Follitropin alfa injection (Cinnal-f)

What is it?

What is Cinnal-f?

Cinnal-f is the brand name of follitropin alfa. Each Cinnal-f pre-filled pen contains 450 or 900 IU of follitropin alfa as ready-to-use solution. Cinnal-f pen is available in a pack containing 1 sterile pre-filled pen and patient information leaflet. Also, the vial of Cinnal-f is manufactured which has 75 IU of follitropin alfa. Cinnal-f vial is available in a pack containing a sterile vial of lyophilized powder, a sterile vial of WFI and patient information leaflet.

Indications

What is Cinnal-f used for?

In adult women, Cinnal-f is used:

• to help healthy ovaries develop (mature) and release an egg
• to help ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program
• together with another medicine called lutropin alfa to help ovulation in women that are not ovulating because their body is producing very little FSH and LH

In adult men, Cinnal-f is used:

• to help produce sperm in men that are infertile

Contraindications

Who should not use Cinnal-f?

Do not use Cinnal-f if you:

• Are allergic to Follicle Stimulating Hormone or any of the other ingredients of this medicine.
• Have a tumor in your hypothalamus or pituitary gland.
• Have uncontrolled thyroid or adrenal problems

are a woman:

• With large ovaries or ovarian cysts of unknown origin.
• With unexplained vaginal bleeding.
• With cancer in your ovaries, womb or breasts.
• With a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.

Are a man:

• With damaged testicles that cannot be healed.

Important information

What should you know about taking Cinnal-f ?

Call your healthcare provider at once if you have abdominal pain or enlargement, diarrhea, nausea, vomiting, oliguria, and dyspnea.

What other drugs could affect Cinnal-f ?

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

• If you use Cinnal-f with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
• If you use Cinnal-f at the same time as a GnRH agonist or antagonist, you may need a higher dose of Cinnal-f to produce follicles.

How to use Cinnal-f ?

Your healthcare provider will prescribe the dose that is right for you.

Is Cinnal-f safe during pregnancy and breastfeeding?

Do not use Cinnal-f if you are pregnant.

It is not known whether this drug is excreted in human milk. The decision should be made by your healthcare provider whether to discontinue nursing or to discontinue the drug.

What happens if you miss a dose?

If you miss a dose of Cinnal-f, contact your healthcare provider right away.

What happens if you overdose?

If you think there has been an overdose, call your poison control center or get medical care right away.

How should Cinnal-f be used ?

Cinnal-f is injected under the skin (subcutaneous). Read the detailed Instructions for Use.

Side Effects

What are some side effects of Cinnal-f?

Like all medicines, Cinnal-f can cause side effects, although not everybody gets them. Tell your healthcare provider or get medical help right away if you have any of the following signs or symptoms:

Ovarian cyst, headache, acne vulgaris, abdominal pain, nausea, mastalgia (in men), upper respiratory tract infection, and injection site reaction.

These are not all the possible side effects of Cinnal-f.

Storage

How to store Cinnal-f?

• Keep Cinnal-f out of the reach of children.
• Do not use if the solution is cloudy, leaking, or has particles.
• Before you use Cinnal-f pens for the first time:
• Store your new, unused Cinnal-f pen in a refrigerator between 2°C and 8°C (36°F to 46°F).
• Do not freeze Cinnal-f.
• Keep Cinnal-f away from direct light.
• Do not use Cinnal-f after the expiration date printed on the carton and the pen.
• After you use Cinnal-f pens and there is still medicine left:
• Store remaining Cinnal-f pens in the refrigerator between 2°C and 8°C (36°F to 46°F) and use within 4 weeks.
• Do not use any medicine left in your pre-filled pen after 28 days.
• Any unused portion of Cinnal-f vial should be discarded.