Saturday 22 September 2012

Tykerb


Generic Name: lapatinib (Oral route)

la-PA-ti-nib

Oral route(Tablet)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain .



Commonly used brand name(s)

In the U.S.


  • Tykerb

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Tyrosine Kinase Inhibitor


Uses For Tykerb


Lapatinib belongs to the group of medicines called antineoplastics or cancer medicines. It is used in combination with capecitabine to treat advanced or metastatic HER2-receptor positive breast cancer (breast cancer that has already spread) after other treatments have failed.


Lapatinib is also used together with letrozole to treat postmenopausal women (women who no longer make estrogen) with hormone-receptor positive and HER2-receptor positive metastatic breast cancer.


Lapatinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern.


Before you begin treatment with lapatinib, you and your doctor should talk about the good this medicine will do as well as the risks of using it.


This medicine is available only with your doctor's prescription.


Before Using Tykerb


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of lapatinib in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lapatinib in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Cisapride

  • Dronedarone

  • Fluconazole

  • Mesoridazine

  • Pimozide

  • Posaconazole

  • Saquinavir

  • Sparfloxacin

  • Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alfuzosin

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Atazanavir

  • Azithromycin

  • Carbamazepine

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Desipramine

  • Dexamethasone

  • Digoxin

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Erythromycin

  • Flecainide

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Levofloxacin

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Moxifloxacin

  • Nefazodone

  • Nelfinavir

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Perflutren Lipid Microsphere

  • Phenobarbital

  • Phenytoin

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Rifabutin

  • Rifampin

  • Rifapentine

  • Ritonavir

  • Salmeterol

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • St John's Wort

  • Sunitinib

  • Telavancin

  • Telithromycin

  • Terfenadine

  • Tetrabenazine

  • Toremifene

  • Trazodone

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Paclitaxel

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Grapefruit Juice

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Diarrhea or

  • Liver disease, history of or

  • Lung disease (e.g., interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.

  • Heart disease, history of or

  • Heart rhythm problems (e.g., congenital long QT syndrome) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become worse.

Proper Use of Tykerb


Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change your dose without checking first with your doctor.


This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


This medicine should be taken at least one hour before or one hour after a meal. All of the lapatinib tablets are taken together as one dose each day.


Lapatinib is given together with capecitabine or letrozole. It is important that you take each medicine at the right time. Follow your doctor's instructions on when to take these medicines.


This medicine often causes diarrhea, nausea, and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Your doctor may give you medicines to help prevent these side effects.


Do not eat grapefruit or drink grapefruit juice while you are using this medicine.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For advanced or metastatic breast cancer with capecitabine:
      • Adults—1250 milligrams (mg) or 5 tablets together as a single dose once a day for 21 days. Your doctor may tell you to repeat the 21-day cycle.

      • Children—Use and dose must be determined by your doctor.


    • For metastatic breast cancer with letrozole:
      • Adults—1500 milligrams (mg) or 6 tablets together as a single dose once a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Tykerb


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Serious heart problems can occur with this medicine. Check with your doctor right away if you are having fast, pounding, or irregular heartbeats; shortness of breath; or unusual tiredness or weakness.


Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; a loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


Check with your doctor immediately if severe diarrhea occurs while taking this medicine. You may need certain medicines to help manage or prevent the diarrhea.


Stop using this medicine and check with your doctor right away if you start having breathing problems, shortness of breath, a cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's Wort) or vitamin supplements.


Tykerb Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Difficult or labored breathing

  • fainting

  • fast or irregular heartbeat

  • severe diarrhea

  • shortness of breath

  • tightness in the chest

  • unusual tiredness or weakness

  • wheezing

Incidence not known
  • Chest pain

  • chills

  • cough

  • fever

  • general feeling of discomfort or illness

  • thickening of bronchial secretions

  • troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • back pain

  • belching

  • cracked lips

  • diarrhea

  • difficulty with swallowing

  • dry skin

  • heartburn

  • indigestion

  • nausea

  • pain in the arms or legs

  • rash

  • redness, swelling, or painful skin

  • scaling of the skin on the hands and feet

  • sleeplessness

  • sores, ulcers, or white spots on the lips, tongue, or the inside of the mouth

  • stomach discomfort, upset, or pain

  • swelling or inflammation of the mouth

  • tingling of the hands and feet

  • trouble sleeping

  • unable to sleep

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tykerb side effects (in more detail)



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More Tykerb resources


  • Tykerb Side Effects (in more detail)
  • Tykerb Dosage
  • Tykerb Use in Pregnancy & Breastfeeding
  • Tykerb Drug Interactions
  • Tykerb Support Group
  • 1 Review for Tykerb - Add your own review/rating


  • Tykerb Prescribing Information (FDA)

  • Tykerb Consumer Overview

  • Tykerb Monograph (AHFS DI)

  • Tykerb MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lapatinib Professional Patient Advice (Wolters Kluwer)



Compare Tykerb with other medications


  • Breast Cancer
  • Breast Cancer, Metastatic

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