caprelsa

Caprelsa (vandetanib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Caprelsa is used to treat thyroid cancer.

Caprelsa is available only from a certified pharmacy under a special program called Caprelsa REMS Program. You must be registered in the program and understand the risks of taking this medicine.

Important information

Do not use Caprelsa if you are pregnant. It could harm the unborn baby.

You should not use this medicine if you have severe liver disease, a personal or family history of Long QT syndrome, or if you have low blood levels of calcium, potassium, or magnesium.

Call your doctor right away if you have a headache with chest pain and severe dizziness, fainting, and fast or pounding heartbeats.

There are many other drugs that can interact with Caprelsa. Tell your doctor about all medications you use. To be sure Caprelsa is not causing harmful effects, your blood may need to be tested often. Your heart rate may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

If you need surgery, tell the surgeon ahead of time that you are using Caprelsa. You may need to stop using the medicine for a short time. Do not stop taking this medication unless your doctor tells you to. If you stop taking Caprelsa for longer than 2 weeks for any reason, do not start taking it again without your doctor"s advice.

Before taking this medicine

You should not use Caprelsa if you are allergic to vandetanib, or if you have:

• severe liver disease;

• a personal or family history of long QT syndrome; or

• low levels of calcium, magnesium, or potassium in your blood.

To make sure Caprelsa is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, or a heart rhythm disorder;

• overactive thyroid;

• kidney disease;

• liver disease;

• low levels of calcium, magnesium, or potassium in your blood;

• epilepsy or other seizure disorder;

• a history of breathing problems;

• severe diarrhea;

• skin problems;

• if you have recently coughed up blood; or

• if you take other medications.

Do not use Caprelsa if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 4 months after your treatment ends.

It is not known whether vandetanib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Caprelsa.

How should I take Caprelsa?

Caprelsa is usually taken once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Caprelsa with or without food.

Do not crush a Caprelsa tablet. Swallow the tablet whole.

To make swallowing easier, place the tablet into a glass of water (2 ounces) and stir until the tablet is dispersed in the water. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add 4 ounces more water to the same glass, swirl gently and drink right away.

The dispersed tablet mixture can also be given through a nasogastric (NG) or gastronomy feeding tube. Follow your doctor"s instructions.

Do not use a broken pill. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

While using Caprelsa, you may need frequent blood tests. Your heart rate may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG) every 2 weeks to 3 months during treatment. Your dose or medication schedule may be changed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using Caprelsa. You may need to stop using the medicine for a short time.

Do not stop taking this medication unless your doctor tells you to. If you stop taking Caprelsa for longer than 2 weeks for any reason, do not start taking it again without your doctor"s advice.

Store at room temperature away from moisture and heat.

Caprelsa dosing information

Usual Adult Dose for Thyroid Cancer:

Initial dose: 300 mg orally once daily.
Duration of therapy: Continue drug until disease progression or unacceptable toxicity occurs.

Use: For the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Caprelsa?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking an herbal supplement containing St. John"s wort at the same time you are taking Caprelsa.

Avoid exposure to sunlight or tanning beds. Caprelsa can make you sunburn more easily, for up to 4 months after you stop taking the medicine. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Caprelsa side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Caprelsa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Caprelsa and call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• confusion, change in mental status, thinking problems, seizure (convulsions), loss of consciousness;

• new or worsening cough, wheezing, shortness of breath;

• swelling, rapid weight gain;

• severe or ongoing diarrhea;

• dry skin, acne, blisters, itching, peeling, redness, or swelling;

• easy bruising, unusual bleeding;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• dangerously high blood pressure - severe headache, pounding in your neck or ears, anxiety, irregular heartbeats;

• thyroid symptoms - extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Caprelsa side effects may include:

• high blood pressure (severe headache, pounding in your neck or ears);

• diarrhea, stomach cramps;

• headache;

• acne, skin rash;

• nausea, loss of appetite; or

• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Caprelsa?

Many drugs can interact with vandetanib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Caprelsa, especially:

• anagrelide, arsenic trioxide, droperidol, methadone;

• an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, rifampicin;

• an antidepressant - citalopram, escitalopram;

• anti-malaria medication - chloroquine, halofantrine;

• heart medicine - amiodarone, digoxin, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, quinidine, sotalol;

• medicine to prevent nausea and vomiting - dolasetron, ondansetron, granisetron; or

• medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete and many other drugs can interact with vandetanib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.