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Caprelsa (Generic Vandetanib)

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WARNING

Vandetanib may extend QT intervals (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death). Inform your doctor if you or anyone in your family has ever experienced long QT syndrome (an hereditary disorder that increases the risk of QT prolongation), low blood levels of calcium, potassium, or magnesium, an irregular heartbeat, heart failure, or a heart attack. If you take any of the following medications: amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide, sotalol (Betapace), chloroquine (Aralen), clarithromycin (Biaxin, in Prevpac), haloperidol (Haldol), certain antiemetic drugs like dolasetron (Anzemet) and gran (Orap). Vandetanib should be stopped immediately if you develop any of the following symptoms: rapid, pounding, or irregular heartbeat; dizziness; lightheadedness; or loss of consciousness. You should also contact your doctor right away or seek emergency medical attention. For several months after you stop taking the medicine, vandetanib may still be present in your body, putting you at risk for side effects.

Keep all of your appointments with your physician and the lab. To ensure that taking vandetanib is safe for you, your doctor will prescribe a number of tests, including blood tests and electrocardiograms (EKGs, tests that capture the electrical activity of the heart). Moreover, your doctor will request these tests if your vandetanib dosage is altered or if you start taking any new medications.

To control the hazards associated with this medicine, a programme called Caprelsa Risk Evaluation and Mitigation Strategy (REMS) has been established. Vandetanib can only be given to you if the physician who is prescribing your medicine is a part of the programme. Only pharmacies that take part in the programme are allowed to provide you with the medication. If you have any queries on how to enrol in the programme or obtain your medication, consult your doctor.

If you need a prescription refill for vandetanib, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

You should discuss the dangers of taking vandetanib with your doctor.

Why is this medication prescribed?

A specific type of thyroid cancer that cannot be surgically removed or that has spread to other bodily parts is treated with vandetanib. Vandetanib belongs to the group of drugs known as kinase inhibitors. It functions by preventing the action of a problematic protein that instructs cancer cells to proliferate. This aids in containing or halting the spread of cancer cells.

How should this medicine be used?

Vandetanib is available as an oral tablet. It is typically taken once day, with or without food. Vandetanib should be taken every day at around the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Vandetanib must be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

With a glass of water, completely assimilate the tablets. Never eat, split, or crush them. Keep your skin away from the crushed tablet if it is to happen accidently. If contact occurs, thoroughly rinse the area with water.

The tablets can be dissolved in water if you are unable to swallow them whole. Put the tablet in a glass with 2 ounces of purified water that isn’t carbonated. To dissolve the tablet, do not use any other liquid. The tablet will not entirely dissolve; instead, it will break up into very little pieces after being stirred in the fluid for around 10 minutes. Consume the concoction immediately. To ensure that you ingest the entire dose of medication, rinse the glass with an additional 4 ounces of non-carbonated water and then sip that water.

Throughout your therapy, your doctor may advise you to take vandetanib at a lower dose or to stop taking it altogether for a while. This is dependent upon how effectively the drug works for you and any negative effects you encounter. Tell your doctor how you are feeling as you receive treatment. Even if you feel good, keep taking vandetanib. Without consulting your doctor, do not discontinue taking vandetanib.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking vandetanib,

  • If you have an allergy to vandetanib, any other medications, or any of the substances in vandetanib tablets, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention any of the following medications as well as those in the IMPORTANT WARNING section, including carbamazepine (Tegretol, Carbatrol, Equetro), dexamethasone, phenobarbital, phenytoin (Dilantin, Phenytek), rifabutin (Mycobutin), rifampin (Rifadin, in Rifamate), rifapentin (Priftin (Synthroid). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Vandetanib may interact with a wide variety of other drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s Wort.
  • Inform your physician if you have recently experienced blood in your cough or any other bleeding issues, and if you have ever experienced high blood pressure, any skin condition, seizures, or any type of lung, kidney, or liver disease.
  • Inform your doctor if you are expecting a child or if you intend to do so. Pregnancy should be avoided for at least 4 months after finishing vandetanib treatment as well as while you are taking it. During your therapy, discuss birth control options with your doctor. Call your doctor right away if you find out you’re pregnant while taking vandetanib. The foetus could be harmed by vandetanib.
  • Inform your doctor if you are nursing a baby.
  • Inform your doctor or dentist that you are taking vandetanib if you are having surgery, including dental surgery.
  • You should be aware that vandetanib may induce blurred vision, weakness, or drowsiness. Before you know how this prescription affects you, do not operate machinery or drive a car.
    Plan to use protective clothing, sunglasses, and sunscreen as well as to minimise excessive or prolonged sun exposure. During therapy with vandetanib and for as least 4 months after quitting it, your skin may become sensitive to sunlight.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it if it has been more than 12 hours since your last dose. Skip the missed dosage and continue with your regular dosing schedule if the next dose is due in less than 12 hours. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Vandetanib could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Heartburn
  • Reduced appetite
  • Slim down
  • Abdominal pain
  • Clogged nose
  • Extreme fatigue
  • Weakness
  • Having trouble falling or staying asleep
  • Depression

Some adverse effects may be severe. Get emergency medical care or call your doctor right away if you develop any of the following symptoms or any of those in the IMPORTANT WARNING section:

  • Diarrhea
  • Acne or a rash
  • Skin that is dry, flaky, or itchy
  • On the skin or in the mouth, blisters or sores
  • Cheeks, hands, or soles of the feet turning red
  • An aching muscle or joint
  • Fever
  • Chest ache (which may get worse with deep breaths or cough)
  • Cramps or shallow breathing
  • Immediate breathlessness
  • Recurring cough
  • Edoema of the lower legs, ankles, feet, or hands
  • Unexpected weight gain
  • Face, arm, or leg numbness or weakness, especially on one side of the body
  • Abrupt confusion
  • Trouble comprehending or speaking
  • Unexpected vision problems in either one or both eyes
  • Sudden difficulties with balance or walking
  • Acutely painful headache
  • Seizures
  • Significant bruising or bleeding

Further negative effects of vandetanib are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to vandetanib, your doctor will request specific lab tests. Throughout your vandetanib treatment, your doctor will also routinely monitor your blood pressure.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Caprelsa®
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