Dinutuximab Solution

GENERIC NAME(S): Dinutuximab

WARNINGS:

Dinutuximab may cause certain serious side effects, including infusion reactions or nerve problems. You will be given this medication in a hospital or clinic so your doctor can monitor you for side effects and provide treatment if needed. Also, you will be prescribed medications (such as acetaminophen, antihistamines including diphenhydramine) before each dose to decrease the risk of serious side effects. Since most people have nerve pain (such as in the abdomen, arms, legs, back, joints) when receiving this medication, narcotic pain reliever is usually given before, during, and after each dose.

If you have side effects, your doctor may temporarily stop or slow down your treatment with this medication. Your doctor may also adjust other medications to help lessen side effects. Tell your doctor right away if you develop symptoms such as fever, chills, severe dizziness, swelling of the face/tongue/throat, trouble breathing, itching, rash, numbness, burning, tingling, weakness, or if you have pain that is not relieved.

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Uses

Uses

This medication is used to treat a certain type of cancer (high-risk neuroblastoma). Dinutuximab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

How to use Dinutuximab Solution

This medication is given by slow injection (infusion) into a vein as directed by your doctor, usually over 10 to 20 hours, for 4 days in a row during each treatment cycle. Other medications are also given along with dinutuximab to decrease the risk of serious side effects (see also Warning section).

The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

Side Effects

Side Effects

See also Warning section.

Nausea, vomiting, diarrhea, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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 of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes, muscle cramps/spasms, difficulty urinating, signs of kidney problems (such as blood in the urine, change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: seizures, severe headache.

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).

This medication can rarely cause a serious condition (capillary leak syndrome), that can sometimes be fatal. Tell your doctor right away if you develop symptoms including swelling, severe dizziness, tiredness, or severe stomach/abdominal pain.

Rarely, this medication may cause a nerve problem of the eye(s). Tell your doctor right away if you develop symptoms such as blurred vision, double vision, drooping upper eyelid, light sensitivity, or widened or unequal pupils (the black part of the eye).

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 dinutuximab, 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: blood/bleeding problems, kidney problems.

Dinutuximab 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).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should use reliable forms of birth control (such as condoms, birth control pills) during treatment and for at least 2 months after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. 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

Laboratory and/or medical tests (such as blood pressure, complete blood count, blood minerals) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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 and will not be stored at home.Information last revised October 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.