Martindale: The Complete Drug Reference

Preparations have been updated for 6 countries.

New monographs: 

• 1,3-Dimethylbutylamine: is a compound related to methylhexaneaminethat may be subject to abuse in sport. 
• 1-Androsterone: is reported to be an anabolic androgenic steroid that may be subject to abuse in sport.
• 5α-Androst-2-ene-17-one: is reported to be an anabolic steroid that may be subject to abuse in sport.
• 5β-Androstane-3α,17-β-diol: is reported to be an anabolic steroid. It may be subject to abuse in sport.
• Alexamorelin: is reported to be a growth hormone-releasing peptide (GHRP) and may be subject to abuse in sport.
• α-Pyrrolidinovalerophenone: an analogue of 3,4-methylenedioxypyrovalerone (MDPV), is reported to have stimulant properties and may be subject to abuse in sport.
• Andarine: is reported to be a selective androgen receptor modulator (SARM). It may be subject to abuse in sport.
• Androsta-3,5-diene-7,17-dione: is reported to be an aromatase inhibitor. It may be subject to abuse in sport.
• AOD-9604: is reported to be a modified fragment of the lipolytic domain of human growth hormone. It may be subject to abuse in sport.
• AsialoEPO: a derivative of erythropoietin (EPO), is reported to be an innate repair receptor agonist. It may be subject to abuse in sport.
• Brexanolone: is a positive allosteric GABA_Areceptor modulator used for the treatment of postpartum depression. 
• Brodalumab: is an anti-IL-17RA monoclonal antibody, now available for the treatment of moderate to severe plaque psoriasis.
• Carbamylated EPO: a derivative of erythropoietin (EPO), is reported to be an innate repair receptor agonist. It may be subject to abuse in sport.
• CJC-1293: is reported to be a growth hormone-releasing hormone (GHRH) analogue and may be subject to abuse in sport.
• CJC-1295: is reported to be a growth hormone-releasing hormone (GHRH) analogue and may be subject to abuse in sport.
• CNTO-530: an erythropoietin (EPO) mimetic fusion protein, is reported to be an erythropoietin-receptor agonist. It may be subject to abuse in sport.
• Dacomitinib: is a tyrosine kinase inhibitor used in the treatment of metastatic non-small cell lung cancer with EGFR mutations.
• Emapalumab: is an interferon gamma blocking monoclonal antibody used for the treatment of primary haemophagocyticlymphohistiocytosis.
• EPO-Fc: an erythropoietin (EPO) fusion protein, is reported to be an erythropoietin-receptor agonist. It may be subject to abuse in sport.
• GHRP-1: is reported to be a growth hormone-releasing peptide (GHRP) and may be subject to abuse in sport.
• GHRP-3: is reported to be a growth hormone-releasing peptide (GHRP) and may be subject to abuse in sport.
• GHRP-4: is reported to be a growth hormone-releasing peptide (GHRP) and may be subject to abuse in sport.
• GHRP-5: is reported to be a growth hormone-releasing peptide (GHRP) and may be subject to abuse in sport.
• Glasdegib: is an orally active hedgehog pathway inhibitor used in combination with low-dose cytarabine for the treatment of acute myeloid leukaemia.
• HGH 176-191: is reported to be a human growth hormone (HGH) peptide fragment. It may be subject to abuse in sport.
• Higenamine: is reported to be a beta₂agonist and may be subject to abuse in sport.
• Inotersen: is a transthyretin-directed antisense oligonucleotide used for the treatment of hereditary transthyretin amyloidosis.
• K-11706: is reported to be a GATA inhibitor and may be subject to abuse in sport.
• Ligandrol: is reported to be a selective androgen receptor modulator and may be subject to abuse in sport.
• Lorlatinib: is a tyrosine kinase inhibitor licensed in the USA for the treatment of ALK-positive metastatic non-small cell lung cancer.
• Patisiran: is a small interfering ribonucleic acid used in the treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.
• RAD-140: is reported to be a selective androgen receptor modulator (SARM). It may be subject to abuse in sport.
• Romosozumab: is a humanised monoclonal antibody that inhibits sclerostin, thereby increasing bone formation and reducing bone resoprtion. It is used in the treatment of osteoporosis.
• Sarecycline: is a tetracycline derivative used orally in the treatment of moderate to severe acne.
• SR-9009: is reported to be an AMP-activated protein kinase (AMPK) activator and may be subject to abuse in sport.
• Tagraxofuspis a CD123-directed cytotoxin used in the treatment of blastic plasmacytoid cell neoplasm.
• Talazoparibis a PARP inhibitor for the treatment of locally advanced or metastatic breast cancer in patients with germline BRCA gene mutations.
• TB-500: is reported to be a synthetic fraction of the protein thymosin-β4 that is involved in cellular processes. It may be subject to abuse in sport.

