What Xalkori is used for and how to use it
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Xalkori Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Non-Small Cell Lung Cancer
Class: Multikinase inhibitors
Form: Capsules
Ingredients: crizotinib, silicon dioxide, microcrystalline cellulose, calcium phosphate dibasic anhydrous, sodium starch glycolate, magnesium stearategelatin, titanium dioxide, red iron oxide,

Crizotinib Capsules

About This Medication

What the Medication is Used For

XALKORI (crizotinib) is used to treat patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (a cancer that cannot be surgically removed for cure) or metastatic (a cancer that has spread to other parts of the body) non-small cell lung cancer (NSCLC) that is a type of lung cancer with a defective gene.

Patients should have their cancer tested and confirmed for ALK-positive NSCLC before receiving treatment with XALKORI.

What it Does

XALKORI may slow or stop the growth of lung cancer. It may help shrink tumors.

When it Should not Be Used

Do not take XALKORI:

  • If you have congenital long QT syndrome – a heart disorder that exists before or at birth.
  • If you are allergic (hypersensitive) to crizotinib or any of the other ingredients of XALKORI, listed under "What the nonmedicinal ingredients are:"

What the Medicinal Ingredient Is

Crizotinib.

What the Nonmedicinal Ingredients Are

Silicon dioxide, microcrystalline cellulose, calcium phosphate dibasic anhydrous, sodium starch glycolate, magnesium stearate. Pink opaque hard gelatin capsule shell: gelatin, titanium dioxide, red iron oxide. White opaque hard capsule shell: gelatin, titanium dioxide. Printing ink: shellac, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.

What Dosage Forms it Comes In

XALKORI is available as 250 mg and 200 mg capsules. The 250 mg capsule is a pink opaque/pink opaque hard gelatin capsule with “Pfizer” on the cap and “CRZ 250” on the body. The 200 mg is a white opaque/pink opaque hard gelatin capsule with “Pfizer” on the cap and “CRZ 200” on the body.

Warnings and Precautions

Serious Warnings and Precautions

XALKORI should be prescribed and used under the supervision of a doctor experienced with drugs used to treat cancer.

Serious side effects with XALKORI include:

  • Heart rhythm disturbances (QT interval prolongation), and very slow heart rate (bradycardia)
  • Serious lung diseases such as interstitial lung disease (that can cause trouble breathing or shortness of breath, cough or fever) or pneumonitis that may result in death
  • Liver toxicity that may result in death

XALKORI has not been studied in patients with liver impairment or severe kidney impairment needing hemodialysis.

XALKORI decreases heart rate and has an effect on the electrical activity of the heart known as QT interval prolongation. These effects can be measured as changes in the electrocardiogram (ECG). Drugs with these effects on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heartbeat), fainting, or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. It is important to follow the instructions of your doctor with regard to dosing or any special tests. You may need to have electrocardiograms (ECGs) and blood tests to measure your levels of potassium, calcium, and magnesium at regular intervals during treatment with XALKORI. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heartbeat), fainting, or seizures, you should seek immediate medical attention.

XALKORI may cause inflammation of the lungs during treatment. This condition may be similar to lung cancer. Tell your doctor or nurse right away if you have any new or worsening symptoms, including difficulty breathing, cough, or fever.

BEFORE you use XALKORI talk to your doctor or pharmacist if:

  • You have any heart disorder, including an irregular heartbeat, an abnormal electrical signal called “prolongation of the QT interval” or a family history of QT interval prolongation or sudden cardiac death at <50 years of age;
    • You have a personal history of fainting spells;
    • You have electrolyte disturbances (e.g., low blood calcium, potassium, or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration);
    • You have an eating disorder or are following a strict diet;
    • You have diabetes, especially with associated nerve disorders
    • You have liver or kidney problems
    • You have symptoms of nerve damage (peripheral neuropathy) such as pain, burning, or numbness
    • You have eye problems
    • You are pregnant, or planning to become pregnant
    • Do not breastfeed while using XALKORI, it is not known if the drug can get into the breast milk, and therefore, into the baby.

XALKORI may cause harm to your unborn baby. Both male and female patients must use an effective birth control method while taking XALKORI and for at least 90 days after the last dose. If you or your partner become pregnant, tell your doctor right away.

Male and female fertility may be affected by treatment with XALKORI.

The use of XALKORI in people younger than 18 years old has not been established.

Do not drive or operate machinery if you feel tired or dizzy, or experience any change in vision while taking XALKORI.

Interactions With This Medication

Tell your doctor or pharmacist about all the medicines you take including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Some medicines can react with XALKORI and may cause serious side effects or may change the amount of XALKORI in your body. You are still able to receive immunizations while taking crizotinib.

