ANGIOMAX Solution for injection (2019)

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Sandoz Inc

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1. Indications and Usage

Angiomax is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia ...

2. Dosage and Administration

2.1 Recommended Dosage Angiomax has been studied only in patients receiving concomitant aspirin. The recommended dose of Angiomax is an intravenous bolus dose of 0.75 mg/kg, followed immediately by an ...

3. Dosage Forms and Strengths

For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg bivalirudin trifluoroacetate*. ...

4. Contraindications

Angiomax is contraindicated in patients with: Active major bleeding; Hypersensitivity (e.g., anaphylaxis) to Angiomax or its components [see Adverse Reactions (6.3)].

5. Warnings and Precautions

5.1 Bleeding Events Angiomax increases the risk of bleeding [see Adverse Reactions (6.1)]. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic ...

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 ...

6.2. Immunogenicity

As with all peptides, 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 ...

6.3. Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ...

7. Drug Interactions

In clinical trials in patients undergoing PCI/percutaneous transluminal coronary angioplasty (PTCA), co-administration of Angiomax with heparin, warfarin, thrombolytics, or GPIs was associated with increased ...

8.1. Pregnancy

Risk Summary There are no data available on use of Angiomax in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Reproduction studies in rats and rabbits administered subcutaneously ...

8.2. Lactation

Risk Summary It is not known whether bivalirudin is present in human milk. No data are available on the effects on the breastfed child or on milk production. Bivalirudin was administered to lactating rats ...

8.4. Pediatric Use

The safety and effectiveness of Angiomax in pediatric patients have not been established.

8.5. Geriatric Use

In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients.

8.6. Renal Impairment

The disposition of Angiomax was studied in PTCA patients with mild, moderate and severe renal impairment. The clearance of Angiomax was reduced approximately 21% in patients with moderate and severe renal ...

10. Overdosage

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Angiomax have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses ...

11. Description

Angiomax contains bivalirudin which is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-glycyl-L-asparagyl-glycyl-L-aspartyl-L-phenylalanyl-L-glutamyl-L-glutamyl-L-isoleucyl-L-prolyl-L-glutamyl-L-glutamyl-L-tyrosyl-L-leucine. ...

12.1. Mechanism of Action

Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays ...

12.2. Pharmacodynamics

In healthy volunteers and patients (with ≥70% vessel occlusion undergoing routine PTCA), bivalirudin exhibited dose- and concentration-dependent anticoagulant activity as evidenced by prolongation of the ...

12.3. Pharmacokinetics

Bivalirudin exhibits linear pharmacokinetics following IV administration to patients undergoing PTCA. In these patients, a mean steady state bivalirudin concentration of 12.3 ± 1.7 mcg/mL is achieved following ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of bivalirudin. Bivalirudin displayed no genotoxic potential in the in vitro bacterial cell reverse mutation ...

14. Clinical Studies

Bivalirudin Angioplasty Trial (BAT) In the BAT studies, patients with unstable angina undergoing PCI were randomized 1:1 to a 1 mg/kg bolus of Angiomax and then 2.5 mg/kg/h for four hours and then 0.2 ...

16.1. How Supplied

Angiomax is supplied as a sterile, lyophilized powder in single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate*. * The range ...

16.2. Storage and Handling

Store Angiomax dosage units at 20 to 25°C (68 to 77°F). Excursions to 15 to 30°C permitted [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider when they occur.