Martindale: The Complete Drug Reference

10th September 2024

Martindale: The Complete Drug Reference

This update contains 3 new monographs and 5 existing monographs have been updated. Preparations have also been updated for 4 countries.

New Monographs

• Mosunetuzumab is a bispecific recombinant monoclonal antibody that binds to both CD20 on B-cells and CD3 receptors on T-cells. It is used for the treatment of relapsed or refractory follicular lymphoma.
• Sparsentan is a dual endothelin and angiotensin II receptor antagonist. It is used to reduce proteinuria in primary immunoglobulin A nephropathy.
• Tofersen, an antisense oligonucleotide, is used for the treatment of amyotrophic lateral sclerosis associated with a superoxide dismutase 1 (SOD1) gene mutation.

Selective Updates – some new, re-validated or changed information

Monographs 

• Acetylcysteine
• Cytisinicline (formerly Cytisine)
• Macrogolglycerides (formerly Macrogol/glycerol Esters)
• Methylpyrrolidone (formerly N-Methylpyrrolidone)
• Trichloromonofluoromethane (formerly Trichlorofluoromethane)

Proprietary Preparations and Manufacturers updated for the following countries and regions:

• Australia
• Finland
• UK†
• USA†

† Countries updated on an ongoing basis

11th June 2024

Martindale: The Complete Drug Reference

This update contains 5 new monographs, and 1 existing monograph has been updated. Preparations have also been updated for 4 countries.

New Monographs

• Mavacamten, a reversible selective inhibitor of cardiac myosin, is used to improve symptoms and functional capacity in obstructive hypertrophic cardiomyopathy.
• Pretomanid is an antimycobacterial used in the treatment of pulmonary, multidrug-resistant tuberculosis. It is an orally active nitroimidazo-oxazine derivative.
• Relugolix is a gonadorelin antagonist used in the hormonal therapy of advanced prostate cancer. It is also used in combination with estradiol and norethisterone for uterine fibroids and endometriosis.
• Teclistamab is a bispecific humanised monoclonal antibody that binds to both B-cell maturation antigen (BCMA) and CD3 receptor on T-cells. It is used in the treatment of relapsed or refractory multiple myeloma.
• Trofinetide, a synthetic analogue of glycine-proline-glutamate, is used for the treatment of Rett syndrome.

Selective Updates – some new, re-validated or changed information.

Monographs:

• Pazopanib Hydrochloride.

Proprietary Preparations and Manufacturers updated for the following countries and regions:

• Belgium
• New Zealand
• UK†
• USA†

† Countries updated on an ongoing basis

12th March 2024

Martindale: The Complete Drug Reference

This update contains 9 new monographs and 4 existing monographs have been updated. Preparations have also been updated for 3 countries.

New Monographs

• Adagrasib is a KRAS^G12C inhibitor used for the treatment of locally advanced or metastatic KRAS^G12C-mutated non-small cell lung cancer.
• Atidarsagene autotemcel is a gene therapy product used for the treatment of metachromatic leukodystrophy.
• Bexagliflozin is a sodium-glucose co-transporter 2 inhibitor used in the treatment of type 2 diabetes mellitus.
• Serdexmethylphenidate is a prodrug of dexmethylphenidate used as the chloride, in a fixed-dose combination product with dexmethylphenidate hydrochloride, for the treatment of attention deficit hyperactivity disorder.
• Teplizumab is a humanised monoclonal antibody that binds to the CD3 antigen on T-lymphocytes and is used to delay the onset of stage 3 type 1 diabetes mellitus.
• Velmanase alfa is an exogenous source of the enzyme, alpha-mannosidase. It is used as enzyme replacement therapy for the treatment of non-neurological manifestations of alpha-mannosidosis in adults and children.
• Vutrisiran is a double-stranded small interfering ribonucleic acid used in the treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.
• Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase that is used in the treatment of Waldenström’s macroglobulinaemia, chronic lymphocytic leukaemia or small lymphocytic lymphoma, marginal zone lymphoma, and mantle cell lymphoma.
• Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is used in the acute treatment of migraine.

New salts or related derivatives added to existing monographs

• Indacaterol Acetate (added to Indacaterol)

Selective Updates – some new, re-validated or changed information

Monographs

• Baricitinib
• COVID-19 vaccines
• Esketamine hydrochloride
• Malaria Vaccines

Treatment reviews

• COVID-19
• Primary hyperoxaluria

Updated names, synonyms and codes; official standards; official preparations

• ATC and ATCvet 2024
• Ph. Eur. 11.0

Proprietary Preparations and Manufacturers updated for the following countries and regions:

• Argentina
• UK†
• USA†

† Countries updated on an ongoing basis

5th December 2023

Martindale: The Complete Drug Reference

This update contains 8 new monographs, and 7 existing monographs have been updated. Preparations have been updated for 5 countries.

