CinnaPoietin®


(Erythropoietin β)

Provide RBC; Provide Life


Overview

CinnaPoietin® (Erythropoietin β) is a medicine that stimulates red-blood-cell growth. It is available as pre-filled syringes in various strengths including 2,000, 4,000 and 10,000 international units (IU).

Dosage Forms and Strengths

CinnaPoietin® is available as pre-filled syringes in the following strengths:

-       2,000 IU

-       4,000 IU

-       10,000 IU

Indication and Usage

Therapeutic Indications:

 

  • Treatment of anemia associated with chronic kidney disease in adults and children on dialysis and symptomatic patients who have not undergone dialysis yet.

 

  • Treatment of anemia and reduction of transfusion requirements in adult patients with non-myeloid malignancies who are receiving chemotherapy, when the chemotherapy stops the bone marrow producing enough blood cells.

 

  • Prevention of anemia of prematurity in infants with a birth weight of 750 gr to 1500 gr and a gestational age of less than 34 weeks.

 

  • To increase the amount of blood that can be taken from adult patients with moderate anemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.

Your doctor, however, may have prescribed CinnaPoietin® for another reason.

How to Use?

  • CinnaPoietin® can be given by your doctor or nurse.
  • Alternatively your doctor, nurse or pharmacist may teach you or your carer how to inject CinnaPoietin®. Do not inject yourself with CinnaPoietin® unless you have received training.
  • Follow all directions given to you by your doctor, nurse or pharmacist carefully. Those directions may differ from the information contained in this leaflet.
  • A CinnaPoietin® patient support kit is available. For more information contact your doctor, healthcare professional or Orchid Pharmed’s patient support center.
 

When to inject CinnaPoietin®?

  • Your doctor will tell you how often to use this medicine.
  • Injecting CinnaPoietin® at the same time of the day will have the best effect. It will also help you remember your injections.
  • Follow your doctor’s instructions exactly on when to inject CinnaPoietin®

How much to inject

  • The dosage of CinnaPoietin® is expressed in international units (IU). Your doctor will tell you how much and how often to inject CinnaPoietin® according to your individual needs.
  • If necessary, depending on your response to treatment, your dose may be changed by your doctor.
  • Your doctor will keep track of your response to CinnaPoietin® by asking questions and doing tests such as taking your blood pressure or taking blood. Do not exceed or change the dose recommended by your doctor.

How to inject it

  • CinnaPoietin® can be administered by subcutaneous (under the skin) or intravenous (into the vein) injection. Your doctor will decide which way is right for you.
  • Intravenous administration

Only a health professional should administer CinnaPoietin® intravenously.

  • Subcutaneous administration
  • It is recommended that the first dose of CinnaPoietin® be administered by a doctor or nurse.
  • Your doctor may discuss whether it would be more convenient for you to receive your injections at home, in which case you or a family member would be instructed on how to give the injection properly. This is a simple procedure and many patients prefer it.
  • If your doctor has directed you to use CinnaPoietin® by subcutaneous injection, please follow the instructions below.
  • You should read these directions from beginning to end before starting your injection. These instructions must be carefully followed. Consult your doctor if you require further instructions.
  • Remember that cleanliness is vital; so be sure to wash your hands!
  • Preparing to self-inject

Before you begin

1. Find a clean, comfortable area.

2. Gather all the medicinal supplies you will need:

- An alcohol swab.

- Some cotton wool or a dry sterile pad.

- A sharps disposal bin.

3. Remove the CinnaPoietin® prefilled syringe from the fridge. Leave it out of the fridge for 30 minutes before use; or gently warm the syringe in the palms of your hands for about 1 minute. Be careful not to shake the medication.

