Eprex Sterile Solution 10000IU/mL: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

EPREX^® is used to increase the production of red blood cells and to decrease the need for red blood cell transfusion. The dose should be gradually adjusted to achieve this goal. EPREX^® may be used in adults and children with chronic kidney disease; adults who have HIV-infection and are receiving a drug called zidovudine; adult cancer patients receiving chemotherapy; and adults scheduled to undergo major elective surgery.

What it does:

EPREX^® is a protein made in the laboratory which acts like a substance naturally made in the human body called erythropoietin. Erythropoietin controls the production of red blood cells in the body.

When it should not be used:

You should not use EPREX^® if:

• you are allergic to any of the ingredients in the product;

• you make antibodies (develop pure red cell aplasia

  [PRCA]) following treatment with any erythropoiesis- stimulating agent;

• you have uncontrolled high blood pressure;

• you cannot for any reason receive adequate

  antithrombotic treatment.

What the medicinal ingredient is:

epoetin alfa

What the nonmedicinal ingredients are:

Glycine and polysorbate 80 as stabilizers, sodium chloride, water for injection and sodium phosphate

Single-use vials^† and pre-filled syringes do not contain preservatives.

What dosage forms it comes in:

Single-use vials^†: 1,000 IU/0.5 mL, 2,000 IU/mL, 4,000 IU/mL, 10,000 IU/mL, 40,000 IU/mL

Single-use pre-filled syringes with PROTECS^®* needle guard: 1,000 IU/0.5 mL, 2,000 IU/0.5 mL, 3,000 IU/0.3 mL, 4,000 IU/0.4 mL, 5,000 IU/0.5 mL, 6,000 IU/0.6 mL, 8,000 IU/0.8 mL, 10,000 IU/mL, 20,000 IU/0.5 mL, 30,000 IU/0.75 mL, 40,000 IU/mL

To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with the PROTECS^® needle guard that is automatically activated to cover the needle after complete delivery of the syringe content.

^†Not marketed in Canada.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

ALL PATIENTS

• To minimize the risks for death and serious

  cardiovascular (heart and blood vessel-related) side effects, your doctor will follow the recommended dosage for each indication.

• Patients with uncontrolled hypertension should not be

  treated with EPREX^® epoetin alfa; blood pressure should be controlled adequately before initiation of therapy.

• EPREX^® epoetin alfa should be used with caution in

  patients with a history of seizures.

• During hemodialysis, patients treated with EPREX^®

  epoetin alfa may require increased anticoagulation with heparin to prevent clotting of the artificial kidney. Patients with pre-existing vascular disease should be monitored closely.

• No cases of viral disease transmission or CJD have

  ever been identified as a result of albumin use.

• Hemoglobin levels during EPREX^® treatment should

  not be higher than 120 g/L (may not apply to surgery patients).

• If you undergo surgery while taking EPREX^®, your

  physician may prescribe a blood thinner, as appropriate for the surgical procedure, to prevent blood clots.

• Antibody-mediated pure red cell aplasia (PRCA) has

  been reported after months to years of treatment with recombinant erythropoietins. If you develop PRCA, you may suddenly become severely anemic and this could result in a dependency on blood transfusions. CHRONIC RENAL FAILURE PATIENTS

• If your hemoglobin is kept too high, you have an

  increased chance of heart attack, stroke, heart failure, blood clots and death. Your doctor should try to keep your hemoglobin between 100 and 120 g/L. CANCER PATIENTS

• If you are a cancer patient and your hemoglobin is

  kept too high (over 120 g/L),

  • your tumor may grow faster,

  • you have an increased chance of heart attack,

    stroke, blood clots and death.

• Your doctor should use the lowest dose of EPREX^®

  needed to avoid red blood cell transfusions.

• In some instances, red blood cell transfusion should be

  the preferred treatment option.

• Once you have finished your chemotherapy course,

  EPREX^® should be discontinued.

BEFORE taking EPREX^®:

• Tell your doctor about any medical problems and about

  any allergies you have or have had in the past.

  • Tell your doctor if you have or have had high blood pressure, seizures, blood clots, liver disease, porphyria, or gout.
  • While you are treated with EPREX^® your doctor will need to check your blood pressure. Your blood pressure will be monitored carefully and any changes outside of the guidelines that your doctor has given you must be reported. If your blood pressure increases, you may need medication to lower it. If you already take blood pressure medication, your doctor may increase the amount.
  • Your doctor will also measure your serum iron levels, red blood cell levels and other factors in your blood, prior to starting and during treatment with EPREX^®, as deemed appropriate.
  • If you are on dialysis, your dialysis prescription may need to be changed while you are being treated with EPREX^®. Your doctor will take blood tests to determine if any change is needed. Your doctor may also need to adjust any medication you receive to prevent blood clotting.

  • Tell your doctor if you are pregnant, if you think you might be pregnant, or if you are trying to become pregnant.

  • Tell your doctor if you are breast-feeding.
  • In many women with severe kidney failure, the monthly period may stop. When these women take EPREX^® they may restart their monthly cycle. If you are a woman with kidney disease, you should discuss contraception with your doctor.