New Monographs

• Bimekizumab is a humanised monoclonal antibody that binds to and blocks proinflammatory cytokines involved in skin inflammation. It is used for the treatment of moderate to severe plaque psoriasis.
• Eflapegrastim is a granulocyte colony-stimulating factor that stimulates the development of granulocytes. It is given to prevent neutropenia as an adjunct in cancer chemotherapy.
• Inebilizumab is a CD19-directed recombinant humanised monoclonal antibody used in the treatment of neuromyelitis optica spectrum disorder.
• Lenacapavir is an HIV-1 capsid inhibitor used with other antiretrovirals for the treatment of multidrug-resistant HIV-1 infection and AIDS in treatment-experienced patients.
• Olipudase alfa is an exogenous source of the enzyme, acid sphingomyelinase. It is used for the treatment of non-CNS manifestations of acid sphingomyelinase deficiency (Niemann-Pick disease type A/B, or type B).
• Satralizumab, a recombinant humanised monoclonal antibody that targets the interleukin-6 receptor, is used in the treatment of neuromyelitis optica spectrum disorder.
• Ublituximab is a recombinant anti-CD20 monoclonal antibody that is used for the treatment of relapsing forms of multiple sclerosis.
• Volanesorsen, an antisense oligonucleotide, is used for genetically-confirmed familial chylomicronemia syndrome with a high risk of pancreatitis, in patients who have had an inadequate response to diet and triglyceride lowering therapy.

New salts or related derivatives added to existing monographs

• Trastuzumab Deruxtecan (added to Trastuzumab)

Selective Updates – some new, re-validated or changed information

Monographs

• Dengue Vaccines (formerly Dengue Fever Vaccines)
• Eculizumab
• Interleukin-6 receptor antagonists
• Lonafarnib
• Remdesivir
• Sarilumab
• Tocilizumab

Updated names, synonyms and codes; official standards; official preparations:

• BP 2022
• BP 2023
• USP-NF 2023, Issue 1
• USP-NF 2023, Issue 2

Proprietary Preparations and Manufacturers updated for the following countries and regions:

• Czech Republic
• Hungary
• Norway
• UK†
• USA†

† Countries updated on an ongoing basis

12th September 2023

Martindale: The Complete Drug Reference

This update contains 22 new monographs, 1 existing monograph update, and 2 existing treatment reviews updates. Preparations have been updated for 4 countries.

New Monographs

• Atoltivimab, maftivimab, and odesivimab are Zaire ebolavirus glycoprotein-directed human monoclonal antibodies used together for the treatment of Zaire ebolavirus infection.
• Belantamab mafodotin is an antibody-drug conjugate consisting of a B-cell maturation antigen (BCMA) directed monoclonal antibody conjugated to a microtubule inhibitor; it is used for the treatment of relapsed or refractory multiple myeloma.
• Berotralstat is a plasma kallikrein inhibitor used for prophylaxis of acute attacks of hereditary angioedema.
• Bulevirtide is a sodium-bile acid co-transporter inhibitor used for the treatment of chronic hepatitis D in compensated liver disease.
• Cabotegravir is an HIV-integrase inhibitor used with rilpivirine for the treatment of HIV infection, and as monotherapy for pre-exposure prophylaxis.
• Casimersen, an antisense oligonucleotide, is given for the treatment of Duchenne muscular dystrophy caused by mutations in the dystrophin gene that are amenable to treatment with exon 45 skipping.
• Deucravacitinib is an inhibitor of tyrosine kinase 2, which is a member of the Janus kinase (JAK) family. It is used for the treatment of moderate to severe plaque psoriasis.
• Futibatinib is a tyrosine kinase inhibitor used in the treatment of locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene alterations.
• Golodirsen, an antisense oligonucleotide, is given for the treatment of Duchenne muscular dystrophy caused by mutations in the dystrophin gene that are amenable to treatment with exon 53 skipping.
• Lumasiran is a small interfering ribonucleic acid (siRNA) used in the treatment of primary hyperoxaluria type 1.
• Mirvetuximab soravtansine is an antibody-drug conjugate consisting of a folate receptor alpha-directed monoclonal antibody conjugated to DM4, a microtubule inhibitor. It is used for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Omidenepag is a prostaglandin E2 receptor agonist. It is used as the isopropyl ester to reduce elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension.
• Pacritinib is an inhibitor of the Janus kinase JAK2 and FMS-like tyrosine kinase 3 (FLT3) used in the treatment of myelofibrosis.
• Pegcetacoplan is a synthetic pegylated cyclic peptide that acts as a complement blocker by inhibiting complement activation at the C3 protein. It is used to reduce haemolysis in patients with paroxysmal nocturnal haemoglobinuria. It is also used for the treatment of geographic atrophy caused by non-neovascular (dry) age-related macular degeneration.
• Pexidartinib is a tyrosine kinase inhibitor used in the treatment of tenosynovial giant cell tumour.
• Relatlimab is a human immunoglobulin G4 monoclonal antibody that is used for the treatment of unresectable or metastatic melanoma.
• Spesolimab is a humanised monoclonal antibody that binds to and blocks the interleukin-36 receptor. It is used for the treatment of generalised pustular psoriasis flares.
• Tirzepatide is a long-acting dual glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist. It is used in the treatment of type 2 diabetes mellitus.
• Trilaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 used in the prevention of chemotherapy-induced myelosuppression.
• Viltolarsen, an antisense oligonucleotide, is given for the treatment of Duchenne muscular dystrophy caused by mutations in the dystrophin gene that are amenable to treatment with exon 53 skipping.

