Follitropin alfa(R-HSFS) 450 IU solution for injection in pre-filled pen*
What Follitropin alfa (R-HSFS) is used for
Follitropin alfa (R-HSFS) is usedto help women get pregnant. It can also be used in men to help them producesperm.
Do not use Follitropin alfa(R-HSFS)
·If you’re allergic to theactive substances or any other component of this medicine.
·If you have primary ovarianfailure (your ovaries no longer make eggs).
·If you have uncontrolledthyroid or adrenal problems.
·If you have cancer in yourfemale organs (ovaries, breast, uterus).
·If you have a pituitarytumor or other tumor in your brain.
·If you have abnormalbleeding from your uterus or vagina.
·If you have ovarian cystsor enlarged ovaries, not due to polycystic ovary syndrome (PCOS).
·If you are pregnant orthink you may be pregnant.
·If you have a tumor in yourmale organs.
Warnings and precautions
·Talk to your doctor aboutall your medical conditions before taking this medicine.
·Using this medicineincreases the risk of developing Ovarian Hyperstimulation Syndrome (OHSS), acondition where ovaries get enlarged.
·Taking this medicine mayraise the chance of getting pregnant with more than one baby at the same time.
·Pregnancy outside the womb(ectopic pregnancy) might occur with this medicine.
·Miscarriage might occurwhen this medicine is used for pregnancy.
·If you have or previouslyhad blood clot problems or have family members with these problems, you have ahigher risk of having them while taking this medicine.
Possible side effects
Stop using this product and seekimmediate medical help if you develop rash; hives; itching; red, swollen,blistered, or peeling skin; wheezing; tightness in the chest or throat; troublebreathing, swallowing, or talking; unusual hoarseness; or swelling of themouth, face, lips, tongue, or throat.
Serious side effects:
·Ovarian HyperstimulationSyndrome (OHSS) where your ovaries get enlarged and fluid builds up in yourabdomen.
·Lung problems with fluid inthe lungs, trouble breathing.
·Blood vessel problems suchas blood clots.
·Allergic reactions.
Other medicines and Follitropinalfa (R-HSFS)
Tell your doctor about all the medicines you are taking.
How to use Follitropin alfa(R-HSFS)
·Take as indicated by yourdoctor.
·The use of this medicineshould be done under the supervision of an expert doctor.
·It is given as an injectionunder the skin (subcutaneous).
·Forovulation induction in women: the recommended dose is 75 units injected daily.Your doctor may gradually increase the dose to 300 units per day.
·Forwomen, the starting dose will be set by your doctor. Your doctor may graduallyincrease the dose for you if necessary.
·Formen: the recommended dose is 450 units per week, mostly in 3 dosages of150 units.
How to store Follitropin alfa(R-HSFS)
·Store theampoule at room temperature 68 to 77°F (20 to 25°C) or in the refrigerator.
·Store the prefilled pen in the refrigerator 2°-8°C(36°-46°F).
·Do not freeze.
·After the first injection,the pen may be stored refrigerated (2°-8°C/36°-46°F) or at room temperature(20°-25°C/68°-77°F) for up to 28 days.
·Keep this medicine out ofreach of children.
·Do not use this medicineafter the expiry date stated on the package. The expiry date refers to the lastday of that month.
*Dosage form androute of administration of Follitropin alfa (R-HSFS) 450 IU/0.75mLpowder and solvent for solution for injection, 1050 IU/1.75mL powder andsolvent for solution for injection, 150 IU solution for injection in pre-filledpen, 300 IU solution for injection in pre-filled pen, 450 IU solution forinjection in pre-filled pen and 900 IU solution for injection in pre-filled pen should be prescribed according to therapeuticindication and disease severity of each individual patient.
