necitumumab 800 mg/50 mL (16 mg/mL) intravenous solution

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Medication name

Generic name:
Necitumumab - injection

Pronunciation
(NE-si-TOOM-oo-mab)

Brand name(s)
Portrazza

Warning

Rarely, heart problems (cardiopulmonary arrest) or sudden death have occurred in people treated with necitumumab. Before starting treatment with this medication, tell your doctor if you have a history of heart disease (such as heart failure, irregular heartbeat, previous heart attack). Get medical help right away if you develop chest/jaw/left arm pain, shortness of breath, or unusual sweating. Your doctor will order certain blood tests (such as magnesium, calcium, and potassium) during and after your treatment to monitor and help decrease your risk for heart problems.

Uses

This medication is used to treat lung cancer. Necitumumab belongs to a class of drugs known as monoclonal antibodies. It works by changing the action of your own immune system, directing it to attack cancer cells. This effect helps slow or stop the growth of cancer cells.

How to use

This medication is given by a health care professional. It is injected slowly into a vein as directed by your doctor, usually over at least 60 minutes. This medication can sometimes cause a serious reaction during the injection. Tell your doctor right away if you develop symptoms such as chills, fever, or breathing problems.

The dosage is based on your medical condition and response to treatment. To get the most benefit, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) before each dose to help prevent serious side effects. Carefully follow your doctor's directions.

Side effects

See also How to Use section.

Skin dryness/itching, headache, upset stomach, weight loss, nausea, vomiting, or diarrhea may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. 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 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:

  • muscle spasms
  • trouble swallowing

Necitumumab can commonly cause skin reactions, such as rash, acne, or redness/swelling/pain of skin around your nails. If the reaction is severe, your doctor may stop or change your treatment schedule or dose of necitumumab. Tell your doctor right away if you develop any skin reactions.

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, tell your doctor or pharmacist if you have any of these conditions. Get medical help right away if any of these side effects occur:

  • shortness of breath/rapid breathing
  • coughing up blood
  • chest/jaw/left arm pain
  • unusual sweating
  • confusion
  • sudden dizziness/fainting
  • pain/swelling/warmth in the groin/calf
  • sudden/severe headaches
  • trouble speaking
  • weakness on one side of the body
  • sudden vision changes

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

Before using necitumumab, 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 clots (such as in the legs, lungs)
  • high blood pressure
  • heart disease
  • stroke

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

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 discuss the use of reliable forms of birth control with their doctors while using this medication and for at least 3 months after treatment has stopped. 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 is not recommended while using this drug and for 3 months after the last dose. Consult your doctor before breast-feeding.

Drug 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

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 calcium, magnesium, potassium levels) should be done while you are using 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 clinic and will not be stored at home.

Important note

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.

Information last revised October 2016.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.