Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
sebelipase alfa, Quantity: 2 mg/mL
Alexion Pharmaceuticals Australasia Pty Ltd
sebelipase alfa
Injection, intravenous infusion
Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; Albumin
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
Kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).
Visual Identification: Clear to slightly opalescent, colourless to slightly coloured (yellow) liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2017-05-18
KANUMA ® K a n u m a ® 2 1 1 0 1 5 _ C M I ( P I 2 1 1 0 1 4 ) 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 KANUMA? Kanuma contains the active ingredient sebelipase alfa rce. Sebelipase alfa rce is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats. Kanuma is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL-D). For more information, see Section 1. Why am I using Kanuma? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE KANUMA? Do not use if you or your child has had a life-threatening allergic reaction to Kanuma, or to egg, 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 Kanuma? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Kanuma 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 KANUMA? • Your doctor or nurse will give Kanuma to you or your child by an infusion (drip) into a vein. More instructions can be found in Section 4. How do I use Kanuma? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING KANUMA? THINGS YOU SHOULD DO • Ask your doctor if you have any questions about why this medicine has been prescribed for you or your child. • Remind any doctor, dentist, nurse or pharmacist you visit that you or your child are using Kanuma. • Keep appointments with your doctor or clinic. It is important to have you or your child's Kanuma infusion at the appointed time each time to make sure Kanuma has the best chance of providing effective treatment for the condition. • This medicine may contain egg proteins. If you or yo Leggi il documento completo
210903_Kanuma PI CCDS v3.0 & 4.0 1 AUSTRALIAN PRODUCT INFORMATION – KANUMA ® (SEBELIPASE ALFA _RCE_) CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Sebelipase alfa _rce_ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Kanuma is supplied as a single-use vial containing 20 mg of sebelipase alfa _rce_ (2 mg/mL). For the full list of excipients, see Section 6.1 - List of Excipients. 3 PHARMACEUTICAL FORM Concentrated solution for intravenous infusion. Kanuma is a clear to slightly opalescent, colourless to slightly coloured solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Kanuma (sebelipase alfa_ rce_) is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D). 4.2 D OSE AND METHOD OF ADMINISTRATION It is important to initiate treatment as early as possible. Kanuma is for intravenous use only. The total volume of the infusion should be administered over approximately 2 hours. Infusion over 1 hour may be considered after patient tolerability is established. The infusion period may be extended in the event of dose escalation. For instructions on the preventive measures and monitoring of hypersensitivity reactions, _see section 4.4 – Special Warnings and Precautions for Use; Hypersensitivity _ _reactions, including anaphylaxis_. RECOMMENDED DOSE INFANTS (< 6 MONTHS OF AGE) PRESENTING WITH LAL-D The recommended starting dose in infants < 6 months of age presenting with rapidly progressive LAL-D is 1 mg/kg administered as an IV infusion once weekly. Dose escalations maybe considered based on suboptimal response to clinical and biochemical criteria, including, poor growth, deteriorating biochemical markers (e.g. liver transaminases, ferritin, C-reactive protein, and coagulation parameters),persistent or worsening organomegaly, increased frequency of intercurrent infections, and persistent or worsening of other symptoms (e.g. gastrointestinal symptoms). A dose escalation to 3 mg/kg should be considered in case of subop Leggi il documento completo