Patient Medication Information: uses, side effects, how to take - Zenapax 5mg/mL
ABOUT THIS MEDICATION
What the medication is used for:
ZENAPAX (daclizumab) is indicated as an accessory agent for the prophylaxis of acute organ rejection in patients receiving renal transplants. In clinical studies the majority of the patients received ZENAPAX in combination with cyclosporine, corticosteroids, and azathioprine.
What it does:
ZENAPAX belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent rejection of transplanted organs, and work by stopping your immune system from reacting to the new organ.
There are many different types of medicines used to prevent transplant rejection. ZENAPAX belongs to a new group of these medicines.
ZENAPAX may be used in combination with other immunosuppressant medicines.
Ask your doctor if you have any questions why ZENAPAX has been prescribed for you.
When it should not be used:
Do not use ZENAPAX if:
- you have had an allergic reaction to ZENAPAX or to any components of this product
Symptoms of an allergic reaction include swelling, itching, rash or breathing difficulties.
What the non-medicinal ingredients are:
Hydrochloric acid, polysorbate 80, sodium chloride, sodium hydroxide, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, water for injections.
What dosage forms it comes in:
ZENAPAX is supplied as a colourless concentrated liquid dosage form for further dilution and intravenous administration. Each vial contains a concentrate of 25 mg of daclizumab in 5 mL of solution.
WARNINGS AND PRECAUTIONS
BEFORE you use ZENAPAX talk to your doctor or pharmacist if:
Your doctor must know about all the following before you are given ZENAPAX.
if you are pregnant or plan to become pregnant
It is not known whether ZENAPAX is harmful to an unborn baby when given to a pregnant woman. It is best to wait 4 months after finishing a course of ZENAPAX before becoming pregnant. If there is a need for ZENAPAX when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby. It is important to take effective contraceptive measures before, while you are receiving ZENAPAX and for four months after stopping.
- if you are breastfeeding or plan to breastfeed
It is not known whether ZENAPAX passes into breast milk. If you are to be given ZENAPAX, your doctor may advise you to stop breast feeding, or to stop receiving ZENAPAX.
- if you have any other health problems
- if you have been given ZENAPAX before
Serious allergic reactions may occur following the administration of ZENAPAX, but this is rare.
The long term effect of ZENAPAX on the ability of your immune system to fight infection is not known.
If you have not told your doctor about any of the above, tell them before you are given ZENAPAX.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop. Some medicines may interfere with ZENAPAX.
Tell you doctor if you are taking any other medicines for the prevention and treatment of transplant rejection. ZENAPAX should not be given with antilymphocyte therapy since the risks of infection or death may be higher.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with ZENAPAX include:
The following medications have been administered in clinical studies with ZENAPAX (daclizumab) with no increase in side effects: cyclosporine, mycophenolate mofetil, ganciclovir, acyclovir, azathioprine, and corticosteroids. There is very limited experience with the use of ZENAPAX and tacrolimus, muromonab-CD3, antithymocyte globulin and antilymphocyte globulin.
PROPER USE OF THIS MEDICATION
Usual dose:
Your doctor will calculate the dose of ZENAPAX according to your body weight. The usual dose is 1 mg for every kilogram you weigh.
How it is given:
ZENAPAX treatment usually occurs in a hospital. ZENAPAX is diluted in 0.9% saline solution and then given as a slow injection into one of your veins (this is called an intravenous infusion) by your doctor or a specially trained nurse. The infusion will take about 15 minutes.
When it is given:
You will receive your first infusion approximately 24 hours before your transplantation operation. You will then receive another infusion at weeks two, four, six and eight after your transplant, for a total of five infusions. It is important to keep having the infusions. This will increase the chances of your new organ continuing to work properly.
Your doctor may select a different schedule for giving you the infusions. Please discuss this with your doctor.
Missed Dose:
If you forget or are unable to meet your hospital appointment for one of the infusions, contact your doctor immediately. Your doctor will arrange another appointment as soon as possible. If you are not sure of the date of your next appointment, check with the hospital or your doctor.
Overdose:
Cases with overdose have been reported with ZENAPAX.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
ZENAPAX helps most people who have transplants but it may have unwanted side effects in some patients. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice the following | ||
| Only if severe | In all cases | |||
Un- common | symptoms of an allergic reaction including swelling, itching, rash or breathing difficulties; | ⌧ | ||
| signs of other infections eg. fever, chills, sore throat or ulcers of the mouth. | ⌧ | |||
ZENAPAX reduces your body's own defence mechanisms to stop you rejecting your transplanted organ. Your body will therefore not be as good at fighting infection as it normally is. People taking ZENAPAX may develop more infections than usual.
As all transplant patients are taking several other immunosuppressive medications while taking ZENAPAX and have recently undergone surgery, it is not known whether the above side effects are caused by ZENAPAX or by the other medications or the surgical procedure.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don’t understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
This is not a complete list of side effects. For any unexpected effects while taking ZENAPAX, contact your doctor or pharmacist.
HOW TO STORE IT
ZENAPAX will be stored in the pharmacy or on the ward in a refrigerator where the temperature stays between 2°C and 8°C.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This brochure does not contain all known information about ZENAPAX. If you have any further questions or concerns about your treatment with ZENAPAX, please contact your doctor or pharmacist.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.rochecanada.com
ZENAPAX is a registered Trade-Mark of Hoffmann-La Roche Limited