NUBEQA 300 MG

What is NUBEQA?

NUBEQA 300 MG contains DAROLUTAMIDE : 300 MG. It is listed in the Health Canada Drug Product Database under DIN 02496348, held by BAYER INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Mar-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is NUBEQA used for?

NUBEQA (darolutamide) is indicated for: • the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC). NUBEQA has not been studied in patients with nmCRPC at low risk of developing metastases (see 14 Clinical Trials). The benefit and risk profile in these patients is unknown. • the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). • the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended dose is 600 mg (two film-coated tablets of 300 mg) NUBEQA taken twice daily, equivalent to a total daily dose of 1200 mg. NUBEQA should be continued until disease progression or unacceptable toxicity. If a patient experiences a Grade 3 or higher toxicity or an intolerable adverse reaction, dosing should be withheld or reduced to 300 mg twice daily until symptoms improve. Then treatment may be resumed at a dose of 600 mg twice daily. Dose reduction below 300 mg twice daily is not recommended. The maximum daily dose is 1200 mg (600 mg twice daily). When NUBEQA is used in combination with docetaxel, dosage and administration recommendations in the docetaxel product monograph should be followed. Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy. When used in combination with docetaxel for patients with mCSPC, the first cycle of docetaxel should be administered within 6 weeks after the start of NUBEQA treatment. Docetaxel should be administered every 3 weeks for up to 6 cycles. Treatment with NUBEQA should be continued until disease progression or unacceptable toxicity even if the administration of docetaxel is delayed, interrupted, or discontinued before completion of 6 cycles. For oral use. The tablets should be taken whole with food. If a dose of NUBEQA is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. The patient should not take two doses together to make up for a missed dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store bottles or blisters at room temperature 15°C to 30°C. Keep out of sight and reach of children. Keep the bottle tightly closed after first opening. Once the bottle is opened the medicinal product has shown to be stable for 3 months. Do NOT use this medicine after the expiry date stated on the product labels. Use this medicine only for 3 months after you first open the bottle. The medicine may not be as effective after 3 months. Do NOT throw away any medicines in the garbage, down the sink or in the toilet. Ask your pharmacist how to throw away expired or unused NUBEQA. These measures will help protect the environment.

How is it supplied?

NUBEQA (darolutamide) 300 mg tablet is presented as white to off-white film-coated oval tablets. The tablets are marked with BAYER on one side and with 300 on the other side. The product is supplied in 120 mL bottles of 120 tablets or blisters containing 112 tablets.

Contraindications

NUBEQA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition, and Packaging.

Warnings and precautions

Cardiovascular: Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. Patients should be monitored for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Hepatic/Biliary/Pancreatic: Serious cases of drug-induced liver injury (DILI), including Hy's law cases, with increases in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) to ≥5x and ≥20x upper limit of normal (ULN), including with concomitant bilirubin elevations ≥2x ULN, have been reported in patients treated with NUBEQA. Monitor serum transaminases and bilirubin as per routine clinical practice. In case of liver function test abnormalities suggestive of idiosyncratic drug-induced liver injury, permanently discontinue NUBEQA. Neurologic: Seizure occurred in patients receiving NUBEQA. Consider withholding NUBEQA in patients who develop a seizure during treatment. Reproductive Health - Teratogenic Risk: Based on the mechanism of action, darolutamide can cause harm to the developing fetus or lead to loss of pregnancy. If the patient is engaged in sexual activity with a pregnant individual, a condom should be used during and for 3 months after completion of treatment with NUBEQA. If the patient is engaged in sexual activity with an individual of childbearing potential, a highly effective contraceptive method (<1% failure rate per year) should be used during and for 3 months after completion of treatment with NUBEQA to prevent pregnancy. Reproductive Health - Fertility: Based on animal studies, NUBEQA may impair fertility in patients of reproductive potential. Patients should not donate sperm during treatment and for 3 months after the last dose of NUBEQA.

Who else supplies DAROLUTAMIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. DAROLUTAMIDE appears in 12 registered pack listings across 11 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.