Portrazza (Intravenous)

Necitumumab injection is used along with gemcitabine and cisplatin to treat squamous non-small cell lung cancer that has spread.

Necitumumab works by interfering with the growth of cancer cells, which the body eventually destroys. Since necitumumab can also affect the growth of normal body cells, it can cause other unwanted effects. Some of these effects can be serious and should be reported to your doctor. Some unwanted effects, like a skin rash, may not be serious but could cause concern. Some unwanted effects may not appear until months or years after using the medicine.

This medicine should be given only by or under the supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to make sure this medicine is working properly and to check for side effects. Blood tests may be needed to check for side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent getting pregnant during therapy and for 3 months after your last dose of this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Low magnesium levels (hypomagnesemia) may occur while you are receiving this medicine. Tell your doctor right away if you experience drowsiness, mood or mental changes, muscle spasms or twitching, seizures, or unusual tiredness or weakness after receiving this medicine.

Blood clots may occur while you are receiving this medicine. Call your doctor if you have chest pain that may spread to your arms, jaw, back, or neck, coughing up blood, nausea, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking, trouble breathing, or unusual sweating.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Infusion-related reactions may occur while you are receiving this medicine. Tell your doctor right away if you have the following symptoms: back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, weakness, or trouble breathing.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been conducted on the effects of necitumumab injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific issues in older adults that would limit the usefulness of necitumumab injection. However, older patients are more likely to develop blood clots (e.g., pulmonary embolism), which may require caution when using necitumumab injection.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In such cases, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Blood clots (e.g., deep vein thrombosis, pulmonary embolism) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. This may worsen these conditions.

Along with its needed effects, Portrazza (Intravenous) may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Abdominal or stomach cramps
• confusion
• convulsions
• decreased urine
• difficulty with breathing
• drowsiness
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain or muscle spasms (tetany) or twitching
• nausea or vomiting
• numbness and tingling around the mouth, fingertips, or feet
• tremor
• unusual tiredness or weakness

Less common

• Anxiety
• back pain
• chest pain or discomfort
• chest tightness
• chills
• cough
• difficulty with speaking
• dizziness or lightheadedness
• double vision
• fainting
• fast heartbeat
• fever
• flushing
• headache
• heart stops
• inability to move the arms, legs, or facial muscles
• no breathing
• no pulse or blood pressure
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• pains in the chest, groin, or legs, especially the calves of the legs
• severe headaches of sudden onset
• slow speech
• sudden loss of coordination
• sudden onset of slurred speech
• sudden shortness of breath or troubled breathing
• sudden vision changes
• sweating
• trouble breathing
• unconscious

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 Portrazza (Intravenous). 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

• Blemishes on the skin
• burning, dry, or itching eyes
• decreased weight
• diarrhea
• discharge or excessive tearing
• dry skin
• itching skin or rash
• loosening of the fingernails
• pimples
• rash with flat lesions or small raised lesions on the skin
• redness or soreness around the fingernails
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• swelling or inflammation of the mouth

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.

In the U.S.

• Portrazza

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for 60 minutes and the infusion will be given on Day 1 and 8 of each 3-week cycle.

You may also receive medicines to help prevent possible allergic reactions to the injection.