This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 2/2022 |
MEDICATION GUIDE BRAFTOVI® (braf-TOE-vee) (encorafenib) capsules | |
Important information: BRAFTOVI is used with other medicines, either binimetinib or cetuximab. Read the Patient Information leaflet that comes with binimetinib if used with binimetinib, and talk to your healthcare provider about cetuximab if used with cetuximab. | |
What is the most important information I should know about BRAFTOVI? BRAFTOVI may cause serious side effects, including:
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What is BRAFTOVI? BRAFTOVI is a prescription medicine used:
It is not known if BRAFTOVI is safe and effective in children. | |
Before taking BRAFTOVI, tell your healthcare provider about all of your medical conditions, including if you:
BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or the other medicines work. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. | |
How should I take BRAFTOVI?
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What are the possible side effects of BRAFTOVI? BRAFTOVI may cause serious side effects, including: See "What is the most important information I should know about BRAFTOVI?"
These are not all the possible side effects of BRAFTOVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729. | |
How should I store BRAFTOVI?
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General information about the safe and effective use of BRAFTOVI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRAFTOVI for a condition for which it was not prescribed. Do not give BRAFTOVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BRAFTOVI that is written for health professionals. | |
What are the ingredients in BRAFTOVI? Active ingredient: encorafenib Inactive ingredients: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, and magnesium stearate of vegetable origin Capsule shell: gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol) Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. Boulder, Colorado 80301. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. LAB-1429-2.0 For more information, go to www.BRAFTOVIMEKTOVI.com or call 1-844-792-7729. © 2020 Array BioPharma Inc. All rights reserved. |
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the following:
New Primary Cutaneous Malignancies
Advise patients to contact their healthcare provider immediately for change in or development of new skin lesions [see Warnings and Precautions (5.1)].
Hemorrhage
Advise patients to notify their healthcare provider immediately with any symptoms suggestive of hemorrhage, such as unusual bleeding [see Warnings and Precautions (5.3)].
Uveitis
Advise patients to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.4)].
QT Prolongation
Advise patients that BRAFTOVI can cause QTc interval prolongation and to inform their physician if they have any QTc interval prolongation symptoms, such as syncope [see Warnings and Precautions (5.5)].
Embryo-Fetal Toxicity
- Advise females with reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with BRAFTOVI [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
- Advise females of reproductive potential to use effective non-hormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose [Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that BRAFTOVI may impair fertility [see Use in Specific Populations (8.3)].
Strong or Moderate CYP3A Inducers or Inhibitors
Coadministration of BRAFTOVI with a strong or moderate CYP3A inhibitor may increase encorafenib concentrations; coadministration of BRAFTOVI with a strong or moderate CYP3A inducer may decrease encorafenib concentrations. Advise patients that they may need to avoid certain medications while taking BRAFTOVI and to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Advise patients to avoid grapefruit and grapefruit juice while taking BRAFTOVI [see Drug Interactions (7.1)].