Dacomitinib

Dacomitinib is a prescription medication used for the treatment of Non-small Cell Lung Cancer. 

• Dacomitinib is available under the following different brand names: Vizimpro.

Common side effects of Dacomitinib include:

• Diarrhea,
• Loss of appetite, 
• Weight loss
• Rash,
• Itching,
• Dry skin,
• Eye redness,
• Dry or itchy eyes,
• Hair loss,
• Problems with the nails,
• Mouth sores,
• Mouth pain, and
• Cold symptoms (stuffy nose, sneezing, sore throat)

Serious side effects of Dacomitinib include:

Hives,

Difficulty breathing,

Swelling of the face, lips, tongue, or throat,

• New or worsening breathing problems
• Chest pain,
• Wheezing,
• Cough,
• Shortness of breath,
• Fever,
• Severe or ongoing diarrhea,
• Swelling, redness, or infection under or around your fingernails or toenails,
• Dry skin,
• Redness,
• Rash,
• Acne,
• Itching, and
• Peeling or blistering

Rare side effects of Dacomitinib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 15 mg
• 30 mg
• 45 mg

Non-small Cell Lung Cancer

Adult dosage

• 45 mg orally once a day
• Continue until disease progression or unacceptable toxicity occurs.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dacomitinib has severe interactions with no other drugs.
• Dacomitinib has serious interactions with at least 64 other drugs.
• Dacomitinib has severe interactions with the following drugs:
  • dengue vaccine
  • deutetrabenazine
  • dextroamphetamine transdermal
  • oliceridine
  • pitolisant
  • siponimod
• Dacomitinib has severe interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dacomitinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dacomitinib?”

Cautions

• Severe and fatal ILD/pneumonitis occurred; monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold treatment and promptly investigate for ILD in patients who present with worsening respiratory symptoms, which may be indicative of ILD (. g, dyspnea, cough, fever); permanently discontinue treatment if ILD is confirmed.
• Severe and fatal diarrhea occurred; promptly initiate antidiarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea
• Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to a pregnant woman (see Pregnancy)
• Dermatologic adverse reactions
  • Rash and exfoliative skin reactions occurred; the incidence and severity of the rash and exfoliative skin reactions may increase with sun exposure.
  • The At time of initiation of treatment, initiate the use of moisturizers and appropriate measures to limit sun exposure.
  • Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids
  • Initiate oral antibiotics for Grade above 2 severe dermatologic adverse reactions.
• Drug interactions overview
  • Dacomitinib inhibits UGT1A1, P-gp, BCRP, and organic cation transporter (OCT)1
  • Dacomitinib is a P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) substrate.
• Concomitant use of acid-reducing agents
  • Avoid use with proton pump inhibitors (PPIs)
  • As an alternative to PPIs, use locally acting antacids, or, if using a histamine 2 (H2)-receptor antagonist, administer dacomitinib at least 6 hours before or 10 hours after taking an H2-receptor antagonist
  • Concomitant use with a PPI decreases dacomitinib concentrations, which may reduce dacomitinib efficacy.
• Effect of dacomitinib on CYP2D6 substrates
  • Concomitant use of dacomitinib increases the concentration of CYP2D6 substrates, which may increase the risk of toxicities of these drugs.
  • Avoid use with CYP2D6 substrates where minimal increases in the concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

Pregnancy and Lactation

• Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to a pregnant woman
• There are no available data on use in pregnant women.
• Verify the pregnancy status of females of reproductive potential before initiating treatment
• Advise females of reproductive potential to use effective contraception during treatment and for at least 17 days after the final dose.
• Lactation
  • There is no information regarding the presence of dacomitinib or its metabolites in human milk or their effects on breastfed infants or milk production.
  • Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for at least 17 days after the last dose