Notable revisions: 

• Ciprofloxacin: the EMA has placed restrictions on the use of fluoroquinolone and quinolone antibacterialsdue to side effects involving the muscles, tendons or joints and the nervous system. The MHRA and FDA have highlighted the risk of aortic aneurysm and dissection with systemic and inhaled fluoroquinolones. 
• Dasatinib: can be used in children with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase, and in children with Philadelphia chromosome-positive acute lymphoblastic leukaemia, with chemotherapy.
• Drugs in sport: World Anti-Doping Agency classifications updated.
• Doxycycline: can be used for the treatment of acute infections in children aged from 8 years, and in children of any age for the treatment of severe or life threateninginfections such as Rocky Mountain spotted fever.  Doxycycline can also be used in adults for the treatment of Rocky Mountain spotted fever. 
• Hydrochlorothiazide: increased risk of non-melanoma skin cancer and squamous cell carcinoma of the lip associated with hydrochlorothiazide use.
• Midostaurin: can be used for the treatment of acute myeloid leukaemia, aggressive systemic mastocytosis(ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL). 
• Sirolimus: can be used for lymphangioleiomyomatosis. 
• Sofosbuvir: risk of hypoglycaemia in diabetic patients on direct-acting antiviral therapy.

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

• Israel
• Italy
• Japan
• Poland
• UK†
• USA†

† Countries updated on an ongoing basis

New monographs:

• Angiotensin II and Angiotensin II Acetate: is a synthetic human angiotensin II that is used as a vasopressor in septic or other distributive shock.
• Apalutamide: is a nonsteroidal anti-androgen that is used for the treatment of non-metastatic, castration-resistant prostate cancer.
• Avatrombopag and Avatrombopag Maleate: is a thrombopoietin receptor agonist licensed to reduce bleeding risk in patients with chronic liver disease undergoing surgery.
• Darvadstrocel: is an allogeneic expanded adipose-derived stem cell therapy. It is used for the treatment of fistulising Crohn’s disease.
• Elagolix and Elagolix Sodium: is a gonadorelin antagonist. It is used for the management of moderate to severe pain associated with endometriosis.
• Emicizumab: is a monoclonal antibody that acts as a factor VIII mimetic. It is used to prevent bleeding episodes in patients with haemophilia A who have developed factor VIII antibodies.
• Eravacycline and Eravacycline Hydrochloride: is a tetracycline derivative that is used for the treatment of complicated intra-abdominal infections.
• Latanoprostene bunod: is a synthetic analogue of dinoprost that is used topically in the treatment of glaucoma and ocular hypertension.
• Padeliporfin and Padeliporfin Potassium: is a bacteriochlorophyll derivative that is used as a photosensitiser for the photodynamic therapy of prostate cancer.
• Plazomicin and Plazomicin Sulfate: is a derivative of sisomicin that is used for the treatment of complicated urinary-tract infections, including pyelonephritis.
• Sodium Zirconium Cyclosilicate: is a potassium binder that is used for the treatment of hyperkalaemia.
• Tecovirimat: is an antiviral that inhibits the orthopoxvirus VP37 envelope wrapping protein that may be used for the treatment of smallpox in the event of an outbreak.
• Tezacaftor: is a cystic fibrosis transmembrane conductance regulator (CFTR) protein corrector that is used in combination with ivacaftor in the treatment of cystic fibrosis.
• Tildrakizumab: is a humanised monoclonal antibody that is an interleukin-23 antagonist and is used for the treatment of plaque psoriasis.

