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Dacomitinib

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What is Dacomitinib?

Dacomitinib (VIZIMPRO) is a kinase inhibitor used to treat non-small cell lung cancer (NSCLC).


Dacomitinib.svg

What are the uses of this medicine?

This medicine is used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic): As your first treatment if your tumor has certain types of abnormal epidermal growth factor receptor (EGFR) gene(s).

How does this medicine work?

  • Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation).
  • In vitro dacomitinib also inhibited the activity of DDR1, EPHA6, LCK, DDR2, and MNK1 at clinically relevant concentrations.

Who Should Not Use this medicine ?

  • This medicine have no usage limitations.

What drug interactions can this medicine cause?

  • Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist.
  • Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

Is this medicine FDA approved?

  • It was approved for use in the United States in 2018.

How should this medicine be used?

Select patients for the first-line treatment of metastatic NSCLC with VIZIMPRO based on the presence of an EGFR exon 19 deletion or exon 21 L858R substitution mutation in tumor specimens.

Recommended Dosage

  • The recommended dosage of VIZIMPRO is 45 mg taken orally once daily, until disease progression or unacceptable toxicity occurs.

Administration

  • Take VIZIMPRO exactly as your healthcare provider tells you.
  • Take your dose at approximately the same time each day.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VIZIMPRO if you have side effects.
  • Take VIZIMPRO 1 time each day with or without food.
  • If you take an antacid or H2 blocker medicine during treatment with VIZIMPRO, take your dose of VIZIMPRO at least 6 hours before or 10 hours after taking the antacid or H2 blocker medicine. Do not change your dose or stop taking VIZIMPRO unless your healthcare provider tells you.
  • If you vomit or miss a dose of VIZIMPRO, do not take another dose or make up for the missed dose. Take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • As Tablets: 15 mg, 30 mg, and 45 mg

This medicine is available in fallowing brand namesː

  • VIZIMPRO

What side effects can this medication cause?

The most common side effects of this medicine include:

  • rash
  • diarrhea
  • mouth pain and sores
  • nail inflammation
  • common cold
  • dry skin
  • decreased appetite
  • decreased weight
  • dry, red, itchy eyes
  • hair loss
  • itching

VIZIMPRO may cause serious side effects, including:

  • Lung or breathing problems
  • Diarrhea
  • Skin reactions

What special precautions should I follow?

  • Minimize exposure to sunlight. VIZIMPRO can cause skin reactions.
  • Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO. Permanently discontinue VIZIMPRO if ILD is confirmed.
  • Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Withhold and reduce the dose of VIZIMPRO based on the severity.
  • Rash and exfoliative skin reactions occurred in patients treated with VIZIMPRO. Withhold and reduce the dose of VIZIMPRO based on the severity.
  • VIZIMPRO can cause fetal harm. Advise females of reproductive potential to use effective contraception.

What to do in case of emergency/overdose?

  • In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Can this medicine be used in pregnancy?

  • There are no available data on VIZIMPRO use in pregnant women.

Can this medicine be used in children?

  • The safety and effectiveness of VIZIMPRO in pediatrics have not been established.

What are the active and inactive ingredients in this medicine?

  • Active ingredient: dacomitinib
  • Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.
  • Film coating contains: Opadry II® Blue 85F30716 containing: Polyvinyl alcohol – partially hydrolyzed, Talc, Titanium dioxide, Macrogol/PEG 3350, and FD&C Blue #2/Indigo Carmine Aluminum Lake.

Who manufactures and distributes this medicine?

  • Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

  • Store VIZIMPRO at 20 °C to 25 °C (68 °F to 77 °F).
  • Keep VIZIMPRO and all medicines out of the reach of children.

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