4. Check the expiry date (EXP). Do not use CinnaPoietin® after the expiry date shown on the pre-filled syringe label.

5. Check that the liquid has no discoloration, cloudiness or particles. The liquid should look clear and colorless.

  • Preparing the syringe and needle

6. Wash your hands thoroughly.

7. Remove the protective covering from the needle packaging.

8. Remove the rubber cap from the end of the syringe.

9. Push the needle firmly onto the syringe while gently twisting.

10. Pull the needle shield straight off the needle.

11. Check the dose of medication your doctor has prescribed. You may need to gently push the plunger to push out some medication to get the dose your doctor has prescribed.

12. If you need to put the syringe (with the needle attached) down, make sure the plastic guard covers the needle and place on a clean flat surface.

13. The syringe is now ready for use.

  • Choosing the injection site

14. Choose an injection site in your stomach area or on the top of your thigh.

15. Avoid your navel and waistline.

16. Change injection sites with each injection to prevent soreness in one spot.

17. Never inject into a red or swollen area.

18. Never inject CinnaPoietin® into a muscle.

  • Preparing the injection site

19. Clean the injection site with an alcohol swab and let the skin dry (10 seconds).

20. Remove the protective needle guard from the end of the syringe and hold the syringe with the needle facing upwards.

21. Grab your skin at the injection site firmly between your thumb and forefinger to elevate your skin.

  • Injecting the medicine

22. Hold the syringe at a 45 degree angle to your skin.

23. Insert the needle in one quick motion with the bevel (flat edge) facing upwards.

24. Slowly push the plunger all the way down.

25. Once all the liquid has left the syringe, pull out the needle at the same angle at which you put it in.

26. Do not recap the needle.

27. If you notice slight bleeding, gently press over the injection site with some cotton wool or a dry sterile pad.

Remember: Most people can learn to give themselves a subcutaneous injection, but if you experience difficulty, please do not be afraid to ask for help and advice from your doctor, nurse or pharmacist.

  • Cleaning up after your injection

28. The needle and syringe must be used once only.

29. Dispose of the needle into a sharps container immediately after injection.

30. Do not replace the needle cover.

31. Never place used needles and syringes into your normal household waste bin.

If you are not sure how to dispose of the needles and syringes, consult your doctor, nurse or pharmacist on how to properly dispose of the syringes and needles.

  • Disposal
    • The syringe is intended for single use only and must be thrown away after the injection. Dispose of the syringe with the needle in a puncture proof container as instructed by your doctor, nurse or pharmacist.
    • Never put the used syringe/needle in your normal household garbage.
    • If your doctor tells you to stop using CinnaPoietin®, or the pre-filled syringe has passed its expiry date, ask your pharmacist what to do with any pre-filled syringes that are left over.

 

 

What should I know BEFORE treatment?

  • When you must not use it

Do not use CinnaPoietin® if:

  • You have had an allergic reaction to epoetin beta or any ingredients listed at the end of this leaflet. Symptoms of an allergic reaction include swelling, itching, rash or breathing difficulties.
  • You have high blood pressure that is not well controlled.
  • You or your baby have phenylketonuria (a genetic metabolic disease).

CinnaPoietin® contains phenylalanine as an inactive ingredient and you should consult your doctor about the risks.

  • You are donating your own blood before surgery, and:
    • You have had a heart attack or stroke in a month before your treatment.
    • You have new or increasing chest pain.
    • You are at risk of blood clots in the veins (deep vein thrombosis) or if you have had clots before.

If any of these applies or might apply to you, tell your doctor at once.

  • The package is torn or shows signs of tampering.
  • The expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed it may have no effect at all, or worse, an unexpected effect.

If you are not sure if you should be using CinnaPoietin®, talk to your doctor.

  • Use in children

CinnaPoietin® is safe to be used in children over 2 years of age who have anemia as a result of kidney disease.

CinnaPoietin® is also safe for treating anemia in premature babies.

 

 

  • Before you start to use it

Your doctor must know about all the following before you start to use CinnaPoietin®.

Tell your doctor if:

• You are pregnant or plan to become pregnant. CinnaPoietin® is not generally recommended for use in pregnant women unless the benefits of treatment outweigh the risks to the unborn baby.

