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RAPIVAB(peramivir injection)for intravenous

2015-07-02 09:57:15 来源: 作者: 【大中小】浏览:375次评论:0条

日前，美国食品药品管理局FDA批准抗病毒药物Rapivab用于治疗成年流感患者。Rapivab是BioCryst制药公司研制的一种神经氨酸苷酶抑制剂（NI）。它是FDA 批准的第三种治疗流感的NI。阿拉巴马大学Richard Whitley表示，Rapivab是第一种被证实安全有效的单剂量NI，也是15年来FDA 批准的一种全新的流感抗病毒治疗方法。
HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use RAPIVAB safely and effectively. See full prescribing information for RAPIVAB.

RAPIVAB™ (peramivir injection), for intravenous use
Initial U.S. Approval: [2014]

INDICATIONS AND USAGE

RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. (1)

Limitations of Use:

Efficacy based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled.
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1)
Efficacy could not be established in patients with serious influenza requiring hospitalization. (1)

DOSAGE AND ADMINISTRATION

Administer as a single dose within 2 days of onset of influenza symptoms (2.1)
Recommended dose is 600 mg, administered by intravenous infusion for a minimum of 15 minutes (2.1)
Renal Impairment: Recommended dose for patients with creatinine clearance 30-49 mL/min is 200 mg and the recommended dose for patients with creatinine clearance 10-29 mL/min is 100 mg (2.2)
Hemodialysis: Administer after dialysis (2.2)
RAPIVAB must be diluted prior to administration (2.3)
See the Full Prescribing Information for drug compatibility information (2.4)

DOSAGE FORMS AND STRENGTHS

Injection: 200 mg in 20 mL (10 mg/mL) in a single-use vial (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. (5.1)
Neuropsychiatric events: Patients with influenza may be at an increased risk of hallucinations, delirium and abnormal behavior early in their illness. Monitor for signs of abnormal behavior. (5.2)

ADVERSE REACTIONS

Most common adverse reaction (incidence >2%) is diarrhea (6)

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-844-273-2327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Live attenuated influenza vaccine (LAIV), intranasal: Avoid use of LAIV within 2 weeks before or 48 hours after administration of RAPIVAB, unless medically indicated (7.1)

USE IN SPECIFIC POPULATIONS

Pregnancy: Use if benefit outweighs risk.(8.1)
Nursing mothers: Caution should be exercised when administered to a nursing woman. (8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2014

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Acute Uncomplicated Influenza

2.2 Dosing in Patients with Renal Impairment

2.3 Preparation of RAPIVAB for Intravenous Infusion

2.4 Drug Compatibility

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Serious Skin/Hypersensitivity Reactions

5.2 Neuropsychiatric Events

5.3 Risk of Bacterial Infections

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Influenza Vaccines

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Patients with Impaired Renal Function

8.7 Patients with Serious Influenza Requiring Hospitalization

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Cardiac Electrophysiology

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Acute Uncomplicated Influenza in Adults

14.2 Serious Influenza Requiring Hospitalization

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.

Limitations of Use:

Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4)].
The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Acute Uncomplicated Influenza

Administer RAPIVAB within 2 days of onset of symptoms of influenza.

The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

2.2 Dosing in Patients with Renal Impairment

Significantly increased drug exposures were observed when RAPIVAB was administered to subjects with renal dysfunction [see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see Clinical Pharmacology (12.3)].

In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1) [see Clinical Pharmacology (12.3)].

Table 1. Dosage Adjustment for Patients with Altered Creatinine Clearance
	Creatinine Clearance* (mL/min)
	≥50	30-49	10-29
* Calculated using the Cockcroft and Gault equation.
Recommended Dose (mg)	600	200	100

2.3 Preparation of RAPIVAB for Intravenous Infusion

Use aseptic technique during the preparation of RAPIVAB to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.

Follow the steps below to prepare a diluted solution of RAPIVAB:

(a): Do not use if seal over bottle opening is broken or missing.
(b): Visually inspect RAPIVAB for particulate matter and discoloration prior to administration.
(c)