Trade Name: Portrazza™
Necitumumab is the generic name for the trade name drug Portrazza™. In some cases, health care professionals may use the trade name Portrazza™ when referring to the generic drug name necitumumab.
Necitumumab is classified as a "monoclonal antibody" and "signal transduction inhibitor" by binding to epidermal growth factor receptors (EGFR). (For more detail, see "How Necitumumab Works" section below).
What Necitumumab Is Used For:
- Indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Necitumumab Is Given:
- Necitumumab is given through an infusion into a vein (intravenous, IV).
- Necitumumab is administered over 60 minutes on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion.
- The amount of necitumumab that you will receive depends on many factors, including you height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.
Important things to remember about the side effects of necitumumab:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and duration.
- Side effects are almost always reversible and will go away after treatment is complete.
- There are many options to help minimize or prevent side effects.
- There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
- There is no data as to the frequency of adverse reactions that may be attributed to necitumumab alone. (In clinical studies necitumumab was used in combination with other chemotherapy medications).
The following side effects are common (occurring in greater than 30%) for patients taking necitumumab:
These side effects are less common side effects (occurring in about 10-29%) of patients receiving necitumumab:
These are rare but serious complications of necitumumab therapy:
Serious heart and lung events have occurred when given with gemcitabine and cisplatin. Electrolytes including magnesium, potassium, and calcium, will be closely monitored with aggressive replacement during and after the administration of necitumumab.
Low magnesium in the blood has been documented when necitumumab is given with gemcitabine and cisplatin. The levels of magnesium, calcium, and potassium will be closely monitored during treatment and for at least 8 weeks following completion of necitumumab.
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, or blurred eyesight.
- Very bad dizziness or passing out.
- Signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the follow:
- Abdominal pain
- Nausea (interferes with ability to eat and unrelieved with prescribed medication).
- Vomiting (vomiting more than 4-5 times in a 24 hour period).
- Diarrhea (4-6 episodes in a 24-hour period).
- Coughing up blood.
- Black or tarry stools, or blood in your stool.
- Blood in urine.
- Mouth sores (painful redness, swelling or ulcers).
- Weight loss.
- Change in eyesight, eye pain or very bad eye irritation.
- Change in nails.
- Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness.
Always inform your health care provider if you experience any unusual symptoms.
- Before starting necitumumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking necitumumab.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Necitumumab is expected to cross the placenta. Based on animal data and the mechanism of action, necitumumab is expected to cause fetal harm if administered during pregnancy. Women of reproductive age should use effective contraception during therapy and for 3 months after the last dose.
- For both men and women: Do not conceive a child (get pregnant) while taking necitumumab. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breast feed while taking necitumumab.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- Necitumumab causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
- Keep you bowels moving. Your health care provider may prescribe a stool softener to help prevent constipation that may be caused by this medicine.
- Wash your hands often.
- You may be at risk of infection. Report fever or any other signs of infection immediately to your health care provider.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
- Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing:
You will be checked regularly by your health care professional while you are taking necitumumab, to monitor side effects and check your response to therapy. Periodic blood work will be drawn to monitor your serum electrolytes, including magnesium, potassium, and calcium (prior to each dose during treatment and for at least 8 weeks following completion). You will be checked for signs/symptoms of infusion-related reactions, dermatological issues and blood clots.
How Necitumumab Works:
Monoclonal antibodies are a relatively new type of "targeted" cancer therapy. Antibodies are part of the immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) entering the body. The antibodies attach to the antigen in order to mark it for destruction by the body's immune system. In the laboratory, scientists analyze specific antigens on the surface of cancer cells (target) to determine a protein to match the antigen. Then, using animal and human proteins, scientists work to create a special antibody that will attach to the target antigen. Antibodies will attach to matching antigens like a key fits a lock. This technology allows treatment to target specific cells, causing less toxicity to healthy cells. Monoclonal antibody therapy can be done only for cancers in which antigens (and the respective antibodies) have been identified.
Necitumumab is a targeted therapy that targets and binds to the epidermal growth factor receptors (EGFR) on the surface of the cell. EGFR is found on the surface of many normal and cancer cells. By binding to these receptors, necitumumab blocks an important pathway that promotes cell division which results in inhibition of cell growth and apoptosis (cell suicide). Necitumumab is believed to work when the tumor cells test positive for expression of EGFR.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.