Dacomitinib

(DAK-oh-MI-ti-nib)

Trade Name: Vizimpro®

Dacomitinib is the generic name for the trade name drug Vizimpro. In some cases, health care professionals may use the trade name Vizimpro when referring to the generic drug name dacomitinib.

Drug Type: Dacomitinib is a targeted therapy. It is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (for more detail, see "How Dacomitinib works" below).

What Dacomitinib Is Used For

• For the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858R substitution mutations, as detected by FDA-approved test

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 Dacomitinib Is Given

• Dacomitinib is a tablet pill, taken by mouth once daily
• Dacomitinib can be taken with or without food
• Take dacomitinib the same time each day
• If you vomit a dose, do not take an additional dose
• If you miss a dose, do not make up the missed dose. Continue with the next scheduled dose

Side Effects

Important things to remember about the side effects of dacomitinib:

• Most people will not experience all of the dacomitinib side effects are listed here.
• Dacomitinib side effects are often predictable in terms of their onset, duration and severity.
• Dacomitinib side effects will improve after therapy is complete.
• Dacomitinib side effects may be quite manageable. There are many options to minimize or prevent the side effects of dacomitinib.

The following side effects are common (occurring in greater than 30%) for patients taking dacomitinib:

• Skin rash
• Bacterial or fungal nail infection (paronychia)
• Dry skin
• Low albumin
• Low calcium
• High blood glucose levels
• Diarrhea
• Mouth sores
• Decreased appetite
• Anemia (low hemoglobin)
• Low white blood cell count
• Increased liver enzymes

These are less common side effects (occurring in 10-29%) for patients receiving dacomitinib:

• Chest pain
• Insomnia
• Hair loss
• Itching
• Redness, swelling, and pain on the palms of the hands and/or the soles of the feet
• Low potassium, magnesium and sodium levels
• Weight loss
• Nausea
• Constipation
• Limb pain
• Musculoskeletal pain
• Weakness/lack of energy
• Inflammation or infection of the eyes
• Increased serum creatinine
• Cough, nasal signs and symptoms, difficulty breathing and upper respiratory tract infection

Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But 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 100.4º F (38º C) or higher, chills (possible signs of infection)
• Shortness of breath
• Rapid heart beat
• Any new rashes on your skin

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• 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)
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Pain or burning with urination
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

• Before starting dacomitinib 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 take aspirin, products containing aspirin unless your doctor specifically permits this.
• Administer dacomitinib at least 6 hours before or 10 hours after a histamine H2-receptor antagonists (e.g. famotidine, ranitidine)
• Avoid proton pump inhibitors (e.g. omeprazole, pantoprazole, esomeprazole)
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking dacomitinib.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Dacomitinib use during pregnancy may cause fetal harm. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking dacomitinib. Barrier methods of contraception, such as condoms, are recommended during dacomitinib use and for up to 17 days after last dose of dacomitinib.
• It is unknown if dacomitinib is present in breast milk. Breastfeeding is not recommended during dacomitinib use and for up 17 days after the last dose of dacomitinib.

Self-Care Tips

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• This medication causes little nausea. 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
• Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
• Avoid sun exposure. Wear SPF 15 (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 While Taking Dacomitinib

You will be checked regularly by your doctor while you are taking dacomitinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) which will also be ordered by your doctor.

How Dacomitinib Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

Dacomitinib is a targeted therapy that targets the epidermal growth factor receptor (EGFR) with exon 19 deletion or exon 21 L858R substitution mutations. The EGFR gene plays an important role in both normal and cancer cells. This gene leads to the production of EGFR protein that tells cells how to grow and divide. A change in the EGFR gene (called a mutation) can alter the way that EGFR protein works. Instead of waiting for its turn to signal a cell to divide or grow, the EGFR protein is out of control and signals all of the time, this out of control EGFR signaling may drive the uncontrolled growth of cancer cells. Dacomitinib targets select mutant forms of EGFR.

Note: We strongly encourage you to talk with your health care professional about you specific medical condition and treatments. The information contained in this website is meant to be helpful and education, but is not a substitute for medical advice.