capivasertib
Truqap · ATC code L01EX27
Also known as: Kapivasertib
- Key facts
- Active substance
- capivasertib
- ATC code
- L01EX27
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- TRUQAP 160 mg film-coated tablets / TRUQAP 200 mg film-coated tablets
- Marketing authorisation holder
- AstraZeneca AB
- Information as of
- 2026-10-28
Key facts
Capivasertib (Truqap) is an oral AKT kinase inhibitor used with fulvestrant for advanced hormone receptor-positive, HER2-negative breast cancer with specific gene alterations.
What it is used for
- In combination with fulvestrant for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following recurrence or progression on or after an endocrine-based regimen.
- Pre- or perimenopausal women also receive an LHRH agonist; in men an LHRH agonist should be considered.
Dosing
- 400 mg (two 200 mg tablets) twice daily, approximately 12 hours apart, for 4 days followed by 3 days off (no dosing on days 5, 6 and 7 of each week).
- Fulvestrant 500 mg on Days 1, 15 and 29, and once monthly thereafter.
- Dose reductions for adverse reactions: first 320 mg, then 200 mg twice daily (same schedule); for hyperglycaemia, diarrhoea and skin reactions see the full text.
- With strong CYP3A4 inhibitors (avoid if possible) or moderate CYP3A4 inhibitors: 320 mg twice daily.
- Mild/moderate renal impairment and mild hepatic impairment: no adjustment; not recommended in severe renal or hepatic impairment.
- Missed dose: take within 4 hours, otherwise skip; at least 8 hours between doses.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Hyperglycaemia, including severe cases with diabetic ketoacidosis and fatal outcomes, can occur at any time; monitor patients with diabetes closely. Not studied in type 1 diabetes, insulin-requiring type 2 diabetes or HbA1c > 8.0%.
- Diarrhoea: start anti-diarrhoeal treatment; interrupt or reduce dose as needed.
- Cutaneous reactions (rash), some severe; dose modification by severity.
Side effects
- Most common: diarrhoea (72.4%), rash (40.6%), nausea (34.6%), fatigue (32.1%), vomiting (21.4%), hyperglycaemia (19.2%), stomatitis (18.6%), headache (17.2%), decreased appetite (16.9%) and urinary tract infection (16.6%).
- Most common grade 3 or 4: rash (12.4%), diarrhoea (10.4%), anaemia (3.4%), hypokalaemia (2.8%), hyperglycaemia (2.5%), stomatitis (2.3%).
Interactions
- Capivasertib is mainly metabolised by CYP3A4 and UGT2B7; strong and moderate CYP3A4 inhibitors increase levels (dose reduction, see above). For other interactions see the full text.
Pregnancy and breastfeeding
- Pregnancy test before starting; effective contraception during treatment and for at least 4 weeks (females) or 16 weeks (males) afterwards.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- TruqapAstraZeneca AB · EMEA/H/C/006017
Source: European Medicines Agency (EMA), product information
Turkey
- TruqapASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Truqap
- Liechtenstein
- Truqap
- Norway
- Truqap
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Truqap – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/truqap-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.