Caprelsa

The regular adult dose of Caprelsa (Vandetanib) is 300 mg taken by mouth, once daily. Caprelsa (Vandetanib) should be taken at approximately the same time each day, and may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Caprelsa (Vandetanib) tablets should not be crushed, as Caprelsa (Vandetanib) is irritating to the skin and soft tissue in the mouth. If you are not able to swallow these tablets whole, you may drop the whole tablet in half a glass of plain water and stir until it is dissolved (approximately 10 minutes). Drink the solution immediately. To make sure there is no medication left in the glass, add another half glass of water to the empty glass and drink that as well. Use only plain, uncarbonated water and do not crush the tablets.

It is important to take Caprelsa (Vandetanib) exactly as prescribed by your doctor. If you miss a dose, and it is 12 hours or more before your next dose, take the missed dose as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Caprelsa (Vandetanib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

100 mg
Each round, white, biconvex, film-coated tablet, impressed with "Z100" on one side and plain on the other, contains 100 mg of Caprelsa (Vandetanib). Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, crospovidone, hypromellose 2910, macrogol 300, magnesium stearate, microcrystalline cellulose, povidone, and titanium dioxide E171.

300 mg
Each oval, white, biconvex, film-coated tablet, impressed with"Z300" on one side and plain on the other, contains 300 mg of Caprelsa (Vandetanib). Nonmedicinal ingredients: calcium hydrogen phosphate dihydrate, crospovidone, hypromellose 2910, macrogol 300, magnesium stearate, microcrystalline cellulose, povidone, and titanium dioxide E171.

Do not take Caprelsa (Vandetanib) if you:

• are allergic to Caprelsa (Vandetanib) or any ingredients of the medication
• have long QT syndrome (a type of irregular heartbeat)
• have high blood pressure that is not controlled
• have uncorrected low levels of potassium, magnesium or calcium in your blood

There may be an interaction between Caprelsa (Vandetanib) and any of the following:

• Alfuzosin
• Amiodarone
• anticancer medications (e.g., Capecitabine, Fluorouracil, Oxaliplatin)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Apomorphine
• Atomoxetine
• azole antifungals (e.g., fluconazole, itraconazole, Voriconazole)
• beta-adrenergic agonists (e.g., formoterol, Indacaterol, olodaterol, salbutamol, salmeterol)
• bisphosphonates (e.g., Alendronate, etidronate)
• Bosentan
• Carbamazepine
• chloroquine
• Deferasirox
• Degarelix
• Digoxin
• Disopyramide
• Domperidone
• Donepezil
• Doxepin
• Dronedarone
• Eliglustat
• Enzalutamide
• Fingolimod
• Flecainide
• fosphenytoin
• Goserelin
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Hydroxyzine
• Leuprolide
• lithium
• Loperamide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Mefloquine
• Metformin
• Methadone
• mifepristone
• Mirtazapine
• Mitotane
• Modafinil
• Pasireotide
• pentamidine
• pentobarbital
• Phenytoin
• Primaquine
• primidone
• procainamide
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, Ofloxacin)
• rifabutin
• rifampin
• rilpivirine
• Romidepsin
• St. John's wort
• Sarilumab
• selective 5-HT receptor antagonists (e.g., Granisetron, Ondansetron)
• selective serotonin inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• siponimod
• Solifenacin
• Sotalol
• Tacrolimus
• Tamoxifen
• Tetrabenazine
• Tocilizumab
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, doxepin, Imipramine, Nortriptyline)
• other tyrosine kinase inhibitors (e.g., Ceritinib, Dabrafenib, Dasatinib, imatinib, Nilotinib)
• Vardenafil
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Caprelsa (Vandetanib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Caprelsa (Vandetanib).

Abnormal heart rhythms: Caprelsa (Vandetanib) may cause a heart rhythm problem called QT prolongation. Sudden death has been reported by patients taking Caprelsa (Vandetanib). If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, Heart Attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how Caprelsa (Vandetanib) may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of Caprelsa (Vandetanib). Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Bleeding: Caprelsa (Vandetanib) can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.

