TYKERB (Page 7 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
The 250 mg tablets of TYKERB are oval, biconvex, orange, and film-coated with ‘GS XJG’ debossed on one side and are available in:
Bottles of 150 tablets: NDC 0078-0671-19
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the following:
Decreased Left Ventricular Ejection Fraction (LVEF)
- TYKERB has been reported to decrease left ventricular ejection fraction which may result in shortness of breath, palpitations, and/or fatigue [see Warnings and Precautions (5.1)]. Advise patients to inform their healthcare provider if they develop these symptoms while taking TYKERB.
Hepatotoxicity and Hepatic Impairment
- Periodic laboratory testing will be performed while taking TYKERB. Advise patients to report signs and symptoms of liver dysfunction to their healthcare provider right away [see Warnings and Precautions (5.2)].
Diarrhea
- TYKERB often causes diarrhea which may be severe in some cases [see Warnings and Precautions (5.4)]. Instruct patients on how to manage and/or prevent diarrhea and to inform their healthcare provider immediately if there is any change in bowel patterns or severe diarrhea occurs during treatment with TYKERB.
Interstitial Lung Disease/Pneumonitis
- Advise patients to report pulmonary signs or symptoms indicative of ILD or pneumonitis [see Warnings and Precautions (5.5)]
Severe Cutaneous Reactions
- Advise patients to report severe cutaneous reactions to their healthcare provider if they develop these symptoms while taking TYKERB [see Warnings and Precautions (5.7)].
Drug and Food Interactions
- TYKERB may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products [see Drug Interactions (7)].
- TYKERB may interact with grapefruit. Advise patients not to take TYKERB with grapefruit products [see Dosage and Administration (2.2) and Drug Interactions (7.2)].
Dosing Administration
- TYKERB should be taken at least one hour before or one hour after a meal, in contrast to capecitabine which should be taken with food or within 30 minutes after food. The dose of TYKERB should be taken once daily. Dividing the daily dose is not recommended [see Dosage and Administration (2.1)].
Embryo-Fetal Toxicity
- Inform female patients of the risk to a fetus and potential loss of the pregnancy. Advise females to inform their healthcare provider if they are pregnant or become pregnant [see Use in Specific Populations (8.1)].
- Advise females of reproductive potential to use effective contraception during treatment with TYKERB and for 1 week after the last dose.
- Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose [see Warning and Precautions (5.8) and Use in Specific Populations (8.1, 8.3)].
Lactation
- Advise patients not to breastfeed during treatment and for 1 week after the last dose of TYKERB [see Use in Specific Populations (8.2)].
Distributed by
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
© Novartis
T2022-23
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: March 2022 |
PATIENT INFORMATIONTYKERB® (TIE-curb)(lapatinib)tablets | |
What is TYKERB? TYKERB is a prescription medicine used:
It is not known if TYKERB is safe and effective in children. | |
Do not take TYKERB if you are allergic to any of the ingredients in TYKERB. A complete list of ingredients in TYKERB can be found at the end of this Patient Information. | |
Before taking TYKERB, tell your healthcare provider about all of your medical conditions, including if you:
For females, tell your healthcare provider if you:
For males with female partners who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TYKERB may affect the way other medicines work, and other medicines may affect the way TYKERB works. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. Do not take other medicines during treatment with TYKERB without first talking with your healthcare provider. | |
How should I take TYKERB?
| |
What are the possible side effects of TYKERB? TYKERB may cause serious side effects, including:
| |
|
|
Your healthcare provider should check your heart function before you start taking TYKERB and during treatment.
| |
Your healthcare provider should do blood tests to check your liver before you start taking TYKERB and during treatment.
Call your healthcare provider right away if you have any of the signs or symptoms of the serious side effects listed above. | |
Common side effects of TYKERB in combination with capecitabine or letrozole include: | |
|
|
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TYKERB. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also get side effects from the other medicines taken with TYKERB. Talk to your healthcare provider about possible side effects you may get during treatment. | |
How should I store TYKERB?
Keep TYKERB and all medicines out of the reach of children. | |
General information about the safe and effective use of TYKERB. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TYKERB for a condition for which it was not prescribed. Do not give TYKERB to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TYKERB that is written for health professionals. | |
What are the ingredients in TYKERB? Active ingredient: Lapatinib. Inactive ingredients: Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Coating: Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 © Novartis For more information, call 1-888-669-6682 or go to www.tykerb.com. |
T2022-24
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.