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Factor XIII A-subunit, recombinant human: Drug information

Factor XIII A-subunit, recombinant human: Drug information
(For additional information see "Factor XIII A-subunit, recombinant human: Patient drug information" and see "Factor XIII A-subunit, recombinant human: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Tretten
Brand Names: Canada
  • Tretten
Pharmacologic Category
  • Antihemophilic Agent
Dosing: Adult
Factor XIII A-subunit deficiency

Factor XIII A-subunit deficiency: IV: 35 units/kg once monthly to achieve a target trough level of factor XIII activity ≥10%; consider dose adjustment if adequate coverage is not achieved (higher doses may not increase the levels of tetrameric factor XIII).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Factor XIII A-subunit, recombinant human: Pediatric drug information")

Factor XIII A-subunit deficiency

Factor XIII A-subunit deficiency: Infants, Children, and Adolescents: IV: 35 units/kg/dose once monthly to achieve a target trough level of factor XIII activity ≥10%; consider dose adjustment if adequate coverage is not achieved (higher doses may not increase the levels of tetrameric factor XIII).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Headache (≥1%)

Hematologic & oncologic: Increased fibrinolysis (increase in fibrin D dimer levels; ≥1%)

Immunologic: Antibody development (non-neutralizing; 2% to 5%)

Local: Pain at injection site (≥1%)

Neuromuscular & skeletal: Limb pain (≥1%)

Contraindications

Hypersensitivity to coagulation factor XIII A-subunit (recombinant) or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: Inhibitory antibodies may occur. Patients with inhibitory antibodies may manifest as an inadequate response to treatment. Factor XIII inhibitory antibodies should be measured when breakthrough bleeding or factor XIII activity levels are suboptimal after apparent adequate dosing.

• Hypersensitivity reactions: May cause allergic reactions; discontinue immediately if signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur and institute appropriate management.

• Thrombotic events: Thromboembolic complications may occur; monitor patients with known risk factors for thrombosis.

Other Warnings/Precautions:

• Appropriate use: Not indicated for use in patients with congenital factor XIII B-subunit deficiency.

Dosage Forms Considerations

Potency is shown as a range for each vial (2,000 to 3,125 units/vial). The actual units of potency of recombinant coagulation factor XIII A-subunit are stated on each vial label and carton.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Tretten: 2000 - 3125 units (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Tretten Intravenous)

2500 unit (Price provided is per AHF Unit): $21.66

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Tretten: 2500 units (1 ea)

Administration: Adult

IV: Administer IV at a rate not exceeding 1 to 2 mL/minute. Do not administer as a continuous infusion or with other infusion solutions.

Administration: Pediatric

IV: Administer IV only at a rate not exceeding 1 to 2 mL/minute. Do not administer with other infusion solutions. Do not administer as drip.

Use: Labeled Indications

Factor XIII A-subunit deficiency: Routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Factor VIIa (Recombinant): Factor XIII A-Subunit (Recombinant) may enhance the thrombogenic effect of Factor VIIa (Recombinant). Risk C: Monitor therapy

Pregnancy Considerations

Pregnant patients with factor XIII deficiency may have an increased risk of bleeding following abortion, antenatal procedures, and delivery. There is also a high rate of pregnancy loss without treatment; close surveillance is recommended. Maternal factor XIII concentrations decrease during pregnancy and dosing frequency should be increased. Additional treatment may be needed prior to delivery or procedures. Factor XIII A-Subunit (Recombinant) may be used in patients with a factor XIII A-subunit deficiency (RCOG [Pavord 2017]).

Breastfeeding Considerations

It is not known if Factor XIII A-Subunit (Recombinant) is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Factor XIII trough levels; development of factor XIII inhibitory antibodies; hypersensitivity reactions; thrombotic events.

Mechanism of Action

Factor XIII A-Subunit (recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2]. rFXIII has been shown to be activated by thrombin in the presence of Ca2+. Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury. After combining with available plasma B-subunits, factor XIII A-subunit (recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.

Pharmacokinetics (Adult Data Unless Noted)

Half-life: Children <6 years: 7.1 ± 1.9 days; Adults: ~ 5.1 ± 2.6 days.

Distribution: Vss: Children <6 years: 61.2 ± 41 mL/kg; Adults: 65.9 ± 26.9 mL/kg.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Novothirteen;
  • (DK) Denmark: Novothirteen;
  • (ES) Spain: Novothirteen;
  • (FI) Finland: Novothirteen;
  • (GB) United Kingdom: Novothirteen;
  • (GR) Greece: Novothirteen;
  • (HU) Hungary: Novothirteen;
  • (IT) Italy: Novothirteen;
  • (JP) Japan: Novothirteen;
  • (NO) Norway: Novothirteen;
  • (NZ) New Zealand: Novothirteen;
  • (PR) Puerto Rico: Tretten;
  • (QA) Qatar: NovoThirteen;
  • (SA) Saudi Arabia: Novothirteen;
  • (SK) Slovakia: Novothirteen
  1. Pavord S, Rayment R, Madan B, et al; for the Royal College of Obstetricians and Gynaecologists. Management of inherited bleeding disorders in pregnancy: Green-top Guideline No. 71 (joint with UKHCDO). BJOG. 2017;124(8):e193–e263. doi: 10.1111/1471-0528.14592. [PubMed 28447403]
  2. Tretten (factor XIII A-subunit [recombinant]) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
  3. Tretten (factor XIII A-subunit [recombinant]) [product monograph]. Mississauga, Ontario, Canada: Novo Nordisk Canada Inc; June 2017.
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