Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
ixazomib citrate, Quantity: 5.7 mg (Equivalent: ixazomib, Qty 4 mg)
Takeda Pharmaceuticals Australia Pty Ltd
ixazomib citrate
Capsule
Excipient Ingredients: microcrystalline cellulose; purified talc; magnesium stearate; Gelatin; titanium dioxide; iron oxide yellow; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
3 capsules, 1 capsule
(S4) Prescription Only Medicine
NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Visual Identification: Light orange gelatin capsule imprinted with the Takeda logo on the cap and 4mg on the body, in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-11-15
NINLARO ® N i n l a r o ® C M I V 2 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING NINLARO? Ninlaro contains the active ingredient ixazomib citrate. Ninlaro is used to treat patients with a type of cancer of the bone marrow called multiple myeloma. It is used in people who have received at least one prior multiple myeloma treatment. For more information, see Section 1. Why am I using Ninlaro? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NINLARO? Do not use if you have ever had an allergic reaction to Ninlaro or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Ninlaro? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ninlaro and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE NINLARO? • Ninlaro is used with two other medicines called lenalidomide (a medicine which affects how your immune system works) and dexamethasone (an anti-inflammatory medicine). • Ninlaro, lenalidomide and dexamethasone are taken in 4 week (28 days) treatment cycles. More instructions can be found in Section 4. How do I use Ninlaro? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NINLARO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Ninlaro. • Read this leaflet carefully before you start using this medicine. It contains important information for you. • Keep this leaflet. You may need to read it again. • Be sure to keep all your doctor's appointments so your progress can be checked. THINGS YOU SHOULD NOT DO • Do not change your dose or stop taking Ninlaro without talking to yo Olvassa el a teljes dokumentumot
NINLARO PI V2.0 (CCDS V4.0) _ _ 1 AUSTRALIAN PRODUCT INFORMATION NINLARO ® (IXAZOMIB CITRATE) 1 NAME OF THE MEDICINE Ixazomib citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NINLARO (ixazomib) is an antineoplastic agent for oral use. Ixazomib citrate, a prodrug, is the drug substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib. NINLARO oral hard capsules contain 5.7 mg, 4.3 mg or 3.3 mg of ixazomib citrate equivalent to 4 mg, 3 mg or 2.3 mg of ixazomib, respectively. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Hard capsule. NINLARO is available in the following strengths: 4 mg: Light orange gelatin capsule imprinted with the Takeda logo on the cap and 4 mg on the body, in black ink 3 mg: Light grey gelatin capsule imprinted with the Takeda logo on the cap and 3 mg on the body, in black ink 2.3 mg: Light pink gelatin capsule imprinted with the Takeda logo on the cap and 2.3 mg on the body, in black ink 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of a physician experienced in the management of multiple myeloma. NINLARO IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE The recommended starting dose of NINLARO is 4 mg (one capsule) administered orally once a week on Days 1, 8, and 15 of a 28 day treatment cycle. The recommended starting dose of lenalidomide is 25 mg administered daily on Days 1 to 21 of a 28 day treatment cycle. The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28 day treatment cycle. NINLARO PI V2.0 (CCDS V4.0) _ _ 2 TABLE 1 DOSING SCHEDULE: NINLARO TAKEN WITH LENALIDOMIDE AND DEXAMETHASONE For additional information regarding lenalidomide and dexamethasone, refer to the res Olvassa el a teljes dokumentumot