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GONAL-F RFF REDI-JECT- follitropin injection, solution


  1. Patient Information
  2. Example:

Patient Information 

Gonal-fRFF Redi-ject(gon-AL-eff ar-eff-eff REH dee-jekt)
(follitropin alfa injection)
for subcutaneous use

Gonal-fRFF* Redi-ject(follitropin alfa injection) for subcutaneous use

*revised formulation female

Read this Patient Information before you start using Gonal-fRFF Redi-jectand each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Gonal-fRFF Redi-ject?

Gonal-fRFF Redi-jectis an injection Pen that delivers a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:

  • help healthy ovaries develop (mature) and release an egg
  • cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

Who should not use Gonal-fRFF Redi-ject?

Do not use the Gonal-fRFF Redi-jectif you:

  • are allergic to recombinant human FSH or any of the ingredients in Gonal-fRFF Redi-ject.

    Before you use Gonal-fRFF Redi-ject, tell your healthcare provider if you:

    • have or have had asthma
    • have been told by a healthcare provider that you have an increased risk for blood clots (thrombosis)
    • have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot (thrombosis)
    • have had stomach (abdominal) surgery
    • have had twisting of your ovary (ovarian torsion)
    • had or have a cyst on your ovary
    • have polycystic ovarian disease
    • have any other medical conditions
    • are breastfeeding or plan to breastfeed. It is not known if Gonal-fRFF Redi-jectpasses into your breast milk. You and your healthcare provider should decide if you will take Gonal-fRFF Redi-jector breastfeed. You should not do both.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    How should I use Gonal-fRFF Redi-ject?

    • Read the "Instructions for Use" that comes with Gonal-fRFF Redi-jectfor information about the right way to use Gonal-fRFF Redi-ject.
    • Gonal-fRFF Redi-jectis given by injection under your skin. Do not inject Gonal-fRFF Redi-jectuntil your healthcare provider has taught you the correct way to use it.
    • Change your injection site as your healthcare provider showed you.
    • Use Gonal-fRFF Redi-jectexactly as your healthcare provider tells you to use it.
    • Do not change your dose of Gonal-fRFF Redi-jectunless your healthcare provider tells you to.
    • Call your healthcare provider if you have any questions about your dose or how to use Gonal-fRFF Redi-ject.

    What are the possible side effects of Gonal-fRFF Redi-ject?

    Gonal-fRFF Redi-jectmay cause serious side effects, including:

    • severe allergic reactions.Women who have used Gonal-f, Gonal-fRFF, or Gonal-fRFF Redi-jectin the past may have a severe allergic reaction right away when they use Gonal-fRFF Redi-jectagain. This severe allergic reaction may lead to death. If you have any of the following symptoms of a severe allergic reaction, stop using Gonal-fRFF Redi-jectand go to the hospital right away:
      • shortness of breath
      • swelling of your face
      • itchy, red bumps or rash on your skin (hives)
    • ovaries that are too large.Gonal-fRFF Redi-jectmay cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area.
    • ovarian hyperstimulation syndrome (OHSS).Using Gonal-fRFF Redi-jectmay cause OHSS. OHSS is a serious medical condition that can happen when your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to suddenly build up in the area of your stomach, chest, and heart, and can cause blood clots to form. In rare cases OHSS has caused death. OHSS may also happen after you stop using Gonal-fRFF Redi-ject. Stop using Gonal-fRFF Redi-jectand call your healthcare provider right away if you have symptoms of OHSS, including:
      • trouble breathing
      • severe lower stomach (pelvic) area pain
      • decreased urine output
      • nausea
      • vomiting
      • weight gain
      • diarrhea
    • lung problems.Gonal-fRFF Redi-jectmay cause serious lung problems including fluid in your lungs (atelectasis), trouble breathing (acute respiratory distress syndrome), and worsening of asthma.
    • blood clots.Gonal-fRFF Redi-jectmay increase your chance of having blood clots in your blood vessels. Blood clots can cause:
      • blood vessel problems (thrombophlebitis)
      • stroke
      • loss of your arm or leg
      • blood clot in your lung (pulmonary embolus)
    • twisting (torsion) of your ovary.Gonal-fRFF Redi-jectmay increase the chance of your ovary twisting if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.
    • pregnancy with and birth of multiple babies.Gonal-fRFF Redi-jectmay increase your chance of having a pregnancy with more than 1 baby. Having a pregnancy and giving birth to more than 1 baby at a time increases the health risk for you and your babies. Your healthcare provider should tell you about your chances of multiple births.
    • birth defects.A baby born after an ART cycle may have an increased chance of having birth defects. Your chances of having a baby with birth defects may increase depending on:
      • your age
      • certain sperm problems
      • your genetic background and that of your partner
      • a pregnancy with more than 1 baby at a time
    • ectopic pregnancy (pregnancy outside your womb).Gonal-fRFF Redi-jectmay increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
    • miscarriage.Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
    • tumors of the ovary.If you have used medicines like Gonal-fRFF Redi-jectmore than 1 time to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    The most common side effects of Gonal-fRFF Redi-jectinclude:

