Product image of Novothirteen (Catridecacog) supplied by GNH India

Novothirteen

Active Ingredient:
Catridecacog
Origin:
EU

Novothirteen (Catridecacog)

Catridecacog, the active ingredient in Novothirteen, is a recombinant factor VIIIa activator presented as a sterile lyophilised powder for intravenous use. It is designed to replace the missing activated factor VIII activity in patients with hemophilia A who have developed inhibitors, helping to control and prevent bleeding episodes.

GNH India supplies Novothirteen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The product meets EU regulatory standards and is distributed under strict quality controls.

Manufacturer / TM Owner

Novo Nordisk A/S

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Indications & Clinical Uses

Novothirteen is used within the hemophilia A therapeutic pathway to manage bleeding in patients with factor VIII inhibitors.

  • Hemophilia A with inhibitors: prophylaxis of spontaneous and traumatic bleeding episodes
  • Hemophilia A with inhibitors: treatment of acute bleeding events
  • Hemophilia A with inhibitors undergoing surgery: control of peri‑operative bleeding

How It Works

  • Catridecacog is a recombinant form of activated factor VIII that directly activates factor X on the surface of activated platelets, bypassing the need for endogenous factor VIII. By restoring the intrinsic tenase complex, it accelerates thrombin generation and stabilises clot formation, thereby compensating for the functional deficiency caused by inhibitors in hemophilia A patients. The molecule remains active in circulation and interacts with phospholipid surfaces, providing rapid haemostatic effect after intravenous administration.

Side Effects

Novothirteen may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Injection site pain or erythema
  • Headache
  • Fever
  • Nausea

Serious or Rare Side Effects

  • Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism)
  • Anaphylactic or severe hypersensitivity reactions
  • Development of neutralising antibodies
  • Disseminated intravascular coagulation

Precautions & Warnings

When using Novothirteen, several precautions should be observed to ensure patient safety and product integrity.

  • Verify inhibitor status: confirm presence of factor VIII inhibitors before initiating therapy
  • Monitor for thrombotic complications: assess for signs of clot formation during and after treatment
  • Assess hypersensitivity history: avoid use in patients with known allergy to catridecacog or its excipients
  • Use cautiously in cardiovascular disease: evaluate risk of thrombosis in patients with coronary artery disease
  • Pregnancy and lactation: limited data; prescribe only if potential benefit justifies potential risk
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake

Avoid Interactions

Novothirteen can interact with other medicines, affecting clotting balance.

Major Interactions (Avoid)

  • Concurrent use of other activated clotting factor products (e.g., recombinant factor VIIa) – increased risk of thrombosis
  • High‑dose estrogen‑containing therapies – heightened thrombotic potential

Moderate Interactions (Monitor Closely)

  • Antifibrinolytic agents (tranexamic acid, aminocaproic acid) – may augment clot formation, monitor closely
  • Heparin or low‑molecular‑weight heparin – possible reduction in anticoagulant effect, adjust dosing as needed
  • Antiplatelet drugs (aspirin, clopidogrel) – may increase bleeding risk, observe patient response

Frequently Asked Questions

Novothirteen is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A who have developed inhibitors against factor VIII. It helps control spontaneous bleeds, trauma‑related hemorrhages, and peri‑operative bleeding by providing activated factor VIII activity through an intravenous injection.

Catridecacog is a recombinant form of activated factor VIII that directly activates factor X on the surface of activated platelets, bypassing the deficient endogenous factor VIII. This restores the intrinsic tenase complex, accelerates thrombin generation, and stabilises clot formation, thereby reducing bleeding in inhibitor‑positive hemophilia A patients.

The dose of Novothirteen is individualized by the prescribing clinician based on the patient’s weight, severity of bleeding, and inhibitor titre. The healthcare professional determines the appropriate amount and frequency, which may differ for prophylaxis, acute bleed treatment, or surgical management.

Data on the use of catridecacog in pregnant or lactating women are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

To request Novothirteen, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed), and import documentation.

Compared with bypassing agents such as recombinant activated factor VII (eptacog alfa) or activated prothrombin complex concentrates, catridecacog offers a different mechanism by directly providing activated factor VIII activity. Clinical choice depends on individual response, inhibitor profile, safety considerations, and physician experience.

Novothirteen must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. The product should be kept in its original packaging until use, and any unused portion should be discarded according to local regulations after the recommended storage period.

Novothirteen is supplied as a sterile lyophilised powder for reconstitution and is administered by intravenous infusion. The reconstituted solution is injected slowly under clinical supervision, with dosing and infusion rate determined by the treating physician based on the clinical situation.

The most serious adverse events include thromboembolic complications such as deep‑vein thrombosis or pulmonary embolism, severe hypersensitivity reactions including anaphylaxis, development of neutralising antibodies that may reduce efficacy, and disseminated intravascular coagulation. Patients should be monitored closely for these signs.

Novothirteen is contraindicated in patients with known hypersensitivity to catridecacog or any of its excipients. It should also be avoided in individuals with a history of severe thrombotic events unless the benefits clearly outweigh the risks, and it is not recommended for use in patients without confirmed factor VIII inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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