ERLEADA 240 MG — DIN 02540185

What is ERLEADA?

ERLEADA 240 MG contains APALUTAMIDE : 240 MG. It is listed in the Health Canada Drug Product Database under DIN 02540185, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 01-Nov-2023. 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 ERLEADA used for?

ERLEADA® (apalutamide tablets) is indicated for: • the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). • the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). ERLEADA® has not been studied in patients with nmCRPC at low risk of developing metastases. The benefit and risk profile in these patients is unknown.

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

How is it administered?

The recommended dose of ERLEADA® is 240 mg (four 60 mg tablets or one 240 mg tablet) administered orally once daily. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ERLEADA® tablets should be swallowed whole. ERLEADA® can be taken with or without food. Alternative Method of Administration with 60 mg Tablets: Administer ERLEADA® 60 mg tablets with applesauce. For patients who have difficulty swallowing tablets whole, the recommended dose of ERLEADA® 60 mg tablets may be mixed in applesauce. Mix whole ERLEADA® tablets in 4 ounces (120 mL) of applesauce by stirring. Do not crush the tablets. Wait 15 minutes, stir the applesauce mixture. Wait another 15 minutes, stir the applesauce mixture until tablets are fully dispersed (well mixed with no chunks remaining). Using a spoon, swallow the mixture right away. Rinse the mixture container with 2 ounces of water and immediately drink the contents. Repeat the rinse with 2 ounces of water one more time to ensure the whole dose is taken. The mixture should be consumed within one hour of preparation. Do not store ERLEADA® mixed in applesauce for later use beyond the one-hour window of preparation. Alternative Method of Administration with 240 mg Tablet: Disperse ERLEADA® 240 mg tablet in water and administer with non-fizzy beverage or soft food. For patients who cannot swallow the tablet whole, the recommended dose of one ERLEADA® 240 mg tablet can be dispersed in non-fizzy water and then mixed with one of the following non-fizzy beverages or soft foods; orange juice, green tea, applesauce, or drinkable yogurt as follows: Place the whole ERLEADA® 240 mg tablet in a cup. Do not crush or split the tablet. Add about 2 teaspoons (10 mL) of non-fizzy water to make sure that the tablet is completely in water. Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture. Add in 6 teaspoons or 2 tablespoons (30 mL) of one of the following non-fizzy beverages or soft foods; orange juice, green tea, applesauce, or drinkable yogurt and stir the mixture. Swallow the mixture immediately. Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately. Do not save the medicine/food mixture for later use. Administer ERLEADA® 240 mg tablet through a feeding tube: ERLEADA® 240 mg tablet can be administered through a nasogastric feeding tube (NG tube) 8 French or greater as follows: Place one 240 mg tablet in the barrel of the syringe (use at least a 20 mL syringe) and draw up 10 mL of non-carbonated water into the syringe. Wait 10 minutes and then shake vigorously to disperse contents completely. Administer immediately through the NG feeding tube. Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube. Dose Modification: If a patient experiences a ≥ Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to ≤ Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted. If the toxicity recurs at Grade 3 or higher, then the dose of apalutamide should be reduced to the next lower dose level. A maximum of 2 dose level reductions (to 120 mg) is allowed. If further dose reductions are needed, apalutamide should be discontinued. Permanently discontinue ERLEADA® in patients who develop a seizure during treatment.

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

Contraindications

ERLEADA® 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. • women who are or may become pregnant.

Warnings and precautions

Cardiovascular: Ischemic Cardiovascular Events (all Grades: 5% vs. 2%), Grade 3 (1% vs. 0.8%), Grade 4 (0.3% vs. 0.1%) and Grade 5 events (0.3% vs. 0.2%) occurred in patients treated with apalutamide versus patients treated with placebo. Reported deaths due to ischemic heart disease were 0.5% in the apalutamide arm and 0.2% in the placebo arm for the combined clinical trials. Patients with clinically significant cardiovascular disease in the past 6 months were excluded from clinical trials. Patients with a cardiac history should be assessed for active cardiac disease before starting therapy and monitored for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors. QTc prolongation: Mean maximum QTcF change from baseline was 20.2 msec. Monitor patients with known history of QT prolongation, risk factors for torsades de pointes, or taking medications known to prolong the QT interval. Musculoskeletal: Fall and Fractures were reported more frequently in patients receiving ERLEADA®. In SPARTAN, falls were reported in 15.6% vs. 9.0% for placebo, and fractures in 11.7% vs. 6.5% for placebo. Patients should be assessed for the risk of fracture and fall and treated to prevent clinical fractures. Neurologic: Ischemic Cerebrovascular Events occurred in 4% of patients treated with ERLEADA® vs. 1% for placebo in SPARTAN. Patients with a history of stroke or transient ischemic attack within 6 months of randomization were excluded from clinical trials. Patients with a history of stroke should be assessed before starting therapy and monitored for signs and symptoms of ischemic cerebrovascular disorders. Optimize management of ischemic cerebrovascular risk factors. Seizures: Permanently discontinue ERLEADA® in patients who develop a seizure during treatment. Five patients (0.4%) treated with ERLEADA® and two patients (0.2%) treated with placebo experienced a seizure. Patients with a history of seizure or predisposing factors for seizure were excluded from clinical studies. Respiratory: Interstitial Lung Disease (ILD) occurred in five patients (0.4%) treated with apalutamide, and in one patient (0.1%) treated with placebo. Post-marketing cases of ILD, including fatal cases, have been observed. In case of acute onset and/or unexplained worsening of pulmonary symptoms, treatment should be interrupted pending further investigation. If ILD is diagnosed, apalutamide should be discontinued. Skin: Severe Cutaneous Adverse Reaction (SCAR) including DRESS and SJS/TEN, which can be life-threatening or may lead to death, have been reported. Discontinue ERLEADA® immediately if signs or symptoms of DRESS/SJS/TEN develop.