patients 1 million more than - rapivab · 2019-08-27 · accessed august 7, 2015. 5. novel...

21 hrs (27%)

59.9

81.8

Hours (median)

0 20 40 60 80

n=97

n = 97

n=100

n = 100

p<0.005 21 hr (27%) REDUCTIONP = .0092

RAPIVAB 600 MG

PLACEBO CONTROL

Ho

urs,

med

ian

RAPIVAB 600 mgPLACEBO

81.8

59.9

80

60

40

20

0

100

12 hrs (29%)

30.2

42.4

Hours (median)

0 20 40 60 80

n=97

n=100

p<0.005

RAPIVAB 600 MG

PLACEBO CONTROL

n = 97n = 100

Ho

urs,

med

ian

RAPIVAB 600 mg PLACEBO

42.430.2

80

60

40

20

0

100

12 hr (29%) REDUCTIONP = .0005

1 MILLION MORE THAN

PATIENTS8

REAL-WORLDEXPERIENCE IN

PLACEBO, %RAPIVAB 600 mg, %

Diarrhea78

& ONLY1ST

one-dose neuraminidase inhibitor

It only takes one dose to be done treating the fl u with Rapivab® (peramivir injection)1

Please see additional Important Safety Information throughout and enclosed full Prescribing Information.

Seqirus USA Inc.King of Prussia, Pennsylvania 19406 © 2016 Seqirus USA Inc. September 2016 US/RIV/0816/0073

the patients who may benefi t from Rapivab, including those…

• Requiring IV rehydration• Presenting with fl u-associated GI issues5

• Who may have diffi culty complying withor swallowing a multidose oral treatment

REDUCESRECOGNIZE

RESPONSIVE support and quick access at 1-844-RAPIVAB or rapivab.com

time to alleviation of symptoms by 21 hours2

Important Safety Information (cont)

• Rare cases of serious skin reactions, including erythema multiforme, have been reported with Rapivab in clinical studies andin postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketingexperience with Rapivab. Discontinue Rapivab and institute appropriate treatment if anaphylaxis or a serious skin reaction occursor is suspected. The use of Rapivab is contraindicated in patients with known serious hypersensitivity or anaphylaxis to Rapivab.

• Patients with infl uenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. Therehave been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with infl uenza whowere receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatricpatients. The contribution of Rapivab to these events has not been established. Patients with infl uenza should be closelymonitored for signs of abnormal behavior.

• Serious bacterial infections may begin with infl uenza-like symptoms or may coexist with or occur as complicationsduring the course of infl uenza. Rapivab has not been shown to prevent such complications.

A full course of antiviral � u treatment in...

A SINGLE 15 TO 30 MINUTE IV INFUSION 1,2

For fl u patients in the emergency department who may not be appropriate for oral treatment1,2

Indication and Important Safety InformationRapivab® (peramivir injection) is indicated for the treatment of acute uncomplicated infl uenza in patients 18 years and older who have been symptomatic for no more than 2 days.

Rapivab is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.


Infl uenza epidemics cause approximately 225,000

hospitalizations and 23,000 deaths in the

United States each year3

The � rst and only full course of antiviral � u therapy in a single dose1,2

Clinical benefi t is greatest when antiviral treatment is administered

early in the illness course. When indicated, antiviral treatment should

be started as soon as possible after illness onset and should not be delayed

even for a few hours to wait for the results of testing.4

CDC RECOMMENDATION: treating the � u withRapivab® (peramivir injection)1

It only takesIt only takes

to be

Rapivab® (peramivir injection) delivers a full course of antiviral fl u therapy in a single dose1,2

• Rapivab allowed patients to return to their normal activities almost 2 days earlier than placebo.2

• Rapivab can be used with OTC supportive therapies such as acetaminophen.2


• Effi cacy of Rapivab was based on clinical trials in which the predominant infl uenza virus type was infl uenza A;a limited number of subjects infected with infl uenza B virus were enrolled.