Drowsiness/reduced alertness: Caprelsa (Vandetanib) may cause drowsiness or blurred vision. If you are feeling tired or weak or you have blurred vision while taking Caprelsa (Vandetanib), avoid driving, operating machinery, and doing other tasks that require alertness.

Fluid and electrolyte balance: Caprelsa (Vandetanib) may cause the levels of electrolytes such as potassium, magnesium, and calcium in the blood to change while taking Caprelsa (Vandetanib). Caprelsa (Vandetanib) can also cause severe diarrhea which can affect electrolyte balance. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Caprelsa (Vandetanib).

Grapefruit juice: Grapefruit juice affects how Caprelsa (Vandetanib) is removed from the body. It may cause too much of the medication to build up in the body and cause possibly harmful side effects. Do not drink grapefruit juice or eat grapefruit at any time while taking Caprelsa (Vandetanib).

Heart failure: People taking Caprelsa (Vandetanib) have experienced heart failure (the heart is not able to pump blood efficiently). This may be accompanied by fluid retention or fluid in the lungs (pulmonary edema). If you experience shortness of breath, chest pain, swelling, or weight gain, contact your doctor immediately.

High blood pressure: Caprelsa (Vandetanib) can cause increased blood pressure, which may become dangerously high and cause stroke. If blood pressure cannot be controlled, the dose of Caprelsa (Vandetanib) may need to be decreased.

Infection: As well as killing cancer cells, Caprelsa (Vandetanib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Kidney Disease or reduced kidney function may cause Caprelsa (Vandetanib) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Caprelsa (Vandetanib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Caprelsa (Vandetanib), and whether any special monitoring is needed.

Liver function: Caprelsa (Vandetanib) has been reported to cause decreased liver function and, in some cases, liver failure that has caused death. If you have a history of liver disease or reduced liver function, discuss with your doctor how Caprelsa (Vandetanib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Caprelsa (Vandetanib), and whether any special monitoring is needed. Caprelsa (Vandetanib) is not recommended for people with moderately-to-severely reduced liver function.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease) causing difficulty breathing has occurred on rare occasions for some people taking Caprelsa (Vandetanib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Caprelsa (Vandetanib), contact your doctor immediately.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like Caprelsa (Vandetanib). If you have had a previous episode of RPLS, Caprelsa (Vandetanib) may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Skin sensitivity: Caprelsa (Vandetanib) may increase the sensitivity of the skin to sunlight, increasing the risk of Sunburn. Wear protective clothing and sunblock while taking Caprelsa (Vandetanib) and for 4 months afterwards.

Caprelsa (Vandetanib) can also cause severe skin reactions that may be life-threatening. If you notice any unusual skin rash or peeling, a rash that develops quickly or develops with fever, contact your doctor immediately.

Thyroid function: Caprelsa (Vandetanib) may affect how thyroid hormone is used by your body. Some people who take thyroid hormone replacement need to have an increased dose of thyroid medication when they take Caprelsa (Vandetanib). If you have thyroid disease or have had your thyroid gland removed, discuss with your doctor how Caprelsa (Vandetanib) may affect your medical condition. Your doctor may want to test your thyroid function regularly with blood tests while you are taking Caprelsa (Vandetanib).

Wound healing: Caprelsa (Vandetanib) may slow the speed at which wounds heal. Ensure any health care professionals, including dentists and other doctors, are aware that you are taking Caprelsa (Vandetanib).

Pregnancy: Caprelsa (Vandetanib) may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking Caprelsa (Vandetanib), contact your doctor immediately. Women of childbearing age who are taking Caprelsa (Vandetanib) should use an effective method of birth control (e.g., birth control pill, condoms) during treatment and for at least 3 months after the last dose of Caprelsa (Vandetanib).

Men receiving Caprelsa (Vandetanib) must use an effective method of contraception during treatment and for 2 months following the last dose.

Breast-feeding: It is not known if Caprelsa (Vandetanib) passes into breast milk. If you are a breast-feeding mother and are taking Caprelsa (Vandetanib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Caprelsa (Vandetanib) have not been established for children.