TABRECTA (Page 5 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Strength | Description | Tablets per bottle | NDC number |
150 mg | Pale orange brown, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘DU’ on one side and ‘NVR’ on the other side. | 56 | 0078-0709-56 |
200 mg | Yellow, ovaloid, curved film-coated tablet with beveled edges, unscored, debossed with ‘LO’ on one side and ‘NVR’ on the other side. | 56 | 0078-0716-56 |
Storage
Dispense in the original package with the desiccant cartridge. 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]. Protect from moisture.
Discard any unused TABRECTA remaining after 6 weeks of first opening the bottle.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Interstitial Lung Disease (ILD)/Pneumonitis
Inform patients of the risks of severe or fatal ILD/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Warnings and Precautions (5.1)].
Hepatotoxicity
Inform patients that they will need to undergo lab tests to monitor liver function. Advise patients to immediately contact their healthcare provider for signs and symptoms of liver dysfunction [see Warnings and Precautions (5.2)].
Pancreatic Toxicity
Inform patients that they will need to undergo lab tests to monitor pancreatic function. Advise patients to immediately contact their healthcare provider for signs and symptoms of pancreatitis [see Warnings and Precautions (5.3)].
Hypersensitivity Reactions
Inform patients that there is a risk of hypersensitivity reactions with TABRECTA. Advise patients to stop taking TABRECTA and immediately contact their healthcare provider for signs and symptoms of hypersensitivity [see Warnings and Precautions (5.4)].
Risk of Photosensitivity
Inform patients that there is a potential risk of photosensitivity reactions with TABRECTA. Advise patients to limit direct ultraviolet exposure by using sunscreen or protective clothing during treatment with TABRECTA [see Warnings and Precautions (5.5)].
Embryo-Fetal Toxicity
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].
Lactation
Advise women not to breastfeed during treatment with TABRECTA and for 1 week after the last dose [see Use in Specific Populations (8.2)].
Distributed by:
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
© Novartis
T2024-19
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 3/2023 | |
PATIENT INFORMATIONTABRECTA® (ta brek tah)(capmatinib) tablets | ||
What is TABRECTA? TABRECTA is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC) that:
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Before taking TABRECTA, tell your healthcare provider about all of your medical conditions, including if you:
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How should I take TABRECTA?
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What should I avoid while taking TABRECTA?
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What are the possible side effects of TABRECTA?TABRECTA may cause serious side effects, including:
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◦ cough | ◦ fever | ◦ trouble breathing or shortness of breath |
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◦ your skin or the white part of your eyes turns yellow (jaundice) ◦ dark or “tea-colored” urine ◦ light-colored stools (bowel movements) ◦ confusion ◦ tiredness ◦ loss of appetite for several days or longer | ◦ nausea and vomiting ◦ pain, aching, or tenderness on the right side of your stomach-area (abdomen) ◦ weakness ◦ swelling in your stomach-area | |
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◦ fever ◦ chills ◦ itching ◦ rash | ◦ dizziness or feeling faint ◦ nausea ◦ vomiting | |
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The most common side effects of TABRECTA include: | ||
• swelling of your hands or feet • nausea • muscle or bone pain • tiredness and weakness • vomiting | • trouble breathing • cough • loss of appetite • changes in certain blood tests | |
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TABRECTA if you develop certain side effects.These are not all of the possible side effects of TABRECTA.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
How should I store TABRECTA?
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General information about the safe and effective use of TABRECTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TABRECTA for a condition for which it was not prescribed. Do not give TABRECTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TABRECTA that is written for health professionals. | ||
What are the ingredients in TABRECTA? Active ingredient: capmatinibInactive ingredients: Tablet core: colloidal silicon dioxide; crospovidone; magnesium stearate; mannitol; microcrystalline cellulose; povidone; and sodium lauryl sulfate.Tablet coating (150 mg): ferric oxide, red; ferric oxide, yellow; ferrosoferric oxide; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.Tablet coating (200 mg): ferric oxide, yellow; hypromellose; polyethylene glycol (PEG) 4000; talc; and titanium dioxide.Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936For more information, go to www.TABRECTA.com or call 1-844-638-5864.© Novartis |
T2023-16
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