Notable revisions: 

• Adalimumab: is used for the treatment of uveitis in children and hidradentis suppurativa in patients 12 years and older.
• Ataluren: is used in children from the age of 2 years old for the treatment of Duchenne muscular dystrophy (DMD).
• Certolizumab pegol: is used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• Daclizumab: it has been withdrawn worldwide for the treatment of multiple sclerosis because of the risk of serious inflammatory brain disorders.
• Fosaprepitant: is used in children from the age of 6 months old for nausea and vomiting associated with chemotherapy.
• Mogamulizumab: is used for the treatment of mycosis fungoides, Sezary syndrome, and cutaneous and peripheral T-cell lymphoma.
• Rufinamide: is used in children from 1 year of age in the treatment of Lennox-Gastaut syndrome.
• Tapentadol: can be used in children from 2 years of age for the management of moderate to severe pain.
• Tiotropium Bromide: is used in children from 6 years of age for the treatment of asthma.

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

• USP41/USNF36.

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

• Belgium
• Czech Republic
• Ireland
• Norway
• UK
• USA

New Monographs:

• Bictegravir: is an HIV-integrase inhibitor used in the treatment of HIV infection. 
• Cerliponase alfa: is a recombinant enzyme used to slow the loss of motor function and language skills in symptomatic patients with late-infantile neuronal ceroid lipofuscinosis type 2. 
• Ertugliflozin: is a sodium-glucose co-transporter 2 inhibitor that is used for the treatment of type 2 diabetes mellitus. 
• Gusekumab: is an antibody that targets interleukin-23 and is used for the treatment of plaque psoriasis. 
• Letermovir: is a CMV DNA terminase complex inhibitor that is used for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant. 
• Macimorelin: is a growth hormone stimulant used orally for the diagnosis of adult growth hormone deficiency. 
• Migalastat: is a stabiliser of the alpha galactosidase A enzyme that is used orally in the treatment of Fabry disease. 
• Naldemedine: is a peripherally-acting opioid antagonist used for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. 
• Ozenoxacin: is a quinolone antibacterial applied topically in the treatment of impetigo. 
• Semaglutide: is a glucagon-like peptide 1 receptor agonist used in the treatment of type 2 diabetes mellitus. 
• Voretigene neparvovec: is a gene therapy product used for treating biallelic RPE65 mutation-associated retinal dystrophy. 

Notable revisions:

• Asfotase alfa: also licensed for paediatric-onset hypophosphatasia. Adverse effects and precautions has been updated. 
• Canagliflozin: abstract on risk of amputation added. 
• Ceftriaxone Sodium: uses and administration has been updated. 
• Ceritinib: uses extended to include first-line treatment of metastatic non-small cell lung cancer. 
• Desmopressin:  new abstract on administration added. Uses and administration has been updated. 
• Eculizumab: also licensed for use in myasthenia gravis. 
• Empagliflozin: also licensed to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus. 
• Interferon Alfa: also licensed for the treatment of hepatitis B in children. Adverse effects have been updated.  
• Metformin: diabetes mellitus abstract has been updated with information on use in the prevention of type 2 diabetes mellitus. 
• Methylthioninium Chloride: new record on incompatibility added and administration in children abstract has been updated. 
• Ocrelizumab: also licensed for the treatment of relapsing and primary progressive multiple sclerosis. 
• Ulipristal acetate: use for treating uterine fibroids restricted following reports of serious liver injury. 

Updated names, synonyms and codes; official standards; official preparation: Ph Eur 9.3 and USP40/USNF35 Suppl 1 and 2. 

Proprietary Preparations and Manufacturers updated for the following countries and regions:  India, Philippines, UK†, USA†, Venezuela. († Countries updated on an ongoing basis)