Moxetumomab Pasudotox-Tdfk Solution, Reconstituted (Recon Soln)

GENERIC NAME(S): Moxetumomab Pasudotox-Tdfk

WARNINGS:

This medication may cause serious (even fatal) blood vessel damage. It can cause fluid to leak from your small blood vessels into other parts of your body. Get medical help right away if you develop symptoms such as swelling of your face/arms/legs, sudden weight gain, shortness of breath, cough, or dizziness.

This medication may also cause serious (even fatal) blood cell and kidney damage. Get medical help right away if you develop symptoms of kidney damage (such as change in the amount of urine, dark urine), unusual bleeding/bruising, fever, vomiting, shortness of breath, fast heartbeat, unusual tiredness, confusion, or seizure.

Careful monitoring by your doctor may decrease your risk. Your doctor may delay or stop treatment with this medication if you have severe side effects.

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Uses

Uses

This medication is used to treat a certain type of cancer (hairy cell leukemia). It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

How to use Moxetumomab Pasudotox-Tdfk Solution, Reconstituted (Recon Soln)

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

This medication is given by injection into a vein as directed by your doctor, usually over 30 minutes. It is given by a health care professional, usually on days 1, 3, and 5 of a 28-day cycle. To decrease the risk of side effects, drink plenty of fluids (such as water, milk, or juice) on days 1 through 8 of each cycle. Depending on your weight, you should drink up to eight or up to twelve full glasses (8 ounces/240 milliliters each) of fluids on these days as directed by your doctor. Ask your doctor for specific directions.

The dosage is based on your medical condition, weight, and response to treatment.

Your doctor may prescribe other medications (such as acetaminophen, antihistamines) before and after each dose to lessen reactions during your treatment. Carefully follow your doctor's directions for all your medications.

Side Effects

Side Effects

See also Warning section.

Reactions during the injection commonly occur. Tell your health care professional right away if you have symptoms during the injection such as chills, fever, flushing, headache, nausea, vomiting, shortness of breath, fast heartbeat, or muscle pain. Your doctor may temporarily stop your treatment if a severe reaction occurs.

Nausea, diarrhea, or constipation 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, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: muscle cramps, numbness/tingling, fast/irregular heartbeat, eye problems (such as blurred vision, dry eye, eye discomfort/pain).

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.

Precautions

Precautions

Before using moxetumomab pasudotox-tdfk, 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: kidney problems, other bleeding/blood problems.

Moxetumomab pasudotox-tdfk can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit 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).

Older adults may be more sensitive to the side effects of this drug, especially kidney damage.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using moxetumomab pasudotox-tdfk. Moxetumomab pasudotox-tdfk may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for at least 30 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Interactions

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.

Overdose

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as weight, blood pressure, kidney function, complete blood count, blood salt/mineral levels) should be done before you start using this medication and while you are using it. Women of childbearing age should have a pregnancy test before starting this medication. Keep all medical and lab appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.Information last revised November 2018. Copyright(c) 2018 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.