Publications
Check out these publications on our products Nubeqa (darolutamide) and Xofigo (radium-223 dichloride)
Darolutamide in mHSPC
ARASENS – PSA responses
Saad et al, European Urology 2024, in press
ARASENS – volume/risk subgroup analysis
Hussain et al, Journal of Clinical Oncology 2023 41:20, 3595-3607
ARASENS – primary publication
Smith et al. N Engl J Med. 2022 Mar 24;386(12):1132-1142.
Darolutamide in nmCRPC
ARIs in nmCRPC – results of the retrospective DEAR study
George et al. JAMA Netw Open. 2024 Aug 1;7(8):e2429783
DDI potential among ARI treated nmCRPC patients
Appukkuttan et al. Expert Rev Anticancer Ther. 2024 Mar 12:1-9.
ARAMIS – extended safety results
Shore et al. Oncologist. 2024 Feb 23:oyae019.
ARAMIS - crossover effect on OS
Shore et al. EJC Volume 195. December 2023
ARAMIS – patients with comorbidities and concomittant medications
Fizazi et al. Eur J Cancer. 2023 Oct:192:113258.
ARAMIS – OS results
Fizazi et al. N Engl J Med. 2020 Sep 10;383(11):1040-1049.
ARAMIS – drug-drug interactions
Shore et al. Target Oncol. 2019 Oct;14(5):527-539
ARAMIS – primary publication
Fizazi et al. N Engl J Med. 2019 Mar 28;380(13):1235-1246.
Radium-223: real world evidence in mCRPC
RALU: Ra-223 followed by Lu-177-PSMA
Rahbar et al. J Nucl Med. 2023
REASSURE clinical outcomes and treatment patterns
Higano et al. EClinicalMedicine. 2023
AS.: Darolutamide. I.: NUBEQA is indicated in comb. with androgen deprivation therapy (ADT) for the treatm. of adult pat. with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is indicated in comb. with docetaxel and ADT for the treatm. of adult pat. with mHSPC, for whom docetaxel therapy is indicated. NUBEQA is indicated in comb. with ADT for the treatm. of adult pat. with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of develop. metastases (especially with a PSA-DT ≤ 10 m.). D/A: 600 mg (two 300 mg film-coated tablets) taken 2/day with a meal (total daily dose of 1200 mg). pat. receiving NUBEQA should also receive an LHRH agonist or antagonist concurrently or have had a bilat. orchiectomy. When used in comb. with docetaxel, the 1. of 6 docetaxel cycles should begin within 6 weeks of starting NUBEQA. CI.: Hypersensitivity to the active pharmaceut. ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Spec.W./Prec.: Renal/hepatic impairment: Closely monitor pat. with severe renal impair. or moderate/severe hepatic impair. for adverse reactions. Hepatotox.: In case of liver funct. test abnormalities suggestive of idiosyncr. DILI, NUBEQA must be permanently discont. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be consid.. Contraception: Sexually active pat. must use a highly effective form of contracept.. Bone density: may be affected during treatm. with NUBEQA due to long-term testosterone suppr. Recent cardiovasc. disease: The safety of NUBEQA in pat. with a clinic. relevant cardiovasc. disease in the last 6 months has not been proven, follow current guidelines. The prescr. dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. AEs.: NUBEQA: Very common: Neutrophil count decr., AST and ALT incr., bilirubin incr., fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, fractures. NUBEQA in comb. with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST incr., ALT incr., bilirubin incr., rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresp. substrates, follow the recommendations in the resp. prescrib. information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatm. with NUBEQA should be avoided. UE: Very common: Neutrophil count decreased, AST and ALT increased, Bilirubin increased, Fatigue. Common: Ischaemic heart disease, Cardiac failure, Rash, Pain in extremities, Fractures. NUBEQA in combination with Docetaxel: Very common: Hypertension including hypertensive emergency, AST increased, ALT increased, Bilirubin increased, Rash. List: B. Bayer (Schweiz) AG, 8045 Zurich. Further inform.: www.swissmedicinfo.ch.
RP-M_DAR-CH-0108-3 07/2025
Drug substance: Radium Ra-223 dichloride. Indication: Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases without known visceral metastases. Anti-androgenic treatment is to be continued to suppress the testosterone levels to castration levels in non-orchiectomized patients. Posology/Administration: 6 injections, each of 55 kBq per kg body weight, given at 4-week intervals. There is no indication for use in children, adolescents and in women. Xofigo is a therapeutic radiopharmaceutical. Only to be used by authorized personnel with a corresponding license issued by the Federal Office of Public Health. Contraindications: Combination with abiraterone acetate plus prednisone/prednisolone. Pregnancy, women of child-bearing age, during lactation. Special warnings and precautions for use: Adherence to the interval given in the Information for Professionals is recommended for sequential use of abiraterone acetate plus prednisone/prednisolone and Xofigo (or inverse sequence). There are no data on the treatment of patients with asymptomatic bone metastases and is therefore not recommended. Bone marrow suppression, a hematological examination must be carried out before starting treatment and prior to every further dose. Not investigated in patients with Crohn’s disease or ulcerative colitis. In cases of spinal cord compression, standard treatment should be completed in accordance with the clinical indication before starting or resuming treatment with Xofigo. Bone fractures must be treated using orthopedic stabilization before starting or resuming treatment with Xofigo. Potential adverse effects on testicles and sperm, reliable contraception required. Contains sodium. Undesirable effects: Very common: thrombocytopenia, diarrhea, vomiting, nausea. Common: neutropenia, pancytopenia, leukopenia, injection site reactions. Uncommon: lymphopenia Interactions: The safety and efficacy of a combination therapy with Xofigo plus chemotherapy have not been investigated, effects on bone marrow suppression may be additive. Pack sizes: 1 vial containing 6 mL solution with 6600 kBq. Dispensing category A Marketing authorization holder: Bayer (Schweiz) AG, Uetlibergstrasse 132, 8045 Zurich.
Detailed Information at www.swissmedicinfo.ch.
RP-XOF-CH-0012-2 09/2021
PP-NUB-CH-0239-4 09/24