    • headache
    • stomach pain
    • stomach bloating
    • bruising at the injection site
    • nausea

    These are not all the possible side effects of Gonal-fRFF Redi-ject. For more information, call your healthcare provider or pharmacist.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store Gonal-fRFF Redi-ject?

    • Before you use Gonal-fRFF Redi-jectfor the first time,store your Pen:
      • in the refrigerator between 36 F to 46 F (2 C to 8 C) until the expiration date, or
      • store your Pen at room temperature between 68 F to 77 F (20 C to 25 C) for up to 3 months or until the expiration date, whichever comes first
    • After you use Gonal-fRFF Redi-jectand there is still medicine left,store your Pen in the refrigerator between 36 F to 46 F (2 C to 8 C) or at room temperature between 68 F to 77 F (20 C to 25 C) up to 28 days. Throw away any unused Gonal-fRFF Redi-jectafter 28 days.
    • Store your Gonal-fRFF Redi-jectwith the Pen cap on in a safe place.
    • Store Gonal-fRFF Redi-jectaway from light.
    • Do not freeze Gonal-fRFF Redi-ject.

    Keep Gonal-fRFF Redi-jectand all medicines out of the reach of children.

    General Information about the safe and effective use of Gonal-fRFF Redi-ject.

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Gonal-fRFF Redi-jectfor a condition for which it was not prescribed. Do not give Gonal-fRFF Redi-jectto other people, even if they have the same condition that you have. It may harm them.

    This Patient Information leaflet summarizes the most important patient information about Gonal-fRFF Redi-ject. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Gonal-fRFF Redi-jectthat is written for health professionals.

    For more information, go to www.fertilitylifelines.com, or call 1-866-538-7879.

    What are the ingredients in Gonal-fRFF Redi-ject?

    Active ingredient: follitropin alfa (r-hFSH)

    Inactive ingredients: sucrose, meta-cresol, di-sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, Poloxamer 188, O-phosphoric acid, sodium hydroxide

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Manufactured for:
    EMD Serono, Inc.
    Rockland, MA 02370

    Revised: January 2014

    EMD Serono

    GONAL-f RFF Redi-ject

    (follitropin alfa injection)

    INSTRUCTIONS FOR USE

    Figure

    GONAL-f RFF Redi-ject

    (follitropin alfa injection)

    Important

    • Read these instructions completely before you begin.
    • Gonal-f RFF Redi-ject (follitropin alfa injection) is for useunder the skin only(subcutaneous).
    • Only use Gonal-f RFF Redi-ject if your healthcare provider trains you on how to use it correctly.

    Warning:Do not reuse needles.

    Warning:Do not share the pen and needles with another person, because doing so can cause an infection.

