CinnoPar®


(Teriparatide)

More Dosing Accuracy, Touch the Patient Preference


CinnoPar® (Teriparatide)

CinnoPar® is provided in multi-dose prefilled delivery device (pen) for subcutaneous injection containing 30 daily doses of 20 mcg.

What is CinnoPar®?

CinnoPar® is a man-made form of a hormone called parathyroid that exists naturally in the body. CinnoPar® increases bone density and increases bone strength to help prevent fractures.

What is CinnoPar® used for?

It is used to treat soft, brittle bones (osteoporosis). Your doctor, however, may have prescribed CinnoPar® for another reason.

What should I know BEFORE taking CinnoPar®?

o   Do not use this medication if you are allergic to teriparatide or any other part of this drug.

o   Before using CinnoPar®, tell your doctor if you are allergic to any drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

o   Before using CinnoPar®, tell your doctor if you have:

·         Paget's disease or other bone disorders (besides osteoporosis);

·         high levels of calcium or alkaline phosphatase in your blood;

·         a condition called hyperparathyroidism;

·         a history of bone cancer or radiation treatment involving your bones; or

·         if you have ever had kidney stones.

o   If you have any of these conditions, you may need a dose adjustment or special tests to safely use CinnoPar®.

o   This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

o   It is not known whether CinnoPar® passes into breast milk. Do not use CinnoPar® without telling your doctor if you are breast-feeding a baby.

o   Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How should I take CinnoPar®?

  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
  •  CinnoPar® is given as an injection under the skin of the thigh or stomach, once a day.
  • Take this drug at the same time of day.
  • Sit down before use.
  •  If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
  • Use each disposable needle only one time. Throw away used needles. Do not reuse needles. Talk with a doctor or pharmacist if you have any questions.
  • Follow the diet and workout plan that your doctor told you about.
  • It is important to use CinnoPar® regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
  • Do not CinnoPar® that is discolored or cloudy or that has particles in it. It should be clear and colorless. Do not use CinnoPar® after the expiration date printed on the pen or pen packaging.
  • Store the CinnoPar® injection pen in the refrigerator but do not allow it to freeze. Take the pen out of the refrigerator only long enough to use it. After use, recap the pen and put it back into the refrigerator.
  • Throw away the injection pen after 30 days of use, even if it still has medicine in it.

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If you have any question, ask your doctor or call us at CinnaGen patient support center (phone number: +982142593 or 24/7 hotline phone number: +989363094949) for free education in your city.

What should I know while taking CinnoPar®?

  • Tell all of your healthcare providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  •  To lower the chance of feeling dizzy or passing out, rise slowly over a few minutes when sitting or lying down. Be careful climbing stairs.
  •  Have a bone density test as you have been told by your doctor. Talk with your doctor.
  •  Have blood work checked as you have been told by the doctor. Talk with the doctor.
  •  Do not take this drug for longer than you were told by your doctor.
  •  Take calcium and vitamin D as you were told by your doctor.
  •  If you smoke, talk with your doctor.
  •  Do not give to a child. Talk with your doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Check all drugs you are taking with your doctor. This drug may not mix well with some other drugs.

 

Side effects:

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

 

  •  Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  •  Chest pain or pressure or a fast heartbeat.
  •  Very bad dizziness or passing out.
  •  Very bad headache.
  •  Blurred eyesight.
  •  Low mood (depression).
  •  Not able to sleep.
  •  Feeling very tired or weak.
  •  Shortness of breath.
  •  Muscle weakness.
  •  Very upset stomach or throwing up.
  •  Very hard stools (constipation).

Teriparatide some other side effects:

Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  •  Dizziness.
  •  Joint pain.
  •  Upset stomach.

This is not a complete list of all side effects that may occur. If you notice any side effects that are not listed here, discuss them with your doctor or contact us at CinnaGen patient support center (phone number: +982142593, 24/7 hotline phone number: +989363094949).