Effi cacy was established in a randomized, double-blind, placebo-controlled trial involving previously healthy adults aged 20 to 64 years who reported onset of infl uenza-like illness within the previous 48 hours. Subjects were randomized to receive a single IV dose of Rapivab 300 mg (n = 99), Rapivab 600 mg (n = 97), or placebo (n = 100).2

Eligible subjects had fever ≥38°C (axillary), a positive rapid antigen test for infl uenza virus, and at least 2 of the following: cough, nasal congestion, sore throat, myalgia, feverishness, fatigue, or headache. The study was well-balanced for baseline demographic and virologic parameters, and the predominant infl uenza virus strain was the A/H1 subtype.2

a Data from Study 621.

Shortens time to alleviation of symptoms by 21 hours2


Reduces time to resolution of fever by 12 hours7,a

3


The most common adverse reaction was diarrhea (8% Rapivab vs 7% placebo).

Lab abnormalities (incidence ≥2%) occurring more commonly with Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose greater than 160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%) and neutrophils less than 1.0 x 109/L (8% vs 6%).

rapivab.com

References: 1. Rapivab [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc; 2016. 2. Kohno S et al. Antimicrob Agents Chemother. 2010;54(11):4568-4574. 3. McLaughlin MM et al. Expert Opin Pharmacother. 2015;16(12):1889-1900. 4. CDC health update regarding treatment of patients with infl uenza with antiviral medications. http://emergency.cdc.gov/han/han00375.asp. Updated January 9, 2015. Accessed August 7, 2015. 5. Novel Swine-Origin Infl uenza A (H1N1) Virus Investigation Team et al. N Engl J Med. 2009;360(25):2605-2615. 6. Singer AC et al. PLoS One. 2013;8(4):e60221. 7. BioCryst Pharmaceuticals, Inc. Summary of clinical effi cacy. Data on fi le. 2014. 8. bioCSL. Development Safety Update Report #5. Data on fi le. 2015.

No subject receiving Rapivab 600 mg experienced a serious adverse event, and <1% discontinued the study because of an adverse reaction.

1

Rapivab® (peramivir injection) has a demonstrated safety profi le

1,2

In clinical trials, diarrhea was the most commonly occurring adverse reaction in patients receiving Rapivab 600 mg (n = 664)

4

SEQRAP16_083-06_HCP_Leave_Behind_MECH_v5.indd 1 9/16/16 4:30 PM

Support and access for Rapivab

Access Rapivab now

HCPCS Level II Code J2547 Injection, Peramivir, 1 mg

RAPIVAB CUSTOMER SUPPORT CENTER

1-844-RAPIVAB OR rapivab.com

Support is availableHave diffi culty swallowing or tolerating oral medication (e.g., those with dysphagia)

Require IV rehydration

May have diffi culty complying with a multidose oral regimen. In a study, it was estimated that up to 55% of patients were noncompliant with prescribed oral antiviral medication6

Present with fl u-associated gastrointestinal (GI) issues such as nausea, vomiting, or diarrhea5

CDCRECOMMENDATION:

Oral antiviral fl u therapy may not be appropriate for all patients


• Infl uenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors(for example, changes in viral virulence) might also diminish clinical benefi t of antiviral drugs. Prescribers should consideravailable information on infl uenza drug susceptibility patterns and treatment effects when deciding whether to use Rapivab.

• Effi cacy could not be established in patients with serious infl uenza requiring hospitalization.

CONSIDER ADMINISTRATION OF RAPIVAB ® (peramivir injection) IN PATIENTS WHO...

Initiate antiviral treatment in patients with risk factors for infl uenza complications4


Antiviral drugs may inhibit viral replication of a live attenuated infl uenza vaccine (LAIV). The concurrent use of Rapivab with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Rapivab dosing and access informationONE 15 TO 30 MINUTE IV INFUSION provides a full course of infl uenza treatment 1


PATIENT POPULATION DOSE

a In patients with chronic renal impairment maintained on hemodialysis, Rapivab should be administered after dialysis at a dose adjusted based on renal function.