    • The pen comes in3 different IUamounts

    Figure

    • Use the attached treatment diary to make sure you take the correct dose.Consult your healthcare provider on proper use of your treatment diary.
    • You might need to use more than one pen to give today's intended dose. Contact your healthcare provider with any questions.
    • The Dose Information Display is used for setting your dose, to confirm a completed dose, and to display the amount remaining to complete your intended dose.

    Gather your supplies

    Take the carton out of the refrigerator at least 30 minutes before you inject to let it warm to room temperature.

    Figure

    Caution: Do not use a microwave or other heating element to warm up the pen.

    Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
    Identify a firm, vertical surface, such as the side of your Gonal-f RFF Redi-ject carton or a wall.
    Fill in the first 5 columns of the treatment diary. Refer to the treatment diary for sample entries.
    You will also need a sharps container, alcohol pads, and a writing utensil (not included).

    Figure

    Get familiar with the parts of your pen and needle

    Figure

    *The numbers on the Dose Information Display and reservoir represent the number of International Units (IU) of medicine.

    Step 1 Get Ready

    Wash your hands with soap and water and dry them well.

    Figure

    Caution: Do not shake the pen. If you shake the pen, air bubbles may appear in the medicine.

    Remove the pen and a new needle from the carton.

    Figure

    Check the expiration date on the pen label.Warning: Do not use an expired pen. Get a new pen from your healthcare provider or pharmacist.

    Figure

    Step 2 Choose and prepare your injection site

    Note:Your healthcare provider should show you the injection sites to use around your stomach area.

    Figure

    Select your injection site and wipe the skin with an alcohol pad to clean the site.
    Choose a different injection site each time you give your injection to reduce redness, irritation, or other skin problems.

    Step 3 Attach your needle

    Pull off the pen cap.

    Figure

    Make sure the plastic reservoir that holds the medicine is not cracked. Confirmthe medicine is clear, colorless, and does not contain particles.If the plastic is cracked or if the liquid is discolored or cloudy, get a new pen from your healthcare provider or pharmacist.
    Check that the needle's peel-off seal is not broken. If it is, get a new needle.
    Peel off the needle seal.

    Figure

    Push the needle on the clear, plastic end of the pen, and twist the needle until you cannot twist is anymore.

    Figure

    Caution: Do not attach the needle too tightly, the needle could be difficult to remove after the injection.

    Pull off the outer needle cap and save it for removing the needle after the injection.

    Figure

    Keeping the needle pointing up, carefully pull off the green inner needle shield and throw it away.

    Figure

    Warning: Do not recap the needle with the green inner needle shield you could get a needle stick injury.

    Important
    IfThen
    Using a new penCheck for a droplet of liquid at the tip of the needle.

    Figure

    If you see a droplet go to Step 4 Dial your Dose
    If no droplet is seen, or you are unsure, follow the instructions inAppendix B.
    Re-using a penYou do not have to check for droplets of liquid at the tip of the needle. Go to Step 4 Dial your Dose

    Step 4 Dial your dose

    Note:Call your healthcare provider if you are unsure of today's intended dose.

    Caution: Do not push or pull the dose knob while you turn it to avoid damaging it.

    Turn the dose knob until your intended dose shows in the Dose Information Display.

    Figure

    Note: You can turn the dose knob backward if you turn it past your intended dose.

    Step 5 Inject your dose

    Important

    Make sure the Dose Information Display matches the intended dose recorded in Column 5 in your treatment diary.

Example: 

If your intended dose is 150IU, confirm that the Dose Information Display reads 150.

Figure

Figure

Caution: You might bend the needle if you do not insert the needle straight in at a 90 angle.

Hold the pen at a 90 angle to the injection site, and push the needle into your skin.
Use your thumb to press the dose knob straight down as far as it will go.

Caution: Do not release the dose knob until you remove the needle from your skin. Hold the dose knob down for a slow count of 5 before you remove the needle from your skin. Then release the knob after removal of the needle from your skin.

