angiomax rtu
Angiomax Rtu (Bivalirudin) is an anti-coagulant used to treat Unstable Angina.
Bivalirudin · by Maia Pharms Inc
Available as a generic: Bivalirudin
Key facts
- Active ingredient
- Bivalirudin
- Drug class
- Anti-Coagulant
- Form
- Injectable
- Strength
- Bivalirudin 250MG/50ML (5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- unstable angina
- Manufacturer
- Maia Pharms Inc
- FDA application
- NDA211215
What is Angiomax Rtu?
From the FDA label:Bivalirudin Injection contains bivalirudin trifluoroacetate, which is a specific and reversible direct thrombin inhibitor. Bivalirudin trifluoroacetate is a synthetic, 20 amino acid peptide salt, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolylglycylglycylglycylglycyl-L-asparagylglycyl-L-α-aspartyl-L-phenylalanyl-L-α-glutamyl-L-α-glutamyl-L-isoleucyl-L-prolyl-L-α-glutamyl-L-α-glutamyl-L-tyrosyl-L-leucine trifluoroacetate. Each molecule of bivalirudin trifluoroacetate contains 1.7 to 2.6 equivalents of trifluoroacetic acid. The molecular formula of bivalirudin free base is C 98 H 138 N 24 O 33 and its molecular weight is 2180.32 Daltons (anhydrous free base peptide). The structural formula of bivalirudin free base is Figure 1: Structural Formula of Bivalirudin Bivalirudin Injection is supplied as a refrigerated, ready-to-use, sterile solution packaged in a 50 mL single-dose vial. Each milliliter of Bivalirudin Injection contains 5 mg bivalirudin (as trifluoroacetate salt)*, 0.8 mg sodium acetate trihydrate, 100 mg polyethylene glycol 400, and Water for Injection. The pH of Bivalirudin Injection may have been adjusted with sodium hydroxide and/or glacial acetic acid to 5.0 to 5.5. The solution is intended for intravenous administration at room temperature (20ºC to 25°C/68ºF to 77°F). *The range of bivalirudin trifluoroacetate is 5.4 to 5.6 mg based on a range…
How to use
The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion for the duration of the procedure. Five minutes after the bolus dose, assess activated clotting time (ACT) to determine if an additional bolus of 0.3 mg/kg is needed. ( 2.1 ) Consider extending duration of infusion post-procedure up to 4 hours in patients with ST segment elevation MI. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of Bivalirudin Injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by a maintenance infusion of 1.75 mg/kg/h for the duration of the procedure. Five minutes after the bolus dose has been administered, assess activated clotting time (ACT) to determine if an additional bolus of 0.3 mg/kg is needed. Consider extending duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post- procedure in patients with ST segment elevation MI (STEMI). 2.2 Dose Adjustment in Renal Impairment Bolus Dose: No reduction in the bolus dose is needed for any degree of renal impairment. Maintenance Infusion: In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h. In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . 2.3 Instructions for Administration…
Side effects
Most common adverse reaction was bleeding (3.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the BAT trials, 79 of the 2161 (3.7%) of subjects undergoing PCI for treatment of unstable angina and randomized to bivalirudin experienced intracranial bleeding, retroperitoneal bleeding, clinically overt bleeding with a decrease in hemoglobin greater than 3 g/dL or leading to a transfusion of greater than 2 units of blood. Immunogenicity/Re-Exposure As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bivalirudin in the studies described below with the…
Warnings
Important safety information
Bleeding events: bivalirudin increases the risk of bleeding. Its anticoagulant effect subsides approximately one hour after discontinuation. ( 5.1 , 6.1 , 12.2 ) Thrombotic risk with coronary artery brachytherapy: An increased risk of thrombus formation, including fatal outcomes, in gamma brachytherapy. ( 5.2 , 6.2 ) 5.1 Bleeding Events Bivalirudin increases the risk of bleeding [see Adverse Reactions ( 6.1 )] . Bivalirudin’s anticoagulant effect subsides approximately one hour after discontinuation [see Clinical Pharmacology ( 12.2 )] . 5.2 Thrombotic Risk with Coronary Artery Brachytherapy An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin in gamma brachytherapy [see Adverse Reactions ( 6.2 )] .
Who should not take Angiomax Rtu
Bivalirudin Injection is contraindicated in patients with: Significant active bleeding; Hypersensitivity to Bivalirudin Injection or its components [see Adverse Reactions ( 6.2 )] . Significant active bleeding ( 4 ) Hypersensitivity to bivalirudin or its components ( 4 )
Overdose — what happens if you take too much
Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis [see Dosage and Administration ( 2.2 )] . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue bivalirudin immediately and monitor the patient closely for signs of bleeding. There is no known antidote to bivalirudin. Bivalirudin is hemodialyzable [see Clinical Pharmacology ( 12.3 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
In clinical trials in patients undergoing PCI, co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications. Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use. ( 7 )
Drug class
May treat (source: NIH RxClass)
See how Angiomax Rtu ranks — best-rated anti-coagulant for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Angiomax Rtu treat?
- Angiomax Rtu (Bivalirudin) may be used to treat unstable angina, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Angiomax Rtu?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Angiomax Rtu. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Angiomax Rtu?
- Angiomax Rtu is marketed by Maia Pharms Inc. You can see Maia Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Angiomax Rtu a brand-name or generic drug?
- Angiomax Rtu is a brand-name product with the active ingredient Bivalirudin. Lower-cost generic equivalents containing Bivalirudin are available — ask your pharmacist.
- Is Angiomax Rtu available over the counter?
- No. Angiomax Rtu is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Angiomax Rtu come in?
- Angiomax Rtu is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Angiomax Rtu?
- Angiomax Rtu is classified as anti-coagulant, direct thrombin inhibitor, per the FDA's Established Pharmacologic Class.
- Is Angiomax Rtu FDA-registered?
- Angiomax Rtu is on record with the U.S. FDA under application number NDA211215. You can verify this on its official FDA label.
- Is Angiomax Rtu safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Angiomax Rtu. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Angiomax Rtu?
- Angiomax Rtu's side effects are taken directly from its FDA label. From the label: Most common adverse reaction was bleeding (3.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
angiomax
Bivalirudin
heparin sodium 1,000 units in sodium chloride 0.9% in plastic container
Heparin Sodium
heparin sodium 2,000 units in sodium chloride 0.9% in plastic container
Heparin Sodium
Compare Angiomax Rtu head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
angiomax rtu
New