Gonal-f® RFF Pen Injection Instructions

B:11.25”
T:11”
Self-injecting With the Ready-to-Use Gonal-f® RFF Pen
1
Prep pen by attaching
the needle
Allow the liquid solution to adjust to room
temperature prior to administering your
injection. Check that the liquid in the Pen
is clear. Do not use the Gonal-f ® RFF Pen if
it is cloudy or contains any particles. If this
happens, report this to your doctor, nurse,
or pharmacist immediately.
Wash hands with soap and water.
Clean pen tip with an alcohol swab.
Remove peel tab from the outer needle cap.
Before your first injection, your doctor,
nurse, or pharmacist will show you how
to set the prescribed dose and use the
Gonal-f ® RFF Pen.
urn dosage dial until prescribed dose
T
(black numbers) is in front of the black
dose arrow mark. For example, if your dose
is 225, then twist until the black arrow
aligns with 225.
Visually confirm that arrow is lined up in
front of the prescribed dose.
If the dose is incorrect, turn dial to the
correct dose.
3
Load the dose and
reconfirm prior to injection
4
Remove needle cap
and inject
After confirming the dose, load the pen by
pulling out the injection button as far as it
will go.
Suitable injection sites on the stomach
will be advised by your fertility specialist.
Occasionally, your fertility specialist may
suggest an alternative site.
Find the last fully visible flat red arrow on
the red scale on the injection button and
reconfirm that this is your correct dose.
lean injection site with an alcohol swab
C
and allow it to air dry.
Note: If this number is lower than your
dose, you may not have enough medication
in your current pen and may need a new
pen to complete your dose. For more
information on how to determine the
additional dose in the new pen,
see reverse.
Remove inner needle cap. Do not touch the
needle or allow it to touch any surface.
Insert the needle into the skin at a 90° angle.
Push injection button until you hear the
button stop clicking.
Keep needle in the skin for at least 5 seconds.
Keep injection button pressed down and
remove the needle.
Remove outer needle cap by gently pulling
it straight off (note: inner cap should not
be removed).
Apply pressure using a gauze pad.
Prime the pen for first-time use
Follow step #1 to attach needle.
Turn dial so the dose arrow is set at 37.5.
The Gonal-f® RFF Pen
Pull out injection button as far as it will go.
Outer
Needle Cap
Remove inner needle cap and hold pen with the needle pointing upwards.
Removable Prefilled
Needle
Reservoir
ap drug reservoir gently to let any air bubbles rise toward the needle
T
(it is normal if a few bubbles remain).
Keep the needle pointing upright and push in the injection button
completely until you hear the first click.
A small amount of liquid should come out of the needle, indicating that the
pen is ready for use (repeat steps if no liquid comes out).
Pen Cap
Inner
Needle Cap
Threaded
Tip
Red
Dosage
Confirmation
Scale
Dosage
Dial
Dose
Arrow
Injection
Button
See reverse side for storage and disposal instructions.
Replace inner needle cap.
RFF, Revised Formulation Female. GONA3D0161_Injection_Instruction Updates_RFF_Pen_Update_r5.indd 1
For more detailed instructions, see Gonal-f® RFF Pen Patient Instructions for Use provided, visit www.fertilitylifelines.com, and talk to your healthcare provider.
3/6/13 12:28 PM
B:8.75”
wist pen clockwise until needle is
T
securely attached.
Set the dose and confirm
T:8.5”
Press pen tip into open end of needle cap.
2
B:11.25”
T:11”
Pull out the injection button on your pen.
If the number at last visible flat red arrow is
lower than your prescribed dose, you do not
have enough medication. Use the chart to
determine how much you need in a new pen:
Find your prescribed dose on the top row
Then, find the dose remaining in your
current pen on the left
Find the intersection between the
prescribed dose and the dose remaining
in your pen
The number in the intersection is the
amount you need in a new pen to
complete your dose
Needle removal and disposal
Your PRescribed dose
Dose remaining in current pen
How to complete a
dose with a new pen
37.5
75
112.5
150
187.5
225
262.5
300
412.5
375
337.5
300
262.5
225
187.5
150
112.5
75
412.5
375
337.5
300
262.5
225
187.5
150
112.5
75
37.5
375
337.5
300
262.5
225
187.5
150
112.5
75
37.5
337.5
300
262.5
225
187.5
150
112.5
75
37.5
300
262.5
225
187.5
150
112.5
75
37.5
262.5
225
187.5
150
112.5
75
37.5
225
187.5
150
112.5
75
37.5
187.5
150
112.5
75
37.5
150
112.5
75
37.5
112.5
75
37.5
75
37.5
37.5
Indication:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for (1) the induction of ovulation and pregnancy in the
anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure
and (2) for the development of multiple follicles in the ovulatory patient participating in an ART program.
Gonal-f® RFF Pen contains follitropin alfa, which is similar to the human hormone follicle-stimulating hormone,
referred to as FSH. FSH belongs to a group of human reproductive hormones.
Gonal-f® RFF Pen should be prescribed only by doctors specializing in infertility problems and their treatment.
Important Risk Information:
Gonal-f® RFF Pen should not be used in patients with allergies to recombinant human FSH products or any
other ingredients in the medication.
Patients with a history of cancer of the sex organs or brain, or uncontrolled thyroid or adrenal disease should
not use Gonal-f® RFF Pen. Women with a history of abnormal bleeding from the uterus or vagina or with
swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.
For Example:
If your prescribed dose is 225 and
you have a remaining dose of 75,
you need a dose of 150 from a new
pen to complete your dose.
Hold pen firmly by drug reservoir.
Grip outer needle cap firmly and unscrew
pen by turning pen counter clockwise.
Dispose of needle in safety container.
Storing the pen
Replace pen cap.
Store pen at room temperature (68º F to 77º F),
away from direct light, or in refrigerator (36º F
to 46º F) for up to 28 days. Do not freeze.
Visit FertilityLifelines.com for a range of
medication support material, including
how-to videos on dosing and administration
for the Gonal-f® RFF Pen.
1-866-LETS TRY (1-866-538-7879)
www.fertilitylifelines.com
The lowest dose expected to achieve the desired results should be used. A doctor should monitor a woman’s
response often to avoid overdose, which can lead to serious side effects, including blood clots.
Women should contact their doctor if severe pain or bloating in the stomach or pelvic area, severe upset
stomach, vomiting, and weight gain are experienced during treatment. These could be signs of a rare but
serious condition known as Ovarian Hyperstimulation Syndrome, or OHSS, which can result in hospitalization.
Use of Gonal-f® RFF Pen by a woman can be associated with fertilization of more than 1 egg. This can lead to
complications for the woman and the birth of 2 or more babies.
The most common side effects reported by women were headache, ovarian cysts, upset stomach, and sinus
infection. Needle injections may cause some discomfort.
For more information, patients should refer to the enclosed prescribing information and patient
information leaflet and talk to their doctor.
RFF, Revised Formulation Female
EMD Serono, Inc. is
a subsidiary of Merck KGaA,
Darmstadt, Germany
©2013 EMD Serono, Inc.
130124-102305
GONA3D0161_Injection_Instruction Updates_RFF_Pen_Update_r5.indd 2
3/6/13 12:28 PM
B:8.75”
375
412.5
T:8.5”
337.5
450