Selective Updates – some new, re-validated or changed information

Monographs

• Mepolizumab

Treatment reviews

• COVID-19
• Primary hyperoxaluria

Proprietary Preparations and Manufacturers updated for the following countries and regions:

• Greece
• India
• UK†
• USA†

† Countries updated on an ongoing basis

19th June 2023

Martindale: The Complete Drug Reference

This update contains 22 new monographs and 1 existing monograph have been updated.
Preparations have been updated for 2 countries.

New monographs:

• Abametapir is a pediculicide that has been used topically for the treatment of head pediculosis.
• Ansuvimab is a Zaire ebolavirus glycoprotein-directed human monoclonal antibody used in the treatment of Zaire ebolavirus infection.
• Belumosudil is a Rho-associated, coiled-coil containing protein kinase-2 (ROCK2) inhibitor used in the treatment of chronic graft-versus-host disease.
• Cenobamate is a carbamate antiepileptic used in the treatment of partial-onset seizures with or without secondary generalisation.
• Fosdenopterin, a synthetic form of cyclic pyranopterin monophosphate (cPMP), is used as substrate replacement therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) type A.
• Ibrexafungerp is a triterpenoid antifungal used for vulvovaginal candidiasis.
• Larotrectinib is a tyrosine kinase inhibitor selective for tropomyosin receptor kinases (TRK). It is used to treat solid tumours that have a neurotrophic TRK gene fusion.
• Loncastuximab tesirine is an antibody-drug conjugate consisting of a CD19-directed monoclonal antibody conjugated to SG3249, an alkylating agent. It is used for the treatment of large B-cell lymphoma.
• Mobocertinib is a tyrosine kinase inhibitor directed against the epidermal growth factor (EGFR) family. It is used in the treatment of locally advanced or metastatic non-small cell lung cancer.
• Naxitamab is a monoclonal antibody that binds to the glycolipid disialoganglioside GD2. It is used for relapsed or refractory high-risk neuroblastoma in bone or bone marrow.
• Oliceridine is an opioid analgesic used in the management of moderate to severe acute pain.
• Onasemnogene abeparvovec, a gene therapy product, is used in children with spinal muscle atrophy type 1 which is associated with mutations in the survival motor neurone 1 (SMN1) gene. It is made from a recombinant adeno-associated virus serotype (AAV9) vector that contains a functional copy of SMN1.
• Osilodrostat inhibits 11β-hydroxylase, an enzyme in the adrenal gland responsible for cortisol biosynthesis. It is used in the treatment of endogenous Cushing’s syndrome.
• Oteseconazole is a tetrazole antifungal used to reduce the incidence of recurrent vulvovaginal candidiasis.
• Pemigatinib is a tyrosine kinase inhibitor of fibroblast growth factor receptors (FGFR); it is used in the treatment of cholangiocarcinoma, and myeloid or lymphoid neoplasms.
• Pralsetinib is a tyrosine kinase inhibitor used in the treatment of advanced or metastatic non-small cell lung cancer and thyroid cancers.
• Roxadustat, a hypoxia-inducible factor, prolyl hydroxylase inhibitor, is used for the treatment of symptomatic anaemia associated with chronic kidney disease.
• Tapinarof is an aryl hydrocarbon receptor agonist used topically in the treatment of psoriasis.
• Tirbanibulin is a tyrosine kinase and microtubule inhibitor that is used for the topical treatment of actinic keratosis.
• Tisotumab vedotin is a monoclonal antibody-drug conjugate consisting of a human immunoglobulin G1 monoclonal antibody conjugated to monomethyl auristatin E, it is used for the treatment of recurrent or metastatic cervical cancer.
• Umbralisib is a phosphoinositide-3 kinase δ (PI3Kδ) and casein kinase CK1ε kinase inhibitor that was used in the treatment of lymphoma before being withdrawn by the FDA due to a potential increased risk of death.
• Vibegron is a beta3-adrenoceptor agonist used in the management of urinary frequency, urgency, and incontinence in overactive bladder syndrome.

Notable revisions:

• Pholcodine has been widely withdrawn due to safety concerns.

Updated names, synonyms and codes; official standards; official preparations:

• PhEur 10.7
• PhEur 10.8

Proprietary Preparations and Manufacturers updated for the following countries and
regions:

• Malaysia
• Russia
• UK†
• USA†

† Countries updated on an ongoing basis.