2 5

Creatinine clearance: 30-49 mL/min


Adults aged 18 years or older a

Renal impairment

600 mg

200 mg

100 mg


21 hrs (27%)

59.9

81.8

Hours (median)

0 20 40 60 80

n=97

n = 97

n=100

n = 100

p<0.005 21 hr (27%) REDUCTIONP = .0092

RAPIVAB 600 MG

PLACEBO CONTROL

Ho

urs,

med

ian


81.8

59.9

80

60

40

20

0

100

12 hrs (29%)

30.2

42.4

Hours (median)

0 20 40 60 80

n=97

n=100

p<0.005

RAPIVAB 600 MG

PLACEBO CONTROL

n = 97n = 100

Ho

urs,

med

ian


42.430.2

80

60

40

20

0

100


1 MILLION MORE THAN

PATIENTS8

REAL-WORLDEXPERIENCE IN


Diarrhea78

& ONLY1ST


It only takes one dose to be done treating the fl u with Rapivab® (peramivir injection)1




• Requiring IV rehydration• Presenting with fl u-associated GI issues5

• Who may have diffi culty complying withor swallowing a multidose oral treatment

REDUCESRECOGNIZE





• Patients with infl uenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. Therehave been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with infl uenza whowere receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatricpatients. The contribution of Rapivab to these events has not been established. Patients with infl uenza should be closelymonitored for signs of abnormal behavior.

• Serious bacterial infections may begin with infl uenza-like symptoms or may coexist with or occur as complicationsduring the course of infl uenza. Rapivab has not been shown to prevent such complications.




Indication and Important Safety InformationRapivab® (peramivir injection) is indicated for the treatment of acute uncomplicated infl uenza in patients 18 years and older who have been symptomatic for no more than 2 days.











CDC RECOMMENDATION: treating the � u withRapivab® (peramivir injection)1

It only takesIt only takes

to be

Rapivab® (peramivir injection) delivers a full course of antiviral fl u therapy in a single dose1,2




• Effi cacy of Rapivab was based on clinical trials in which the predominant infl uenza virus type was infl uenza A;a limited number of subjects infected with infl uenza B virus were enrolled.

Effi cacy was established in a randomized, double-blind, placebo-controlled trial involving previously healthy adults aged 20 to 64 years who reported onset of infl uenza-like illness within the previous 48 hours. Subjects were randomized to receive a single IV dose of Rapivab 300 mg (n = 99), Rapivab 600 mg (n = 97), or placebo (n = 100).2

Eligible subjects had fever ≥38°C (axillary), a positive rapid antigen test for infl uenza virus, and at least 2 of the following: cough, nasal congestion, sore throat, myalgia, feverishness, fatigue, or headache. The study was well-balanced for baseline demographic and virologic parameters, and the predominant infl uenza virus strain was the A/H1 subtype.2





3




rapivab.com



1

Rapivab® (peramivir injection) has a demonstrated safety profi le

1,2


4


21 hrs (27%)

59.9

81.8

Hours (median)

0 20 40 60 80

n=97

n = 97

n=100

n = 100

p<0.00521 hr (27%) REDUCTIONP = .0092

RAPIVAB 600 MG

PLACEBO CONTROL

Ho

urs, med

ian


81.8

59.9

80

60

40

20

0

100

12 hrs (29%)

30.2

42.4

Hours (median)

0 20 40 60 80

n=97

n=100

p<0.005

RAPIVAB 600 MG

PLACEBO CONTROL

n = 97 n = 100

Ho

urs, med

ian


42.430.2

80

60

40

20

0

100


1 MILLION MORE THAN

PATIENTS 8

R E A L-W O R L DEXPERIENCE IN

PLACEBO, % RAPIVAB 600 mg, %

Diarrhea 7 8

& ONLY 1ST


It only takes one dose to be done treating the fl u with Rapivab

® (peramivir injection)

1




•Requiring IV rehydration•Presenting with fl u-associated GI issues

5

•Who may have diffi culty complying withor swallowing a multidose oral treatment

REDUCES RECOGNIZE




•Rare cases of serious skin reactions, including erythema multiforme, have been reported with Rapivab in clinical studies andin postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketingexperience with Rapivab. Discontinue Rapivab and institute appropriate treatment if anaphylaxis or a serious skin reaction occursor is suspected. The use of Rapivab is contraindicated in patients with known serious hypersensitivity or anaphylaxis to Rapivab.

