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Ordering Nubeqa®
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Active substance: Darolutamide. Indication: NUBEQA, in combination with docetaxel and androgen deprivation therapy (ADT), is indicated for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC), for whom docetaxel therapy is indicated. NUBEQA, in combination with ADT, is indicated for the treatment of adult patients with non-metastatic, castration-resistant prostate cancer (nmCRPC), for those who are at high risk of developing metastases (especially with a PSADT ≤ 10 months). Dosage/Administration: 600 mg (two 300-mg film-coated tablets) taken twice daily with a meal (total daily dose of 1200 mg). Patients receiving NUBEQA should also receive an LHRH analogue concurrently or have had a bilateral orchiectomy. Patients with mHSPC should start treatment with NUBEQA in combination with six cycles of docetaxel. Contraindications: Hypersensitivity to the active pharmaceutical ingredient or to one of the excipients. Women who are pregnant or of childbearing potential. Special warnings/precautions for use: Renal/hepatic impairment: Closely monitor patients with severe renal impairment or moderate/severe hepatic impairment for adverse reactions. Hepatotoxicity: In case of liver function test abnormalities suggestive of idiosyncratic DILI, NUBEQA must be permanently discontinued. ADT can prolong the QT interval: In case of risk factors or concomitant medication that prolong the QT interval, ECG monitoring should be considered. Contraception: Sexually active patients must use a highly effective form of contraception. Bone density: may be affected during treatment with NUBEQA due to long-term testosterone suppression. Recent cariovascular disease: The safety of NUBEQA in patients with a clinically relevant cardiovascular disease in the last six months has not been proven, follow current guidelines. The prescribed dose is practically “sodium free”. Do not take if you have hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Adverse effects: NUBEQA: Very common: Neutrophil count decreased, AST increased, bilirubin increased, fatigue. Common: Ischaemic heart disease, cardiac failure, rash, pain in extremities, musculoskeletal pain, fractures. NUBEQA in combination with docetaxel: Very common: Hypertension including occasional hypertensive emergency, AST increased, ALT increased, bilirubin increased, rash. Interactions: BCRP inhibitor, OATP 1B1 and 1B3, in the case of concurrent use with corresponding substrates, follow the recommendations in the respective prescribing information. Weak CYP3A4 inducer. Substrate of CYP3A4, P-gp, and BCRP. Use of strong CYP3A4 inducers and P-gp inducers during treatment with NUBEQA should be avoided. Dispensing category: B. Authorization holder: Bayer (Schweiz) AG, Uetlibergstrasse 132, 8045 Zurich.
For detailed information, please refer to the published medicinal product information at www.swissmedicinfo.ch.
MA-M_DAR-CH-0241-1 07/2024
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-0240-3 06/24
