# Kesimpta Approved Terms (generic test content)

A populated generic template used during pilot testing of the Proof Check skill. The content here is not brand-specific. It exists so the Terminology category of the proof check has something meaningful to flag against while brand-specific Approved Terms files are being prepared by the medical writing teams.

**Brand teams:** when you populate the real Approved Terms file for your brand, replace the entire content below with the brand-specific terminology, brand names, generic drug names, disease and condition spellings, clinical abbreviations, and banned phrases that apply to your brand. Keep the section headings (Brands and products, Drugs and ingredients, Diseases and conditions, Clinical terminology, Notes) so the skill can parse the file consistently.

**Note on brand entries:** the example brand entry below is a placeholder. Replace `Kesimpta` with the actual brand name. Add additional brand variants (e.g., extended-release, combination products) if relevant.

## Brands and products

- **\<Brand\>** — replace this entry with the brand's actual approved form. Capitalisation: title case (most common, e.g., "Veltassa"). Trademark: \® on first mention only.
- **\<Brand Variant\>** — replace with any extended-release, combination, or sub-product variants. State the exact capitalisation and trademark convention for each.

## Drugs and ingredients (generic names)

Australian English spellings of common active ingredients and excipients. Replace or extend with brand-specific entries.

- atorvastatin
- rosuvastatin
- ezetimibe
- pravastatin
- simvastatin
- patiromer
- glecaprevir
- pibrentasvir
- ribociclib
- ofatumumab
- metformin
- insulin glargine
- empagliflozin
- dapagliflozin
- sacubitril
- valsartan

## Diseases and conditions

Australian English spellings of common diseases and conditions. The skill flags US spellings or US-style drift against these forms.

- primary hypercholesterolaemia (not hypercholesterolemia)
- mixed dyslipidaemia (not dyslipidemia)
- familial hypercholesterolaemia (FH) (not hypercholesterolemia)
- atherosclerotic cardiovascular disease (ASCVD)
- type 2 diabetes (T2D) — define abbreviation on first use
- chronic hepatitis C virus infection (HCV)
- hyperkalaemia (not hyperkalemia)
- multiple sclerosis (MS)
- relapsing-remitting multiple sclerosis (RRMS)
- hormone receptor-positive HER2-negative advanced or metastatic breast cancer (HR+ HER2-)
- chronic kidney disease (CKD)
- end-stage renal disease (ESRD)
- haemodialysis (not hemodialysis)
- paediatric (not pediatric)
- foetus and foetal (not fetus / fetal)
- oestrogen and oestradiol (not estrogen / estradiol)
- haematology, haematological (not hematology / hematological)
- anaemia (not anemia)
- oedema (not edema)

## Clinical terminology

Standard clinical abbreviations and their AU English expansions. Used as the dictionary for the "abbreviation defined on first use" rule and for catching wrong expansions.

- LDL-C — low-density lipoprotein cholesterol
- HDL-C — high-density lipoprotein cholesterol
- triglycerides (TG)
- HbA1c — glycated haemoglobin (not "glycosylated haemoglobin")
- intention-to-treat (ITT)
- per-protocol (PP)
- hazard ratio (HR)
- confidence interval (CI)
- relative risk reduction (RRR)
- absolute risk reduction (ARR)
- number needed to treat (NNT)
- number needed to harm (NNH)
- major adverse cardiovascular events (MACE)
- creatine kinase (CK)
- alanine aminotransferase (ALT)
- aspartate aminotransferase (AST)
- estimated glomerular filtration rate (eGFR)
- progression-free survival (PFS)
- overall survival (OS)
- annualised relapse rate (ARR) — note context, do not confuse with absolute risk reduction
- expanded disability status scale (EDSS)
- adverse event (AE)
- serious adverse event (SAE)
- treatment-emergent adverse event (TEAE)
- pharmacokinetics (PK)
- pharmacodynamics (PD)
- product information (PI)
- consumer medicine information (CMI)
- Medicines Australia Code of Conduct (MA Code)
- Pharmaceutical Benefits Scheme (PBS)
- Therapeutic Goods Administration (TGA)

## Notes

### Banned marketing phrases

These phrases are flagged at Medium confidence wherever they appear. Add brand-specific overrides if the brand permits any of these in specific contexts.

- groundbreaking
- revolutionary
- first-in-class (unless substantiated against an approved comparator list)
- game-changing
- breakthrough
- paradigm-shifting
- unprecedented
- next-generation (without substantiation)
- best-in-class (without substantiation)
- world-leading
- world-class
- innovative
- novel (unless qualifying a specific mechanism)
- cutting-edge

### Preferred phrasings

- Use "people with \<condition\>" not "patients" in patient-facing materials. HCP-facing materials may use "patients".
- Use "people living with \<condition\>" for chronic conditions in patient-facing copy.
- Use "treatment with \<Brand\>" not "\<Brand\> therapy" unless the house style explicitly prefers therapy.
- Avoid "suffering from" or "victims of" for any condition.

### Trademark conventions

- Brand name and the registered or trademark symbol (\®, \™) on first mention only, per Ward house style.
- Subsequent mentions: brand name without symbol.
- Brand name is title case unless the brand guidelines specify all caps.

### What to replace when the brand team populates this file

Brand teams should replace the placeholder entries above with brand-specific terminology. The structure (section headings, formatting) should remain the same so the skill can parse the file consistently. Generic clinical terminology, AU English spellings, banned marketing phrases, and preferred phrasings can usually stay as-is unless the brand has a specific exception.