•Patients with infl uenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. Therehave been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with infl uenza whowere receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatricpatients. The contribution of Rapivab to these events has not been established. Patients with infl uenza should be closelymonitored for signs of abnormal behavior.

•Serious bacterial infections may begin with infl uenza-like symptoms or may coexist with or occur as complicationsduring the course of infl uenza. Rapivab has not been shown to prevent such complications.


A SINGLE 15 TO 30 MINUTE IV INFUSION

1,2


Indication and Important Safety InformationRapivab

® (peramivir injection) is indicated for the treatment of acute uncomplicated infl uenza

in patients 18 years and older who have been symptomatic for no more than 2 days.










even for a few hours to wait for the results of testing.

4

CDC RECOMMENDATION: treating the � u withRapivab

® (peramivir injection)1

It only takes It only takes

to be

Rapivab® (peramivir injection) delivers a full course

of antiviral fl u therapy in a single dose1,2

•Rapivab allowed patients to return to their normal activities almost 2 days earlier than placebo.2

•Rapivab can be used with OTC supportive therapies such as acetaminophen.2


•Effi cacy of Rapivab was based on clinical trials in which the predominant infl uenza virus type was infl uenza A;a limited number of subjects infected with infl uenza B virus were enrolled.

Effi cacy was established in a randomized, double-blind, placebo-controlled trial involving previously healthy adults aged 20 to 64 years who reported onset of infl uenza-like illness within the previous 48 hours. Subjects were randomized to receive a single IV dose of Rapivab 300 mg (n = 99), Rapivab 600 mg (n = 97), or placebo (n = 100).

2

Eligible subjects had fever ≥38°C (axillary), a positive rapid antigen test for infl uenza virus, and at least 2 of the following: cough, nasal congestion, sore throat, myalgia, feverishness, fatigue, or headache. The study was well-balanced for baseline demographic and virologic parameters, and the predominant infl uenza virus strain was the A/H1 subtype.

2


Shortens time to alleviation of symptoms by 21 hours

2


Reduces time to resolution of fever by 12 hours

7,a

3




rapivab.com


No subject receiving Rapivab 600 mg experienced a serious adverse event, and <1% discontinued the study because of an adverse reaction.1

Rapivab® (peramivir injection) has a demonstrated safety profi le1,2


4

SEQRAP16_083-06_HCP_Leave_Behind_MECH_v5.indd 19/16/16 4:30 PM

Support and access for Rapivab

Access Rapivab now

HCPCS Level II Code J2547 Injection, Peramivir, 1 mg

RAPIVAB CUSTOMER SUPPORT CENTER

1-844-RAPIVAB OR rapivab.com

Support is availableHave diffi culty swallowing or tolerating oral medication (e.g., those with dysphagia)

Require IV rehydration

May have diffi culty complying with a multidose oral regimen. In a study, it was estimated that up to 55% of patients were noncompliant with prescribed oral antiviral medication6

Present with fl u-associated gastrointestinal (GI) issues such as nausea, vomiting, or diarrhea5

CDCRECOMMENDATION:

Oral antiviral fl u therapy may not be appropriate for all patients


• Infl uenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefi t of antiviral drugs. Prescribers should consider available information on infl uenza drug susceptibility patterns and treatment effects when deciding whether to use Rapivab.

• Effi cacy could not be established in patients with serious infl uenza requiring hospitalization.

CONSIDER ADMINISTRATION OF RAPIVAB ® (peramivir injection) IN PATIENTS WHO...

