication in a hospital or clinic so your doctor can watch for these serious side effects and provide treatment if needed. If you have side effects, your doctor may temporarily stop or slow down your treatment with this medication. Also, your doctor may prescribe other medications before you receive blinatumomab to decrease the risk of side effects.

This medication is used to treat a certain type of cancer (acute lymphoblastic leukemia-ALL). Blinatumomab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start using blinatumomab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

The dosage and treatment schedule are based on your medical condition, weight, and response to treatment. To reduce your risk of side effects, your doctor may prescribe other medications (such as dexamethasone) before each treatment to help reduce side effects. Also, your doctor may start this medication at a low dose and gradually increase your dose.

This medication is given by slow injection (infusion) into a vein as directed by your doctor. A special machine (infusion pump) is used for giving the injection, usually over 4 weeks (28 days), followed by a break (usually 2 weeks) during which you will not be given blinatumomab. After the break, your doctor will decide if you will be given another treatment cycle with this medication. In later treatment cycles, your breaks may be longer (8 weeks). Do not change the settings on the infusion pump since you might get the wrong dose. Ask your health care professional right away if you have any questions about the infusion pump.

See also Warning section.

Nausea, heartburn, constipation, shaking (tremor), swelling ankles/feet/hands, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Blinatumomab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using blinatumomab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• brain/nerve disorders
• current or returning infections
• seizures
• Down syndrome

This drug may make you dizzy, confused, or cause seizures. Alcohol or marijuana (cannabis) can make you more dizzy or confused. Do not drive, use machinery, or do anything that needs alertness while you are receiving this medication. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Blinatumomab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using blinatumomab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using blinatumomab. Blinatumomab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 48 hours after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 48 hours after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.