What should I do if I miss a dose?

o   Use a missed dose as soon as you think about it.

o   If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

o   Do not use 2 doses or extra doses.

o   Do not change the dose or stop this drug. Talk with the doctor.

Pregnancy and lactation

Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether teriparatide passes into breast milk. Do not use CinnoPar® without telling your doctor if you are breast-feeding a baby.

How should I store CinnoPar®?

  • Store in a refrigerator (2-8 C0. Do not freeze).
  • Do not use if it has been frozen.
  • Protect from light.
  • Throw away any part not used after 30 days.
  • Keep out of the reach of children.

Guidance on how to inject with a CinnoPar® pen

  1. Take the pen out of the refrigerator and wait until it reaches room temperature.
  2. Wash your hands with water and soap.
  3. The preferred injection sites are thighs and abdomen. (As it is shown in figure 3). Rotate the injection site with every injection
  4. Hold the Pen with one hand. Remove the Cap by pulling with the other hand.
  5. Wipe the pen’s septum with an alcohol swab.
  6. Pull off the paper tab from the back of the needle. While the outer needle shield still attached, place the needle on the pen and rotate clockwise to fix it on the pen. Use a new needle for every injection.
  7. Pull to remove needle outer shield. You will need needle outer shield to remove the needle after injection is finished.
  8. Gently remove the inner needle shield and throw it away. Hold your pen with the needle pointing up.
  9. In the first use, rotate the dose dialer until “2” aligns with the pointer in the dose displaying window.
  10. Tap the cartridge gently with your finger to help air bubbles rise to the top. Some small bubbles may remain in the cartridge.
  11. Press the thumb button until “0” aligns with the pointer in the dose displaying window. If you saw a drop of liquid come out of the needle, it means the pen is ready to use. If nothing comes out of the tip, repeat steps 9 to 11. If the problem does not resolve after four attempts, switch with a new needle. If the problem continues to exist, contact CinnaGen patient support center.
  12. Rotate the dose dialer until number “8” appears in the dose displaying window.
  13. Rub the injection site with an alcohol swab.
  14. Insert the needle straight into the skin at a 90-degree angle.
  15. Press the thumb button till number “0” appears in the dose displaying window.
  16. Hold the thumb button down and count slowly to 6 to ensure that the medicine has completely injected into the skin. Remove the needle out of your skin when you finished counting.
  17. Carefully replace the outer needle shield on the needle. Rotate the capped needle counterclockwise. Properly discard both the needle and the outer needle shield as directed by your health care professional
  18. Replace the cap on the pen. Store CinnoPar® pen in the refrigerator at 36° to 46°F (2-8°C).

Notes:

  1. Store CinnoPar® pen in the refrigerator (2-8°C) and keep the pen out of the reach of children.
  2. Protect the pen from direct sunlight.
  3. The pen is for use by one person only. It should not be shared with others.
  4. Do not shake the pen.
  5. Do not place CinnoPar® pen in water and oil, or wash or clean it with any liquid.
  6. Remember, this pen is designed for easy injection by yourself, but to inject for the first time, request instructions from your doctor, pharmacist or nurse. You can also receive free administration training at one of the CinnaGen patient support centers.
  7. If you turn dose dialer more than enough (wrong dose dialed), simply turn the dose dialer counterclockwise to correct the dose.
  8. When you are setting the dose, never press the thumb button, since it leads to withdrawal of the drug.
  9. Do not touch the Dose Dialer with your other fingers while pressing on the center of the Thumb Button. This may block the injection.
  10. You cannot rotate the dose dialer to a value more than what is in it. Avoid turning the dose dialer by force. Throw away the pen or use the remaining units in the pen and complete your dose with a new pen.
  11. If you saw drug liquids on the pen after you withdrew the pen from your skin, in the next injections, hold the needle in your skin for a longer time.
  12. Subcutaneous injection may cause transient pain or minor bruising in the injection area.
  13. If the injection was not successful for any reason, please contact your health care provider or CinnaGen patient support center.

FAQs

A Max time for using CinnoPar is two years.
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