Initiate antiviral treatment in patients with risk factors for infl uenza complications4


Antiviral drugs may inhibit viral replication of a live attenuated infl uenza vaccine (LAIV). The concurrent use of Rapivab with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Rapivab dosing and access informationONE 15 TO 30 MINUTE IV INFUSION provides a full course of infl uenza treatment 1


PATIENT POPULATION DOSE

a In patients with chronic renal impairment maintained on hemodialysis, Rapivab should be administered after dialysis at a dose adjusted based on renal function.

2 5



Adults aged 18 years or older a

Renal impairment

600 mg

200 mg

100 mg


21 hrs (27%)

59.9

81.8

Hours (median)

0 20 40 60 80

n=97

n = 97

n=100

n = 100

p<0.005 21 hr (27%) REDUCTIONP = .0092

RAPIVAB 600 MG

PLACEBO CONTROL

Ho

urs,

med

ian


81.8

59.9

80

60

40

20

0

100

12 hrs (29%)

30.2

42.4

Hours (median)

0 20 40 60 80

n=97

n=100

p<0.005

RAPIVAB 600 MG

PLACEBO CONTROL

n = 97n = 100

Ho

urs,

med

ian


42.430.2

80

60

40

20

0

100


1 MILLION MORE THAN

PATIENTS8

REAL-WORLD EXPERIENCE IN


Diarrhea78

& ONLY1ST


It only takes one dose to be done treating the flu with Rapivab® (peramivir injection)1



the patients who may benefit from Rapivab, including those…

• Requiring IV rehydration• Presenting with flu-associated GI issues5

• Who may have difficulty complying withor swallowing a multidose oral treatment

REDUCESRECOGNIZE





• Patients with influenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. Therehave been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with influenza whowere receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatricpatients. The contribution of Rapivab to these events has not been established. Patients with influenza should be closelymonitored for signs of abnormal behavior.

• Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complicationsduring the course of influenza. Rapivab has not been shown to prevent such complications.

A full course of antiviral flu treatment in...


For flu patients in the emergency department who may not be appropriate for oral treatment1,2

Indication and Important Safety InformationRapivab® (peramivir injection) 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.



Influenza epidemics cause approximately 225,000



The first and only full course of antiviral flu therapy in a single dose1,2

Clinical benefit is greatest when antiviral treatment is administered




CDC RECOMMENDATION: treating the flu withRapivab® (peramivir injection)1

It only takes

to be

Rapivab® (peramivir injection) delivers a full course of antiviral flu therapy in a single dose1,2




• Efficacy of Rapivab was 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.

Efficacy was established in a randomized, double-blind, placebo-controlled trial involving previously healthy adults aged 20 to 64 years who reported onset of influenza-like illness within the previous 48 hours. Subjects were randomized to receive a single IV dose of Rapivab 300 mg (n = 99), Rapivab 600 mg (n = 97), or placebo (n = 100).2

Eligible subjects had fever ≥38°C (axillary), a positive rapid antigen test for influenza virus, and at least 2 of the following: cough, nasal congestion, sore throat, myalgia, feverishness, fatigue, or headache. The study was well-balanced for baseline demographic and virologic parameters, and the predominant influenza virus strain was the A/H1 subtype.2





3




rapivab.com

References: 1. Rapivab [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc; 2016. 2. Kohno S et al. Antimicrob Agents Chemother. 2010;54(11):4568-4574. 3. McLaughlin MM et al. Expert Opin Pharmacother. 2015;16(12):1889-1900. 4. CDC health update regarding treatment of patients with influenza with antiviral medications. http://emergency.cdc.gov/han/han00375.asp. Updated January 9, 2015. Accessed August 7, 2015. 5. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team et al. N Engl J Med. 2009;360(25):2605-2615. 6. Singer AC et al. PLoS One. 2013;8(4):e60221. 7. BioCryst Pharmaceuticals, Inc. Summary of clinical efficacy. Data on file. 2014. 8. bioCSL. Development Safety Update Report #5. Data on file. 2015.


1

Rapivab® (peramivir injection) has a demonstrated safety profile

1,2


4


patients 1 million more than - rapivab · 2019-08-27 · accessed august 7, 2015. 5. novel...

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