WATCH NOW: Clinical experience with ALPROLIX

Calculate your patient’s ALPROLIX® starting dose for routine prophylaxis, bleed control, or surgery1

Select your patient’s age:

Patient weight:


Starting prophylactic dose:

The recommended starting regimens for adults and adolescents ≥12 years of age are either 50 IU/kg once weekly or 100 IU/kg once every 10 days. For children <12 years of age, the recommended starting regimen is 60 IU/kg once weekly. Adjust dosing based on individual response. More frequent or higher doses may be needed in children <12 years of age, especially in children <6 years of age.

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, the individual patient’s pharmacokinetic profile, and/or the patient’s clinical condition. Patients may vary in their pharmacokinetic (eg, half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ALPROLIX on the individual clinical response.


Information in the above calculator is provided as a guide for dosing ALPROLIX for prophylaxis, the control of bleeding episodes, and perioperative management. Your independent medical consideration should be given to maintaining factor IX activity at or above the target range.

Select your patient’s age:

Patient weight:


Minor to 
moderate* 
bleed control

Major bleed control


Factor IX level required
(IU/dL or % of normal)

30-60

80-100


Dose Range (IU/kg

30-60

80-100

for adults and children ≥6 years of age

50-100

133-167

for children <6 years of age

*Minor and moderate bleed events. For example: uncomplicated hemarthroses, superficial muscle (except iliopsoas) without neurovascular compromise, superficial soft tissue, mucous membranes.

Major bleed events. For example: iliopsoas and deep muscle with neurovascular injury, or substantial blood loss; pharyngeal, retropharyngeal, retroperitoneal, CNS.

On average, one IU of ALPROLIX per kg body weight increases the circulating level of factor IX by approximately 1% (IU/dL) in adults and children ≥6 years of age and by 0.6% (IU/dL) in children <6 years of age. Consider determining the patient’s in vivo recovery (in IU/dL per IU/kg) prior to elective major surgery and verify that the target factor IX level has been achieved prior to major surgery and for major bleeds.

Dose and duration of treatment depend on the severity of the factor IX deficiency, the location and extent of bleeding, the individual patient’s pharmacokinetic profile, and/or the patient’s clinical condition. Patients may vary in their pharmacokinetic (eg, half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ALPROLIX on the individual clinical response.


Frequency of dosing (hours)

Repeat every 48 hours if there is further evidence of bleeding

Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days. Due to the long half-life of ALPROLIX, the dose may be reduced, and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.


Information in the above calculator is provided as a guide for dosing ALPROLIX for prophylaxis, the control of bleeding episodes, and perioperative management. Your independent medical consideration should be given to maintaining factor IX activity at or above the target range.

Select your patient’s age:

Patient weight:


Surgery type:

*Major surgery was defined as any surgical procedure with or without general anesthesia in which a major body cavity was penetrated and exposed, or a substantial impairment of physical or physiological functions was produced.


Preoperative dose:

X 83-133 IU/kg =



Factor IX level required
(IU/dL or % of normal)

50-80 
(initial level)


Dose range (IU/kg)

50-80 
for adults and children ≥6 years of age

83-133 
for children <6 years of age

On average, one IU of ALPROLIX per kg body weight increases the circulating level of factor IX by approximately 1% (IU/dL) in adults and children ≥6 years of age and by 0.6% (IU/dL) in children <6 years of age. Consider determining the patient’s in vivo recovery (in IU/dL per IU/kg) prior to elective major surgery and verify that the target factor IX level has been achieved prior to major surgery and for major bleeds.


Frequency of dosing (hours)

A single infusion may be sufficient. Repeat as needed after 24—48 hours until bleeding stops and healing is achieved.

Consider a repeat dose after 6-10 hours and then every 24 hours for the first 3 days. Due to the long half-life of ALPROLIX, the dose may be reduced, and frequency of dosing may be extended after day 3 to every 48 hours or longer until bleeding stops and healing is achieved.


Information in the above calculator is provided as a guide for dosing ALPROLIX for prophylaxis, the control of bleeding episodes, and perioperative management. Your independent medical consideration should be given to maintaining factor IX activity at or above the target range.

Eligibility criteria apply. Those with federal and state government insurance, such as Medicare, Medicaid, TRICARE®, or state pharmaceutical assistance programs are not eligible. Other eligibility requirements may apply. Sanofi Genzyme reserves the right to modify or discontinue programs at any time. All rights reserved. Not valid where prohibited by law. TRICARE is a registered trademark of the Department of Defense (DoD), DHA.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS:

  • Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with factor replacement therapies, and have been reported with ALPROLIX. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.
  • Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor IX levels have been achieved and maintained.
  • The use of Factor IX products has been associated with the development of thromboembolic complications.
  • Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. The safety and efficacy of using ALPROLIX for immune tolerance induction have not been established.

ADVERSE REACTIONS:

  • The most common adverse reactions (incidence ≥1%) in previously untreated patients were injection site erythema, hypersensitivity, and Factor IX inhibition. The most common adverse reactions (incidence ≥1%) in previously treated patients were headache, oral paresthesia, and obstructive uropathy.

INDICATION:

ALPROLIX® is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use
ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

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Reference: 1. ALPROLIX [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.