p; 3 (0.4) 4 (0.6)
Non-fatal PE 2 (1.1) 2 (1.3) 3 (0.4) 2 (0.3)
VTE-related Death 2 (1.1) 0 3 (0.4) 5 (0.8)
Symptomatic Events ‡ 4 (2.3) 3 (2.0) 9 (1.3) 10 (1.6) CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
BEVYXXA (betrixaban) capsules are available as listed below.
The 40 mg size 4 capsules are light grey with 40 printed in black, and have a light blue cap with PTLA printed in white.
Bottles of 100 (NDC 69853-0202-1)
The 80 mg size 2 capsules are light grey with 80 printed in black, and have a blue cap with PTLA printed in white.
Bottles of 100 (NDC 69853-0201-1)
Storage and Handling
Store at room temperature; 20°C to 25°C (68°F to 77°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Bleeding
Advise patients that it might take longer than usual for bleeding to stop, and that they may bruise or bleed more easily when treated with BEVYXXA. Instruct patients to report any unusual bleeding to their physician [see WARNINGS AND PRECAUTIONS (5.1)].
Instruct patients to tell their physicians and dentists that they are taking BEVYXXA, and/or any other products known to affect bleeding (including nonprescription products, such as aspirin or NSAIDs), before any surgery or medical or dental procedure is scheduled and before any new drug is taken [see WARNINGS AND PRECAUTIONS (5.1, 5.4)].
Use in Patients with Severe Renal Impairment
Advise patients that the risk of bleeding is higher in people who have severe kidney problems (severe renal impairment) [see WARNINGS AND PRECAUTIONS (5.3)].
Spinal/Epidural Hematoma
Advise patients having neuraxial anesthesia or spinal puncture to watch for signs and symptoms of spinal or epidural hematomas, such as numbness or weakness of the legs, or bowel or bladder dysfunction [see WARNINGS AND PRECAUTIONS (5.2)]. Instruct patients to contact their physician immediately if any of these symptoms occur.
Pregnancy and Lactation
Advise female patients to inform their physicians if they are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed during treatment with BEVYXXA [see USE IN SPECIFIC POPULATIONS (8.1, 8.2)].
How to Take BEVYXXA
Instruct patients to take BEVYXXA with food, and instruct patients on what to do if a dose is missed [see DOSAGE AND ADMINISTRATION (2.2)].
SPL UNCLASSIFIED SECTION
Manufactured for:
Portola Pharmaceuticals, Inc.
South San Francisco, California 94080, USA
BTX-US-V.1.4
MEDICATION GUIDE
MEDICATION GUIDE
BEVYXXA® (BEV vix a)
capsules
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 6/2017
What is the most important information I should know about BEVYXXA?
BEVYXXA can cause serious side effects, including:
Bleeding problems. BEVYXXA can increase the risk of bleeding, which can be serious and may lead to death. This is because BEVYXXA is a blood thinner medicine that reduces blood clotting. The risk of bleeding is higher in people who have severe kidney problems (severe renal impairment).
You may have a higher risk of bleeding if you take BEVYXXA and take other medicines that increase your risk of bleeding, including:
aspirin or aspirin containing products
long-term (chronic) use of non-steroidal anti-inflam |