Figure

Remove the needle from your skin, release the dose knob, and put the pen on the table.
After injecting, fill in "Yes" or "No" in Column 6 of the treatment diary to record if the Dose Information Display shows "0".

Warning: If the Dose Information Display does not show "0", you did not complete your dose.

Fill in Column 7 of the treatment diary with the number in the Dose Information Display.
You will need to use a second pen to inject the number shown in the Dose Information Display to complete your dose.

Step 6 Remove and throw away your needle

Warning: You must remove the needle from the pen and throw away after each injection to avoid risk of infection.

Lay the outer needle cap on its side on a flat surface.
Hold the pen with the needle attached in one hand, and slip the needle into the outer needle cap without using your other hand.

Figure

Push the capped needle against a firm, vertical surface, such as a Gonal-f RFF Redi-ject carton or a wall, until you hear a "click".

Figure

Twist off the capped needle and throw it away in a FDA-cleared sharps disposal container. SeeAppendix Cfor proper disposal information.

Figure

After removing the needle, recap the pen.

Figure

If the pen is empty after your injection, throw it away in a FDA-cleared sharps disposal container. SeeAppendix Cfor proper disposal information.

Step 7 Record your injection

Important

After injecting, fill in Column 7 of the treatment diary by recording the number you see in the Dose Information Display.
If the Dose Information Display shows "0", you have completed your dose.
If the Dose Information Display does not show "0", you did not complete your dose.You need to inject the number shown in the Dose Information Display using a second pen.
Follow the instructions inAppendix A: Completing an Incomplete dose.
The amount you need to inject using the second pen might be less than expected because of the extra medicine (see note below).Always inject the amount you wrote in Column 7 of the treatment diary to complete your dose.
Refer to the treatment diary for sample entries.

Note:The pen contains extra medicine to ensure that you receive the full amount indicated on the pen (300 IU, 450 IU, or 900 IU).

Appendix A: Completing an incomplete dose

The number recorded in Column 7 in the treatment diary indicates the number you need to dial with the second pen to complete today's intended dose. To complete the dose with a second pen, repeat Steps 1 through 7.

Appendix B: How to create a droplet of liquid

If you do not see a droplet of liquid on the tip of the needle when using a pen for the first time, turn the dose knob until the Dose Information Display reads "25".

Figure

With the needle pointing up, gently tap the reservoir so that any air bubbles rise to the top.

Figure

Hold the pen with the needle pointing up. Slowly press the dose knob in all the way. One or more tiny drops of liquid will appear at the tip of the needle. Release the dose knob. Make sure that the Dose Information Display reads "0".

Figure

Go to Step 4 Dial your dose.

Appendix C: How to throw away used needles and empty pens

Put used needles and empty pens in a FDA-cleared sharps disposal container immediately after use.

Figure

Warning: Do not throw away loose needles and pens in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • Made of heavy-duty plastic,
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • Upright and stable during use,
  • Leak resistant, and
  • Properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
  • Do notreuse the needles
  • Do notthrow way (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do notrecycle your used sharps disposal container.
For more information, go to http:/www.fda.gov/safesharpsdisposal.

Appendix D: How to store your pen

Store all pens with the cap attached and away from light.
Store new pens in the refrigerator between 36 F and 46 F (2 C and 8 C) until the expiration date, or at room temperature between 68 F and 77 F (20 C and 25 C) for up to 3 months or until the expiration date, whichever comes first.
Do not freeze the pen.
Keep the pen out of reach of children.
If you have medicine left in a pen after injecting, store it in the refrigerator or at room temperature for up to 28 day. After 28 days, you must throw away (discard) your pen in a FDA-cleared sharps disposal container. SeeAppendix Cfor proper disposal information.

For more information, call 1-866-538-7879.

To view the Instructions for Use video, please visit www.Rediject.com

Figure

Figure

EMD Serono, Inc

Rockland, MA 02370

EMD Serono, Inc. is an affiliate of Merck: KGaA, Darmstadt, Germany

2017 EMD Serono, Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: November 2017



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