Zenapax
daclizumab
Medicinal product no longer authorised
Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Zenapax is and what it is used for
Before you use Zenapax
How to use Zenapax
Possible side effects
How to store Zenapax
Further information
Daclizumab belongs to a group of medicines called immunosuppressants. These medicines help to suppress your body’s natural response to reject your transplanted organ.
Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. Monoclonal antibodies are proteins which recognise and bind to other unique proteins in the body called antigens. Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes. This activity suppresses the body’s natural immune response which otherwise might cause transplant rejection.
Zenapax is used to prevent your body from rejecting transplanted kidneys. Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax.
if you are breast-feeding.
Please read the section below on breast-feeding.
if you have ever had an allergic reaction to other immunosuppressive medicines, which help to suppress the body’s natural defence mechanisms.
Therapy with medicines which help to suppress the body’s natural defence mechanisms can increase the risk for developing malignancies or infections. Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Serious allergic reactions may occur following the administration of proteins. Allergic reactions following the infusion of Zenapax have been reported rarely. In the event that you do develop an allergic reaction, your doctor will treat you with appropriate medication.
Medicinal product no longer authorised
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important because using more than one medicine at the same time may strengthen or weaken the effect of the medicines you are taking. Therefore, Zenapax should not be used with other drugs without your doctor’s consent.
You must not use this medicine if you are breast-feeding.
You should not use this medicine if you are pregnant unless your doctor decides that it is necessary for you.
Zenapax may cause damage to your unborn or breast-feeding baby. Tell your doctor straightaway if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax.
There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery.
Zenapax is NOT for direct injection. It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients.
A health care professional will give you a suitable dose (normally 1 mg/kg of body weight) in the form of an intravenous infusion over a 15- minute period. The first dose is given within 24 hours before your transplant. You will receive 4 subsequent doses which are spaced 14 days apart from each other. In total you should receive 5 doses of Zenapax for a complete treatment course. A course of treatment usually lasts for 8 weeks.
You may receive subsequent infusions within a day before or after the scheduled administration. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Zenapax can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects occur: cough and shortness of breath, including when laying flat, vomiting, confusion or passing less urine then normal. These side effects may occur when using Zenapax. These side effects can be serious and you may need urgent medical attention.
Very common side effects (occurring in 1 or more patients out of 10) are:
difficulty sleeping
shaking (tremor)
headache
high blood pressure (hypertension)
difficulty breathing
constipation; diarrhoea; vomiting; nausea; or heartburn
pain in joints and muscles
excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema)
Medicinal product no longer authorised
problems with wound healing
Common side effects (occurring in between 1 and 10 patients out of 100) are inflammation of the throat (pharyngitis); runny nose (rhinitis); diabetes mellitus; high blood sugar (hyperglycaemia); fluid overload; dehydration; anxiety; depression; dizziness; sensation of pins and needles; blurred vision; fast heart rate (tachycardia); bleeding (haemorrhage); blood clot (thrombosis); low blood pressure (hypotension); accumulation of lymph fluid in one part of the body (lymphocele); severe shortness of breath, including when laying flat at night (pulmonary oedema); fluid on the lungs (pleural effusion); collapsed lung (atelectasis); lack of oxygen in the body (hypoxia); congestion; cough; noisy or abnormal breath sounds, including crackling breath sounds (rales); bloated stomach; stomach pain or discomfort; flatulence; haemorrhoids; rash; itchy skin; acne; night sweats; increased sweating; excessive hair growth (hirsutism); back pain; muscle cramps, particularly in the legs; pain in the joints (arthralgia); pain in the muscles (myalgia); chest pain; pain in general; tiredness; skin irritation at the site of injection; fever; chills; general weakness; pain in the loins and changes or difficulty in passing urine (hydronephrosis); blood in the urine; pain on passing urine (dysuria); reduced urine output (oliguria); pain following surgery.
Rarely, allergic reactions (hypersensitivity) to Zenapax may occur.
Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children. Store in a refrigerator (2 °C – 8 °C).
Keep the vial in the outer carton in order to protect from light. Do not freeze.
Do not use Zenapax after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP. The expiry date refers to the last day of that month..
The active substance is daclizumab.
The other ingredients are polysorbate 80, sodium chloride, sodium dihydrogen phosphate, anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injections.
Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution. One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
Medicinal product no longer authorised
Zenapax is available in pack sizes of 1 or 3 vials. Not all pack sizes may be marketed.
Roche Registration Limited 6 Falcon Way
Shire Park
Welwyn Garden City AL7 1TW
United Kingdom
Roche Pharma AG Emil-Barell-Strasse 1,
D-79639 Grenzach-Wyhlen Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
(Voir/siehe Belgique/Belgien)
Рош България ЕООД Тел: +359 2 818 44 44
Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Roche s. r. o.
Tel: +420 - 2 20382111
Roche a/s
Tlf: +45 - 36 39 99 99
(See United Kingdom)
Roche Nederland B.V. Tel: +31 (0) 348 438050
Roche Pharma AG Tel: +49 (0) 7624 140
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche Eesti OÜ
Tel: + 372 - 6 112 401
Roche Austria GmbH Tel: +43 (0) 1 27739
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Roche
Tél: +33 (0) 1 46 40 50 00
Medicinal product no longer authorised
Roche România S.R.L. Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Tel: +354 540 8000
Roche S.p.A.
Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 9 525 331
Γ.Α.Σταµάτης & Σια Λτδ. Τηλ: +357 - 22 76 62 76
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA Tel: +371 - 7 039831
Roche Products Ltd.
Tel: +44 (0) 1707 366000
UAB “Roche Lietuva” Tel: +370 5 2546799