Caprelsa

• Risk factors: Taking other medications that cause QT prolongation | Born with QT prolongation | History of abnormal heart rhythms (arrhythmias) | Taking medications that interact with Caprelsa (vandetanib)

Caprelsa (vandetanib) can lengthen the time period from when the heart squeezes and then relaxes. This is known as QT prolongation and is tested with an electrocardiogram (EKG). When this happens, it raises the risk for life-threatening abnormal heart rhythms.

Your risk of QT prolongation is greater if you have low levels of calcium, potassium, or magnesium in your body, or if you’re taking other medications that cause QT prolongation. Your provider might run tests to make sure your electrolytes are normal. Be sure to tell your provider about all the medications you’re taking and don’t start any new medications while taking Caprelsa (vandetanib) without talking to your provider or pharmacist first. If you feel your chest pounding, short of breath, chest pain, feeling faint, or lightheaded while taking Caprelsa (vandetanib), call 911 right away.

Due to the risk of QT prolongation, Caprelsa (vandetanib) is only available through a restricted program called Caprelsa (vandetanib) Risk Evaluation and Mitigation Strategy (REMS). This program is set so that only select providers and pharmacies can dispense or prescribe this medication. If you have questions about the REMS program, talk with your provider.

Caprelsa (vandetanib) can sometimes cause serious skin reactions, such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Although this is rare, these skin reactions can lead to hospitalization and other complications. Severe skin reactions can happen at any time while taking Caprelsa (vandetanib) and even up to 4 months after stopping treatment. Get medical care right away if you have a rash, blistering or peeling skin, painful sores on your face, swelling, or trouble breathing.

Rare, but serious lung problems, including inflammation of the lungs and pneumonia can happen while taking Caprelsa (vandetanib). Let your provider know if you have difficulty breathing, cough, or fatigue during your treatment.

• Risk factors: Heart problems

Caprelsa (vandetanib) can lead to new or worsening heart failure and affect how well your heart pumps blood through your body. If you have heart problems, your provider will monitor you more regularly to make sure it doesn't get worse. Tell your provider if you have symptoms of heart problems including, shortness of breath that worsens with activity or while lying flat, swelling in your legs or feet, sudden weight gain, fatigue, or dizziness.

Rare cases of a brain condition called posterior reversible encephalopathy syndrome (PRES) have happened with people taking Caprelsa (vandetanib). It can occur from swelling and narrowing of blood vessels in the brain and have serious symptoms. Get medical help right away if you have sudden severe headaches, sudden confusion, sudden vision loss or vision changes, behavioral changes, or seizures. You’ll have to stop the medication right away if you have PRES.

• Risk factors: Diabetes | High cholesterol | Alcohol use | High blood pressure

Caprelsa (vandetanib) can cause a stroke . Get emergency help right away if you have any signs of a stroke, including weakness or numbness in your arms, brain, legs, or face on one side of the body, trouble speaking, blurred vision, loss of balance, trouble walking, or confusion.

Caprelsa (vandetanib) can raise the risk of serious bleeding, which can result in death. Bleeding can happen anywhere in the body. Tell your provider right away if you experience any serious or unusual bleeding. Get urgent medical attention if you have severe or sudden headaches, extreme weakness, change in vision, large amounts of blood in your stool, or coughing up blood.

Caprelsa (vandetanib) can cause low levels of thyroid hormone (hypothyroidism), an important hormone needed for your body to function normally. Your provider will check your thyroid levels regularly while you’re taking this medication to make sure your thyroid hormone levels are normal.

• Risk factors: History of high blood pressure

Caprelsa (vandetanib) can raise your blood pressure. Your provider might ask you to monitor your blood pressure at home. If your blood pressure starts to rise, you might need to start blood pressure lowering medications. Also if your blood pressure gets too high, your provider might have you lower your dose of Caprelsa (vandetanib) or stop taking the medication altogether. Let your provider know if you notice symptoms of high blood pressure, such as dizziness and headaches.

• Risk factors: History of kidney problems

Caprelsa (vandetanib) can lead to kidney problems that can be serious. Your provider will monitor your kidney health regularly through lab work. If you develop kidney problems, you might need to stop Caprelsa (vandetanib). Talk with your provider if you notice changes in how often you urinate or if there is any blood in your urine so they can check for kidney issues.

Caprelsa (vandetanib) can make it harder for wounds to heal. Tell your provider if you have any injuries or if your wounds aren't healing or healing very slowly. Let your provider know if you have any planned surgeries or procedures. Your provider will need to give you instructions on when to stop and restart Caprelsa (vandetanib). In general, you should stop taking Caprelsa (vandetanib) for at least 1 month before surgery and for at least 2 weeks after surgery so that your wounds can heal.

Caprelsa (vandetanib) can cause harm to unborn babies. If you’re able to become pregnant, your provider will have you do a pregnancy test before starting treatment. Use effective birth control while taking this medication and for at least 4 months after your last dose.