  • In patients with kidney disease, due to the possibility of an increase in blood pressure, there is a small chance of having a seizure when therapy starts. During the initial phase of treatment, your doctor may advise you to avoid driving, using machines or doing anything else that could be dangerous if you are not alert.

  • If you are a home dialysis patient, you should continue to check your access, as your doctor or nurse has shown you, to make sure it is working. Be sure to let your healthcare professional know right away if there is a problem.

  • If you are a cancer patient you should be aware that

    EPREX^® is a red blood cell growth factor and in some circumstances your cancer may grow faster. You should discuss treatment options for your anemia with your doctor.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all medications you are using, including those obtained without a prescription and any other remedies or dietary supplements. It is especially important that your doctor know if you are taking high blood pressure medication.

PROPER USE OF THIS MEDICATION

Follow your doctor's instructions about when and how to take this medication.

EPREX^® Sterile Solution is injected under the skin (subcutaneously) into the arms, legs or abdomen.

While you are receiving EPREX^®, your doctor will measure your red blood cells. Your doctor will use this information to adjust the dose to the amount right for you.

Do not shake EPREX^® Sterile Solution. The solution in the vial^† or pre-filled syringe should always be clear and colourless. Do not use EPREX^® Sterile Solution if the contents of the vial^† or pre-filled syringe appear discoloured or cloudy, or if the vial^† or pre-filled syringe appears to contain lumps, flakes, or particles. If the vial^† or pre-filled syringe has been shaken vigorously, the solution may appear to be frothy and should not be used.

Single-use vials^† and pre-filled syringes of EPREX^® Sterile Solution do not contain preservatives and therefore are to be used once and discarded. Any unused portion of a vial^† or pre-filled syringe should not be used.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, contact your doctor for instructions.

Preparing and Injecting the Dose

Important: To help avoid contamination and possible infection, follow these instructions exactly.

Single-Use Vials^†

Use the Correct Syringe: Your doctor has instructed you on how to give yourself the correct dosage of EPREX^®. This dosage will usually be measured in units per milliliter or ccs. It is important to use a syringe that is marked in tenths of milliliters (for example, 0.1, 0.2, etc., mL or cc). Failure to use the proper syringe can lead to a mistake in dosage, and you may receive too much or too little EPREX^®. Only use disposable syringes and needles as they do not require sterilization; they should be used once and disposed of as instructed by your doctor.

1. 1.

   Take a vial out of the refrigerator. The liquid needs

   to come to room temperature. This usually takes between 15 to 30 minutes.

   1. 2. Check the vial, to make sure it is the right dose, has not passed its expiry date, is not damaged, and the liquid is clear and not frozen. When using the multi-use vial, record the date of first entry for each vial on the inside flap of the box.
   2. 3. Assemble the other items you will need for your injection: a syringe, needle and antiseptic swabs.
   3. 4. Wash your hands.
   4. 5. Remove the cap from the top of the vial but do not remove the rubber stopper. Clean the rubber stopper with an antiseptic swab.
   5. 6. Remove the needle cover from the syringe. Pull the syringe plunger out to fill the syringe with an amount of air equal to the amount of liquid prescribed by your doctor.
   6. 7. Put the vial on a flat surface and push the syringe needle through the rubber stopper. Push the syringe plunger down to add the air into the vial.
   7. 8. Turn the vial and the syringe upside down. Pull on the syringe plunger to fill the syringe with the correct amount of liquid from the vial. It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
   8. 9. Remove the syringe and needle from the vial. Hold the syringe with the needle pointing up to see if it has any air bubbles inside. If there are air bubbles gently press the plunger until all of the air (but none of the liquid) has been removed.
   9. 10. Choose an injection site. Good sites are the top of the thigh and around the tummy (abdomen) but away from the navel. Vary the site from day to day.
   10. 11. Use an antiseptic swab on the injection site, to disinfect it.
   11. 12. Pinch a fold of skin between your thumb and index finger. Don’t squeeze it.
   12. 13.

       Push the syringe needle in fully.

       Your doctor or nurse may have shown you how to do this.

   13. 14. Check that you haven’t punctured a blood vessel. Pull back slightly on the plunger. If you see blood, take the syringe out and choose a new injection site.
   14. 15. Push the plunger with your thumb as far as it will go to inject the liquid. Push it slowly and evenly, keeping the skinfold pinched.

1. 16.

   When the plunger is pushed as far

   as it will go, take out the needle and

   let go of the skin.

2. 17.

   Press an antiseptic swab over the injection site for a

   few seconds after the injection.

3. 18.

   Dispose of your used syringe in a safe container (see

   Disposal of Syringes) and dispose of your vial.

^† Not marketed in Canada

Single-Use Pre-filled Syringe with PROTECS^® needle guard

To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with the PROTECS^® needle guard that is automatically activated to cover the needle after complete delivery of the syringe content.

1. 1.

   Take a syringe out of the refrigerator. The liquid

   needs to come to room temperature. This usually takes between 15 to 30 minutes.

2. 2.

