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Caprelsa is used to treat a type of thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.
Caprelsa may only be available under a special restricted distribution program called the Caprelsa REMS Program. Only healthcare providers and pharmacies registered with the program are able to prescribe and distribute Caprelsa. Your healthcare provider will explain this program to you and you will likely receive Caprelsa from a specialty pharmacy.
How does this medication work?
Caprelsa works by slowing down the growth and spread of tumors.
What are the beneficial effects of this medication and when should I begin to have results?
What: Caprelsa has been shown to improve progression-free survival (the amount of time a patient lives without the cancer progressing).
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's instructions. It is important that you take Caprelsa exactly as your healthcare provider has prescribed.
How do I know it is working?
Your healthcare provider may order tests regularly to check how well this medication is working.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Caprelsa can cause a change in the electrical activity of your heart called QT prolongation, which can cause irregular heartbeats that may be life threatening. You should not take Caprelsa if you have had a condition called long QT syndrome since birth. Your healthcare provider should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone, as well as the electrical activity of your heart with a test called an electrocardiogram (ECG). Only healthcare providers and pharmacies certified with the restricted distribution program are able to prescribe and dispense Caprelsa.
More common side effects may include: diarrhea, rash, acne (pimples), nausea, high blood pressure, headache, loss of appetite, upper respiratory infections, stomach pain.
Less common side effects may include:
Serious skin reactions with symptoms such as skin rash or acne, dry skin, itching, blisters, sores in your mouth, peeling of your skin, fever, muscle or joint aches, or redness or swelling of your face, hands, or soles of your feet.
Breathing problems with symptoms such as new or worsening cough or shortness of breath.
Caprelsa may increase your risk of having a stroke. Tell your healthcare provider right away if you develop numbness or weakness of the face, arms, or legs, especially on one side of your body; sudden confusion, trouble speaking, or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, or loss of balance or coordination; or sudden, severe headache.
A condition called Reversible Posterior Leukoencephalopathy Syndrome with symptoms such as headaches, seizure, confusion, changes in vision, or problems thinking.
Caprelsa may also cause bleeding, heart problems, or changes in your thyroid hormone levels.
Harm to your unborn baby. Contact your healthcare provider immediately if you believe or suspect you are pregnant while you are receiving Caprelsa.
Do not take Caprelsa if you are allergic to it or any of its ingredients.
Do not take Caprelsa if you have any heart problems, including a condition called long QT syndrome.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Caprelsa. Also, talk to your healthcare provider about your complete medical history, especially if you if you are pregnant, plan to become pregnant, or are breastfeeding, or if you have any of the following: heart problems (including long QT syndrome and irregular heartbeat); liver or kidney problems; low blood calcium, magnesium, or potassium levels; high blood levels of thyroid-stimulating hormone; high blood pressure; skin problems; a history of breathing problems; recent history of coughing up blood or bleeding; diarrhea; seizures.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: The recommended dose is 300 milligrams once a day.
If you have kidney problems, your healthcare provider may adjust your dose appropriately.
Take Caprelsa exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Caprelsa without first talking to your healthcare provider.
Take Caprelsa with or without food.
Do not crush Caprelsa tablets.
If you cannot swallow Caprelsa tablets whole, you can place your dose in a glass that contains 2 ounces of noncarbonated water. Stir the tablet(s) in the water for about 10 minutes or until the tablet(s) are in very small pieces. Swallow the mixture right away. If any tablet mixture remains in the glass, mix with an additional 4 ounces of noncarbonated water and swallow the mixture.
Do not expose your skin to excessive sunlight. Caprelsa can make your skin more sensitive to sunlight. Use sun block and wear clothes that cover your skin during your treatment with Caprelsa and for 4 months after stopping your Caprelsa treatment.
Do not drive a car, operate heavy machinery, or engage in other dangerous activities until you know how Caprelsa affects you.
If Caprelsa is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Caprelsa may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
Caprelsa can harm your unborn baby if you take it during pregnancy. Women who are able to become pregnant should avoid pregnancy and use effective birth control during treatment and up to 4 months after the last dose. The effects of Caprelsa during breastfeeding are unknown. Do not breastfeed while you are taking Caprelsa. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Caprelsa and it is more than 12 hours until your next dose, take the missed dose as soon as you remember and return to your regular dosing schedule. However, if your next dose is less than 12 hours away, skip the missed dose and take your next dose at the normal time. Do not take two doses at once.
Store at room temperature.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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