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Switching between liquid and tablet/capsule formulations - Which medicines require extra care?

19 July 2021For a small number of medicines, there are differences in equivalent doses of oral formulations of the same medicine. This needs to be considered when…
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Refrigerated Storage

NoxafilMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Noxafil
Concentrate for solution for infusion, 300mg

Contact MSD in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

23 February 2022
London MI Service

Medicine Compliance Aid Stability

NoxafilMerck Sharp & Dohme Ltd

Merck Sharp & Dohme Ltd
Noxafil
Tablets 100mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special storage conditions
7 July 2015

Lactation Safety Information

Caspofungin, depending on organism/indication
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Serious adverse effects reported in adults
Use only when other antifungals are considered inappropriate
Monitor infant for gastro-intestinal disturbances, especially if used for prolonged periods or in high doses, although unlikely to occur.
10 November 2020

New Medicines

Noxafil Fungal infections in children - gastro-resistant tablet and concentrate for solution for infusion

Information

Noxafil
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

None
Launched
Launched
Jan 22EMA approval for an extension to the approved indications to include the paediatric population for Noxafil gastro-resistant tablets and Noxafil concentrate for solution for infusion [3].
Nov 21CHMP recommends a change to the indications for Noxafil gastro-resistant tablets and Noxafil concentrate for solution for infusion to include treatment of invasive aspergillosis in paediatric patients from 2 years of age weighing more than 40 kg and adults with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products (previously only licensed in adults). Also, use in children aged 2 years and older weighing more than 40kg (previously only licensed in adults) as prophylaxis of fungal infections in patients receiving treatment with remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high-risk of developing invasive fungal infections; and hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high-risk of developing invasive fungal infections [1].
Jun 21Noxafil delayed-release tablets and injection approved in the US for treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. Also prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows (Noxafil injection: adults and pediatric patients 2 years of age and older; Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg) [2].

Category

Triazole antifungal
Variable, as multiple indications
Fungal infections in children - gastro-resistant tablet and concentrate for solution for infusion
Oral and
Intravenous infusion

Evidence based evaluations

Noxafil Fungal infections in children - gastro-resistant powder and solvent for oral suspension

Information

Noxafil
New formulation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

None
Approved (Licensed)
Launched
Jan 22EMA approves a new pharmaceutical form for Noxafil, a gastro-resistant powder and solvent for oral suspension [3].
Nov 21The proposed indication for Noxafil gastro‑resistant powder and solvent for oral suspension is for use in the treatment of the following fungal infections in paediatric patients from 2 years of age: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Also to be licensed for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age: Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high‑risk of developing invasive fungal infections; Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high‑risk of developing invasive fungal infections [1].
Nov 21CHMP recommends approval of new Noxafil gastro-resistant powder and solvent for oral suspension formulation, with same indications as existing formulations [1].
May 21FDA approves new formulation Noxafil PowderMix for delayed-release oral suspension for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy in pediatric patients 2 years of age and older (who weigh 40 kg or less) [2].

Category

Triazole antifungal
Variable, as multiple indications
Fungal infections in children - gastro-resistant powder and solvent for oral suspension
Oral

Evidence based evaluations