Class: Biological Therapy

Generic Name: Necitumumab

Trade Name: Portrazza®

For which conditions is this drug approved? Portrazza is approved for use in combination with the chemotherapy drugs Gemzar® (gemcitabine) and Platinol® cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer.

What is the mechanism of action? Portrazza belongs to a class of drugs known as monoclonal antibodies (a type of protein made in the laboratory that can bind to substances in the body, including cancer cells). Specifically, Portrazza targets the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells that is involved in cancer growth. By blocking the EGFR pathway, Portrazza helps keep cancer cells from growing.

How is Portrazza typically given (administered)? You’ll receive Portrazza as an intravenous (into the vein) infusion. A healthcare professional will give you the infusion, which will take 60 minutes, on the first and eighth day of each three-week cycle. After the Portrazza infusion, you’ll receive the Gemzar and Platinol infusion.

How are patients typically monitored? During treatment with Portrazza, your doctor will watch you for the following:

• Cardiac arrest and hypomagnesemia (low magnesium in the blood). Your doctor will closely monitor the levels of electrolytes in your blood before each infusion and for at least eight weeks after you finish treatment with Portrazza.
• Venous and arterial thromboembolic events (when blood clots form in a deep vein, blood clots breaking lose, or sudden interruption of blood flow)
• Skin problems
• Infusion-related reactions

What are the common (occur in 30% or more of patients) side effects of treatment with Portrazza?

• Rash
• Electrolyte abnormalities

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Portrazza?

• Acne-like papules and pustules
• Vomiting
• Diarrhea
• Stomatitis (inflammation of the mouth and lips)
• Weight loss
• Coughing up blood

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Protect your skin from the sun during treatment with Portrazza by wearing protective clothing and using a broad-spectrum sunscreen.
• Tell your doctor about all of your health conditions.
• Be especially sure to tell your doctor if you have:
  • A history of heart problems
  • A history of high blood pressure
  • A history of lung problems
  • Have had or are at high risk for blood clots
• Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications, herbal remedies, and vitamin supplements.

Are there any special precautions patients should be aware of before starting treatment?

• Tell you doctor if you are pregnant or may become pregnant. Portrazza may harm your unborn baby. To avoid getting pregnant, use an effective form of birth control while receiving Portrazza and for at least three months after finishing treatment.
• Tell you doctor if you are breastfeeding. You should not breastfeed while receiving Portrazza and for at least three months after finishing treatment.

When should patients notify their physician?

Tell you doctor right away (or have your caregiver contact your doctor or emergency care) if you have signs or symptoms of the following:

• Cardiac arrest
  • Loss of consciousness or fainting
  • No heartbeat (or pulse) can be felt
  • Racing heartbeat
  • Feeling dizzy or light-headed
  • Chest pain
  • Shortness of breath, nausea, or vomiting
• Hypomagnesemia
  • Abnormal eye movements
  • Convulsions
  • Fatigue
  • Muscle spasms or cramps
  • Muscle weakness
  • Numbness
• Venous and arterial thromboembolic events
  • Acute onset of shortness of breath
  • Sharp chest pain that worsens during breathing
  • Cough
  • Coughing up blood
  • Temporary loss of consciousness
  • Swelling and warmth to touch or tenderness in lower-extremities
  • Rapid breathing
  • Abnormally rapid heart rate
  • Fever
  • Bluish discoloration of the skin due to poor circulation or inadequate oxygenation of the blood

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.