coagulation factor IX , Fc fusion protein

(redirected from Alprolix)

coagulation factor IX (Recombinant), Fc fusion protein

(ko-a-gyoo-lay-shun fac-tor nine eff-cee fyoo-zhun proh-teen),

Alprolix

(trade name)

Classification

Therapeutic: hemostatic agents
Pharmacologic: clotting factor replacements
Pregnancy Category: C

Indications

Factor IX replacement (DNA-derived) to control and prevent bleeding episodes perioperatively or prophylactically in patients with Hemophilia B.

Action

Replaces deficient Factor IX in patients with Hemophilia B.

Therapeutic effects

Decreased incidence and severity of bleeding.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Used up in clotting process.
Half-life: Adults—86.5 hr; children 12–17 yr—84 hr; children 6–11 yr—72.2 hr; children 2–5 yr—66.4 hr.

Time/action profile (decreased bleeding/risk of bleeding)

ROUTEONSETPEAKDURATION
IVrapidunknown6–48 hr †
† Up to 10 days when used prophylactically.

Contraindications/Precautions

Contraindicated in: Known hypersensitivity.
Use Cautiously in: Obstetric: Use in pregnancy only if clearly needed; Lactation: Use caution if breastfeeding; Pediatric: Children <12 yr have ↑ clearance, shorter duration of action (↑ dose/kg or more frequent dosing may be required).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Cardiovascular

  • thrombembolism (↑risk with continuous infusion via central catheter) (life-threatening)

Gastrointestinal

  • perioral paresthesia

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • production of neutralizing antibodies (inhibitors)

Interactions

Drug-Drug interaction

Bleeding risk may be ↑ by anticoagulants, antiplatelet agents, aspirin, fibrinolytics, NSAIDs, SSRIs andSNRIs.

Route/Dosage

One unit/kg increases circulating Factor IX (FIX) level by 1%.

Intravenous (Adults and Children) Minor and moderate bleeding— amount needed to produce a circulating FIX level of 30–40 IU/dL, repeated every 48 hr as needed; Major bleeding— amount needed to produce a circulating FIX level of 80–100 IU/dL, repeat after 6–10 hr, then every 24 hr for three days, then every 48 hr until healing occurs; Perioperative management (minor procedures)—amount needed to produce a circulating FIX level of 50–80 IU/dL as a single infusion, may be repeated after 24–48 hr until bleeding ceases and healing has occurs; Perioperative management (major procedures)—amount needed to produce a circulating FIX level of 60–100 IU/dL as a single infusion, may be repeated after 6–10 hr and then every 24 for 3 days until bleeding ceases and healing occurs (additional doses may be given every 48 hr if needed);Routine prophylaxis—50 IU/kg once weekly or 100 IU/kg every 10 days. Doses may be modified according to need/response.

Availability

Lyophilized powder for IV injection (requires reconstitution): 500 IU vial, 1000 IU vial, 2000 IU vial, 3000 IU vial

Nursing implications

Nursing assessment

  • Assess for signs and symptoms of allergic reactions (angioedema, chest tightness, hypotension, rash, nausea, vomiting, paresthesia, restlessness, wheezing, dyspnea). If symptoms occur, discontinue therapy and treat symptomatically.
  • Lab Test Considerations: If expected Factor IX activity levels are not attained or if bleeding is not controlled with recommended dose, perform a Bethesda assay to determine if inhibitors are present.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Intravenous Administration
  • Allow medication and diluent to come to room temperature before use. Follow manufacturer's guidelines for mixing. Final solution should be clear to slightly opalescent and colorless. Do not shake. Do not use solutions that are discolored or contain particulate matter. Use reconstituted solution within 3 hr. Do not refrigerate or freeze after reconstitution. Do not administer reconstituted solution in same tubing or container with other medications. Vials can be stored at room temperature for up to 6 mo and then should be discarded; do not return to refrigerator.
  • Rate: Administer as a bolus infusion over several min. Determine rate based on patient's comfort; no >10 mL/min.

Patient/Family Teaching

  • May be self-administered with proper training. Instruct patient to read Patient Information and Instructions for Use prior to starting therapy and with each refill in case of changes.
  • Advise patient to notify health care professional immediately if signs and symptom of allergic reactions.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Control and prevention of bleeding in adults and children with Hemophilia B.
References in periodicals archive ?
Our report predicts revenues of eight top brands: - Kadcyla - Adcetris - Tresiba - Alprolix - Eloctate - Gazyva/Gazyvaro - Plegridy - Afrezza.
Swedish Orphan Biovitrum AB has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets.
Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
You also get revenue predictions for five expected agents, including these: -- Rixubis -- Eloctate -- Alprolix
Sandrock has been responsible for the clinical development and approval of Tysabri, Plegridy, Tecfidera, Alprolix, and Eloctate.
Biogen has submitted a Marketing Authorization Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA).
The US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body.
5 Fused Factors: Biogen Idec's Eloctate and Alprolix 7.
Earlier this year, Biogen's hemophilia B treatment Alprolix was approved in the U.
Other catalysts could be in the form of FDA approval for candidates like Eloctate, Alprolix (both for hemophilia) and Plegridy (relapsing MS).
The company could see three new product launches this year - hemophilia drugs Eloctate and Alprolix, and multiple sclerosis drug Plegridy.