• You are breast-feeding or plan to breast-feed.

Because epoetin beta occurs naturally in the body, it has not been possible to determine whether CinnaPoietin® passes into the breast milk following injection. Your doctor will discuss the risks and benefits of using CinnaPoietin® if you are breast-feeding.

• You have any other health problems especially the following:

- Blood clotting diseases

- High blood pressure - It is important to follow all your doctor’s instructions to control your blood pressure, including any changes to your diet

- Cancer

- Epilepsy

- Excess levels of Aluminum in blood as a result of kidney disease treatment

- Folic acid or vitamin B12 deficiencies

- You have had problems with another erythropoietin-type medicine

- Liver disease

- Any other illness or health problems.

• You are using CinnaPoietin® for donating your own blood before surgery and you weigh less than 50kg.

• You are allergic to any other medicines, foods, dyes or preservatives.

Do not misuse CinnaPoietin®. Misuse by healthy people may lead to an excessive increase in the number of blood cells in the blood. Such an increase may cause life-threatening effects on the heart and blood vessels.

  • Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.

Some medicines may interfere with CinnaPoietin® and may affect how well it works. Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking CinnaPoietin®.

Ask your doctor or pharmacist if you are not sure about any medicine.

 

What should I know DURING treatment?

  • Things you must do
  • Use CinnaPoietin® exactly as your doctor has prescribed.
  • Tell all doctors, dentists and pharmacists who are treating you that you are using CinnaPoietin®.
  • Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.
  • If you have blood pressure problems it is important to follow all your doctor’s instructions to control your blood pressure, including any changes to your diet, while using CinnaPoietin®.
  • Most people’s blood iron levels decrease when using CinnaPoietin®. Almost all patients will need to be treated with iron supplements.
  • Tell your doctor if you become pregnant while using CinnaPoietin®.
  • Tell your doctor if, for any reason, you have not used CinnaPoietin® exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
  • Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor will keep track of your response to CinnaPoietin® by asking questions and doing tests such as taking your blood pressure or taking blood.
  • Things you must not do
  • Do not stop using CinnaPoietin® or change the dose without first checking with your doctor.
  • Do not let yourself run out of medicine over the weekend or on holidays.
  • Do not give CinnaPoietin® to anyone else even if they have the same condition as you.
  • Do not use CinnaPoietin® to treat other complaints unless your doctor says to.
  • Do not switch to any other brands of epoetin without consulting your doctor.
 

 

  • Things to be careful of
  • Be careful of driving or operating machinery until you know how CinnaPoietin® affects you.
  • CinnaPoietin® is not expected to affect your ability to drive a car or operate machinery.
  • Side effects
  • Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using CinnaPoietin®.
  • CinnaPoietin® helps most people with anemia but it may have unwanted side effects in a few people.
  • 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.
  • Tell your doctor if you notice any of the following and they worry you:
    • Feeling tired or lacking energy, looking pale; this may be due to changes in your blood iron levels. Your doctor may prescribe an iron supplement for you.
    • Headache
  • Bleeding or bruising more easily
  • Swelling of the arms, feet or legs
  • Stinging around the injection area
  • Chest or throat infection, difficulty breathing, cough
    • Weakness
    • Nausea and vomiting
  • Pain with urination or increased urgency and/or frequency of urination.
  • Tell your doctor immediately if you notice the following:
  • Stabbing, migraine-like headache
  • Cardiac (heart) symptoms such as chest pain, shortness of breath, double vision, dizziness, or tingling of extremities (fingers and toes).
  • A severe allergic reaction (very rare) is occurring, especially just after an injection. This must be treated at once.
  • If you notice unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint; or if you collapse, contact your doctor or go to Accident and Emergency.
  • You experience flu-like symptoms (very rare) particularly when starting treatment. These include fever, chills, headaches, pain in the limbs, bone pain and/or generally feeling unwell. These reactions are usually mild to moderate and go away within a few hours or days.
  • This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Other side effects may occur in some people and there may be some not yet known.
  • If you notice any effects that are not listed here, discuss them with your doctor or contact us at Orchid Pharmed patient support center phone number: +982122382641, 24/7 hotline phone number: +989363094949
  • 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.