Especially tell your doctor if you take:

  • Medicines that may affect your heartbeat such as :
    • medicines for heart rhythm problems (anti-arrhythmics) such as quinidine, amiodarone
    • medicines for depression such as amitryptyline and imipramine
    • medicines for psychoses such as pimozide, ziprasidone, and haloperidol
    • medicines for infections (antibiotic) such as azithromycin, clarithromycin, moxifloxacin, and ciprofloxacin
    • medicines for fungal infection such as ketoconazole and itraconazole
    • medicines to treat malaria such as quinine and chloroquine
    • medicines for nausea and vomiting such as ondansetron, domperidone, and dolasetron
    • methadone
    • pentamidine
    • other cancer medicines such as sunitinib, nilotinib, lapatinib, and vandetanib
    • asthma drugs such as formoterol and salmeterol
    • medicines that decrease electrolyte levels (water pills, laxatives)
    • some medicines for high blood pressure, which may also decrease the heart rate such as verapamil, diltiazem, and atenolol
  • HIV medicines such as atazanavir, saquinavir, ritonavir and indinavir
  • Other antibiotics such as rifampin and rifabutin
  • St. John's wort

Keep a list of your medicines. Show it to your doctor or pharmacist. Talk with your doctor before starting any new medicines.

Proper Use of This Medication

Usual Dose

  • 250 mg taken by mouth twice daily, unless instructed otherwise by your doctor. Do not crush, dissolve or open the capsules. The capsules can be taken with or without food.
  • Do not drink grapefruit juice or eat grapefruit, or products containing grapefruit extracts, star fruit, pomegranate, Seville oranges or other similar fruits. They may change the amount of XALKORI in your body.

Overdose

If you take more XALKORI than you should, or in case of drug overdose, contact a health care practitioner, or hospital emergency department, or a Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take it as soon as you remember. Do not take it if it is less than 6 hours until the next dose. Just take the next dose at your regular time. Do not take more than 1 dose of XALKORI at a time. Tell your doctor or nurse about the missed dose at your next visit.

Side Effects And What to Do About Them

Possible serious side effects include:

  • Heart tracing abnormality that could lead to heart rhythm disturbance – Tell your doctor or nurse right away if you experience dizziness, fainting, palpitations (irregular heartbeat), seizures, or chest discomfort.
  • Liver problems – Tell your doctor or nurse right away if you are feeling more tired than usual, your skin and whites of your eyes turn yellow, if you experience stomach pain, your urine turns dark or brown (tea color), you have nausea or vomiting, you have decreased appetite, you bleed or bruise more easily than normal, or if you have itching.
  • Lung inflammation – Tell your doctor or nurse right away if you have any new or worsening symptoms including difficulty breathing, cough or fever.
  • Vision problems - XALKORI may cause partial or complete loss of vision in one or both eyes. Tell your doctor right away if you have any loss of vision or if you have any change in vision such as difficulty seeing out of one or both eyes. Your doctor may stop XALKORI treatment and refer you to an eye doctor if you develop severe vision problems while taking XALKORI.

Very common side effects (these are likely to affect more than 10 in every 100 people):

  • Nausea, diarrhea, vomiting, constipation, swelling of the hands and feet, tiredness, trouble sleeping, weakness, dizziness, neuropathy (symptoms include numbness, prickling or tingling, burning, freezing, throbbing and/or shooting pain), change of taste, decreased appetite, abnormal liver enzymes, cough, shortness of breath, respiratory infections (such as tonsillitis, pharyngitis, laryngitis, and sinusitis), chest pain, low heart rate, abdominal pain, low red and white blood cell count, headache, fever, mouth ulcers, back pain, pain in joints, pain in extremities (hands, feet, arms, legs), and rash.
  • Visual changes such as perceived flashes of light, blurry vision, and double vision. They most commonly began soon after starting treatment with XALKORI.

Common side effects (these are likely to affect between 1 and 10 in every 100 people):

  • Upset stomach, and low blood pressure. Talk with your doctor about ways to handle these problems.

Serious Side Effects how Often They Happen and What to Do About Them

Symptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only if serveIn all
cases
Common
(≥1% to
<10%)
Lung
inflammation:
difficulty
breathing,
cough or fever
Infection of
the lung
(pneumonia)
Vomiting
Uncommon
(≥0.1% to
<1%)
Heart tracing
abnormality
that could
lead to heart
rhythm
disturbance:
dizziness,
fainting, or
chest
discomfort
Liver
problems:
feeling more
tired than
usual, skin
and whites of
eyes turn
yellow,
stomach pain,
urine turns
dark or brown
(tea color),
nausea or
vomiting,
decreased
appetite, bleed
or bruise more
easily than
normal, or
itching
Visual loss:
partial or
complete loss
of vision in
one or both
eyes
Fever
associated
with a marked
decrease in
the number of
neutrophils (a
type of white
blood cells)
Closed
pouches of
fluid within
the kidneys
(complex
kidney cysts):
includes
symptoms
such as pain
in the back or
side and blood
in urine

This is not a complete list of side effects. For any unexpected effects while taking XALKORI, contact your doctor or pharmacist.

How to Store It

  • Keep XALKORI and all medicines out of the reach of children.
  • Store XALKORI at room temperature at 25°C (with excursions between 15°C to 30°C). Do not touch or handle crushed or broken XALKORI capsules. XALKORI is formulated with a capsule to prevent contact with the active ingredient.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full Product Monograph, prepared for health professionals can be found at:http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.