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The following information outlines essential safety warnings related to the use of Xalkori (crizotinib). It is important to understand these risks and precautions, and to discuss any concerns with your healthcare provider.

• Serious Lung Problems: Although uncommon, Xalkori (crizotinib) may lead to a serious lung condition known as interstitial lung disease (ILD). Contact your healthcare provider immediately if you experience a sudden or worsening cough, trouble breathing, or fever. Treatment may need to be paused or discontinued while the cause is investigated.

• Serious Liver Problems: Individuals with a history of liver issues should exercise caution, as Xalkori can exacerbate liver conditions.

• Abnormal Heart Rhythm: Patients with a history of heart failure, abnormal heart rhythms, or those taking medications that affect heart rhythm should be aware of the increased risk.

• Slow Heart Rate (Bradycardia): Those with a history of bradycardia or who are taking medications like metoprolol that can slow heart rate should monitor for changes.

• Serious Eye Problems: Vision changes, including blurred vision or significant vision loss, may occur. Adults should have an eye exam before starting treatment and monthly thereafter. Young adults and children should have an initial exam, another one month after starting, and then every three months. Depending on the severity of vision changes, discontinuation of Xalkori may be necessary.

• Nausea and Diarrhea: Children and young adults with ALCL or IMT may experience nausea, vomiting, and diarrhea. Preventive medication should be taken before each dose and as needed. Your healthcare provider can also suggest treatment options for diarrhea and provide dietary advice. Persistent symptoms lasting more than three days should be reported to your provider.

• Harm to Unborn Baby: Animal studies suggest potential harm to an unborn child or increased miscarriage risk. Females who can become pregnant should use birth control during treatment and for 45 days after the last dose. Notify your provider if pregnancy occurs. Males with partners who can become pregnant should use condoms during treatment and for at least three months post-treatment.

When taking this medication, some common side effects might be experienced, though they are often mild. These include nausea, vomiting, diarrhea, headache, tiredness, joint pain, constipation, mouth sores, heartburn, dizziness, and changes in taste or appetite. Muscle pain and runny nose with symptoms like a sore throat may also occur. It's important to monitor these effects and consult a healthcare provider if they persist or worsen.

There are also more serious side effects that, although rare, need immediate medical attention. These include severe liver issues indicated by persistent nausea, vomiting, stomach pain, dark urine, or yellowing of the skin or eyes. Serious lung problems may manifest as sudden coughing, fever, or difficulty breathing. Heart rhythm disturbances such as irregular heartbeat, severe dizziness, or fainting are critical signs to watch for. Additionally, vision changes, like blurry vision or sensitivity to light, swelling of the extremities, easy bruising or bleeding, and symptoms of infection such as fever or chills should be promptly reported to a healthcare professional.

In rare cases, severe allergic reactions may occur, which can include rash, intense itching, swelling of the face, tongue, or throat, and difficulty breathing. If any of these symptoms appear, seek medical help immediately. Remember, while some of these side effects can be concerning, many individuals using this medication do not experience severe issues. Always report any new or worsening symptoms to your healthcare provider for guidance.

Drug Interactions with Crizotinib

Crizotinib, marketed as Xalkori, may interact with a variety of medications and supplements. It is crucial to inform your healthcare provider about all the medications and supplements you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Certain medications can alter how crizotinib is processed in your body, potentially impacting its effectiveness. These include azole antifungals (like itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), seizure medications (like carbamazepine and phenytoin), and St. John's wort.

Additionally, crizotinib can interfere with the elimination of other medications from your body, affecting their performance. Medications that might be affected include alfentanil, flibanserin, fentanyl, tacrolimus, and others.

Moreover, crizotinib use is not recommended in combination with certain medications due to potential adverse interactions. These include drugs such as atazanavir, cisapride, and several others that can affect heart rhythm (QT prolongation). If these medications are necessary, your healthcare provider may adjust the dosages or frequency of administration.

There are also medications that are generally not recommended to be used with crizotinib unless specifically required. In such cases, your doctor may need to make adjustments to your treatment plan. These include drugs such as amiodarone, atenolol, digoxin, diltiazem, and others.

Lastly, some medications may increase the risk of side effects when used with crizotinib, but might still be the best treatment option for you. These include midazolam and suvorexant, among others. Your healthcare provider will closely monitor your therapy and may adjust dosages as needed to minimize risks.

Always consult with your healthcare provider before making any changes to your medication regimen to ensure safety and efficacy.