   Check the syringe to make sure it is the right dose,

   has not passed its expiry date, is not damaged, and the liquid is clear and not frozen.

3. 3.

   Choose an injection site. Good sites

   are the top of the thigh and around

   the tummy (abdomen) but away from

   the navel. Vary the site from day to

   day.

4. 4.

   Wash your hands. Use an antiseptic swab on the

   injection site, to disinfect it.

5. 5.

   Take the cover off the syringe by holding the barrel

   and pulling the cover off carefully without twisting it. Don’t push the plunger, touch the needle or shake the syringe.

6. 6.

   Pinch a fold of skin between your

   thumb and index finger. Don’t

   squeeze it.

7. 7.

   Push the needle in fully. Your

   doctor or nurse may have shown

   you how to do this.

8. 8.

   Check that you haven’t punctured

   a blood vessel. Pull back slightly on the plunger. If you see blood, take the syringe out and choose a new injection site.

9. 9.

   Push the plunger with your thumb as far as it will

   go to inject all of the liquid. Push it slowly and evenly, keeping the skinfold pinched. The needle guard will not activate unless the entire dose is given.

   1. 10.

      When the plunger is pushed as

      far as it will go, take out the

      needle and let go of the skin.

   2. 11. Take your thumb off the plunger. Allow the syringe to move up until the entire needle is covered by the needle guard.
   3. 12. Press an antiseptic swab over the injection site for a few seconds after the injection.
   4. 13.

      Dispose of your used syringe in a safe container (see

      Disposal of Syringes).

   5. 14.

      Only take one dose of EPREX^® from each syringe.

      If any liquid remains in the syringe after an injection, the syringe should be properly disposed of, not reused (see Disposal of Syringes).

Disposal of Syringes

1. 1. Place all used needles and syringes in a hard plastic container with a screw-on cap, or a metal container with a plastic lid, such as a coffee can properly labelled as to content. If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard-plastic container is used, always screw the cap on tightly after each use. When the container is full, tape around the cap or lid, and dispose of according to your doctor's instructions.
2. 2. Do not use glass or clear plastic containers (or any other container) that will be recycled or returned to a store.
3. 3. Always store the container out of the reach of children.
4. 4. Please check with your doctor, nurse, or pharmacist for other suggestions.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Any medicine may have unwanted effects. The side effects you might experience may vary depending on the reason you are taking EPREX^®. Tell your doctor or pharmacist about any unusual sign or symptom whether listed or not. The side effects reported most often in all patients receiving EPREX^® are flu-like symptoms such as dizziness, drowsiness, fever, headache, muscle and joint pain and weakness, and gastrointestinal disturbances such as nausea, vomiting and diarrhea. Redness, burning and pain at the place where EPREX^® is given have also been reported.

Be sure to tell your doctor if you have an increase in headaches or develop unusual headaches, as this may be a sign of increased blood pressure.

There is a possible association of a worsening of increased blood pressure if red blood cell production occurs too rapidly. Your doctor may need to reduce your dose of EPREX^® and initiate or increase blood pressure medication. Signs and symptoms of serious cardiovascular events may include but are not limited to: chest pain, leg pain and swelling, shortness of breath, sudden weakness, numbing or tingling of face, arm or leg, an increase in headaches or severe sudden headaches, loss of vision or loss of speech, lightheadedness.

Patients experiencing these signs or symptoms should contact their doctor immediately.

Patients should NOT discontinue their medication without consulting their doctor first.

Additional side effects which have been reported more often in chronic renal failure patients than other patients include increases in blood pressure, clotted access, seizures and pure red cell aplasia (PRCA). PRCA is a condition in which severe and sudden anemia (characterized by symptoms such as severe tiredness/fatigue, and shortness of breath on mild exertion) develops due to failure of the bone marrow to produce red blood cells. PRCA could result in a dependency on blood transfusions. Should you be diagnosed with PRCA, your doctor will stop your EPREX^® therapy and may initiate treatment with drugs and/or blood transfusions to help increase your red blood cell count.

If you develop signs of allergy such as difficulty breathing, hives, itching, rash, or swelling of the throat, face, eyelids, mouth or tongue, discontinue the use of EPREX^® and contact your doctor or obtain medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking EPREX^®, contact your doctor or pharmacist.

HOW TO STORE IT

• Store unopened in a refrigerator between 2 and 8

  degrees centigrade. Do not freeze. Protect from light.

• Do not use this product after the expiry date written on

  the package.

• Keep this and all medicines in a safe place away from

  children.

• If you are using EPREX^® at home, it is important that

  the vial^† or syringe be stored in your refrigerator although not in the freezer compartment. EPREX^® should not be frozen. Do not use EPREX^® if it has been frozen. Leave the EPREX^® vial^† or syringe to stand for about 15 to 30 minutes until it reaches room temperature prior to using it.

  • When the pre-filled syringe or single-use vial^† is about to be used, it may be removed from the refrigerator and stored at room temperature (not above 25°C) for one single period of maximum 7 days.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals, can be found at: http://www.janssen.ca

or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: June 2011

^† Not marketed in Canada.