What should I do if I miss a dose?

o   If it is almost time for your injection, skip the injection you missed and have your next injection when you are meant to.

o   Otherwise, inject it as soon as you remember, and then go back to using CinnaPoietin® as you would normally.

o   Do not have a double dose to make up for the injection that you missed.

o   Because CinnaPoietin® is administered over prolonged periods, occasional missed doses are not expected to have a significant effect on your treatment.

o   If you are not sure what to do, ask your doctor or pharmacist.

o   If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

Pregnancy and Lactation

  • Pregnancy
  • Postnatal observations of the live offspring (F1 generation) of female rats treated with epoetin beta rch during gestation and lactation revealed no effect of epoetin beta rch at doses up to 1280 U/kg s.c. There were, however, decreases in body weight gain, eyelid opening, and delayed testicular descent and vaginal opening in the F1 fetuses at doses of 320 IU/kg s.c. and above.

    Only limited experience in human lactation has been gained. Endogenous erythropoietin is excreted into breast milk but it is not known whether it is absorbed by the neonatal gastrointestinal tract in functional form. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with CinnaPoietin® should be made taking into account the benefit of breast-feeding to the child and the benefit of CinnaPoietin® therapy to the woman.

     

    Pregnancy category: C

    Epoetin beta rch was not teratogenic in rats and rabbits at doses of up to 3000 IU/kg/day i.v. when administered during the period of organogenesis. Epoetin beta rch caused post-implantation loss and decreased fetal weight in animals dosed prior to mating right through gestation at doses of 160 U/kg/day S.C. and above. Kinked tails were observed in rat pups and fetuses (from 160 U/kg S.C. upwards). These effects are thought to be related to the pharmacodynamic action of the drug.

    All safety information with regards to exposure of CinnaPoietin® during pregnancy have been gained from post marketing experience. A review of the available post marketing data does not show evidence of a causal association between harmful effects with respect to pregnancy, embryonal/fetal development or postnatal development and treatment with CinnaPoietin®. However in the absence of clinical study data, caution should be exercised when prescribing to pregnant women.

    Ø Nursing mothers

    Postnatal observations of the live offspring (F1 generation) of female rats treated with epoetin beta rch during gestation and lactation revealed no effect of epoetin beta rch at doses up to 1280 U/kg s.c. There were, however, decreases in body weight gain, eyelid opening, and delayed testicular descent and vaginal opening in the F1 fetuses at doses of 320 IU/kg s.c. and above.

    Only limited experience in human lactation has been gained. Endogenous erythropoietin is excreted into breast milk but it is not known whether it is absorbed by the neonatal gastrointestinal tract in functional form. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with CinnaPoietin® should be made taking into account the benefit of breast-feeding to the child and the benefit of CinnaPoietin® therapy to the woman.

How Supplied / Storage and Handling

  • Store CinnaPoietin® pre-filled syringes in the fridge at 2 to 8 ºC. Do not freeze.
  • Always keep CinnaPoietin® in its carton, in the fridge, until it is time to use it. This will protect CinnaPoietin® from being affected by light.
  • If you take the pre-filled syringes out of the pack they may not keep well.
  • You can use CinnaPoietin® if it has been left out of the fridge for no longer than 3 days (a single period only) at room temperature (up to 25 ºC).
  • Do not store CinnaPoietin® or any other medicine in a bathroom or near a sink or any other place where there is high humidity.
  • Do not leave CinnaPoietin® in the car or on window sills.
  • Heat and dampness can destroy some medicines.
  • Keep CinnaPoietin® in an appropriate container on the top shelf of a fridge is a good place to store CinnaPoietin®.

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